Government of India
Ministry of Commerce and IndustryDirectorate General of Foreign Trade
Maulana Azad Road, New Delhi 110011
Norms Committee-Ill
Para 4.7 Decision
Meeting No. 03/82/2017 of 2017-18 dated 17.05.2017 considered the cases/issues underDuty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining toChemical and Allied products falling under Chapter 29 and 30, scheduled to be held on17.05.2017 but actually held on 25.09.2017 under the Chairmanship of Shri J.V. Patil, Add).DGFT in Room No.04, Udyog Bhawan, New Delhi.
Following members were present:-
Shri Nirmal Kumar, Dy. Director General of Foreign TradeShri Arun Kumar, Consultant, Department of Pharmaceuticals.
Note:
In certain cases the decision of the Norms Committee refers to the Recommendations/
Observations / Deficiencies received from the concerned Technical authority in the samecase or a different case of another firm with the same product A scanned copy of suchdocument is placed at the end of the Minutes. In some cases, the scanned copy uploadedmay be unsigned. In both these instances, the scanned copy uploaded is to be accepted.The Committee does not approve SCOMET items and all applicants are understood.
MEETING NUMBER : 3/82-ALC4/2017 MEETING DATE : 17.05.2017
1
Case No.:60/I7/82-ALC4/2016 Party Name:MYLANLABORATORIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/O50/01021/AM17/
RLA File
:09/24/040/00021/AM14/
Lic.No/Date:0910055945
07.05.2013
Defer Date:
08.11.2017
Decision : Deferred.
2
Case No.:40/l/82-ALC4/2017 Party Name:ONEIROCHEMICALS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01394/AM17/
RLA File
:34/24/040/00066/AM 14/
Lic.No/Date:3410037331
03.07.2013
Defer Date:
08.11.2017
Decision: Deferred.
3
Case No.:5/17/82-ALC4/2016 iParty Name:SNF [INDIA] PVT.|ltd., Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00966/AM17/
RLA File:26/24/040/00012/AM14/
Lic.No/Date:2610012456
27.02.2014
Defer Date:
08.11.2017
Decision: Deferred.V
Case No.:6/5/82-ALC4/2014 Party NameiUNITED'BIOTECH PVT.LTD.
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Approved
4
HQ File:01/82/050/00323/AM15/
RLA File;05/24/040/00034/AM15/
Lic.No/Date:0510384810
24.04.2014
Defer Date:
Decision : The Committee decided to ratify norms on based on the recommendation of D/oPharmaceuticals O.M.No.35011/420/2014-Pl(Norms) dated June 2016 or as applied by the firmwhichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessary action as perdecision of NO.
5
Case No.:61/4/82-ALC4/2014 Party NameiV & V PHARMAINDUSTRIES
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00309/AM15/
RLA File
:03/95/040/00190/AM15/
Lic.No/Date:0310785305
13.06.2014
Defer Date:
08.11.2017
Decision : Deferred.
6
Case No.:73/9/82-ALC4/2014 Party Name:D. R. COATS INK& RESINS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00870/AM15/
RLA File
:03/94/040/00755/AM14/
Lic.No/Date:0310786181
30.06.2014
Defer Date:
08.11.2017
Decision: Deferred.
7
Case No.:396/5/82-ALC4/2015 Party Name:ESTEEMINDUSTRIES PVT. LTD,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00536/AM16/
RLA File
:17/24/040/00047/AM15/
Lic.No/Date.T710005887
24.07.2014
Defer Date:
08.11.2017
Decision : Deferred.
8
Case No.:8/6/82-ALC4/2014 Party Name:V &, V PHARMAINDUSTRIES
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/00410/AM15/
RLA File
:03/95/040/00331/AM15/
Lic.No/Date:0310787382
28.07.2014
Defer Date:
08.11.2017
Decision: Deferred.
9
Case No.:55/13/82-
ALC4/2014
Party Name:HETERODRUGS LIMITED,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status: Approved
HQ File:01/82/050/0l058/AM15/
RLA File!:09/24/040/00269/AM15/
Lic.No/Date:0910060864'
20.08.2014Defer Date
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/36/2015-PI(Norms) dated June 2015, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
10
Case No.:31/9/82-ALC4/2014 Party Name:AMBERNATHORGANICS PVT. LTD.
Meet No/Date;3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00828/AM15/
RLA File
:03/94/040/00074/AM15/
Lic.No/Date;0310787610
04.08.2014
Defer Date:
08.11.2017
Decision: Deferred.
11
Case No.:2I4/13/82-
ALC4/2014
Party Name:BLlSS GVSPHARMA LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01217/AM15/
RLA File
:03/94/040/00386/AM15/
Lic.No/Date:0310787982
12.08.2014
Defer Date:
08.11.2017
Decision : Deferred for comment of DoP.
12
Case No.:226/13/82-
ALC4/20I4
Party NameiBLlSS GVSPHARMA LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01229/AM15/
RLA File
:03/94/040/00481/AM15/
Lic.No/Date:0310788323
25.08.2014
Defer Date:
Decision : The Committee decided to ratify norms on based on the recommendation of D/oPharmaceuticals O.I\/l.No.35011/30/2016-PI(Norms) dated October 2014 or as applied by the firmwhichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessary action as perdecision of NC.
13
Case No.:224/13/82-
ALC4/2014
Party Name:DELTAFINOCHEM PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01227/AM15/
RLA File
:03/94/040/00391/AM15/
Lic.No/Date:0310788515
28.08.2014
Defer Date:
08.11.2017
Decision: Deferred.
14
Case No.:223/I3/82-
ALC4/2014
Party Name:KRISHNAANTIOXIDANTS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01226/AM15/
RLA File
:03/94/040/00508/AM15/
Lic.No/Date:0310788647
02.09.2014
Defer Date:
08.11.2017
Decision : Deferred.
15
Case No.:400/5/82-ALC4/2015 Party Name:YASH RASAYAN& CHEMICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00540/AM16/
RLA File
:34/24/040/00120/AM15/
Lic.No/Date:3410040554
15.09.2014
Defer Date:
08.11.2017
Decision : Deferred.
16
Case No.:29/13/82-ALC4/2014 Party NameJUBILANT LIFESCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01032/AM15/
RLA Filel
:05/23/040/00268/AM15/
Lic.No/Date:0510391490
08.10.2014
Defer Date:
08.11.2017
Decision : Deferred for comment of DoP.
17
Case No.: 124/13/82-
ALC4/2014
Party NameiPANACEA]BIOTEC LTD.,
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Approved '
HQ File:01/82/050/01127/AM15/
RLA File
;05/24/040/003I9/AM15/
Lic.No/Date:0510391623
17.10.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.No.BT/IL/05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as appliedby the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NO.
18
Case No.:79/I/82-ALC4/2017 Party Name:R L FINE CHEM Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File;01/82/050/01433/AM17/
RLA Filei
:07/24/040/00269/AM15/
Lic.No/Date;0710106923
10.11.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/498/2013-Pl(Norms) dated 21.11.2013, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA'concerned may take necessary action as per decision of NC.
19
Case No.:198/5/82-ALC4/2015 Party Name:SHASUNPHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00338/AMI6/
RLA Filei
;04/24/040/00205/AM15/
Lic.No/Date:0410159704
11.11.2014
Defer Date:,
08.11.2017
Decision: Deferred.
20
Case No.:126/8/82-ALC4/2015 Party Name:BAYERCROPSCIENCE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00922/AM16/
RLA File;
:03/94/040/00710/AM15/
Lic.No/Date:031079117718.11.2014
Defer Date:
08.11.2017
Decision: Deferred.
21
Case No.:221/5/82-ALC4/2015 Party Name:VlVlMED LABSLIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00361/AM16/
RLA File,
:09/24/040/00537/AM15/
Lic.No/Date:0910061442
23.12.2014
Defer Date:
08.11.2017
4
Decision: Deferred.
22'
Case No.:n4/5/82-ALC4/2015 Party Name:NATIONAL TUBEINDUSTRIES,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File:01/82/050/00254/AM16/
RLA File
:03/95/040/00756/AMI5/
Lic.No/Date;0310792363
24.12.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation ofMSMEO.M.No. TU2017-GG and F-DC MSME{ChemicaI Division) dated May 2017, uploaded atthe end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1.RA concerned may take necessary action as per decision of NO.
23
Case No.:2I8/S/82-ALC4/2015 Party Name:VIVIMED LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00358/AM16/
RLA File
:09/24/040/00552/AMI5/
Lic.No/Date:0910061462
29.12.2014
Defer Date:
08.11.2017
Decision: Deferred.
24
Case No.:80/l/82-ALC4/2017 Party NatneiR L FINE CHEM Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01434/AM17/
RLA File
:07/24/040/00331/AMI5/
Lic.No/Date:0710107348
31.12.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/544/2014-PI(Norms) dated March 2015, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC
25
Case No.:45/5/82-ALC4/2015 Party Name:SUVEN LIFESCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00]85/AM16/
RLA File
:09/24/040/00558/AM15/
Lic.No/Date:0910061483
05.01.2015
Defer Date:
08.11.2017
Decision : The Committee decided tO' call for information from the firm based on the
recommendation of D/o Pharmaceuticals O.M.No. 35011/1/2016-PI(Norms) dated 01.06.2016,uploaded at the end of these minutes and deferred the case.
26'
Case No.:149/5/82-ALC4/2015 Party NameiALCHEMIELABORATORIES
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00289/AM16/
RLA File
:03/94/040/00813/AM15/
Lic.No/Date:0310792673
08.01.2015
Defer Date:
08.11.2017
Decision : Deferred.
27
Case No.:219/5/82-ALC4/2015 Party NameiBHAGIRADHACHEMICALS & INDUSTRIES
LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File RLA File Lic.No/Date:0910061517 Defer Date:
:01/82/050/00359/AM16/ :09/24/040/00549/AM15/ 09.01.2015 08.11.2017
Decision : Deferred.
28
Case No.:88/5/82-ALC4/2015 . Party NameiABEERSPHARMACEUTICALS PVT
LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00228/AM16/
RLA File
:05/23/040/00486/AM15/
Lic.No/Date:0510392949
21.01.2015
Defer Date:
08.11.2017
Decision: Deferred.
29
Case No.:275/5/82-ALC4/2015'Party NameiBAYER'CROPSCIENCE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00415/AM16/
RLA File
:03/94/040/00930/AM15/
Lic.No/Date:0310793539
03.02.2015
Defer Date:
08.11.2017
Decision : Deferred.
30
Case No.:309/5/82-ALC4/2015 Party Name:SHREEVALLABH CHEMICAL
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00449/AM16/
RLA File
:08/24/040/00417/AM15/ 1Lic.No/Date:0810134670
25.02.2015
Defer Date:'
08.11.2017
Decision : Deferred.
31
Case No.:61/17/82-ALC4/2016 Party Name:MYLAN'LABORATORIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01022/AM17/
RLA File'
:09/24/040/00607/AM15/
Lic.No/Date:0910061652
26.02.2015
Defer Date:
08.11.2017
Decision : Deferred.
32
Case No.:273/5/82-ALC4/2015 Party Name:BHARATSERUMS & VACCINES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00413/AM16/
RLA File
:03/94/040/01055/AM15/
Lic.No/Date:0310794262
27.02.2015
Defer Date:
08.11.2017
Decision: Deferred.
33
Case No.:303/5/82-ALC4/2015 Party Name:ASSOCIATEDDYESTUFF PVT. LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00443/AM16/
RLA File
:08/24/040/00422/AM15/
Lic.No/Date:0810134739
05.03.2015
Defer Date:
08.11.2017
Decision: Deferred.
34Case No.:300/5/82-ALC4/2015 Party Name:ADVANCE
PETROCHEMICALS
Meet No/Date:3/82-
ALC4/2017
Status:
Deferred
LIMITED 17.05.2017
HQ File:01/82/050/0D440/AM16/
RLA File
:08/24/040/00448/AM15/
Lic.No/Date:0810134768
11.03.2015
Defer Date:
08.11.2017
Decision : Deferred.
35
Case No.:447/5/82-ALC4/2015 Party NameiAARTIINDUSTRIES LIMITED
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:ai/82/05D/00587/AMI6/
RLA File
:03/94/040/0113l/AMI5/
Lic.No/Date:0310794543 '
12.03.2015
Defer Date:
08.11.2017
Decision: Deferred.
36
Case No.:29/5/82-ALC4/2015 Party Name:ASSOClATEDDYESTUFF PVT. LTD
Meet No/Date;3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/OOI69/AM16/
RLA File
:08/24/040/00483/AM15/
Lic.No/Date:0810134917
25.03.2015
Defer Date:
08.11.2017
Decision : Deferred.
37
Case No.:40/8/82-ALC4/2015 Party NameiSYNTHOCHIRALS PVT. LTD
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/05G/00836/AM16/
RLA File
:09/24/040/00042/AMI6/
Lic.No/Date:09I0061937
27.04.2015
Defer Date:
08.11.2017
Decision: Deferred.
38,
Case No.:75/8/82-ALC4/2015 Party Name:PORUSLABORATORIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Rejected.
HQ File:01/82/050/0087 I/AM 16/
RLA File
:09/24/040/00051/AM16/
Lic.No/Date:0910061986
06.05.2015
Defer Date:
Decision : The Committee based on the recommendation of D/o Pharmaceuticals O.M.No.
35011/2/2016-PI(Norms) dated 14.12.2016, upioaded at the end of these minutes, noted thatproduct to be exported and its raw material to be imported are the same drug-intermediates forMontelukast and no manufacturing activity appears to be involved. The Committee accordinglydecided to reject the case. RA concerned may take further necessary action as per decision ofNC.
39
Case No.:97/8/82-ALC4/20I5 Party , Nanie:ASCENTFINECHEM PVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00893/AM16/
RLA File
;08/24/040/00051/AM16/
Lic.No/Date:08I0135338
22.05.2015
Defer Date:
08.11.2017
Decision: Deferred.
40
Case No.:86/8/82-ALC4/2015 Party Name:VIVIMED LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00882/AM16/
RLA File
:09/24/04_0/00131/AM16/Lic.No/Date:091006209129.05.2015
Defer Date:
08.11.2017
Decision : Deferred for comments from AYUSH.
41
Case No.:187/7/82-ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/00792/AM16/
RLA File
:08/24/040/00057/AM16/
Lic.No/Dale:0810135435
05.06.2015
Defer Date:
08.11.2017
Decision: Deferred.
42
Case No.:24/I3/82-ALC4/2016 Party Name:ARENE LIFESCIENCES LIMITED.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/00652/AM17/
RLA File
:09/24/040/00034/AM16/Lic.No/Date:0910062155
10.06.2015
Defer Date:
08.11.2017
Decision: Deferred.
Case
No.: 110/8/82-
ALC4/2015
Party
Name:MAC CHEM PRODUCTS (INDIA)PRIVATE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved |
43
HQ File,:01/82/050/00906/
AM 16/
RLA File :03/95/040/00205/AM16/ Lic.No/Date:0310796822
24.06.2015
Defer Date:
Decision : The Committee decided to ratify norms on based on the recommendation of D/oPharmaceuticals O.M.No.35011/74/2016-Pl (Norms) dated June 2016 or as applied by the firm'whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessary action as perdecision of NO.
44
Case No.:97/14/82-ALC4/2015 Party Name:VIVIMED LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status;
Deferred
HQ File
:01/82/050/01233/AM16/
RLA File'
:09/24/040/00186/AMI6/Lic.No/Date:0910062271
01.07.2015
Defer Date:
08.11.2017
Decision : The Committee decided to refer the case to AYUSH.
45
Case No.:108/17/82-
ALC4/2016
Party Name:GLOBALiCALCIUM PRIVATE
LIMITED,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01069/AM17/
RLA File
:07/24/040/00112/AM16/
Lic.No/Date:0710I08483
08.07.2015
Defer Date:
08.11.2017
Decision : Deferred.
46
Case No.:50/8/82-ALC4/2015 Party Name:PUSILINBIOTECHNOLOGY PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00846/AM16/RLA File
:06/24/040/00014/AM16/Lic.No/Date:061003818909.07.2015
Defer Date:
08.11.2017
Decision : Deferred.
47
Case No.:54/14/82-ALC4/2015 Party Name:B10L0GlCAL ELTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0119D/AM16/
RLA File
:09/24/040/0D524/AM15/
Lic.No/Date:0910062332
15.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
48
Case No.:59/14/82-ALC4/2015 Party Name:B10L0GICAL ELTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01195/AM16/
RLA File
:09/24/040/0D525/AM15/
Lic.No/Date:0910062331
15.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
49
Case No.:49/8/82-ALC4/2015 Party Name:M.L.A.INDUSTRIES
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00845/AM16/
RLA File
:06/24/040/00015/AM16/
Lic.No/Date:0610038193
16.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
50
Case No.:49/14/82-ALC4/2015 Party Name:SYNTHOCHIRALS PVT. LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01185/AM16/
RLA File
:09/24/040/00205/AM16/
Lic.No/Date:0910062344
17.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
51
Case No.:l/10/82-ALC4/2015 Party Name:SALlCYLATES &CHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/05O/0a957/AM16/
RLA File
:09/24/040/OD211/AM16/
Lic.No/Date:0910062393
28.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
52
Case No.: 131/14/82-
ALC4/2015
Party NameiSALlCYLATES &CHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01267/AM16/
RLA File
:09/24/040/00212/AM16/
Lic.No/Date;0910062413
30.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
53
Case No.:60/14/82-ALC4/2ai5 Party Name:PORUSLABORATORIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
,
HQ File:01/82/050/01196/AM16/
RLA File
:09/24/040/00256/AM16/
Lic.No/Date:0910062418
31.07.2015
Defer Date:
08.11.2017
Decision: Deferred.
54
Case No.:169/14/82-
ALC4/2015
Party NameiDEEPAKNOVOCHEM
TECHNOLOGIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01305/AMI6/
RLA Filei
:31/83/040/00018/AM16/
Lic.No/Date:3110065573
03.08.2015
Defer Date:
08.11.2017
Decision : Deferred.
55
Case No.:17/8/82-ALC4/2015 Party Name:VIVIMED LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00813/AMI6/
RLA File,
:09/24/040/00251/AM16/
Lic.No/Date:0910062426
03.08.2015
Defer Date:
08.11.2017
Decision : Deferred.
56
Case No.:168/14/82-
ALC4/2015
Party Name:DEEPAK,NOVOCHEM
TECHNOLOGIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01304/AM16/
RLA File
:3I/83/040/00024/AM16/
Lic.No/Date;3110065579
04.08.2015
Defer Date:
08.11.2017
Decision : Deferred.
57
Case No.:18/I4/82-ALC4/2015 Party NameiMETROPOLITANEXIMCHEM PRIVATE LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01154/AM16/
RLA File
:03/95/040/00317/AMI6/
Lic.No/Date:031079803910.08.2015
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:155/14/82-
ALC4/20I5
Party Name:SUNPHARMACEUTICAL
INDUSTRIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
58HQ File'
:01/82/050/0I291/AM16/
RLA File.
:05/24/040/00237/AM16/
Lic.No/0ate:O51039527111.08.2015
Defer Date:
08.11.2017
Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/781/2015-PI(Norms) dated 26.04.2016,uploaded at the end of these minutes and deferred the case
59'
Case No.:ll/18/82-ALC4/2015 Party NamerSTERLINGAUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/01476/AM16/
RLA File
:03/95/040/00327/AM16/Lic.No/Date:031079811713.08.2015
Defer Date:
08.11.2017
Decision: Deferred.
10
60
Case No.:34/14/82-ALC4/2015 Party Name:TRANSPEKINDUSTRY LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01170/AM16/
RLA File
:34/24/040/00144/AM16/
Lic.No/Date:34I004I464
17.08.2015
Defer Date:
08.11.2017
Decision: Deferred.
61
Case No.:56/13/82-ALC4/2015 • Party NamerPANACEABIOTEC LTD.,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File:01/82/050/01019/AM16/
RLA File
:05/24/040/00183/AM16/
Lic.No/Date:0510395354
18.08.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.NO.BT/IU05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as appliedby the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NO.
62
Case No.;68/14/82-ALC4/2015 Party Name:SALICYLATES &CHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01204/AM16/
RLA File
:09/24/040/00368/AM15/
Lic.No/Date:09I00625I8
19.08.2015
Defer Date:
08.11.2017
Decision: Deferred.
63
Case No.:24/14/82-ALC4/2015 Party Name:SHUBHAMSPECIALTY PRODUCTS
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01160/AM16/
RLA File
:03/95/040/00348/AM16/
Lic.No/Date:03I07985I6
27.08.2015
Defer Date:
08.11.2017
Decision: Deferred.
64
Case No.:116/16/82-
ALC4/2015
Party Name:PANERA BIOTECPVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;0I/82/a50/01436/AM16/
RLA File
:O5/24/O4O/O0I81/AM16/
Lic.No/Date:0510395496
01.09.2015
Defer Date:
08.11.2017
Decision: Deferred.
65
Case No.:124/7/82-ALC4/2016 Party Name:AARTIINDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00298/AM17/
RLA File,
:03/94/040/00424/AMI6/
Lic.No/Date:0310798671
04.09.2015
Defer Date:
08.11.2017
Decision : Deferred.
66
Case No.:46/I4/82-ALC4/2015 Party Name:MALWAOXYGEN & INDUSTRIAL
GASES PVT.LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
11
HQ File
:01/82/050/01182/AM16/
RLA File
;56/24/040/00005/AM16/Lic.No/Date:56I0004674
09.09.2015
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:72/l/82-ALC4/20I7 Party Name;R L FINE CHEM Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
67
HQ File
:01/82/050/01426/AM17/
RLA File.
:07/24/040/00186/AM16/Lic.No/Date:07I010870809.09.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/498/2013-PI(Norms) dated 21.11.2013. uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
68
Case . No.: 157/14/82-
ALC4/2015
Party Name:AETHER'INDUSTRIES LIMITED
Meet No/Date:3/82-|ALC4/20I7
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01293/AMI6/
RLA File,
:52/24/040/00042/AMI6/Lic.No/Date:521004I63010.09.2015
Defer Date:
08.11.2017
Decision : Deferred.
69,
Case No.:35/16/82-ALC4/2015 Party Name:D. R. COATS INK& RESINS PVT. LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File':01/82/050/01355/AM16/
RLA File
:03/94/040/00415/AMI6/Lic.No/Date:031079897721.09.2015
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:I17/14/82-
ALC4/2015
Party NameiSHASUN-PHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
70HQ File
:01/82/050/01253/AM16/RLA File
:04/24/040/00I40/AM16/Lic.No/Date:0410161044
22.09.2015
Defer Date:
08.11.2017
Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/776/2015-PI(Norms) dated June 2016,uploaded at the end of these minutes and deferred the case.
71,
Case No.:79/14/82-ALC4/2015 Party Name:ABEERSPHARMACEUTICALS PVTLTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File-
:01/82/050/01215/AM16/
RLA File
:05/23/040/00274/AM 16/Lic.No/Date:051039577330.09.2015
Defer Date:
08.11.2017
Decision: Deferred.
72'
Case Na.:69/16/82-ALC4/2015,Party Name:PIDILITE,INDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/01389/AMI6/
RLA File
:03/95/040/00350/AM15/Lic.No/Date:03I0799U330.09.2015
Defer Date:
08.11.2017
12
Decision: Deferred.
73)
Case No.: 139/14/82-
ALC4/2015
Party Name:MAMTAPOLYCOATS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01275/AM16/
RLA File
:34/24/040/00178/AM16/
Lic.No/Date:3410041581
08.10.2015
Defer Date:
08.11.2017
Decision : Deferred.
74
Case No.:62/16/82-ALC4/2015 Party Name:SURVIVALTECHNOLOGIES PVT.LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01382/AM16/
RLA File
:03/95/040/00491/AM16/
Lic.No/Date:0310799292
08.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
75
Case No.:164/14/82-
ALC4/2015
Party Name:AASHABIOCHEM
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01300/AM16/
RLA File
:10/24/040/00049/AM16/
Lic.No/Date:I010059293
12.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
76
Case No.: 116/13/82-
ALC4/2016
Party Name:SOFTGELHEALTH CARE PVT. LTD.,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File;01/82/050/00744/AM17/
RLA File
:04/24/040/00143/AM16/
Lic.No/Date:0410161132
20.10.2015
Defer Date:
08.11.2017
Decision : Deferred.
77
Case No.:72/16/82-ALC4/2015 Party Name:STERLING,AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01392/AM16/
RLA File
:03/95/040/00102/AM16/
Lic.No/Date:0310799579
21.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
78
Case No.:73/16/82-ALC4/2015 Party Name:STERLINGAUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01393/AM16/
RLA File
:03/95/040/00087/AM16/
Lic.No/Date:0310799578
21.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
79
Case No.:29/16/82-ALC4/2015 Party Name:SALICYLATES &CHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
13
,
HQ File:0I/82/050/01349/AM16/
RLA File'
:09/24/040/00379/AM16/
Lic.No/Date:0910062768
23.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
o00
Case No.: 129/16/82-
ALC4/2015
Party Name: SURVIVALTECHNOLOGIES PVT.LTD. ,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01449/AM16/
RLA File*
:03/95/040/00505/AM16/
Lic.No/Date:0310799628
23.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
81
Case No.:161/14/82-
ALC4/2015
Party NameiKAIRAVCHEMOFARBE INDUSTRIES;
LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01297/AM16/
RLA File
:03/94/040/01226/AM15/
Lic.No/Date:0310799680
26.10.2015
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:31/I6/82-ALC4/2015 Party Name:MSNlLABORATORIES PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
82HQ Filei:01/82/050/01351/AM16/
RLA Filei
:09/24/040/00423/AM16/
Lic.No/Date:0910062790
28.10.2015
Defer Date:
08.11.2017 t
Decision : The Committee decided to caii for information from the firm based on the,recommendation of D/o Pharmaceuticais O.M.No. 35011/837/2015-PI(Norms) dated 18.05.2016,uploaded at the end of these minutes and deferred the case.
83
Case No.:74/16/82-ALC4/2015 Party Name:PERFECTVITAMINS PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01394/AM16/
RLA
:03/95/040/00518/AM16/
File Lic.No/Date:0310799705
28.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
84,
Case No.:75/16/82-ALC4/2015 Party Name:SURVIVAL|TECHNOLOGIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01395/AM16/
RLA
:03/95/040/00525/AM16/
File Lic.No/Date:0310799704
28.10.2015
Defer Date:
08.11.2017
Decision: Deferred.
85
Case No.:48/16/82-ALC4/2015 Party Name:0SPECIALITIES PVT.LTD.
C Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File!:01/82/050/01368/AM16/
RLA
:03/95/040/00549/AM16/
File' Lic.No/Date:031079987330.10.2015
Defer Date:
08.11.2017
Decision : Deferred.
14
86,
Case No.:159/14/82-
ALC4/2015
Party Name: SUNPHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01295/AM16/
RLA File
:05/24/040/00343/AM16/
Lic.No/Date:0510396075
30.10.2015
Defer Date:
08.11.2017
Decision : The Committee decided to call for Information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/781/2015-PI(Norms) dated 26.04.2016,uploaded at the end of these minutes and deferred the case.
87
Case No.:n8/16/82-
ALC4/2015
Party Name:SUNPHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01438/AM16/
RLA File.
:05/24/040/00345/AM16/
Lic.No/Date:0510396076
30.10.2015
Defer Date:
08.11.2017
Decision : The Committee decided to call for Information from the firm based on the
recommendation of D/o Pharmaceuticals O.M.No. 35011/781/2015-Pi{Norms) dated 26.04 2016,uploaded at the end of these minutes and deferred the case.
88
Case No.:53/16/82-ALC4/2015 Party Name:LAXMI ORGANICINDUSTRIES LTD.,
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0I373/AM16/
RLA File
:03/95/040/00540/AM16/
Lic.No/Date:0310800090
06.11.2015
Defer Date:
08.11.2017
Decision: Deferred.
89
Case No.:89/16/82-ALC4/2015 Party Name:GULBRANDSENCHEMICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
;01/82/050/0I409/AM16/
RLA File
:34/24/040/00203/AM16/
Lic.No/Date:3410D41666
09.11.2015
Defer Date:
08.11.2017
Decision: Deferred.
90
Case No.: 114/16/82-
ALC4/2015
Party Name:SHIVA BIOCHEM
INDUSTRIES
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01434/AM16/
RLA File
:50/24/040/000I7/AM16/
Lic.No/Date:5010002240
16.11.2015
Defer Date:
08.11.2017
Decision : Deferred.
91
Case No.:4/20/82-ALC4/2015 Party Name:AIMS IMPEXPVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01587/AM16/
RLA File
:03/94/040/00656/AM16/
Lic.No/Date:0310800363
23.11.2015
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:31/l/82-ALCl/2016 Party Name:PAYAL Meet No/Date:3/82- Status:
92 PETROCHEM PRIVATE ALC4/2017 Deferred
LIMITED 17.05.2017
15
I■IQ File I01/82/050/0I805/AM16/ :
ILA File I05/24/040/00347/AM16/ :
.ic.No/Date:0510396399 I>3.11.2015 (
Defer Date:18.11.2017
]decision: Deferred.
Case No.:32/16/82-ALC4/2015 1̂ arty NametlNTERMED, Meet No/Date:3/82-\LC4/201717.05.2017
Status:Deferred
93 HQ File01/82/050/01352/AM16/
RLA File04/24/040/00177/AM16/
Lic.No/Date;041016I34326.11.2015
Defer Date:D8.11.2017
Decision: Deferred.
Case No.:2/l/82-ALCI/2016 ?arty NamerUNIJULES LIFESCIENCES LTD. ^
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
94HQ File;:0I/82/050/01776/AM16/
RLA File;03/95/040/00632/AMI6/ !
Lic.No/Date:031080041626.11.2015
Defer Date:,08.11.2017
Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals O.M.No. 35011/98/2016-PI(Norms) dated June16.02.2017, uploaded at the end of these minutes and deferred the case.
Case No.:58/20/82-ALC4/2015 ■ Party NameiNEOGENiCHEMICALS LIMITED
1
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
HQ File^:0I/82/050/01641/AM16/
RLA File:03/95/040/00182/AM15/
Lic.No/Date:031080055001.12.2015
Defer Date:08.11.2017
Decision: Deferred.
Case No.:3/l/82-ALCl/2016 Party Name:NEOGEN>CHEMICALS LIMITED
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
96 HQ File:01/82/050/01777/AM16/
RLA File:03/95/040/00529/AM15/
Lic.No/Date:031080054701.12.2015
Defer Date:08.11.2017
Decision : Deferred.
Case No.:5/l/82-ALCl/2016 Party Name:NEOGENCHEMICALS LIMITED
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
97 HQ File:01/82/050/01779/AM16/
RLA File:03/95/040/00239/AM15/
Lic.No/Date:031080055101.12.2015
Defer Date:08.11.2017
Decision : Deferred.
Case No.:I27/I6/82-ALC4/2015
Party Name:BLUELINEFOODS (INDIA) PVT.LTD,
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
98 ■ HQ File:01/82/050/01447/AM16/
RLA File:07/24/040/00267/AM16/
Lic.No/Date:071010914608.12.2015
Defer Date:08.11.2017
Decision: Deferred.
16
99'
Case No.;36/20/82-ALC4/201S Party Name:BAYER VAPIPVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/016I9/AM16/
RLA File
:03/94/040/00651/AM16/
Lic.No/Date:0310800833
09.12.2015
Defer Date:
08.11.2017
'Decision : Deferred.
100'
Case No.:110/20/82-
ALC4/20I5
Party NametPROCESSAGROCHEM INDUSTRIES
PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01693/AM16/
RLA File,
:56/24/040/Oa040/AM16/
Lic.No/Date:5610004767
10.12.2015
Defer Date:
08.11.2017
Decision: Deferred.
101
Case No.:45/20/82-ALC4/2015 Party Name:KRlSHNAANTIOXIDANTS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01628/AMI6/
RLA File
:03/94/040/00736/AM16/
Lic.No/Date:0310800992
14.12.2015
Defer Date:
08.11.2017
Decision: Deferred.
102
Case No.:14/20/82-ALC4/2015 Party Naine:KOPRANRESEARCH
LABORATORIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/01597/AM16/
RLA File,
:03/94/040/00728/AM16/
Lic.No/Date:0310801252
21.12.2015
Defer Date:
08.11.2017
Decision : The Committee decided to call for information from the firm based on the
recommendation of D/o Pharmaceuticals O.M.No.35011/866/2015-PI(Norms) dated18.05.2016 uploaded at the end of these minutes and deferred the case.
103
Case No.:19/20/82-ALC4/2015 Party Name:LAXMIORGANIC INDUSTRIES
LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01602/AM16/
RLA File
:03/95/040/00009/AM16/
Lic.No/Date:0310801275
22.12.2015
Defer Date:
08.11.2017
Decision: Deferred.
104
Case No.:20/20/82-ALC4/2015 Party Name:LAXMlORGANIC INDUSTRIES
LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01603/AM16/
RLA File
:03/95/040/00267/AM16/
Lic.No/Date:0310801273
22.12.2015
Defer Date:
08.11.2017
Decision : Deferred.
105
Case No.:47/20/82-ALC4/2015 Party Name:AMINES &PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File RLA File Lic.No/Date:0310801428 Defer Date:
17
:01/82/050/01630/AM16/ :03/94/040/00792/AM16/ 31.12.2015
Decision : The Committee decided to ratify norms based on repeat basis as per earlier decisiontaken by NO in its meeting No.18/82 dated19.12.2013, uploaded at the end of these minutes oras applied by the firm whichever is less under para 4.07 of HBP V0I.I.RA concerned may takenecessary action as per decision of NO.
Case No.:98/20/82-ALC4/2015 Party NameiFRESENIUSKABI ONCOLOGY LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
106
HQ File.:01/82/050/01681/AM16/
RLA Filei:05/23/040/00338/AM16/
Lic.No/Date:0510397164 '
31.12.2015
Defer Date:
08.11.2017
Decision : The Committee decided to call for information from the firm based on the
recommendation of D/o Pharmaceuticals O.M.No. 35011/68/2016-Pl(Norms) dated June 2016,uploaded at the end of these minutes and deferred the case.
107
Case No.:101/20/82-
ALC4/2015
Party Name:SONGWON'SPECIALTY CHEMICALS
INDIA PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01684/AM16/
RLA File
:34/24/040/00226/AM 16/
Lic.No/Date:3410041775
31.12.2015
Defer Date:
08.11.2017
Decision: Deferred.
108
Case No.:I19/20/82-
ALC4/2015
Party Name;SYNTHOCHIRALS PVT. LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01702/AM16/
RLA File
:09/24/040/00582/AM16/
Lic.No/Date:0910063066
31.12.2015
Defer Date:
08.11.2017
Decision: Deferred.
109
Case No.:104/20/82-
ALC4/2015
Party NameiBEST VALUECHEM PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01687/AM16/
RLA File
:34/24/040/00253/AM16/
Lic.No/Date:3410041778
04.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
110
Case No.:105/20/82-
ALC4/2015
Party Name:BEST VALUECHEM PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01688/AM16/
RLA File
:34/24/040/00252/AM16/
Lic.No/Date:3410041782
05.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
111
Case No.:26/20/82-ALC4/2015 Party Name:AMINES &PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File RLA File Lic.No/Date:0310801601 Defer Date:
18
:01/82/050/01609/AM16/ |:03/94/040/00802/AM16/ 06.01.2016 08.11.2017
Decision: Deferred.
112
Case No.:7/l/82-ALCl/2016 Party Name:PRIVl ORGANICSLTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0178I/AM16/
RLA File
:03/95/040/00688/AM16/
Lic.No/Date:0310801600
06.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
113
Case No.:76/20/82-ALC4/2015 Party NameiAIMS IMPEXPVT. LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01659/AM16/
RLA File
:03/94/040/00790/AM16/
Lic.No/Date:0310801644
07.01.2016
Defer Date:
08.11.2017
Decision : Deferred.
114
Case No.:48/l/82-ALCl/2016 Party Name:INDO AMINESLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01822/AM16/
RLA File
:03/94/040/00785/AM16/
Lic.No/Date:0310801728
12.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
115
Case No.:82/l/82-ALCl/2016 Party Name:PRIVI ORGANICSLTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01856/AM16/
RLA File
:03/95/040/0069Q/AM16/
Lic.No/Date:0310801719
12.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
116
Case No.:66/l/82-ALCl/2016 Party Name:BTL EXPORTSPVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01840/AM16/
RLA File
:03/94/040/00831/AM16/
Lic.No/Date:0310801850
18.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
117
Case No.:79/I/82-ALCI/2016 Party Name:PRIVI ORGANICSLTD
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01853/AM16/
RLA File
:03/95/040/0a689/AM16/
Lic.No/Date:0310801831
18.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
118Case No.;lI4/20/82-
ALC4/20I5
Party Name:GULBRANDSENCHEMICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
Status:
Deferred
19
17.05.2017
HQ File:01/82/050/01697/AM16/
RLA File;:34/24/040/00263/AM16/
Lic.No/Date:3410041814
19.01.2016
Defer Date:
08.11.2017
Decision : Deferred.
119
Case No.:50/l/82-ALCl/2016 Party Name:AMINES &PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01824/AM16/
RLA File.
:03/94/040/0D861/AM16/
Lic.No/Date:0310801928
20.01.2016
Defer Date:
08.11.2017
Decision : Deferred.
120
Case No.:68/l/82-ALCl/2016
1
Party Name:BTL EXPORTS'PVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01842/AM16/
RLA File
:03/94/040/00834/AM16/
Lic.No/Date:0310801927
20.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
121
Case No.:106/20/82-
ALC4/2015
Party Name;MOREPENiLABORATORIES LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01689/AM16/
RLA File
:05/24/040/00515/AM16/
Lic.No/Date:0510397367
20.01.2016
Defer Date:
08.11.2017 '
Decision : The Committee decided to call for Information from the firm based on the'recommendation of D/o Pharmaceuticals O.M.No. 35011/4/2016-PI(Norms) dated 1.6.2016,uploaded at the end of these minutes and deferred the case.
122,
Case No.:38/l/82-ALCl/2016 Party Name:SURVIVALTECHNOLOGIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01812/AM16/
RLA File:
;03/95/040/00798/AM16/
Lic.No/Date:0310801923
20.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
123
Case No.:49/l/82-ALCl/2016 Party Name:AMINES &PLASTICIZERS LIMITED
Meet . No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01823/AM16/
RLA File.
:03/94/040/00869/AM16/
Lic.No/Date:0310801950
21.01.2016
Defer Date:
08.11.2017
Decision: Deferred.
124
Case No.;72/7/82-ALC4/2016 Party Name:OGENESYSTEMS INDIA LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00246/AM17/
RLA File'
:09/24/040/00620/AM16/
Lic.No/Date:0910063151
22.01.2016
Defer Date:
08.11.2017
20
Decision: Deferred.
125
Case No.:27/l/82-ALCl/2016 Party Name:BODALCHEMICALS LTD
Meet No/Date:3/82-'ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01801/AM16/
RLA File
:08/24/040/00325/AM16/
Lic.No/Date:0810137105
01.02.2016
Defer Date:
08.11.2017
Decision : Deferred.
126
Case No.:40/l/82-ALCl/2016 Party NameiMAGNOLIALIMITED.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/ai814/AM16/
RLA File
:03/95/040/01074/AMI5/
Lic.No/Date:0310802I75
02.02.2016
Defer Date:
08.11.2017
Decision: Deferred.
127
Case No.:37/I/82-ALCl/2016 Party Name:STERLINGAUXILIARIES PVTLTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/0]811/AM16/
RLA File,:03/95/040/00639/AM16/
Lic.No/Date:0310802231
04.02.2016
Defer Date:
08.11.2017
Decision: Deferred.
128
Case No.:43/l/82-ALCl/2016 Party Name:AARTIINDUSTRIES LIMITED
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01817/AM16/
RLA File
:03/94/040/00882/AM16/
Lic.No/Date:0310802261
05.02.2016
Defer Date:
08.11.2017
Decision: Deferred.
129
Case No.:69/l/82-ALCl/2016 Party Name:ENCUBEETHICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01843/AM16/
RLA File
:03/94/040/00922/AM16/
Lic.No/Date:0310802291
08.02.2016
Defer Date:
08.11.2017
Decision: Deferred.
130
Case No.:39/l/82-ALCl/2016 Party NameiPERFECTVITAMINS PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01813/AM16/
RLA File
:03/95/040/a0847/AM16/
Lic.No/Date:0310802292
08.02.2016
Defer Date:
08.11.2017
Decision: Deferred.
131
Case No.:45/I/82-ALCl/2016 Party Name:KAlRAVCHEMOFARBE INDUSTRIES
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
21
HQ File]:01/82/050/018I9/AM16/
RLA File
:03/94/040/00859/AM16/
Lic.No/Date:0310802380
09.02.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:79/7/82-ALC4/2016
1
Party Name:OPTIMUS
DRUGS PRIVATE LIMITED :
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
132HQ Filei:01/82/050/00253/AM17/
RLA File'
:09/24/040/00586/AM16/
Lic.No/Date:09I0063240
10.02.2016
Defer Date:
08.11.2017 .
Decision : The Committee decided to call for information based on the recommendation of D/oPharmaceuticals O.M.No. 35011/138/2016-PI(Norms) dated August 2016, uploaded at the end ofthese minutes and deferred the case.
133
Case No.:41/l/82-ALCl/2016 Party Name:STERLING|AUXILIARIES PVT LTD
Meet No/Date:3/82-|
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01815/AM16/ '
RLA Filei
:03/95/040/00826/AM16/
Lic.No/Date:0310802395
10.02.2016
Defer Date:
08.11.2017
Decision: Deferred.
134
Case No.:78/l/82-ALCI/2016 Party NameiSTERLING'AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File-:01/82/050/01852/AM16/ 1
RLA Filel
:03/95/040/00752/AM16/ 1Lic.No/Date:0310802451
10.02.2016
Defer Date:|08.11.2017
Decision: Deferred.
135
Case No.:26/l/82-ALCl/20I6 Party Name:UMAENTERPRISE
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01800/AM16/
RLA File
:08/24/040/00396/AM16/
Lic.No/Date:0810137202
15.02.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:56/l/82-ALCl/2016 Party Name:ZIMiLABORATORIES LTD.
1
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
136,HQ File
:01/82/050/01830/AM16/
RLA File
:03/95/040/00887/AM16/
Lic.No/Date:0310802649
16.02.2016
Defer Date:
08.11.2017
Decision : The Committee decided to call for information based on the recommendation of D/oPharmaceuticals O.M.No. 35011/28/2016-PI(Norms) dated August 2016, uploaded at the end ofthese minutes and deferred the case.
137
Case No.:17/l/82-ALCl/2016 Party Name:ARJUNCHEMICALS PVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File'
;01/82/050/0l791/AM16/
RLA File;
:04/24/040/00229/AM16/ 1Lic.No/Date:0410161613
17.02.2016
Defer Date:
08.11.2017
22
Decision: Deferred.
138
Case No.:82/7/82-ALC4/2016 Party Name:OPTIMUSDRUGS PRIVATE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00256/AM17/
RLA File
:09/24/040/00721/AM16/
Lic.No/Date:0910063357
03.03.2016
Defer Date:
08.11.2017
Decision: Deferred.
139
Case No.:59/7/82-ALC4/2016 Party Name:RUCHI SOYAINDUSTRIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/a0233/AM17/
RLA File
:56/24/040/00054/AM16/
Lic.No/Date:5610004864
11.03.2016
Defer Date:
08.11.2017
Decision: Deferred.
140
Case No.:24/2/82-ALC4/2016 Party Name:SCOPECHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00024/AM17/
RLA File
:03/95/040/00955/AM16/
Lic.No/Date:0310803229
11.03.2016
Defer Date:
08.11.2017
Decision: Deferred.
141
Case No.:15/l/82-ALCl/2016 Party Name:COVALENTLABORATORIES PRIVATE,
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01789/AM16/
RLA File
:09/24/040/00713/AM16/
Lic.No/Date:0910063416
15.03.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/241/2016-PI(Norms) dated 19.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
142
Case No.:109/7/82-ALC4/2016 Party Nanie:BEST VALUECHEM PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00283/AM17/
RLA File
:34/24/040/00336/AM16/
Lic.No/Date:3410041989
21.03.2016
Defer Date:
08.11.2017
Decision: Deferred.
143
Case No.:138/7/82-ALC4/2016 Party Name:ALTALABORATORIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00312/AMI7/
RLA File
:03/94/040/01112/AM16/
Lic.No/Date:0310803707
01.04.2016
Defer Date:
08.11.2017
Decision: Deferred.
|l44 Case No.:24/7/82-ALC4/2016 Party Name: DEEPAK Meet No/Date:3/82- Status:
23
NOVOCHEM
TECHNOLOGIES LTDALC4/20I7
17.05.2017
Deferred
HQ File
:01/82/050/00198/AM17/
RLA File
:31/83/040/00186/AM16/Lic.No/Date:311006611105.04.2016
Defer Date:
08.11.2017
Decision : Deferred.
.
145
Case No.:123/7/82-ALC4/2016 Party Name:AARTIINDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00297/AM17/
RLA File
:03/94/040/01038/AM16/Lic.No/Date;031080381906.04.2016
Defer Date:
08.11.2017 •
Decision: Deferred.
146
Case No.:45/7/82-ALC4/2016 Party Name:ASTRALSTERITECH PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File'
:01/82/050/00219/AM17/ 'RLA File'
:34/24/040/00009/AM17/Lic.No/Date:3410042064
13.04.2016 !Defer Date:
08.11.2017
Decision: Deferred.
147
Case No.:50/7/82-ALC4/2016 Party Name:BODALCHEMICALS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:0]/82/050/00224/AM17/RLA Filei
:08/24/040/00005/AM17/Lic.No/Date:0810137692 '18.04.2016
Defer Date:
08.11.2017
Decision : Deferred.
148
CaseNo.:15/7/82-ALC4/2016 > Party Narae:SUPREETCHEMICALS PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00189/AM17/RLA File
:52/24/040/00006/AM17/Lic.No/Date:521004186925.04.2016
Defer Date:
08.11.2017
Decision: Deferred.
149'
Case No.:148/7/82-ALC4/2016 Party Name:HEMA DYE'CHEM PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00322/AM17/RLA File
:03/94/040/00055/AM17/Lic.No/Date:031080421126.04.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:49/7/82-ALC4/2016 Party NamerPANACEABIOTEC LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
150 HQ File.
01/82/q50/00223/AM17/RLA File
05/24/040/00009/AM17/Lic.No/Date:051039839205.05.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.^o.BT/IL/05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as applied
24
by the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NC.
151
Case No.:8/7/82-ALC4/2016 Party Name: STRIDESSHASUN LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00182/AM17/
RLA File
:04/24/040/00009/AM17/
Lic.No/Date:0410161871
05.05.2016
Defer Date:
08.11.2017
Decision : The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals O.M.No. 35011/154/2016-PI(Norms) dated Sept 2016, uploaded at the end ofthese minutesand deferred the case.
152
Case No.:9/7/82-ALC4/2016 Party Name:STRlDESSHASUN LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00183/AM17/
RLA File
:04/24/040/00010/AM17/
Lic.No/Date:0410161872
05.05.2016
Defer Date:
08.11.2017
Decision :The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals O.M.No. 35011/154/2016-PI(Norms) dated Sept. 2016, uploaded at the end ofthese minutes and deferred the case.
153
Case No.:163/7/82-ALC4/2016 Party Name:AMINES &'PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/00337/AM17/
RLA File
:03/94/040/00090/AM17/
Lic.No/Date:0310804480
09.05.2016
Defer Date:
08.11.2017
Decision : Deferred.
154
Case No.:18/7/82-ALC4/2016 Party Name:CONTlNENTALCHEMICALS
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00192/AM17/
RLA File
:08/24/040/00044/AM17/
Lic.No/Date:0810137877
09.05.2016
Defer Date:
08.11.2017
Decision : Deferred.
'155
Case No.:51/7/82-ALC4/2016 Party NameiJUBILANT LIFESCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00225/AM17/
RLA File
:05/23/040/00539/AM16/
Lic.No/Date:0510398432
09.05.2016
Defer Date:
08.11.2017
Decision: Deferred.
156
Case No.:159/7/82-ALC4/2016 Party Name:BLUE CIRCLEORGANICS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00333/AM17/
RLA File
:03/94/040/00061/AM17/
Lic.No/Date:0310804534
10.05.2016
Defer Date:
08.11.2017
25
Decision: Deferred.
157'
Case No.:160/7/82-ALC4/2016 Party Name:BLUE CIRCLEORGANICS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ Filci:01/82/050/00334/AM17/
RLA File,
:03/94/040/00036/AM17/
Lic.No/Date:0310804533
10.05.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:76/7/82-ALC4/2016 Party NameiFRESENIUS'KABI ONCOLOGY LIMITED i
Meet No/Date:3/82-,
ALC4/2017
17.05.2017
Status:
Deferred
158HQ File:01/82/050/00250/AM17/
RLA File.
:05/23/040/00031/AM17/
Lic.No/Date;0510398443
10.05.2016
Defer Date:
08.11.2017
Decision : The Committee decided to call for Information based on the recommendation of D/o'
Pharmaceuticals O.M.No. 35011/200/2016-PI(Norms) dated August 2016, uploaded at the end ofthese minutes and deferred the case.
159
Case No.:137/7/82-ALC4/2016 Party Name:RELIANCE'INDUSTRIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00311/AM17/
RLA File
:03/95/040/00763/AM16/
Lic.No/Date:0310804513
10.05.2016
Defer Date:
08.11.2017
Decision: Deferred.
160
Case No.:157/7/82-ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File.:01/82/050/00331/AM17/
RLA File]
:03/94/040/00122/AM17/
Lic.No/Date:0310804628
12.05.2016
Defer Date:'
08.11.2017
Decision: Deferred.
161
Case No.:86/ll/82-ALC4/2016 Party Name:ALMELO'PRIVATE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00620/AM17/
RLA File
:09/24/040/00056/AM17/
Lic.No/Date:0910063626
17.05.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:85/ll/82-ALC4/2016,Party Name:COVALENTLABORATORIES PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
162
HQ File
:01/82/050/0a619/AM17/
RLA File
;09/24/040/00028/AM17/
Lic.No/Date:0910063644
17.05.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals O.M.No. 35011/241/2016-PI(Norms) dated 19.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
26
163'
Case No.:71/17/82-ALC4/2016 Party Name:GLOBALCALCIUM PRIVATE
LIMITED,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01032/AM17/
RLA File
:07/24/040/00385/AM16/
Lic.No/Date:0710109823
17.05.2016
Defer Date:
08.11.2017
Decision : Deferred.
164
Case No.:82/ll/82-ALC4/2016 Party Name:SENTlSSPHARMA PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00616/AM17/
RLA File,
:05/24/040/00624/AMI6/
Lic.No/Date:0510398507
17.05.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/281/2016-PI(Norms) dated 15.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
165
Case No.:83/ll/82-ALC4/2016 Party NameiBIOLOGICAL ELTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00617/AM17/
RLA File
:09/24/040/00307/AM15/
Lic.No/Date:0910063658
19.05.2016
Defer Date:
08.11.2017
Decision : Deferred.
166
Case No.:139/7/82-ALC4/2016 Party Name:GANGWALCHEMICALS (P) LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00313/AM17/
RLA File
:03/94/040/00149/AM17/
Lic.No/Date:0310804914
23.05.2016
Defer Date:
08.11.2017
Decision: Deferred.
167
Case No,:140/7/82-ALC4/2016 Party Name:GANGWALCHEMICALS (P) LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00314/AM17/
RLA File
:03/94/040/00148/AM17/
Lic.No/Date:0310804913
23.05.2016
Defer Date:
08.11.2017
Decision: Deferred.
168
Case No.:153/7/82-ALC4/2016 Party Name:BAYERCROPSCIENCE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00327/AM17/
RLA File
:03/94/040/00115/AM17/
Lic.No/Date:0310804948
24.05.2016
Defer Date:
08.11.2017
Decision : Deferred.
|l69|CaseNo.:134/7/82-ALC4/2016 |Party Name:ORBIT LIFE Meet No/Date:3/82- Status:
27
SCIENCE PVT. LTD. ALC4/20I7
17.05.2017
Deferred
HQ File:01/82/050/00308/AM17/
RLA File
:03/95/040/00069/AM17/
Lic.No/Date:0310804944
24.05.2016
Defer Date:
08.11.2017
Decision : The Committee decided to call for information based on the recommendation of D/o
Pharmaceuticals O.M.No. 35011/145/2016-PI(Norms) dated July, 2016, uploaded at the end ofthese minutes and deferred the case.
170
Case No.:43/10/82-ALC4/2016'
1
Party NameiO CSPECIALITIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/00389/AM17/
RLA File
:03/95/040/00I69/AMI7/
Lic.No/Date;0310805124
01.06.2016
Defer Date:'
08.11.2017
Decision: Deferred.
171
Case No.:2/ll/82-ALC4/2016 Party NameiMANALPPETROCHEMICALS
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00536/AM17/
RLA File
:04/24/040/00270/AM 16/
Lic.No/Date;0410162005
02.06.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:8/U/82-ALC4/2016 Party Name:SOFTGEL'HEALTH CARE PVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved ,
172
HQ File:01/82/050/00542/AM17/
RLA File
:04/24/040/00042/AM 17/
Lic.No/Date:0410162009
03.06.2016
Defer Date:
•
Decision : The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals O.M.No. 35011/382/2016-PI(Norms) dated 12.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA,concerned may take necessary action as per decision of NC.
173
Case No.:61/11/82-ALC4/2016'1
Party NameiKEKULE:PHARMA LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/00595/AM17/
RLA File'
:09/24/040/00017/AM17/
Uc.No/Date:091006378I
09.06.2016
Defer Date:
08.11.2017
Decision: Deferred.
, 174
Case No.:29/13/82-ALC4/2016 Party Name:KUTCH'CHEMICAL INDUSTRIES
LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00657/AM17/
RLA File
:34/24/040/00068/AM17/
Lic.No/Date:3410042260
10.06.2016
Defer Date:
08.11.2017
Decision: Deferred.
175
Case No.:62/ll/82-ALC4/20I6 Party Name:SALICYLATES &CHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
28
HQ File:01/82/050/00596/AM17/
RLA File
:09/24/040/00077/AM17/
Lic.No/Date:0910063788
10.06.2016
Defer Date:
08.II.20I7
Decision: Deferred.
176
Case No.:64/ll/82-ALC4/2016 Party NameiSALICYLATES &
CHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/a0598/AMI7/
RLA File
:09/24/040/00076/AM17/
Lic.No/Date:0910063789
10.06.2016
Defer Date:
08.11.2017
Decision : Deferred.
177
Case No.:89/13/82-ALC4/2016 Party Name:UMAENTERPRISE
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00717/AMI7/
RLA File
;08/24/040/00099/AM17/
Lic.No/Date:0810138I54
10.06.2016
Defer Date:
08.11.2017
Decision : Deferred.
178
Case No.:5/ll/82-ALC4/2016 Party Name:ASCENTFINECHEM PVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00539/AM17/
RLA File
:08/24/040/OOI04/AM17/
Lic.No/Date:0810138218
28.06.2016
Defer Date:
08.11.2017
Decision : Deferred.
179
Case No.:16/ll/82-ALC4/2016 Party Name:PERFECTVITAMINS PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/aD550/AM17/
RLA File
:03/95/040/00255/AMI7/
Lic.No/Date:0310805798
29.06.2016
Defer Date:
08.11.2017
Decision: Deferred.
180
Case No.:198/17/82-
ALC4/2016
Party Name:NASENSE LABSPVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01159/AMI7/
RLA File
:09/24/040/00172/AMI7/
Lic.No/Date:0910063874
30.06.2016
Defer Date:
08.11.2017
Decision: Deferred.
181
Case No.:7/ll/82-ALC4/2016 Party Name:PANERA BIOTECPVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/0D541/AM17/
RLA File
:05/24/040/00136/AM17/
Lic.No/Date:0510398951
30.06.2016
Defer Date:
08.11.2017
Decision: Deferred.
|182 |Case No.:185/17/82- |Party NameiAUROBINDO Meet No/Date:3/82- Status:
29
ALC4/20I6 PHARMA LIMITED ALC4/2017
17.05.2017
Deferred
HQ File]:01/82/050/01146/AM17/
RLA File,:09/24/040/00147/AM17/
Lic.No/Date:0910063885
04.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:14/ll/82-ALC4/2016 Party Name:PALADIN'PAINTS AND CHEMICALS ■PVT. LTD.,
Meet No/Date;3/82-ALC4/20I7
17.05.2017
Status:
Deferred
183 HQ File:01/82/050/00548/AM17/
RLA File:03/95/040/00277/AM17/
Lic.No/Date:0310805923
04.07.2016
Defer Date:;08.11.2017 ■
Decision: Deferred.
<:ase No.:48/n/82-ALC4/2ai6' I'i
I
'arty Name:J.B. CHEMICALSI Ifc PHARMACEUTICALS i
JMITED
vieet No/Date:3/82- S\LC4/2017 I
7.05.2017
>tatu$:
)eferred
1
184
-IQ File 101/82/050/00582/AM17/
ILA Filei 103/94/040/00255/AM17/ (
.ic.No/Date:0310805960 I
35.07.2016 (
Defer Date;'
38.11.2017
Decision : The Committee decided to call for information from the firm based on therecommendation of D/o Pharmaceuticals forwarded O.M.No.35011/344/2016-PI(Norms)dated 3.4.2017 uploaded at the end of these minutes and deferred the case.
Case No.:3/13/82-ALC4/2016 Party Name:SUN'PHARMACEUTICAL
INDUSTRIES LTD.,
VIeet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Deferred
185 HQ File!:01/82/050/00631/AM17/ I
RLA File];05/24/040/00143/AM17/
Lic.No/Date:0510399022
06.07.2016 :
Defer Date:'
08.11.2017
Decision: Deferred.
Case No.:13/ll/82-ALC4/2016 Party Name:S M CHEMICAL]VAPl PRIVATE LIMITED
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Deferred
186 HQ File:01/82/050/00547/AM17/
RLA File!:03/95/040/00225/AM17/
Lic.No/Date:0310806063
11.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:42/ll/82-ALC4/2D16 Party Name:AARTIINDUSTRIES LIMITED
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Deferred
187 HQ File:01/82/050/00576/AM17/
RLA File:03/94/040/00198/AM17/
Lic.No/Date:0310806121
12.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
-
188
Case No.:52/ll/82-ALC4/2016 Party Name:J.B. CHEMICALS& PHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00586/AM17/
RLA File:03/94/040/00288/AM17/
Lic.No/Date:03l0806I13
12.07.2016
Defer Date:
30
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/343/2016-PI(Norms) dated 24.08.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
189'
Case No.:32/13/82-ALC4/2016 Party Name:J.B. CHEMICALS& PHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File:01/82/050/0D660/AM17/
RLA File
:03/94/040/00291/AMI7/
Lic.No/Date:03I0806I65
12.07.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/379/2016-PI(Norms) dated 14.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
190
Case No.:89/ll/82-ALC4/2016 Party Name:MALWAOXYGEN & INDUSTRIAL
GASES PVT.LTD.,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00623/AMI7/
RLA File
:56/24/040/000I5/AM17/
Lic.No/Date:56I0004949
12.07.2016
Defer Date:
08.II.20I7
Decision: Deferred.
191
Case No.:10/ll/82-ALC4/2016 Party Name:MATRlX FINE
SCIENCES PVT.LTD.,Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00544/AM17/
RLA File
:03/95/040/00304/AM17/
Lic.No/Date:0310806238
14.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
192'
Case No.:56/n/82-ALC4/2016 Party Name:NEOGENCHEMICALS LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/0D590/AM17/
RLA File
:03/95/040/00746/AMI6/
Lic.No/Date:0310806245
14.07.2016
Defer Date:
08.II.20I7
Decision: Deferred.
193
Case No.:67/ll/82-ALC4/2016 Party Name:FRESENIUS.
KABI ONCOLOGY LIMITED
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00601/AM17/
RLA File
:05/23/040/00065/AMI7/
Lic.No/Date:05I0399I29
19.07.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/348/2016-PI(Norms) dated 03.04.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
194
Case No.:66/ll/82-ALC4/2016 Party Name:JUBILANT LIFE
SCIENCES LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
31
HQ File;01/82/050/00600/AM17/
RLA File,:05/23/040/00147/AM17/
Lic.No/Date:0510399I30 '
19.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
195
Case No.:21/ll/82-ALC4/2016 Party Name:NEOGENCHEMICALS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;:01/82/050/00555/AM17/
RLA File
:03/95/040/00206/AM17/
Lic.No/Date:0310806373 i
19.07.2016
Defer Date:;
08.11.2017 '
Decision: Deferred.
196
Case No.: 18/11/82-ALC4/2016 Party Name:RESONANCESPECIALTIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/OD552/AM17/
RLA Filei
:03/95/040/00262/AMI7/
Lic.No/Date:0310806401
19.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
197
Case No.:35/ll/82-ALC4/2016 Party NameiAARTI'INDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00569/AM17/
RLA File
:03/94/040/00283/AM17/
Lic.No/Date:0310806427
20.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
198
Case No.:74/ll/82-ALC4/2016 Party Name:KLJ'PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00608/AM17/
RLA Filei
:05/23/040/00195/AM17/
Lic.No/Date:0510399160
20.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:19/ll/82-ALC4/2016 Party NaraeiREANNONPHARMACEUTICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
\99-
HQ File:01/82/050/00553/AM17/
RLA Filei
:03/95/040/00326/AM17/
Lic.No/Date:0310806484
21.07.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/315/2016-PI(Norms) dated 5.09.2017, uploaded at the end of,these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
200
Case No.:83/13/82-ALC4/2016 Party NameiREANNONPHARMACEUTICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00711/AMI7/
RLA File
:03/95/040/00327/AM17/ ;Lic.No/Date:0310806482
21.07.2016
Defer Date:.
08.11.2017
Decision: Deferred.
32
201
Case No.:25/ll/82-ALC4/2016 Party NameiSTERLlNGAUXILIARIES PVT LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/00559/AMI7/
RLA File
:03/95/040/00180/AM17/
Lic.No/Datei0310806477
21.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
202
Case No.:26/ll/82-ALC4/2016 Party NameiSTERLlNGAUXILIARIES PVT LTD
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00560/AM17/
RLA File
103/95/040/00116/AM17/
Lic.No/Datei0310806480
21.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
203
Case No.:27/ll/82-ALC4/2016 Party NameiSTERLlNGAUXILIARIES PVT LTD
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00561/AM17/
RLA File
:03/95/040/00143/AM17/
Lic.No/Date:0310806474
21.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
204
Case No.:20/13/82-ALC4/2016 Party NameiFRESENIUSKABI ONCOLOGY LIMITED
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00648/AM17/
RLA File
105/23/040/00211/AM17/
Lic.No/Datei0510399202
22.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
205
Case No.:20/ll/82-ALC4/2016 Party NameiNEOGENCHEMICALS LIMITED
Meet No/Datei3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00554/AM17/
RLA File
I03/95/040/00498/AM16/
Lic.No/Date:0310806509
22.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
206
Case No.:3I/ll/82-ALC4/2016 Party NameiSTERLlNG,AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00565/AM17/
RLA File
103/95/040/00168/AM17/
Lic.No/Datei0310806532
22.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
207
Case No.:7/13/82-ALC4/2016 Party NameiSTYRAXPHARMA PRIVATE
LIMITED
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00635/AM17/
RLA File
I26/24/040/00013/AM17/
Lic.No/Datei2610012765
22.07.2016
Defer Date:
33
Decision : The Committee decided to ratify norms based on the recommendation of D/o,Pharmaceuticals O.M.No. 35011/357/2016-PI{Norms) dated 31.08.2017, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
208
Case No.:70/11/82-ALC4/2016,Party NameiARCHI EXIM,PVT. LTD.
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File^:01/82/050/00604/AM17/
RLA File
:08/24/040/00150/AMI7/
Lic.No/Date:0810138353
25.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
209
Case No.:71/l 1/82-ALC4/2016,Party Name:ARCHI EXIMlPVT. LTD.
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00605/AM17/
RLA File
:08/24/040/00151/AM17/
Lic.No/Date:0810138354
25.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:144/13/82-
ALC4/2016
Party Name:CADILAHEALTHCARE LTD
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Approved
210
HQ File::01/82/050/00772/AMI7/
RLA File
:08/24/040/00154/AM17/
Lic.No/Date:0810138352
25.07.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/374/2016-PI(Norms) dated 08.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
211
Case No.:32/ll/82-ALC4/2016 ■
1
Party NameiSTERLING.AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00566/AM17/
RLA File'
:03/95/040/00290/AM17/
Lic.No/Date:0310806544
25.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
212
Case No.:55/ll/82-ALC4/2016^ Party Name:SWISSPARENTERALS PVT.LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ Filci:0I/82/050/00589/AMI7/
RLA File:
:08/24/040/00156/AM17/
Lic.No/Date:0810138362
25.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
213'
Case No.:22/ll/82-ALC4/2016 Party NameiENCUBEETHICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status;
Approved
HQ File;
:01/82/050/00556/AM17/
RLA File
:03/94/040/00262/AM17/Lic.No/Date:0310806600 '
26.07.2016Defer Date: ,
34
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/333/2016-PI(Norms) dated 06.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
214
Case No.:77/ll/82-ALC4/2016 Party NameiASIATIC DRUGS&PHARMACEUT1CALS PVT.
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:OI/82/050/00611/AM17/
RLA File
:05/23/040/00124/AM17/
Lic.No/Date:0510399240
27.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
215
Case No.:78/ll/82-ALC4/2016 Party Name:ASIATIC DRUGS.fePHARMACEUTICALS PVT.
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/00612/AM17/
RLA File
:05/23/040/00123/AM17/
Lic.No/Date:0510399239
27.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
216
Case No.:79/ll/82-ALC4/2016 Party Name:ASlATIC DRUGS&PHARMACEUTICALS PVT.
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00613/AM17/
RLA File
:05/23/040/00119/AM17/
Lic.No/Date:0510399242
27.07.2016
Defer Date:
08.11.2017
Decision : Deferred.
217
Case No.:80/ll/82-ALC4/2016 Party Name:ASIATIC DRUGS&PHARMACEUTICALS PVT.
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/00614/AM17/
RLA File
;05/23/040/00125/AM17/
Lic.No/Date:0510399241
27.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
218
Case No.:67/I3/82-ALC4/2016 Party Name:BDRPHARMACEUTICALS
INTERNATIONAL PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00695/AM17/
RLA File
:03/94/040/00335/AM17/
Lic.No/Date:0310806658
27.07.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/338/2016-PI(Norms) dated 5.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
219
Case No.:84/13/82-ALC4/2016 Party Name:PAYALPETROCHEM PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00712/AM17/
RLA File
;05/24/040/00I70/AM17/
Lic.No/Date:0510399250
27.07.2016
Defer Date:
08.11.2017
35
Decision : Deferred.
220
Case No.:64/13/82-ALC4/20I6,Party Name:AARTlINDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File.:01/82/050/00692/AM17/
RLA File
;03/94/040/00177/AM17/
Lic.No/Date:0310806697
28.07.2016
Defer Date:
08.11.2017
Decision: Deferred.
221
Case No.:112/17/82-
ALC4/20I6
Party Name:GLOBALCALCIUM PRIVATE'
LIMITED,
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File.:01/82/050/01073/AMI7/
RLA File
:07/24/04O/00I53/AMI7/
Lic.No/Date:07I0110200
04.08.2016
Defer Date:
08.11.2017
Decision : Deferred.
222
Case No,:50/13/82-ALC4/2016 Party Name:DELTA,FINOCHEM PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00678/AM17/
RLA File'
:03/94/040/00286/AM17/
Lic.No/Date:0310806966
09.08.2016
Defer Date:
08.11.2017
Decision : Deferred.
223
Case No.:10/13/82-ALC4/2016 Party Name:FRESENIUS'KABI ONCOLOGY LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00638/AM17/
RLA File,
:05/23/040/00229/AM17/
Lic.No/Date:05I0399392
09.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:26/13/82-ALC4/2016 Party Name:VIVIMED LABS (,ALATHUR) PRIVATELIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
224
HQ File
:01/82/050/00654/AM17/
RLA File'
:04/24/040/00065/AM17/
Lic.No/Date:0410162171
09.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/358/2016-PI(Norms) dated 1.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
225
Case No.:17/13/82-ALC4/2016 Party Name:HELLO PAINTS;(P) LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:OI/82/050/00645/AM17/
RLA File
:05/23/040/00220/AMI7/
Lic.No/Date:051039944911.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
|226 lease No.:76/I3/82-ALC4/2016 Party Name:JINDAL DRUGS'Meet No/Date:3/82- Status:
36
PRIVATE LIMITED ALC4/2017
17.05.2017
Deferred
HQ File
;0I/82/050/0D704/AM17/
RLA File
:03/94/040/00391/AM17/
Lic.No/Date:0310807030
11.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
227
Case No.:18/13/82-ALC4/20I6 Party NameiJUBILANT LIFESCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00646/AM17/
RLA File
:05/23/040/00230/AM17/
Lic.No/Date:0510399442
11.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
228
Case No.:61/13/82-ALC4/20I6 Party Name:S M BCORPORATION OF INDIA
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File':0I/82/050/00689/AM17/
RLA File'
:03/95/040/00388/AM17/
Lic.No/Date:0310807070
11.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
229
Case No.:78/13/82-ALC4/2016 Party NameiAARTLINDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00706/AM17/
RLA File
:03/94/040/00371/AM17/
Lic.No/Date:0310807104
12.08.2016
Defer Date:
08.11.2017
Decision : Deferred.
230
Case No.:190/17/82-
ALC4/2016
Party Name:GLANDPHARMA LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01151/AMI7/
RLA File
:09/24/040/00223/AMI7/
Lic.No/Date:0910064041
16.08.2016
Defer Date:
08.11.2017
Decision : Deferred.
231
Case No.:ll/13/82-ALC4/2016 Party Name:CADILAHEALTHCARE LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00639/AM17/
RLA File
:08/24/040/00190/AM17/
Lic.No/Date:0810138500
17.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/374/2016-PI(Norms) dated 08.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
232
Case No.:40/13/82-ALC4/20I6 Party Name:AETHERINDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File RLA File Lic.No/Date:5210042006 Defer Date:
37
;01/82/050/00668/AM17/ :52/24/040/00036/AM17/ 19.08.2016 08.11.2017
Decision : Deferred.
i:aseNo.:I9/13/82-ALC4/2016 I1
^arty Name:FRESENIUSCABI ONCOLOGY LIMITED i
Vleet No/Date:3/82- i
\LC4/2017 , 117.05.2017
Status:
deferred
WQ File ]01/82/050/00647/AM17/
^A File05/23/040/00234/AM17/
^ic.No/Date:0510399492
19.08.2016
Defer Date:
38.11.2017
[)ecision : Deferred.
Case No.:150/13/82-'
ALC4/2016
Party Name:SUNiPHARMACEUTICAL
INDUSTRIES LTD.,
Vieet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
234 HQ File:01/82/050/00778/AM17/
RLA File:05/24/040/00201/AMI7/
Lic.No/Date:0510399507
19.08.2016
Defer Date:,
08.11.2017
Decision : Deferred.
.
Case No.:152/13/82-
ALC4/2016
Party Name:SUNPHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
235
HQ File:01/82/050/00780/AM17/
RLA File':05/24/040/00200/AM17/
Lic.No/Date:0510399505 ■
19.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/420/2016-Pi(Norms) dated 11.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is iess under para 4.07 of HBP Vol.1.RAconcemed may take necessary action as per decision of NO.
.
Case No.:7/17/82-ALC4/2016 Party Name:AMINES &■PLASTICIZERS LIMITED
Meet No/Date:3/82-iALC4/201717.05.2017
Status:Approved
236
HQ File:01/82/050/00968/AM17/
RLA File:03/94/040/00437/AM17/
Lic.No/Date:031080724422.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on repeat basis as per earlier decisiontaken by NC in its meeting No.11/82 dated 26.11.2014, upioaded at the end of these minutes oras appiied by the firm whichever is less under para 4.07 of HBP Vol.l.RA concerned may takenecessary action as per decision of NC.
Case No.:69/13/82-ALC4/2016 Party Name:J.B. CHEMICALS& PHARMACEUTICALSLIMITED
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Approved
237
HQ File:01/82/050/00697/AM17/
RLA File:03/94/040/00339/AM17/
Lic.No/Date;031080728922.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticais O.M.No. 35011/394/2016-PI(Norms) dated 08.09.2017, upioaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.l.RAconcemed may take necessary action as per decision of NC. _
238Case No.:68/13/82-ALC4/2016 Party Name:J.B. CHEMICALS
& PHARMACEUTICALSMeet No/Date:3/82-ALC4/2017
Status:Approved
38
LIMITED 17.05.2017
HQ File:OI/82/050/00696/AM17/
RLA File
:03/94/040/00453/AMI7/
Lic.No/Date:03108073I6
23.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/395/2016-PI(Norms) dated 07.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever Is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NO.
239
Case No.: 156/13/82-
ALC4/2016
Party NameiMAHIMA LIFESCIENCES PVT.LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00784/AM17/
RLA File
:05/24/040/00214/AM17/
Lic.No/Date:0510399536
23.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
240
Case No.:141/13/82-
ALC4/2016
Party Name:RHYDBURGPHARMACEUTICALS LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00769/AM17/
RLA File
:05/24/040/00239/AM17/
Lic.No/Date:0510399535
23.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/416/2016-PI(Norms) dated 15.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
241,
Case No,:94/13/82-ALC4/2016 Party NametBODALCHEMICALS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00722/AM17/
RLA File
:08/24/040/00I37/AM17/
Lic.No/Date:0810I38556
29.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
242
Case No.: 123/13/82-
ALC4/2016
Party Name:D. R. COATS INK& RESINS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00751/AM17/
RLA File
:03/94/040/00265/AM17/
Lic.No/Date:0310807443
30.08.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case Ng.:81/13/82-ALC4/2016 Party Name:PANACEABIOTEC LTD.,
Meet No/Date;3/82-
ALC4/2017
17.05.2017
Status:
Approved
243
HQ File;Ql/82/050/00709/AM17/
RLA File
:05/24/040/00258/AM17/
Lic.No/Date:0510399580
30.08.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of DBT O.M.No.BT/IL/05/316/2010-PID dated 05.06.2017, uploaded at the end of these minutes or as appliedby the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may take necessaryaction as per decision of NC.
39
244
Case No.: 124/13/82-
ALC4/2016
Party Name:ELPPE;CHEMICALS PRIVATE,
LIMITED
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00752/AM17/
RLA Filet
:03/94/040/00464/AM17/
Lic.No/Date:0310807534
01.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
245
Case No.:163/13/82-
ALC4/2016
Party Name;HETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File':01/82/050/00791/AM17/
RLA File
:09/24/040/00285/AM17/
Lic.No/Date:0910064084
01.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
246
Case No.:164/13/82-t
ALC4/2016
Party Name:HETERO LABSjLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/00792/AM17/
RLA File
:09/24/040/003II/AM17/
Lic.No/Date:0910064091
01.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
247
Case No.: 168/13/82-1
ALC4/2016
Party NamerHETERO LABS'LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File;01/82/050/00796/AM17/
RLA File
:09/24/040/0030I/AM17/
Lic.No/Date:0910064085
01.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
248
Case No.: 170/13/82-
ALC4/2016
Party NamerHETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00798/AM17/ '
RLA File,:09/24/040/00284/AM17/
Lic.No/Date:0910064083 '
01.09.2016
Defer Date:,
08.11.2017
Decision: Deferred.
249
Case No.:196/17/82-
ALC4/2D16
Party NamerORCHLABORATORIES INDIA PVT
LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01157/AMI7/
RLA File
:09/24/040/00292/AM17/
Lic.No/Date:0910064089
01.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
'250
Case No.:95/13/82-ALC4/2016 Party NameiACULIFEHEALTHCARE PRIVATE
LIMITED,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File:01/82/050/00723/AM17/
RLA File
:08/24/040/00161/AM17/
Lic.No/Date:0810138597
02.09.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o
40
Pharmaceuticals forwarded vide O.M. No. 35011/409/2016-PI(Norms) dated Sept. 2014,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NC.
251
Case No.:122/13/82-
ALC4/2016
Party NameiKAIRAVCHEMOFARBE INDUSTRIES
LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File':01/82/050/00750/AMI7/
RLA File
:03/94/040/00374/AM17/
Lic.No/Date:0310807578
02.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
252
Case No.: 109/13/82-
ALC4/2016
Party Name:AURAPHARMACEUTICALS PVT.
LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00737/AMI7/
RLA File
:03/94/040/00484/AM17/
Lic.No/Date:0310807613
06.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
253
Case No.: 197/17/82-
ALC4/2016
Party Name:EYTAN LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0n58/AM17/
RLA File
:09/24/040/00252/AM17/
Lic.No/Date:0910064110
08.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
254
Case No.:I67/13/82-
ALC4/2016
Party Name:HETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00795/AM17/
RLA File
:09/24/040/00300/AM17/
Lic.No/Date:0910064112
08.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
255
Case No.:169/13/82-
ALC4/2016
Party NameiHETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00797/AM17/
RLA File'
:09/24/040/00302/AM17/
Lic.No/Date:0910064113
08.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
256
Case No.:209/17/82-
ALC4/2016
PartyName:INTERNATIONAL
HEALTHCARE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0I170/AM17/
RLA File
:09/24/040/00246/AM17/
Lic.No/Date:0910064103
08.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
257Case No.:108/13/82-
ALC4/2016
Party NamerJ.B. CHEMICALS& PHARMACEUTICALS
Meet No/Date:3/82-
ALC4/2017
Status:
Approved
41
LIMITED 17.05.2017
HQ File!:01/82/050/00736/AM17/ i
RLA File!:03/94/040/00506/AM17/ ;
Lic.No/Date;0310807686
08.09.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/318/2016-PI(Norms) dated 04.09.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
258
Case No.:207/17/82-
ALC4/2016
Party Name:MYLAN'LABORATORIES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01168/AM17/
RLA File
:09/24/040/00310/AM17/
Lic.No/Date:0910064117
08.09.2016
Defer Date:
08.11.2017
Decision; Deferred.
259
Case No.:137/13/82-i
ALC4/2016
Party Name:NAVINFLUORINE
INTERNATIONAL LIMITED '
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0D765/AM17/
RLA File'
;03/95/040/00437/AM17/
Lic.No/Date:0310807709
08.09.2016
Defer Date:'
08.11.2017
Decision: Deferred.
260
Case No.:186/17/82-
ALC4/2016
Party Name:SALICYLATES &,CHEMICALS PRIVATEi
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/01147/AM17/ !
RLA Filei
:09/24/040/00231/AM17/
Lic.No/Date:0910064100
08.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
261
Case No.:199/17/82-
ALC4/2016
Party Name:SALICYLATES &,CHEMICALS PRIVATE^
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01160/AM17/
RLA File,:09/24/040/0a075/AM17/
Lic.No/Date:0910064099
08.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
262
Case No.:159/13/82-;
ALC4/2016
Party Name:SUN|PHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/00787/AM17/
RLA File
:05/24/040/00264/AM17/
Lic.No/Date:0510399649
08.09.2016
Defer Date:'
08.11.2017
Decision: Deferred.
263
Case No.:208/17/82-
ALC4/2ai6
Party Name:SUVEN LIFE,SCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01169/AM17/
RLA File
:09/24/040/00256/AM17/
Lic.No/Date:0910064101 '
08.09.2016
Defer Date:
08.11.2017
42
Decision: Deferred.
264
Case No.: 166/13/82-
ALC4/2016
Party Name:HETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File;01/82/050/00794/AM17/
RLA File
:09/24/040/00314/AM17/
Lic.No/Date:0910064123
09.09.2016
Defer Date:
08.II.20I7
Decision: Deferred.
265
Case No.: 165/13/82-
ALC4/2016
Party Name:HONOUR LABLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00793/AM17/
RLA File
:09/24/040/0032I/AM17/
Lic.No/Date:09I0064126
09.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
266
Case No.:206/17/82-
ALC4/2016
Party Name:AUROBINDOPHARMA LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01167/AM17/
RLA File
:09/24/040/00277/AMI7/
Lic.No/Date:09I0064I33
12.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
267
Case No.: 105/13/82-
ALC4/2016
Party NameiAARTI DRUGSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00733/AM17/
RLA File
:03/94/040/00487/AMI7/
Lic.No/Date:0310807836 '
16.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
268
Case No.:46/13/82-ALC4/2016 Party NameiGOPINATHCHEM-TECH LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00674/AM17/
RLA File
:08/24/040/00215/AMI7/
Lic.No/Date:0810138683
16.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
269
Case No.:103/13/82-
ALC4/2016
Party NameiJ.B. CHEMICALS& PHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/a0731/AM17/
RLA File
:03/94/040/005I6/AM17/
Lic.No/Date:03I0807914
20.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
270
Case No.:119/13/82-
ALC4/2016
Party Name:GLOBALCALCIUM PRIVATE
LIMITED,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
43
HQ File:01/82/05q/00747/AM17/
RLA File'
:07/24/040/00207/AM17/ ;Lic.No/Date:0710110442
21.09.2016
Defer Date:
08.11.2017 '
Decision: Deferred.
271
Case No.:45/13/82-ALC4/2016 Party Name:BIO TECHOPHTHALMICS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00673/AM17/
RLA Filei:08/24/040/00216/AM17/
Lic.No/Date:0810138715
22.09.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/353/2016-Pi{Norms) dated 06.09.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
272
Case No.:91/13/82-ALC4/2016 Party NameiCADILA,HEALTHCARE LTD i
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00719/AMI7/
RLA File,
:08/24/040/00242/AM17/
Lic.No/Date:0810138723
22.09.2016
Defer Date:'
08.11.2017
Decision: Deferred.
273
Case No.:100/13/82-
ALC4/2016
Party NameiK V AROCHEM'PVT. LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00728/AM17/
RLA Filel
:03/94/040/00525/AM17/
Lic.No/Date:0310807975
22.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
274
Case No.:I92/17/82-
ALC4/2016
Party NameiSATYADEEPTHA
PHARMACEUTICALS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01153/AM17/
RLA File
:09/24/040/00332/AM17/
Lic.No/Date:0910064172
22.09.2016
Defer Date:,08.11.2017 '
Decision: Deferred.
275
Case No.:82/13/82-ALC4/2016.Party Name:VERTELLUSSPECIALTY MATERIALS!
(INDIA) PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/00710/AM17/
RLA File^
:52/24/040/00040/AM17/
Lic.No/Date:5210042029
22.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
276
Case No.;56/17/82-ALC4/2016;Party Name:J.B. CHEMICALS!& PHARMACEUTICALS!
LIMITED
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01017/AM17/
RLA File
:03/94/040/00582/AM17/
Lic.No/Date:0310808049
26.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
44
2ir
Case No.:102/17/82-
ALC4/2016
Party Name:PAB ORGANICSPVT.LTD,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01063/AM17/
RLA File
:34/24/040/00180/AM17/
Lic.No/Date:3410042558
26.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
278
Case No.: 193/17/82-'
ALC4/2016
Party NameiPORUSLABORATORIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/DI154/AM17/
RLA File
:09/24/040/00345/AMI7/
Lic.No/Date:0910064185
26.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
279
Case No.:195/17/82-
ALC4/2016
Party Name:PORUSLABORATORIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01156/AM17/
RLA File
:09/24/040/00344/AM17/
Lic.No/Date:0910064184
26.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
280
Case No.:55/17/82-ALC4/2016 Party Name:AMINES &PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01016/AM17/
RLA File
:03/94/040/00570/AM17/
Lic.No/Date:0310808091
27.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
281
Case No.:13/17/82-ALC4/2016 Party Name:GUJARATORGANICS LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00974/AM17/
RLA File
:03/94/040/00585/AM17/
Lic.No/Date:0310808096
27.09.2016
Defer Date:.
08.11.2017
Decision: Deferred.
282
Case No.:113/13/82-
ALC4/2016
Party Name:HETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/00741/AM17/
RLA File
:09/24/040/0a342/AM17/
Lic.No/Date:0910064191
27.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
283
Case No.: 114/13/82-
ALC4/2016
Party NamerHETERO LABSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00742/AM17/
RLA File
:09/24/040/00341/AM17/
Lic.No/Date:0910064192
27.09.2016
Defer Date:
08.11.2017
45
Decision: Deferred.
ooN(
Case No.:54/17/82-ALC4/2016 Party Name:K V AROCHEMPVT. LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File.:0I/82/050/01015/AM17/
RLA File
:03/94/040/00524/AM17/
Lic.No/Date:0310808098 .
27.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
285
Case No.:139/13/82-
ALC4/2016
Party Name:VISWAATCHEMICALS LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File::01/82/050/00767/AM17/
RLA File
:03/95/040/00302/AMI7/
Lic.No/Date:0310808110 ,
27.09.2016.
Defer Date:
08.11.2017 '
Decision: Deferred.
286
Case No.:194/17/82-
ALC4/2016
Party Name:SUVEN LIFE,SCIENCES LIMITED
Meet No/Date: 3/82-.
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/01155/AM17/
RLA File
:09/24/040/00339/AM17/
Lic.No/Date:09I0064206
29.09.2016
Defer Date:,
08.11.2017
Decision: Deferred.
287
Case No.:12/17/82-ALC4/2016 Party NamerALIVIRAANIMAL HEALTH LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00973/AM17/
RLA File,
:03/94/a40/00557/AM17/
Lic.No/Date:0310808216
30.09.2016
Defer Date:'
08.11.2017
Decision: Deferred.
288
Case No.:90/13/82-ALC4/2016 Party Name:AMI ORGANICSPVT LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/00718/AM17/
RLA File;
:52/24/040/00042/AM17/ i
Lic.No/Date:5210042032 ;30.09.2016
Defer Date:
08.11.2017
Decision : Deferred.
289
Case No.:125/13/82-
ALC4/2016
Party Name:SURVIVALTECHNOLOGIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File.:ai/82/050/00753/AM17/
RLA File'
:03/95/040/00490/AM17/ :Lic.No/Date:0310808208 :
30.09.2016
Defer Date:,08.11.2017
Decision : Deferred.
290
Case No.:126/13/82-,
ALC4/20I6
Party Name:SURVIVAL,TECHNOLOGIES PVT.LTD. |
Meet No/Date:3/82-,
ALC4/2017 ;17.05.2017
Status:
Deferred
46
HQ File:01/82/050/00754/AM17/
RLA File
:03/95/040/00410/AM17/
Lic.No/Date:0310808209
30.09.2016
Defer Date:
08.11.2017
Decision: Deferred.
291
Case No.:129/l/82-ALC4/2017 Party Name:GRANULESINDIA LIMITED
Meet No/Date:3/82-'ALC4/2017
17.05.2017
Status:
Approved
HQ File,:01/82/050/01483/AM17/
RLA File
:09/24/040/00365/AM17/
Lic.No/Date;0910064234 ;
05.10.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/270/2016-PI(Norms) dated Oct. 2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoi.l.RA concerned may take necessary action as per decision of NO.
292
Case No.:182/17/82-
ALC4/2016
Party Name:MYLANLABORATORIES LIMITED
Meet No/Date:3/82-,
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/01143/AM17/
RLA File
:09/24/040/00305/AM17/
Lic.No/Date:0910064230
05.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
293
Case No.:204/17/82-
ALC4/2016
Party Name:NAGARJUNAAGRICHEM LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01165/AM17/
RLA File
:09/24/040/00313/AM17/
Lic.No/Date:0910064232
05.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
294
Case No.:29/17/82-ALC4/2016 Party Name:PALADINPAINTS AND CHEMICALS
PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00990/AM17/
RLA File
:03/95/040/00514/AM17/
Lic.No/Date:0310808276
05.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
295
Case No.:200/17/82-
ALC4/2016
Party Name:AUROBINDO'PHARMA LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01161/AM17/
RLA File
:09/24/040/00312/AM17/
Lic.No/Date:0910064252
06.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
296
Case No.:ll/17/82-ALC4/2016 Party Name:CIPLA LIMITED. Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00972/AMI7/
RLA File
:03/94/040/00617/AM17/
Lic.No/Date:0310808312
06.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
47
297
Case No.:75/17/82-ALC4/2016 Party NameiMAHAVIRSYNTHESIS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/^2/050/01036/AM17/RLA File
:52/24/040/00043/AM17/Lic.No/Date:521004203806.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:205/17/82-
ALC4/2016
Party Name:SATYADEEPTHA
PHARMACEUTICALS LTD
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
298
HQ File
:01/82/050/01166/AM17/RLA File
:09/24/040/00375/AM17/Lic.No/Date:091006423506.10.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o,Pharmaceuticals forwarded vide O.M. No. 35011/135/2016-PI(Norms) dated July 2016, uploaded^at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1 .RA concerned may take necessary action as per decision of NO.
299
Case No.:33/17/82-ALC4/2ai6'Party NameiYASHOiINDUSTRIES PVT.LTD.
Meet No/Date:3/82-,
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/Oa994/AM17/
RLA File
:03/95/040/00546/AM17/Lic.No/Date:031080837613.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
300
Case No.:69/17/82-ALC4/2016 Party Nanie:PORUSLABORATORIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01030/AMI7/RLA File
:09/24/040/00374/AM17/Lic.No/Date:091006426514.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
301
Case No.:201/17/82-
ALC4/2016
Party Name:PORUS|LABORATORIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File'
:01/82/050/01162/AM17/RLA File'
:09/24/040/00354/AM17/Lic.No/Date;0910064264 '14.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
302
Case No.:49/17/82-ALC4/2016,Party Name:CIPLA LIMITED. Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/OI010/AM17/
RLA File
03/94/040/00622/AM17/Lic.No/Date:031080843317.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
.
303Case No.:9/17/82-ALC4/20I6 Party Name:CLARIANT
INDIA LIMITEDMeet No/Date:3/82-
ALC4/2017
Status:
Deferred
48
17.05.2017
HQ File:01/82/050/00970/AM17/
RLA File
:03/94/040/00629/AM17/
Lic.No/Date:0310808422
17.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
304
Case No.:39/17/82-ALC4/2016 Party Name:PRIVI ORGANICSLTD
Meet No/Date:3/82-;
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01000/AM17/
RLA File
:03/95/040/00324/AM17/
Lic.No/Date:0310808410 ,
17.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
305
Case No.:31/17/82-ALC4/2016 Party Name:REANNONPHARMACEUTICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00992/AM17/
RLA File
:03/95/040/00540/AM17/
Lic.No/Date:0310808412
17.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
306
Case No.:25/I7/82-ALC4/2016 Party Name:CLARIANTINDIA LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00986/AM17/
RLA File
:03/94/040/00648/AM17/
Lic.No/Date:0310808508
18.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
307
Case No.:214/17/82-
ALC4/2016
Party NameiDEEPAKNOVOCHBM
TECHNOLOGIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01175/AM17/
RLA File
:31/83/040/00071/AM17/
Lic.No/Date:3110066376
20.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
308
Case No.:76/17/82-ALC4/2016 Party Name:GOLD STARINTERNATIONAL
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01037/AM17/
RLA File
:52/24/040/00046/AMI7/
Lic.No/Date:5210042057
25.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
309
Case No.:94/17/82-ALC4/20I6 Party Name:SHlVAPHARMACHEM LTD
Meet No/Date:3/82-
ALC4/20i7
17.05.2017
Status:
Deferred
HQ File;01/82/050/01055/AM17/
RLA File
:34/24/040/00204/AM17/
Lic.No/Date:3410042618
25.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
49
310
Case No.:15/17/82-ALC4/2016 Party Name:HARMONYLIFESCIENCE PRIVATELIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00976/AM17/RLA File
;03/94/040/00672/AM17/Lic.No/Date:0310808773
26.10.2016
Defer Date:
08.11.2017
Decision: Deferred.
311
Case No.:20/I7/82-ALC4/2016 Party Name:BLUE CIRCLEORGANICS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/00981/AM17/RLA File
:03/94/040/00606/AM17/Lic.No/Date:0310808832
27.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
312
Case No.;21/17/82-ALC4/2016 Party NameiBLUE CIRCLEORGANICS PVT. LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File
;01/82/050/aD982/AM17/RLA File
:03/94/040/00548/AMI7/Lic.No/Date:031080883027.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
313
Case No.:95/17/82-ALC4/2016'Party Name:CONCORD'BIOTECH LTD
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status;
Deferred
HQ File
:01/82/050/01056/AM17/RLA File
:08/24/040/00268/AM17/Lic.No/Date:081013899728.10.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:18/17/82-ALC4/2016 Party Name;J.B. CHEMICALS^& PHARMACEUTICALS.LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
314
HQ File:01/82/050/00979/AM17/
RLA File.
:03/94/040/00718/AM17/Lic.No/Date:0310809038
08.11.2016Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/343/2016-Pl(Norms) dated 24.08.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
•
Case No.:43/17/82-ALC4/2016i Party NamerJ.B. CHEMICALS'& PHARMACEUTICALS'
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
'315
HQ File
01/82/050/01004/AM17/RLA File
03/94/040/00703/AM17/Lic.No/Date:031080903908.11,2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/343/2016-PI(Norms) dated 24.08.2017.uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07'Df HBP Vol.l.RA concerned may take necessary action as per decision of NC.
|316 |Case No.:22/17/82-ALC4/20I6 Party Name:J.B. CHEMICALS Vleet No/Date:3/82- iStatus:
50
& PHARMACEUTICALS
LIMITED
ALC4/2017
17.05.2017
Approved
HQ File:01/82/050/a0983/AM17/
RLA File
:03/94/040/00726/AM17/
Lic.No/Date:0310809070
09.11.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals fonwarded vide O.M. No. 35011/343/2016-Pi(Norms) dated 24.08.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP VoI.I.RA concerned may take necessary action as per decision of NO.
317
Case No.:88/17/82-ALC4/2016 Party Name:SHIVAPHARMACHEM LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01049/AM17/
RLA File
:34/24/040/00220/AM17/
Lic.No/Date:3410042652
09.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
318
Case No.:26/17/82-ALC4/2016 Party Name:STERLlNGAUXILIARIES PVT LTD
Meet No/Date;3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00987/AM17/
RLA File
:03/95/040/00348/AM17/
Lic.No/Date:0310809069
09.11.2016
Defer Date:'
08.11.2017
Decision : Deferred.
319
Case No.:37/17/82-ALC4/2016 Party NameiSTERLlNGAUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00998/AM17/
RLA File
:03/95/040/00344/AM17/
Lic.No/Date:0310809065
09.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
320
Case No.:l7/I7/82-ALC4/2016 Party NameT.B. CHEMICALS& PHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/00978/AM17/
RLA File
:03/94/040/00730/AM17/
Lic.No/Date:0310809095
10.11.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/343/2016-PI(Norms) dated 24.08.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Voi.lRA concerned may take necessary action as per decision of NC.
321
Case No.:45/17/82-ALC4/2016 Party NameiKRISHNAANTIOXIDANTS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01006/AM17/
RLA File
:03/94/040/00704/AM 17/
Lic.No/Date:0310809094
10.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
322Case No.:2/I5/82-ALC4/20I6 Party Name:STERLING
AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
Status:
Deferred
51
17.05.2017
HQ File01/82/050/00816/AM17/
RLA File03/95/040/00449/AMI7/
Lic.No/Date:0310809088 '10.11.2016
Defer Date:
38.11.2017
Decision: Deferred.
Case No.:41/17/82-ALC4/2016, ^arty Name:STERLING'AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
323 HQ File,:01/82/050/01002/AM17/
RLA File':03/95/040/00515/AM17/
Lic.No/Date:0310809091 ,10.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:103/17/82-;ALC4/2016
Party Nanie:FRESENIUSiKABI ONCOLOGY LIMITED
Meet No/Date:3/82-.
ALC4/2017
17.05.2017
Status:
Deferred
324 HQ File:01/82/050/01064/AM17/
RLA File':05/23/040/00370/AM17/
Lic.No/Date:0510400406
11.11.2016
Defer Date:
08.11.2017 '
Decision : Deferred.
CaseNo.:92/l/82-ALC4/2017 , Party Name:HARMONYlLIFESCIENCE PRIVATEjLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
S2t> HQ File,:01/82/050/01446/AM17/
RLA File:03/94/040/00701/AM17/
Lic.No/Date:0310809129
11.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:19/17/82-ALC4/2016!Party Name:HIKAL LIMITED Meet No/Date:3/82-'
ALC4/20I7
17.05.2017
Status:
Deferred
326 HQ File:01/82/050/00980/AM17/
RLA File;03/94/040/00687/AM17/
Lic.No/Date:0310809149 '
11.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:101/17/82-
ALC4/2016
Party Name:JUBILANTGENEEUCS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
327 HQ File:01/82/050/01062/AM17/
RLA File:05/23/040/00372/AMI7/
Lic.No/Date:0510400404
11.11.2016
Defer Date:
08.11.2017 ■
Decision: Deferred.
'328
Case No.:130/17/82-
ALC4/2016
Party Name:BAYER VAPIPVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01091/AM17/
RLA File
:03/94/040/00735/AMI7/
Lic.No/Date:0310809204
22.11.2016
Defer Date:'
08.11.2017
Decision : Deferred.
52
329
Case No.:138/17/82-
ALC4/2016
Party Name:MAPLE CROSSREMEDIES PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/0I099/AM17/
RLA File,
:03/95/040/00624/AM17/
Lic.No/Date:0310809210
22.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
330
Case No.:66/17/82-ALC4/2016 Party Name:MEGHMANIINDUSTRIES LTD,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01Q27/AM17/
RLA File
:08/24/040/00293/AM17/
Lic.No/Date:0810139050
22.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
331
Case No.: 118/1/82-ALC4/2017 Party Name:RELIANCEINDUSTRIES LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01472/AM17/
RLA File
:03/95/040/00542/AM17/
Lic.No/Date:0310809220
22.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
332
Case No.:91/17/82-ALC4/2016 Party Name:RONAKCHEMICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01052/AM17/
RLA File
:34/24/040/0D224/AM17/
Lic.No/Date:3410042673
22.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
333
Case No.:124/17/82-
ALC4/2016
Party Name:SURVIVALTECHNOLOGIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01085/AM17/
RLA File
:03/95/040/0a639/AM17/
Lic.No/Date:0310809216
22.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
334
Case No.: 120/17/82-
ALC4/2016
Party Name:ZIMLABORATORIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01081/AM17/
RLA File
:03/95/040/006a2/AM17/
Lic.No/Date:0310809205
22.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
335
Case No.:141/17/82-
ALC4/2016
Party Name:MELOGSPECIALITY CHEMICALS
PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01102/AM17/
RLA File
:03/95/040/00610/AM17/
Lic.No/Date:0310809264
23.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
53
Case No.:98/17/82-ALC4/2016;'
'arty Name:NECTARLIFESCIENCES LIMITED, ,
^eet No/Date;3/82-
ALC4/2017 '17.05.2017
Status:
Deferred
336 HQ File01/82/050/D1059/AM17/
RLA File22/24/040/0007I/AM17/
Lic.No/Date:2210015595
23.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
337
Case No.:99/17/82-ALC4/2016 Party Name:SAURAV'CHEMICALS LTD,
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01060/AM17/
RLA File
:22/24/O40/0a073/AM17/
Lic.No/Date:2210015598
23.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
,338
Case No.:l/17/82-ALC4/2016 Party Naine:YASHOINDUSTRIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/00962/AM17/
RLA File'
:03/95/040/00640/AM17/
Lic.No/Date:0310809268
23.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
■339
Case No.:87/17/82-ALC4/2016 Party Name:ASIATIC DRUGSi&PHARMACEUTICALS PVT.LTD.
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
HQ File:01/82/050/01048/AM17/
RLA File:05/23/040/00365/AM17/
Lic.No/Date:051040045324.11.2016
Defer Date:08.11.2017
Decision: Deferred.
340
Case No.:86/17/82-ALC4/2016. Party Naine:ALCHEMINTERNATIONAL PVT. LTD.
Meet No/Date:3/82-iALC4/201717.05.2017
Status:Deferred
HQ File:01/82/050/01047/AM17/
RLA File:05/23/040/a0358/AM17/
Lic.No/Date:051040047425.11.2016
Defer Date:,08.11.2017
Decision: Deferred.
341
Case No.:155/17/82-ALC4/2016
Party NameiCIPLA LIMITED. Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
HQ File:01/82/050/01116/AM17/
RLA File:03/94/040/00757/AM17/
Lic.No/Date:031080932325.11.2016
Defer Date:08.11.2017
Decision: Deferred.
342
Case No.:179/17/82-ALC4/2016
Party Name:BLUE CIRCLEORGANICS PVT. LTD.
Meet No/Date:3/82-ALC4/201717.05.2017
Status:Deferred
HQ File:01/82/050/01140/AM17/
RLA File:03/94/040/00744/AM17/
Lic.No/Date:031080937328.11.2016
Defer Date:08.11.2017
54
Decision: Deferred.
343
Case No.:89/17/82-ALC4/2016 Party Name:CADILAi
PHARMACEUTICALS LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File:01/82/050/01050/AM17/
RLA File
;08/24/040/00319/AM17/
Lic.No/Date:0810139094
28.11.2016
Defer Date:
Decision :The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/132/2017-PI(Norms) dated 13.04.2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Voi.1 .RA concerned may take necessary action as per decision of NO.
344
Case No.: 129/17/82-
ALC4/2016
Party Name:DELTAFINOCHEM PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ Filei;01/82/050/01090/AM17/
RLA File
:03/94/040/00675/AM17/
Lic.No/Date:0310809367
28.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
345
Case No.:180/17/82-
ALC4/2016
Party Name:ENCUBEETHICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0114I/AM17/
RLA File
:03/94/040/00689/AM17/
Lic.No/Date:0310809370
28.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
346
Case No.:84/17/82-ALC4/2016 Party NameiMOREPENLABORATORIES LTD.,
Meet No/Date:3/82-,ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01045/AM17/
RLA File
:05/24/040/00415/AM17/
Lic.No/Date:0510400507
28.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
347
Case No.:163/17/82-
ALC4/2016
Party Name:AVA
CHEMICALS PVT.LTD.,Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/OI124/AM17/
RLA File
:03/94/040/00734/AM17/
Lic.No/Date:0310809399
29.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
348
Case No.:164/17/82-
ALC4/2016
Party NameiAVA
CHEMICALS PVT.LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01125/AM17/
RLA File
:03/94/040/00733/AM17/
Lic.No/Date:0310809398
29.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
|349 Case No.:165/17/82- Party Name:AVA Meet No/Date:3/82- Status:
55
1 \LC4/2016 CHEMICALS PVT.LTD., ALC4/2017
17.05.2017
)eferred
HQ File,.01/82/050/01126/AM17/
RLA File,03/94/040/00731/AM17/
Lic.No/Date;0310809396
29.11.2016
Defer Date:,
08.11.2017
necision: Deferred.
350!
Case No.:118/17/82-ALC4/20I6
Party NameiSUPREET'CHEMICALS PVT.LTD.
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01079/AM17/
RLA File';52/24/040/00050/AM17/
Lic.No/Date:5210042073 '
29.11.2016
Defer Date:
08.11.2017
Decision : Deferred.
351
Case No.:139/17/82-ALC4/2016
Party Name:ZIMLABORATORIES LTD.
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01100/AM17/
RLA File:03/95/040/00684/AM17/
Lic.No/Date:031080940629.11.2016
Defer Date:
Ph™u«cals vTde" 0.m: Na' 35011/404/2012.P,(Norms, dated 12.097017uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.0of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
1
::ase No.:151/I7/82-;I\LC4/2016 '
^arty Natne:STERLING!\UXIL1AR1ES PVT LTD ■ i
Vieet No/Date;3/82- i\LC4/2017 1
17.05.2017
Status:
Deferred
352 HQ File01/82/050/01112/AM17/
RLA File03/95/040/00676/AM17/
Lic.No/Date:0310809433
30.11.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:85/I7/82-ALC4/20I6,Party Name:SENTISSPHARMA PVT.LTD.
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Approved ,
353
HQ File:01/82/050/01046/AM17/
RLA File-.05/24/040/00416/AM17/ |
Lic.No/Date:051040057001.12.2016
Defer Date;
Decision : The Committee decided to ratify norms based on the recommendation ot u/oPharmaceuticais forwarded vide O.M. No. 35011/41/2016-Pi(Norms dated18.11.2016 uploadedat the end of these minutes or as applied by the firm whichever is tess under para 4.07 of HBPVol 1 RA concerned may take necessary action as per decision of NO.
Case No.: 116/17/82-ALC4/2016
Party Name:AETHERINDUSTRIES LIMITED
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Deferred
'354 HQ File:01/82/050/01077/AM17/ .
RLA File:52/24/040/00053/AM17/
Lic.No/Date:5210042078
02.12.2016
Defer Date:
08.11.2017
Decision ; Deferred. -
[355 Case No.:133/17/82-ALC4/2016
Party Naine:AMlNES &PLASTICIZERS LIMITED
Meet No/Date:3/82-ALC4/2017
Status:
, Approved
56
17.05.2017
HQ File:01/82/050/01094/AM17/
RLA File
:03/94/040/00771/AM17/
Lic.No/Date:0310809551
02.12.2016
Defer Date;
Decision : The Committee decided to ratify norms based on repeat basis as per earlier decisiontaken by NO In its meeting No.19/82 dated02.01.2014, uploaded at the end of these minutes oras applied by the firm whichever is less under para 4.07 of HBP Vol.1.RA concerned may takenecessary action as per decision of NO.
Case No.:132/17/82-
ALC4/2016
Party Name;J.B. CHEMICALS& PHARMACEUTICALS
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
356
HQ File:01/82/050/01093/AM17/
RLA File
:03/94/040/00775/AM17/
Lic.No/Date:0310809552
02.12.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/516/2015-PI(Norms) dated30.08.2016,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NC.
357
Case No.:128/l/82-ALC4/2017 Party NamerSTRIDES.SHASUN LIMITED
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01482/AM17/
RLA File
104/24/040/00145/AM17/
Lic.No/Date:0410162536
02.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
358
Case No.:97/17/82-ALC4/2016 Party Name:CADlLAHEALTHCARE LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01058/AMI7/
RLA File
:08/24/040/00324/AM 17/
Lic.No/Date:0810139218
05.12.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/570/2013-PI(Norms) dated 24.12.2013,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NC.
359
Case Nq.:181/17/82-
ALC4/2016
Party Nanie:CENTAURPHARMACEUTICALS PVT.
LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01I42/AM17/
RLA File
:03/94/040/00537/AM17/
Lic.No/Date:03i 0809606
05.12.2016
Defer Date:
Decision ; The Committee decided to ratify norms on pro-rata basis based on therecommendation of D/o Pharmaceuticals O.M. No. 35011/347/2016-PI(Norms) dated 03.04.2017,uploaded at the end of these minutes or as applied by the firm whichever Is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NC.
360
Case No.:131/17/82-
ALC4/2016
Party NameiELPPECHEMICALS PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01092/AM17/
RLA File
:03/94/040/00794/AM 17/
Lic.No/Date:0310809604
05.12.2016
Defer Date:
08.11.2017
57
Decision: Deferred.
Case No.: 128/17/82-
ALC4/2016
*arty Name:GLENMARKPHARMACEUTICALS LTD., ;
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
361 HQ File'01/82/050/01089/AM17/
RLA Filej03/94/040/00801/AM17/
Lic.No/Date:0310809609 ,05.12.2016
Defer Date:
08.11.2017 '
Decision: Deferred.
Case No.:82/17/82-ALC4/2016, Party NameiGOPINATH,CHEM-TECH LTD.,
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
362 HQ File,:OI/82/050/01043/AM17/
RLA File
:08/24/040/00318/AM17/
Lic.No/Date:0810139204
05.12.2016
Defer Date;,
08.11.2017
Decision: Deferred.
Case No.:31/l/82-ALC4/2017 Party Name:RONAK|CHEMICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
363 HQ File:01/82/050/01385/AM17/
RLA File:34/24/040/00225/AM17/
Lic.No/Date:34100427I9
05.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
364
Case No.:96/17/82-ALC4/2016 Party Name:CADILAHEALTHCARE LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01057/AM17/
RLA Filei:08/24/040/00326/AM17/ _ '
Lic.No/Date:0810139221
06.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
;365
Case No.:78/17/82-ALC4/2016;1
Party Name;INDIA GLYCOLS,LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred '
HQ File:01/82/050/01039/AM17/
RLA File
:05/23/040/00412/AM17/
Lic.No/Date:0510400608
06.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
366
Case No.:135/17/82-
ALC4/2016
Party Name:YASHOINDUSTRIES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status: '
Deferred
HQ File:01/82/050/01096/AM17/
RLA File
:03/95/040/00697/AM17/
Lic.No/Date:0310809629
06.12.2016
Defer Date:,
08.11.2017
Decision : Deferred.
!367
Case No.:79/17/82-ALC4/2016 Party Name:ABEERSPHARMACEUTICALS PVT
LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
58
HQ File01/82/050/01040/AM17/
RLA File
05/23/040/00426/AM17/
Lic.No/Date:0510400659
07.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
368
Case No.:80/17/82-ALC4/2016 Party NameiABEERSPHARMACEUTICALS PVT'
LTD
VIeet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01041/AM17/
RLA File
:05/23/040/00424/AM17/
Lic.No/Date:051040065 8 '
07.12.2016
Defer Date:,
08.11.2017
Decision : Deferred.
369
Case No.:83/17/82-ALC4/2016 Party NameilNDO PHYTOCHEMICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01044/AM17/
RLA File
:05/23/040/00361/AM17/
Lic.No/Date:0510400646
07.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
370
Case No.:126/17/82-
ALC4/2016
Party Name:AMINES &PLASTICIZERS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01087/AM17/
RLA File
:03/94/040/00803/AM17/
Lic.No/Date:0310809672
08.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
371
Case No.:127/I7/82-
ALC4/2016
Party Name:KAIRAVCHEMOFARBE INDUSTRIES
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01088/AM17/
RLA File
:03/94/040/00800/AM17/
Lic.No/Date:0310809684
08.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
372
Case No.:81/17/82-ALC4/2016 Party NameiBIO TECHOPHTHALMICS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01042/AM17/
RLA File
:08/24/040/00360/AM17/
Lic.No/Date:0810I39254
09.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
373
Case No.:36/l/82-ALC4/2017 Party NameiENVEE DRUGSPVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01390/AM17/
RLA File
:34/24/040/00232/AM17/
Lic.No/Date:3410042744
09.12.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/123/2012-PI(Norms) dated July 2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1 .RA concerned may take necessary action as per decision of NO.
59
Case No.:37/l/82-ALC4/2017 Party Name:ENVEE DRUGSPVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
374
HQ File:01/82/050/01391/AM17/
RLA File
:34/24/040/00239/AM17/
Lic.No/Date:3410042740
09.12.2016
Defer Date:
1
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.WI. No. 35011/123/2D12-Pi(Norms) dated July 2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoI.I.RA concerned may take necessary action as per decision of NO.
375
Case No.:29/l/82-ALC4/2017 Party Name:GULBRANDSENCHEMICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File'
;01/82/050/01383/AM17/
RLA File'
:34/24/040/0Q247/AM17/
Lic.No/Date:3410042741
09.12.2016
Defer Date:
08.11.2017
' Decision : Deferred.
376
Case No.:187/17/82-
ALC4/2016
Party Name:SRINIPHARMACEUTICALS
PRIVATE LIMITED
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01148/AM17/
RLA File'
:09/24/040/00483/AM17/Lic.No/Date:09I0064463
09.12.2016
Defer Date:
08.11.2017
' Decision : Deferred.
377
Case No.:148/17/82-
ALC4/2016
Party NameiSTERLING,AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01109/AM17/RLA File
:03/95/040/00703/AM17/Lic.No/Date:0310809708
09.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
.
378
Case No.:158/17/82-
ALC4/2016
Party Name:STERLING,AUXILIARIES PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017 ■
Status:
Deferred
HQ File
:01/82/050/01119/AM17/RLA File
:03/95/040/00690/AM17/Lic.No/Date:031080972709.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:159/17/82-
ALC4/2016
Party Name;UNIMAXLABORATORIES PVT.LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
379
HQ File'
:01/82/050/01120/AM]7/RLA File'
:03/95/040/00669/AM17/Lic.No/Date:0310809709
09.12.2016Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/119/2012-PI(Norms) dated July 2016. uploaded'at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoI.I.RA concerned may take necessary action as per decision of NC.
60
380
Case No.: 107/17/82-
ALC4/2016
Party Name:AMANTAHEALTHCARE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01068/AM17/
RLA File
:08/24/040/00361/AM17/
Lic.No/Date:0810139255
13.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
381
Case No.: 178/17/82-
ALC4/2016
Party Name:AMINES &PLASTICIZBRS LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01139/AM17/
RLA File
:03/94/040/00804/AM17/
Lic.No/Date:0310809744
13.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
382
Case No.:146/17/82-
ALC4/2016
Party Name:CIPLA LIMITED. Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01107/AM17/
RLA File
:03/94/040/00835/AM17/
Lic.No/Date:0310809781
13.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
383
Case No.:173/17/82-
ALC4/2016
Party Name:HARMONYLIFESCIENCE PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01I34/AM17/
RLA File
:03/94/040/00815/AM17/
Lic.No/Date:0310809753
13.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
384
Case No.:19/I/82-ALC4/2017 Party Name:IND-SWIFTLABORATORIES LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01373/AM17/
RLA File
:22/24/040/00081/AM17/
Lic.No/Date:2210015609 '
13.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
385
Case No.: 142/17/82-
ALC4/2016
Party Name:JINDAL DRUGSPRIVATE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01103/AM17/
RLA File
:03/94/040/00818/AM17/
Lic.No/Date:0310809757
13.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
386
Case No.: 143/17/82-
ALC4/2016
Party Name:JINDAL DRUGSPRIVATE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01104/AM17/
RLA File
:03/94/040/00819/AM17/
Lic.No/Date:0310809758
13.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
61
Case No.:160/17/82-
\LC4/2016
*arty Name:SIRMAXOjCHEMICALS PVT LTD
Meet No/Date:3/82-:
\LC4/2017
17.05.2017
Status:
)eferred •
387 HQ File01/82/050/01121/AM17/
RLA File
03/95/040/00492/AM17/
Lic.No/Date:0310809770
13.12.2016
Defer Date:
08.I1.2O17
Decision: Deferred.
CaseNo.:35/l/82-ALC4/2017 , i^arty Name:ALEMBIC'PHARMACEUTICALS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
388 HQ File..01/82/050/01389/AM17/
RLA File:34/24/040/00248/AM17/
Lic.No/Date:3410042751
14.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
Case No.:153/17/82-,
ALC4/2016
Party Name:PALADINPAINTS AND CHEMICALS
PVT LTD
Meet Nb/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
389 HQ File'-.01/82/050/01114/AM17/
RLA File'
:03/95/040/00699/AM17/
Lic.No/Date:0310809824
14.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
)
Case No.: 147/17/82-
ALC4/2016
Party Name:S M CHEMICALVAPI PRIVATE LIMITED
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
390 HQ File:01/82/050/01108/AM17/
RLA File'
:03/95/040/00659/AMI7/
Lic.No/Date:0310809834
14.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
391
Case No.:213/17/82-
ALC4/2016
Party NameiCADILA'HEALTHCARE LTD
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/01174/AM17/
RLA File
:08/24/040/00321/AM17/
Lic.No/Date:0810139295
15.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
'392
Case No.:177/17/82-
ALC4/2016
Party Name:CAMPHOR &ALLIED PRODUCTS
LIMITED,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/01138/AMI7/
RLA File
:03/94/040/00845/AMI7/
Lic.No/Date:0310809853
15.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
393
Case No.:176/17/82-
ALC4/2016 ■
Party NameiGITANJALICHEMICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01137/AM17/
RLA File
:03/94/040/00741/AM17/
Lic.No/Date:0310809851
15.12.2016
Defer Date:
08.11.2017
62
Decision: Deferred.
394
Case No.: 149/17/82-
ALC4/2016
Party NameiSTERLINGAUXILIARIES PVT LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/0 111 0/AM17/
RLA File
:03/95/040/00721/AM17/
Lic.No/Datei0310809874
15.12.2016
Defer Datei
08.11.2017
Decision: Deferred.
395
Case No.: 150/17/82-
ALC4/2016
Party NameiSTERLINGAUXILIARIES PVT LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01111/AM17/
RLA File
:03/95/040/00722/AMI7/
Lic.No/Datei0310809877
15.12.2016
Defer Datei
08.11.2017
Decision: Deferred.
396
Case No.:152/17/82-
ALC4/2ai6
Party NameiSTERLINGAUXILIARIES PVT LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01113/AM17/
RLA File
:03/95/040/00724/AM17/
Lic.No/Datei0310809913
15.12.2016
Defer Datei
08.II.20I7
Decision: Deferred.
397
Case No.:18/l/82-ALC4/2017 Party NameiFRESENIUSKABI ONCOLOGY LIMITED
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01372/AM17/
RLA File
I05/23/040/00446/AM17/
Lic.No/Date:0510400846
16.12.2016
Defer Datei
08.11.2017
Decision: Deferred.
398
Case No.:48/l/82-ALC4/2017 Party NameiBENZO CHEMINDUSTRIES PRIVATE
LIMITED
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01402/AM17/
RLA File
I03/94/040/00723/AM17/
Lic.No/Datei0310809935
19.12.2016
Defer Datei
08.11.2017
Decision: Deferred.
399
Case No.:49/l/82-ALC4/2D17 Party NameiBENZO CHEMINDUSTRIES PRIVATE
LIMITED
Meet No/Datei3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01403/AM17/
RLA File
I03/94/040/00725/AM17/
Lic.No/Date:0310809937
19.12.2016
Defer Datei
08.11.2017
Decision: Deferred.
400
Case No.:30/l/82-ALC4/2017 Party NameiSRIAM LABSPRIVATE LIMITED
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
63
HQ File
:01/82/05q/01384/AM17/RLA File
:09/24/040/00508/AM17/Lic.No/Date:091006448820.12.2016
Defer Date:i
08.11.2017 '
Decision: Deferred.
1
,401
Case No.:46/l/82-ALC4/2017 Party NameiKRISHNAANTIOXIDANTS PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01400/AMI7/RLA File
:03/94/040/00774/AM17/Lic.No/Date:03I081003621.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
402
Case No.:124/l/82-ALC4/2017 Party Name:TORINORGANICS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01478/AMI7/RLA File
:35/24/040/00070/AM16/Lic.No/Date:3510045080
21.12.2016
Defer Date:
08.11.2017
• Decision: Deferred.
Case No.:123/I/82-ALC4/2017 Party Name:HETERO DRUGSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
,403HQ File
:0I/82/050/01477/AM17/RLA File
:09/24/040/00519/AM17/Lic.No/Date:091006450822.12.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/130/2017-PI(Norms) dated 12.04.2017,,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
404
Case No.:50/l/82-ALC4/2017 Party Nanie:CLARIANT'INDIA LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01404/AM17/RLA File'
;03/94/040/00881/AM17/Lic.No/Date:031081009923.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
.
405
Case No.:125/l/82-ALC4/2017 Party Name:TORIN'ORGANICS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01479/AMI7/ilLA File
35/24/040/00045/AM17/Lic.No/Date:3 510045085
23.12.2016Defer Date:
08.11.2017 '
Decision: Deferred.
—
dflK r
Case No.:61/I/82-ALC4/2017 Party Name:ADlSHANKCHEMICALS PVT.LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File01/82/050/01415/AM17/
File!03/94/040/00680/AM17/ :
Lic.No/Date:0310810150 ■
28.12.2016 (Defer Date:'
18.11.2017 '
Decision: Deferred.
64
4071
i
Case No.:94/l/82-ALC4/2017 Party Name:BIO TECHOPHTHALMICS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File:01/82/050/01448/AM17/
RLA File
:08/24/040/00399/AM17/
Lic.No/Date:0810139402
28.12.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/353/2016-PI(Norms) dated Sept. 2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Voi.l.RA concerned may take necessary action as per decision of NO.
408
Case No.:4/l/82-ALC4/2017 Party Name:RASULAPHARMACEUTICALS &
FINE CHEMICALS
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01358/AM17/
RLA File
:09/24/040/00509/AM17/
Lic.No/Date:0910064538
28.12.2016
Defer Date:
08.11.2017
Decision : Deferred.
409
Case No.:60/I/82-ALC4/2017 Party Name:AGIOPHARMACEUTICALS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01414/AM17/
RLA File
:03/94/040/00836/AM17/
Lic.No/Date:0310810193
29.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
410
Case No.:6/l/82-ALC4/2017 Party Name:INFlNITYLABORATORIES PVT.LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01360/AM17/
RLA File
:22/24/040/00083/AM17/
Lic.No/Date:2210015625
29.12.2016
Defer Date:
08.11.2017
Decision: Deferred.
'411
Case No.:58/l/82-ALC4/2017 Party Name:GlTANJALICHEMICALS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01412/AM17/
RLA File
:03/94/040/00855/AM17/
Lic.No/Date:0310810278
03.01.2017
Defer Date:
08.11.2017
Decision : Deferred.
412
Case No.:32/l/82-ALC4/2017 Party Name:ALEMBICPHARMACEUTICALS LTD
Meet No/Date:3/82-,
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01386/AM17/
RLA File
:34/24/040/00268/AM17/
Lic.No/Date:3410042818
04.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
413Case No.:59/l/82-ALC4/2017 Party Name:HEMA DYE
CHEM PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
Status:
Deferred
65
17.05.2017
HQ File:01/82/050/01413/AM17/
RLA File
:03/94/040/00851/AM17/
Lic.No/Date;0310810295
04.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
414
Case No.:22/l/82-ALC4/2017 Party Name:ASCENT'FINECHEM PVT. LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01376/AM17/
RLA File,
;08/24/040/00388/AMI7/
Lic.No/Date:0810139477 ■
05.01.2017
Defer Date:,
08.11.2017 ,
Decision: Deferred.
Case No.:62/I/82-ALC4/2017 Party Name:CTXLIFESCIENCES PVT LTD,
1
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
415
HQ File:01/82/050/014I6/AMI7/
RLA Filei:03/94/040/00854/AM17/ '
Lic.No/Date:0310810349 !05.01.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o|Pharmaceuticals forwarded vide O.M. No. 35011/206/2014-PI(Norms) dated Oct. 2014 uploadedlat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP'Vol.1.RA concerned may take necessary action as per decision of NO.
416
Case No.:53/l/82-ALC4/2017 Party Name:CIPLA LIMITED. Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01407/AM17/
RLA File;:03/94/040/00915/AM17/
Lic.No/Date:0310810380
06.01.2017
Defer Date:'
08.11.2017
i Decision : Deferred.
Case No.:26/l/82-ALC4/2017 Party Name:HETERO DRUGSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
:4i7'
HQ Filei:01/82/050/0I380/AM17/
RLA File'
:09/24/040/00533/AM17/
Lic.No/Date:0910064559
06.01.2017
Defer Date:
Decision :The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals fonvarded vide O.Wl. No. 35011/494/2012-PI(Norms) dated 17.10.2012,'uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.l.RA concemed may take necessary action as per decision of NC.
418
Case No.:56/l/82-ALC4/2017 Party Name:GLENMARKPHARMACEUTICALS LTD.,
Meet No/Date:3/82-,
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/01410/AMI7/
RLA File
:03/94/040/00822/AM17/
Lic.No/Date:0310810390
09.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
419
Case No.:55/l/82-ALC4/2017 Party Name:AARTI DRUGSLIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
66
HQ File:01/82/050/01409/AM17/
RLA File'
:03/94/040/00900/AM17/
Lic.No/Date:0310810464
11.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
420
Case No.:54/l/82-ALC4/2017 Party Name:AARTIINDUSTRIES LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:0I/82/050/01408/AM17/
RLA File
:03/94/040/00805/AM17/
Lic.No/Date:03I0810483 '
12.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
421
Case No.:27/l/82-ALC4/2017 Party NameiCADILA'HEALTHCARE LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01381/AM17/
RLA File
:08/24/040/00323/AM17/
Lic.No/Date:0810139533
12.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
422
Case No.:63/l/82-ALC4/2017 Party NameiFINE ORGANICINDUSTRIES PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01417/AM17/
RLA File
:03/94/040/0G919/AM17/
Lic.No/Date:0310810497
12.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
423
Case No.:28/l/82-ALC4/2017 Party Name:CADlLAHEALTHCARE LTD
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File:01/82/050/01382/AM17/
RLA File
:08/24/04D/00430/AM17/
Lic.No/Date:08I0139539
13.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
424
Case No.:52/l/82-ALC4/2017 Party NameiCIPLA LIMITED. Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01406/AM17/
RLA File
;03/94/D40/00942/AM17/
Lic.No/Date:03108105I9
13.01.2017
Defer Date:
08.11.2017
Decision : Deferred.
425
Case No.:64/l/82-ALC4/2017 Party Name:KAIRAVCHEMOFARBE INDUSTRIES
LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01418/AM17/
RLA File
:03/94/040/00918/AM17/
Lic.No/Date:0310810510
13.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
426 |Case No.:25/l/82-ALC4/2017 Party Nanie:AUROBINDO Meet No/Date:3/82- Status:
67
PHARMA LIMITED ALC4/20I7
17.05.2017
Deferred
HQ Filel:01/82/050/01379/AM17/
RLA File!
:09/24/040/00550/AM17/
Lic.No/Date:09I0064590
16.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
427
Case No.:n5/l/82-ALC4/2017'Party Name:BIO TECH|OPHTHALMICS PVT LTD !
(
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status;
Deferred
HQ File:01/82/050/01469/AMI7/
RLA Filei
:08/24/040/00381/AM17/
Lic.No/Date:0810I39552
16.01.2017
Defer Date:'
08.11.2017
Decision: Deferred.
428
Case No.:21/l/82-ALC4/2017 , Party Name:PCL OIL &|SOLVENTS LTD.,
Meet No/Date:3/82-[ALC4/20I7
17.05.2017
Status:
Deferred
HQ File,:01/82/050/01375/AM17/
RLA Filei
:05/24/040/00506/AM17/
Lic.No/Date:05I0401302 ■
16.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
429
Case No,:34/I/82-ALC4/2017 Party NameiREINEiLIFESCIENCE
Meet No/Date;3/82-'
ALC4/2017 '17.05.2017
Status: ,
Deferred
HQ File:01/82/050/01388/AM17/
RLA File:
:34/24/040/00276/AM17/
Lic.No/Date:3410042838 '
16.01.2017
Defer Date:i
08.11.2017
Decision: Deferred.
Case No.:7/l/82-ALC4/2017 Party NameiSUN,PHARMACEUTICAL
INDUSTRIES LTD., ,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
430.
HQ File!
:01/82/050/01361/AM17/ _ ;RLA Filei
:05/24/040/00475/AM17/ !Lic.No/Date:0510401297 '
16.01.2017
Defer Date: i
Decision : The Committee decided to ratify norms based on the recommendation of D/oiPharmaceuticais forwarded vide O.M. No. 35011/96/2012-PI(Norms) dated July 2012, uploaded,at the end of these minutes and import item at Si.No.1, 3 to 14 aiiowed on^ prorate basis or as'applied by the firm whichever is iess under para 4.07 of HBP VoI.I.RA concerned may takenecessary action as per decision of NO.
431,
Case No.:33/l/82-ALC4/2017 Party Name:SUPERINDUSTRIAL LINING PVT'
LTD
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred '
HQ File:01/82/050/01387/AMi7/
RLA File,:34/24/040/00288/AMI7/ ■
Lic.No/Date:3410042837
16.01.2017
Defer Date:'
08.11.2017
Decision: Deferred._ j
432
Case No.:69/l/82-ALC4/2017 Party Name:KOPRAN'RESEARCH
LABORATORIES LTD.
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Approved
68
HQ File
:01/82/050/01423/AM17/
RLA File.
:03/94/040/00949/AM17/
Lic.No/Date:0310810565
17.01.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/296/2012-PI(Norms) dated Sept. 2012,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
4331
Case No.:24/I/82-ALC4/2017 Party Name:SUNPHARMACEUTICAL
INDUSTRIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/OI378/AM17/
RLA File
:05/24/040/00508/AMI7/
Lic.No/Date:051040I320
17.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
434
Case No.:67/l/82-ALC4/2017 Party Name:BDRPHARMACEUTICALS
INTERNATIONAL PVT. LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File;01/82/050/0142I/AM17/
RLA File
:03/94/040/00950/AM17/
Lic.No/Date:0310810626
19.01.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/168/2016-PI(Norms) dated27th March 2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NC.
435
Case No.:68/l/82-ALC4/2017 Party Name:GOPALDASVISRAM & CO.LTD.
Meet No/Date:3/82-i
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01422/AM17/
RLA File
:03/94/040/00966/AM17/
Lic.No/Date:0310810631
19.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
436
Case No.:38/l/82-ALC4/2017 , Party Name:BELCHEM INDS.INDIA PVT. LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;0I/82/050/01392/AM17/
RLA File
:03/94/040/00699/AM17/
Lic.No/Date:03I08I0688
23.01.2017
Defer Date:
08.11.2017
Decision: Deferred.
437
Case No.:I14/l/82-ALC4/2017 Party Name:BIO TECHOPHTHALMICS PVT LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01468/AM17/
RLA File
:08/24/040/00379/AM17/
Lic.No/Date:0810139595
25.01.2017
Defer Date:
08,11.2017
Decision: Deferred.
438
Case No.:3/l/82-ALC4/2017 Party Name:DHANUKALABORATORIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File RLA File Lic.No/Date:0510401381 Defer Date:
69
: :01/82/050/01357/AM17/ :05/23/040/00507/AM17/ 25.01.2017 08.11.2017
.Decision : Deferred.
i4391
Case No.:65/l/82-ALC4/2017 Party Name:K V AROCHEMPVT. LTD
.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01419/AM17/
RLA File
:03/94/040/00976/AM17/Lic.No/Date:0310810753
25.01.2017
Defer Date:
08.11.2017
, ,Decision: Deferred.
.
^40
Case No.:2/l/82-ALC4/2017 Party Name:ALKAL01DSCORPORATION
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:
:0I/82/050/01356/AM17/
RLA File
:02/24/040/00216/AM17/Lic.No/Date:0210207287
27.01.2017
Defer Date:
08.11.2017
Decision : Deferred.
Case No.:39/l/82-ALC4/2017 Party NameiNECTARLIFESCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
441.
HQ File
:0I/82/050/01393/AMI7/RLA File,
:22/24/040/00097/AMI7/Lic.No/Date:221001563827.01.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o!Pharmaceuticals forwarded vide O.M. No. 35011/13/2Q14-PI(Norms) dated Sept 2014, uploadediat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1 .RA concerned may take necessary action as per decision of NO.
442
Case No.;113/l/82-ALC4/2017i Party Name:CORONAiREMEDIES PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File!
:01/82/050/01467/AM17/RLA File!:08/24/040/00387/AM17/
Lic.No/Date:0810139606
30.01.2017
Defer Date:,08.11.2017
Decision: Deferred.
443
CaseNo.:13/l/82-ALC4/2017 j Party Name:MEDICAMEN!BIOTECH LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01367/AMI7/RLA File,
:05/24/040/00543/AMI7/ 'Lic.No/Date:051040142131.01.2017
Defer Date:
08.11.2017
Decision : Deferred.
_
444
CaseNo.:95/l/82-ALC4/2017 'Party Name:CADILAiPHARMACEUTICALS LTD.
VIeet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File,0I/82/050/01449/AM17/
■ILA File08/24/040/00449/AM17/
Lic.No/Date:0810139633 '01.02.2017
Defer Date:08.11.2017
Decision : Deferred.
70
445
Case No.:105/l/82-ALC4/2017 Party NameiCADILAHEALTHCARE LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01459/AM17/
RLA File
;08/24/040/00451/AM17/
Lic.No/Date:0810139644
02.02.2017
Defer Datei
08.11.2017
Decision: Deferred.
446
Case No.:108/l/82-ALC4/2017 Party NameiCADILAHEALTHCARE LTD
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01462/AM17/
RLA File,
:08/24/040/00450/AM17/
Lic.No/Datei08I0139643
02.02.2017
Defer Datei
08.11.2017
Decision: Deferred.
447,
Case No.:16/l/82-ALC4/2017 Party NameiJUBILANT LIFESCIENCES LIMITED
Meet No/Datei3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File
:Dl/82/050/01370/AM17/
RLA File
:05/23/040/00431/AM17/
Lic.No/Datei05I0401465
02.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
448
Case No.:14/l/82-ALC4/2017 Party NameiPAYALPOLYPLAST PRIVATE
LIMITED
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;01/82/050/01368/AM17/
RLA File
;05/24/040/00468/AM17/
Lic.No/Date:0510401470
02.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
449
Case No.:15/l/82-ALC4/2017 Party NameiPAYALPOLYPLAST PRIVATE
LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01369/AM17/
RLA File
I05/24/040/0D493/AM17/
Lic.No/Datei0510401471
02.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
450
Case No.:8/l/82-ALC4/2017 Party NameiHPL ADDITIVESL1MITED(F0RMERLYKNOWN HIGH POLYMER
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01362/AM17/
RLA File
I05/23/040/00458/AMI7/
Lic.No/Datei05I0401502
03.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
4511
Case No.:10/l/82-ALC4/2017 Party NameiJODAS EXPOIMPVT.LTD.,
Meet No/Datei3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File
:0I/82/050/0I364/AM17/
RLA File
I05/23/040/0D521/AM17/
Lic.No/Datei0510401481
03.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
71
Case No.:9/l/82-ALC4/2017 Party Name:KLJ ORGANICLTD
VIeet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
At>2 HQ File!:01/82/050/01363/AM17/
RLA File
:05/23/040/00520/AMI7/
Lic.No/Date:0510401500
03.02.2017
Defer Date:
08.II.20I7
Decision: Deferred.
453
Case No.: 12/1/82-ALC4/2017 Party Name:PAYALPOLYPLAST private!LIMITED S
Meet No/Date:3/82-
ALC4/2017-
17.05.2017 !
Status:
Deferred
HQ Filei:01/82/050/01366/AM17/
RLA File,;05/24/040/00504/AM17/
Lic.No/Date:0510401484 '03.02.2017
Defer Date:,
08.11.2017 ■
Decision : Deferred.
454
Case No.:117/l/82-ALC4/2017!Party Name:CADILA,HEALTHCARE LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01471/AM17/
RLA File
:08/24/040/00452/AM17/
Lic.No/Date:0810139654
06.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
455
Case No.:116/l/82-ALC4/2017 Party Name:CADILAiHEALTHCARE LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01470/AM17/
RLA File
:08/24/040/00453/AM 17/
Lic.No/Date:0810139668
07.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
456,
Case No.:41/l/82-ALC4/2017 Party NameiGODAVARIDRUGS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File':01/82/050/01395/AM17/
RLA File>
:09/24/040/00607/AM17/
Lic.No/Date:0910064654
07.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
457
Case No.:98/l/82-ALC4/2017 Party Name:lND-SWIFTLABORATORIES LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01452/AM17/
RLA File
:22/24/040/00I01/AM17/
Lic.No/Date:2210015648
07.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
^458
Case No.:112/l/82-ALC4/2017 Party NameiDR. REDDYSLABORATORIES LIMITED
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File;01/82/050/0I466/AM17/
RLA File
:09/24/040/00573/AM17/
Lic.No/Date:0910064671
08.02.2017
Defer Date:
72
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/293/2014-PI(Norms) dated November 2014,uploaded at the end of these minutes or as applied by the firm whichever Is less under para 4.07of HBP Vol.1 .RA concerned may take necessary action as per decision of NO.
459
Case No.:n/l/82-ALC4/2017 Party Name:SUN'PHARMACEUTICAL
INDUSTRIES LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01365/AM17/
RLA File^
:05/24/040/00557/AM17/
Lic.No/Date:0510401582
08.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
460
Case No.:96/l/82-ALC4/2017 , Party Name:AMI ORGANICS^PVT LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:0I/82/050/0I450/AM17/
RLA File
:52/24/040/00075/AM]7/
Lic.No/Date:5210042175
10.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
461
Case No.:97/l/82-ALC4/2017 Party Name:AMI ORGANICSPVT LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01451/AM17/
RLA File':52/24/040/00076/AM17/
Lic.No/Date:5210042176 '
10.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
462
Case No.:17/l/82-ALC4/2017 Party Name:MOREPENLABORATORIES LTD.,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
HQ File:01/82/050/01371/AM17/
RLA File
:05/24/040/00576/AM17/
Lic.No/Date:0510401608
13.02.2017
Defer Date:
Decision ; The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/378/2016-PI{Norms) dated 8th Sept. 2017,'uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07,of HBP Vol. 1. RA concerned may take necessary action as per decision of NC.
463
Case No.:110/l/82-ALC4/2017 Party Name:JUBILANT LIFESCIENCES LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01464/AMI7/
RLA File
:05/23/040/00499/AM17/
Lic.No/Date;0510401624
14.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
464
Case No.:120/l/82-ALC4/2017 Party Name:DEEPAKNOVOCHEM
TECHNOLOGIES LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01474/AMI7/
RLA File
:31/83/040/00136/AM17/
Lic.No/Date:3110066589
15.02.2017
Defer Date:
08.11.2017 ^
73
Decision : Deferred.
Case No.:l 11/1/82-ALC4/2017; Party Name:JUBILANTjGENERICS LTD
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
4bb HQ File01/82/050/01465/AM17/
RLA File'.05/23/040/00530/AM17/
Lic.No/Date:0510401659
15.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
466
Case No.:107/l/82-ALC4/2017,Party Name:SCOTT EDIL'ADVANCE RESEARCH LAB,
AND EDU LTD
Meet No/Date:3/82-^
ALC4/2017
17.05.2017
Status:
Deferred
HQ File;:01/82/050/01461/AM17/ ,
RLA File
:22/24/040/00105/AM17/
Lic.No/Date:2210015655 ,15.02.2017
Defer Date:,
08.11.2017 '
Decision : Deferred.
467:
Case No.: 106/1/82-ALC4/2017'Party Name:PARAMOUNT'AROMACHEM PVT.LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ Filej;01/82/050/01460/AM17/ 1
RLA File:
:05/24/040/00581/AM17/
Lic.No/Date:051040I672 ;
16.02.2017
Defer Date:;
08.11.2017 ,
Decision : Deferred.
468
Case No.;109/l/82-ALC4/2017 Party NameiHELLO PAINTS(P) LTD
i
Meet No/Date:3/82-
ALC4/2017
17.05.2017 I
Status:
Deferred
HQ File:01/82/050/01463/AM17/
RLA File:;05/23/040/00559/AM17/
Lic.No/Date:0510401721 ■
20.02.2017
Defer Date:'
08.11.2017
1 Decision: Deferred.
Case No.:119/l/82-ALC4/2017 Party NameilNTASPHARMACEUTICALS LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved .
469
HQ File:01/82/050/01473/AM17/
RLA File
;08/24/040/00471/AM17/
Lic.No/Date:0810139760
22.02.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o'Pharmaceuticals forwarded vide O.M. No. 35011/814/2014-PI(Norms) dated August 2014,'uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO.
Case No.:100/l/82-ALC4/2017 Party NameiMAHIMA LIFESCIENCES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
470HQ File:01/82/050/01454/AM17/
RLA File
:05/24/040/00587/AM17/
Lic.No/Date:0510401781
23.02.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/222/2016-PI(Norms) dated Sept. 2017,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07'
74
of HBP Vol.1.RA concerned may take necessary action as per decision of NC.
Case No.:101/I/82-ALC4/2017 Party NameiMAHIMA LIFESCIENCES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
471
HQ File
:01/82/050/01455/AMI7/
RLA File
:05/24/040/00586/AM17/
Lic.No/Date:051040178023.02.2017
Defer Date:
08.11.2017
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/729/2015-PI(Norms) dated 27.4.2016, uploadedat the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVoI.I.RA concerned may take necessary action as per decision of NC.
Case No.:102/l/82-ALC4/2017 Party Name:SENTISSPHARMA PVT.LTD.
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
472'
HQ File
:01/82/050/01456/AM17/
RLA File
:05/24/040/00600/AM17/
Lic.No/Date:0510401782
23.02.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M.No. 35011/281/2016-PI(Norms) dated 15.09.2017, uploaded at the end ofthese minutes or as applied by the firm whichever is less under para 4.07 of HBP VoI.I.RAconcerned may take necessary action as per decision of NC.
473
Case No.:103/l/82-ALC4/20I7 Party Name:SWATIMENTHOL & ALLIED
CHEMICALS LTD.,
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Deferred
HQ File
:01/82/050/01457/AMI7/
RLA File
:29/24/040/00009/AMI7/
Lic.No/Date:2910025281
23.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
474
Case No.:104/l/82-ALC4/2017 Party Name:SWATlMENTHOL & ALLIED
CHEMICALS LTD.,
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01458/AM17/
RLA File
:29/24/040/00008/AM17/Lic.No/Date:2910025280
23.02.2017
Defer Date:
08.11.2017
Decision : Deferred.
475
Case No.:122/l/82-ALC4/2017 Party Name:ARIHANTSIDDHAR LABORATORIES
PVT.LTD
Meet No/Date;3/82-
ALC4/2017
17.05.2017
Status:
Deferred
HQ File:01/82/050/01476/AM17/
RLA File
:31/83/040/00162/AM17/
Lic.No/Date:3110066602
28.02.2017
Defer Date:
08.11.2017
Decision: Deferred.
476
Case No.:99/l/82-ALC4/2017 Party Name:MAHIMA LIFESCIENCES PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File
■.01/82/050/01453/AM17/RLA File:05/24/040/00592/AM17/
Lic.No/Date:051040179428.02.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o
75
Pharmaceuticals forwarded vide O.M. No. 35011/28/2013-Pl(Norms) dated April 2015 uploaded!at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBPVol.1.RA concerned may take necessary action as per decision of NC. ^
Case No.:121/l/82-ALC4/2017,Party NameiCLEAN SCIENCE,AND TECHNOLOGY'PVT.LTD. ;
Meet No/Date:3/82-iALC4/2017
17.05.2017
Status:
Deferred
4/7 HQ Filel:01/82/050/01475/AM17/
RLA File!:31/83/040/00168/AM17/
Lic.No/Date;3110066608
02.03.2017
Defer Date:'
08.11.2017 ,
Decision: Deferred.
<:ase No.:23/l/82-ALC4/2ai7 , 1̂ arty Name:V.D.H. 1DRGANICS PVT. LTD ;
V4eet No/Date:3/82- 1\LCM2m
17.05.2017
Status:
)eferred
478 ■HQ File'01/82/050/01377/AM17/
RLA Filei05/24/040/00531/AM17/
Lic.No/Date:0510401847
33.03.2017
Defer Date:
38.11.2017
Decision : Deferred. . .
Case No.:l/l/82-ALC4/2ai7 , Party Name:JUBILANT LIFE,SCIENCES LIMITED
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Deferred ,
479 HQ File:01/82/050/01355/AM17/
RLA File.:05/23/040/00553/AM17/
Lic.No/Date:0510401912
09.03.2017
Defer Date:'
08.11.2017
Decision: Deferred.
.
Case No.:l/3/82-ALC4/2017 Party Name;DIVISLABORATORIES LTD
Meet No/Date:3/82-ALC4/2017
17.05.2017
Status:
Approved
480
HQ File:01/82/050/00002/AMI8/
RLA File:09/24/040/00014/AM18/
Lic.No/Date:0910064932
21.04.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals forwarded vide O.M. No. 35011/209/2016-PI(Norms) dated Sept. 2016.uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
-
Case No.:3/3/82-ALC4/2ai7 Party Name:CADILAHEALTHCARE LTD
Meet No/Date:3/82-
ALC4/20I7
17.05.2017
Status:
Approved
481
HQ File:01/82/050/00004/AM18/
RLA File:08/24/040/00007/AM18/
Lic.No/Date:0810140133
24.04.2017
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o,Pharmaceuticals forwarded vide O.M. No. 35011/289/2016-PI(Norms) dated September 2017,,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07'of HBP Vol.1.RA concerned may take necessary action as per decision of NC
482
Case No.:2/3/82-ALC4/2017 Party Name:SRIAM LABSPRIVATE LIMITED
Meet No/Date:3/82-
ALC4/2017
17.05.2017
Status:
Approved
HQ File,RLA File Lic.No/Date:0910064939 Defer Date:
76
:01/82/050/00003/AM18/ :09/24/040/00697/AM17/ '24.04.2017 ^
Decision : The Committee decided to ratify norms based on the recommendation of D/oiPharmaceuticals forwarded vide O.M. No. 35011/97/2015-PI(Norms) dated August 2015,uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07of HBP Vol.1.RA concerned may take necessary action as per decision of NO
Case No.:4/3/82-ALC4/2017 Party Name:SRIAM LABSiPRIVATE LIMITED
Meet No/Date:3/82-|ALC4/2017
17.05.2017 ^ :
Status:
Approved '
1
4831
HQ File:01/82/050/00005/AM18/
RLA File
;09/24/040/00698/AM17/
Lic.No/Date:0910064941 ,24.04.2017
Defer Date:
1
1
1
Decision : The Committee decided to ratify norms based on the recommendation of D/oPharmaceuticals O.M. No. 35011/757/2015-PI(Norms) dated 2nd May 2016, uploaded at the endof these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC.
1 Case No.:6/3/82-ALC4/2017 Party NameiHETERO LABSlLIMITED
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Approved
484
HQ File:01/82/050/00007/AM18/
RLA File
:09/24/040/00053/AMI8/
Lic.No/Date:0910064990
01.05.2017
Defer Date:
•
Decision : The Committee decided to ratify norms based on the recommendation of D/o>Pharmaceuticals O.M. No. 35011/226/2014-Pl(Norms) dated Oct. 2014, uploaded at the end of,these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.RAconcerned may take necessary action as per decision of NC
485!
Case No.:5/3/82-ALC4/2017 Party Name:PCL OIL &SOLVENTS LTD.
Meet " No/Date:3/82-'
ALC4/2017
17.05.2017 i
Status:
Deferred
HQ File,:01/82/050/00006/AM18/
RLA File
;05/24/040/00043/AMI8/
Lic.No/Date:05I0402397
01.05.2017 ,Defer
Date:08.11.2017
1
Decision: Deferred.
486
Case No.:225/I3/82-
ALC4/2014
Party Narae:DELTA.FINOCHEM PVT.LTD.
Meet No/Date:3/82-
ALC4/2017
17.05.2017J
Status:
Deferred
HQ File:01/82/050/01228/AM15/
RLA File
:03/94/040/00397/AM15/
Lic.No/Date:0310788514
28.08.2014
Defer Date:
08.11.2017
Decision: Deferred.
487
Case No.:7/3/82-ALC4/20I7 Party Name:KAIRAVCHEMOFARBE
INDUSTRIES LTD.
Meet No/Date:3/82-'
ALC4/2017
17.05.2017
Status:
Deferred
HQ File,:01/82/050/00008/AM18/
RLA Filei:03/94/040/00075/AM18/
Lic.No/Date:0310813093
05.05.2017
Defer ;Date:08.11.2017!
'Decision: Deferred.
77
Manual Agenda of NC Meeting No. 03/82/2017Scheduled to be held on 25.09.2017
Case No. B- 01M.No.OS/AWl-lB
Date 25.09.2017
M/s. RA Chem Pharma LtdFile No. 01/82/050/00857/AM 16
RLA NO.09/24/040/00045/AM 16Adv.Auth. No. 0910062053 dated. 21.05.2015Adv.Auth. No. 0910061970 dated. 01.05.2015
Decision; The Committee considered this case for revision of norms as per agenda. IheCommittee decided to revised norms based on the recommendation of D/o PharmaceuticalsO.M.No.35011/682/2015-PI(Norms) dated 22.3.2016, uploaded at the end of these minutes or asapplied by the firm whichever is iess. RA concerned may take further necessary action as per thedecision of NC.
Case No. B- 02
M.NO.03/AM-18
Date 25.09.2017
M/s. RA Chem Pharma Ltd
File No. 01/82/050/00363/AM 16
RLA NO.09/24/040/00559/AM 15
Adv.Auth. No. 0910061477 dated. 02.01.2015
Decision: The Committee considered this case for correction in description of import item as peragenda. The Committee decided correct the description of import item to read as "3-Amlno-4-Methyl-2-thiophene Carboxylic Acid Methyl Ester" without any other change. RA concernedmay take further necessary action as per the decision of NC.
Case No. B- 03
M.NO.03/AM-18
Date 25.09.2017
M/s. Organica Aromatics Pvt LtdFiie No. 01/82/050/01105/AM 12
RLA NO.07/24/040/00314/AM 12
Adv.Auth. No. 0710084171 dated. 23.11.2011
Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to ratify norms on repeat basis as per the eariier decision of NC meetingNo.15/82 dated 07.07.2009, uploaded at the end of these minutes or as appiied by the firmwhichever is less. RA concerned may take further necessary action as per the decision of NC.
Case No. B- 04
M.NO.03/AM-18
Date 25.09.2017
M/s. KLJ Plasticizers Ltd
File No. 01/82/050/00280/AM 15
RLA NO.05/23/040/00536/AM 14
Adv.Auth. No. 0510383274 dated. 01.04.2014
Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to send copy of application to DIPP (Chemical) for comments and deferredthe case.
Case No. B- 05 M/s. RA Ghem Pharma
78
M.NO.03/AM-18
Date 25.09.2017
File No. 01/82/050/00651/AM 15
Adv.Auth. No. 0910055973 dated. 09.05.2013
Adv.Auth. No. 0910057516 dated. 10.09.2013
Adv.Auth. No. 0910059417 dated. 25.02.2014
Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to send a copy of application to D/o Pharmaceuticals for comments anddeferred the case.
Case No. B- 06
M.No.03/A!\/l-18
Dale 25.09.2017
M/s. Tide Industries
File No. 01/82/050/00531/AMIS
RLA F.No 34/24/040/00138/AIV115Adv.Aulh. No. 3410040551 dated 15.09.2014
Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to ratify norms on repeat basis based on the recommendation of D/o C&PCU.O.No.14010/40/2011-Ch-ll dated 04.03.2016, uploaded at the end of these minutes or asapplied by the firm whichever is less. RA concerned may take further necessary action as per thedecision of NC.
Case No. B- 07
M.No.03/Al\/l-18
Date 25.09.2017
M/s. Tide industries
File No. 01/82/050/00458/AM 16
RLA No.34/24/040/00310/AM15
Adv.Auth. No. 3410040978 dated. 23.02.2015
Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to ratify norms on repeat basis based on the recommendation of D/o C&PCU.O.No.14010/40/2011-Ch-ll dated 04.03.2016, uploaded at the end of these minutes or asapplied by the firm whichever is less. RA concerned may take further necessary action as per thedecision of NC.
Case No. B- 08
M.NO.03/AM-18
Date 25.09.2017
M/s. H.J. Arochem (P) LtdFile No. 01/82/050/01484/AM 15
RLA No.08/24/040/00341/AM15
Adv.Auth. No. 0810134067 dated. 16.12.2014
Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to send a copy of application to DIPP ((Chemical) for comments and deferredthe case.
Case No. B- 09
M.NO.03/AM-18
Date 25.09.2017
M/s KLJ Piasticlzers Ltd
File No. 01/82/050/00772/AM 11
RLA No.05/23/040/00078/ AM11
Adv.Auth. No. 0510267557 dated. 06.07.2010
Decision: The Committee considered this case for amendment in description of import item as peragenda. The Committee decided to send a copy of application to C&PC for comments anddeferred the case.
79
Case No. B-10
M.NO.03/AM-18
Date 25.09.2017
Mis Aurobindo Pharma Ltd
File No. 01/82/050/01164/AM 17
RLA No.09/24/040/00330/AM17
Adv.Auth. No. 0910064257 dated. 10.10.2016
Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to revise the norm based on the recommendation of D/o PharmaceuticalO.M.No.35011/173/2016-Pl(Norms) dated 26.09.2016. upioaded at the end of these minutes oras applied by the firm whichever is less. RA concerned may take further necessary action as perthe decision of NC.
Case No. B-11
M.NO.03/AM-18
Date 25.09.2017
M/s Fresenius Kabi Oncology LtdFile No. 01/82/050/00788/AM 17
RLA No.05/23/040/00252/ AMI 7
Adv.Auth. No. 0510399569 dated. 29.08.2016
Decision: The Committee considered this case for revision of norms as per agenda. TheCommittee decided to send a copy of application to D/o Pharmaceuticals for comments anddeferred the case.
Case No. B-12
M.NO.03/AM-18
Date 25.09.2017
M/s Aarti industries Ltd
Fiie No. 01/82/050/00411/AM 16
RLA No.03/94/040/00882/AM15
Adv.Auth. No. 0310792412 dated. 29.12.2014
Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to send a copy of application to DlPP(Chemical) for comments and deferredthe case.
Case No. B-13
M.NO.03/AM-18
Date 25.09.2017
M/s Enaltec Labs Pvt Ltd
Fiie No. 01/82/050/01820/AM 16
RLA No.03/94/040/00906/AM16
Adv.Auth. No. 0310802288 dated. 08.02.2016
Decision: The Committee considered this case for correction in description of import items as peragenda. The Committee decided to amend the description of import items as mentioned inadvance authorisation. RA concerned may take further necessary action as per decision of NC.
Case No. B-14
M.NO.03/AM-18
Date 25.09.2017
M/s Maghmani LLPFiie No. 01/82/171/00353/AM 17
Decision: The Committee considered this case for revision of SION A-343 and A-3488 published
80
for 'Paracetamole' as per agenda.
The Committee recommended to revise SION A-343 and A-3488 as per recommendation of D/oPharmaceuticals O.I\/I.No.35011/351/2016-PI(Norms) dated 07.04.2017 as per details givenbelow:-
SION No. Qty. OfParacetamole
Description of Raw Materials Existingqty.
Revised
qty.
A-343 1kg 1. Phenol 1.1kg 1.1kg
2. Sodium Nitrite G.95kg 0.95kg
3. Acetic Anhydride 0.95kg 0.75kg
A-3488 1kg 1. Para Amino Phenol 0.91kg 0.80kg
2. Acetic Anhydride 0.85kg 0.75kg
The above modification/revision of SIONs would be effect from date of issue of Public Notice.
Case No. B-15
M.NO.03/AM-18
Date 25.09.2017
M/s. H.J. Arochem (P) LtdFile No. 01/82/050/01268/AM 15
RLA No.08/24/040/00265/ AM15
Adv.Auth. No. 0810133768 dated. 10.11.2014
Decision: The Committee considered this case for ratification of norms as per agenda. TheCommittee decided to send a copy of application to DlPP(Chemical) for comments and deferredthe case.
Case No. B-16
M.NO.03/AM-18
Date 25.09.2017
M/s. Jubilant Life Sciences Ltd
File No. 01/82/050/00431/AM 17
RLA No.05/23/040/00172/AM17
Adv.Auth. No. 0510398972 dated. 04.07.2016
Decision: The Committee considered this case for correction In export product of norms as peragenda. It is decided to refer the case to DIPP (Chemical) of their comments and deferred thecase.
Case No. B-17
M.NO.03/AM-18
Date 25.09.2017
M/s. Jubilant Life Sciences Ltd
File No. 01/82/050/00431/AM 16
RLA No.05/23/040/00544/AM15
Adv.Auth. No. 0510393616 dated. 18.03.2015
Decision: The Committee considered this case for correction in the export products as per agendaand decided to refer the case to DlPP(Chemical) and deferred the case.
Case No. B-18
M.NO.03/AM-18
Date 25.09.2017
M/s. Jubilant Generics Ltd
File No. 01/82/050/00885/AM 17
RLA No.05/23/040/00299/AM17
Adv.Auth. No. 0510400077 dated. 07.10.2016
Decision: The Committee considered this case for correction in the norms as per agenda. TheCommittee decided to correction/amend the description of export product to read as"Tables/Capsules" as per the request. RA concerned may take further necessary action as perthe decision of NC.
81
Case No. B-19
M.NO.03/AIVI-18
Date 25.09.2017
M/s. Jubilant Generics Ltd
File No. 01/82/050/00421/AM 17
RLA No.05/23/040/00076/ AM17
Adv.Auth. No. 0510398582 dated. 24.05.2016
Decision: The Committee considered this case for correction in the norms as per agenda. TheCommittee decided to send copy of application to DoP and deferred the case.
Case No. B- 20
M.NO.03/AM-18
Date 25.09.2017
M/s. Jubilant Generics Ltd
File No. 01/82/050/00890/AM 17RLA NO.05/23/040/00298/AM17
Adv.Auth. No. 0510400076 dated. 07.10.2016
Decision: The Committee considered this case for correction in the norms as per agenda. TheCommittee decided to send copy of application to DoP and deferred the case.
Case No. B- 21
M.NO.03/AM-18
Date 25.09.2017
M/s. Jubilant Generics Ltd
File No. 01/82/050/00891/AM 17RLA NO.05/23/040/00323/AM17Adv.Auth. No. 0510400088 dated. 13.10.2016
Decision. 1 he Committee considered this case for amendment in the norms as per agenda. TheCommittee decided to maintain status quo.
82
F. No.35011/420/2014-Pi (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Office Memorandum
2c
Udyog Bhawan, New Delhi,Dated: June, 2016
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/sUnited Biotech Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/323/AM-15/DES-3/454 datedthe 30/7/14 vide which application from M/s United Biotech Pvt. Ltd. was sent to this Department forfixation of norms under para: 4.7 for the. export of Ticarcillin and Clavulanic Acid Injection in3.2gm and 1.6gm strengths. This department has examined the matter and the following norms arefurnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import item Norms Recommended
1 Ticarcillin Disodium and Pot Clavulanate (15:1) 1.68gm/1.60gm vialAnd
3.36gm/3.20gm vial
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade.Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi
F. No.35011/36/2015-PI (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
Udyog Bhavvan,New Delhi,Dated the June, 2015
Office MemorandumSubject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case ofM/sHetero Labs Ltd. ^
3/962 dit'ed 01/82/50/1058/AM-15/DES-0/962 dated the 06/01/15 vide which application from M/s. Hetero Labs Ltd was sent to this
SSdrL Th ""''i'"' ""der.para: 4.7 for the export of LevofloxacinHemihydrate. This department has examined the matter and the following norms arefurnished under nnra 4 7 nf T-Ttin^ a /tt.i ,s ® die
S.No. Import Item Qty. Recommended kg/kg.
1.
Ethyl(S)-9,10-Difluoro-3-Methyl-7-Oxo-2,3-
Dihydro-7H"Pyrido(l,2,3-DE)-I,4-Benzoxazine-6-Carboxylate
0.8571
2. This issues with the approval of Director (PI).
Directorate General of Foreign Trade,Department of Commerce,(Slui M.V. Singh, FTDO),Udyog Bhawan, New Delhi
(Barnali Kliastgir)Under Secretary to the Government of India
Phone:23071162
F. NO.35011/30/2016-PI -Norms
Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
\A7-
11^
Shastri Bhawan,Ne\Ar Delhi, the October 31, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/sBliss GVS Pharma Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/01849/AM-16/DES-3/37dated the 05/04/2016 vide which application from M/s Bliss GVS Pharma Ltd. was sent to thisDepartment for fixation of norms under para: 4.7 for the export of various Suppositories. Thisdepartment has examined the matter and the following norms are furnished urider para 4.7 of HandBook of Procedures (Vol.1) 2009-14: -
8. No Export Item Qty S.
No.Import Item Quantity allowed
for 1000
Suppositories
1. Recticin-100
Suppositories (eachcontaining Indomethacin100 mg)
1000
Nos.
1. Indomethacin 102 gm
2. lndometacina-100 mgSuppositories (eachcontaining Indomethacin100 mg)
1000
Nos.
2. Indomethacin 102 gm
3. GMETH Suppositories(each containingIndomethacin 100 mg)
1000
Nos.
3. Indomethacin 102 gm
4. Indogen-S Suppositories(each containingIndomethacin 100 mg)
1000
Nos.
4. Indomethacin 102 gm
2) This issues with the approval of competent authority.
(Raj Kumar)Under Secretary to the Government of India
Phone: -23071162
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi-110011
GOVERNMENT OF INDIAMINISTRY OF SCIENCE & TECHNOLOGYDEPARTMENT OF BIOTECHNOLOGY
M «IRH
Wttifll 3>l sfn
^^-2, 7m Tito ̂ 3ito
^ i^-110003
Block-2,7th Floor, C.G.O. ComplexLodhI Road, New DelhM10003
BT/IL/05/316/2010-PID Date: 05.06.2017
OFFICE MEMORANDUM
Subject: Applications of M/s. Panacea Biotec Ltd., New Delhi, for fixation of I/O Norms forthe export of '62/0-DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)'
The undersigned is directed to refer to the Directorate General of Foreign Tradecommunications vide 1) HQ File Number 01/82/050/01127/AM15/-Dated:05 12 2014* 2) HOFile Number 01/82/050/01019/AM16/-Dated:28.10.2015; 3) HQ File Number01/82/050/00223/AM17/-Dated:28.06.2016 and 4) HQ File Number 01/82/050/00709/AM17/-Dated:29.09.2016 forwarding applications of M/s. Panacea Biotec Ltd., New Delhi, for fixationof I/O Norms for the export of different quantities of '62/0-DTwP-HepB-Hib-PentavalentVaccine (Easyfive TT) (single dose vial of 0.5 ml presentation)' requiring three import inputsnamely i) purified Diptheria Toxoid concentrate antigen bulk, ii) purified Tetanus Toxoidconcentrate antigen bulk and iii) Inactivated whole cell pertussis Bulk. As per the informationfurnished by the applicant, the I/O norms for the above four cases/applications are fixedherewith.
For export of 1 million vials (single dose vial of 0.5 ml presentation) of 'DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)', norm for the imported items are;
1. Purified Diptheria Toxoid concentrate antigen bulk (@ -2050 Lf/ml) = 13.64 Ltr
2. Purified Tetanus Toxoid concentrate antigen bulk (@ -1900 Lf/ml) = 5.23 Ltr3. Inactivated whole cell pertussis bulk (@ -192 OU/ml) = 86.46 Ltr
This issues with the approval of Secretary. Department of Biotechnology.
0^
(Amit Parikh)Scientist 'D'
To,Shri Nirmal Kumar
Deputy DGFTRoom No. 303, Directorate General of Foreign TradeMinistry of Commerce & IndustryUdyog Bhawan, New Delhi-01
Website: http://wvvw.dbtlndia.nlc.in http://www.btlsnet.gov.ln^jWTelephone : 24363012, 243G2329 "^Fax : 011-24362884
(25^ c 4^
F. No.35011/498/2013-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan,New Delhi, the 21 November, 2013
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1)2009-14 Case of M/s R L Fine Chem Ltd.
The undersigned is directed to refer to DGFT U.O.No.0I/82/50/1370/AM13/DES-3/197 dated the 17/05/13 vide which applicationfrom M/s. R L Fine Chem Ltd was sent to this Department for fixation of normsunder para: 4.7 for the export of Clomipramine Hcl. This department hasexamined the matter and the following norms are furnished under para 4.7 ofHand Book of Procedures (Vol.1) 2009-14:-
S.No. Import Item Qty. Recommended kg/kg..
1. Bormo 3 Chloro Propane 0.85
2. 3 Chloro Iminodibenzyl 0.91
This issues with the approval of Director (Cost).
(Raj Kumar)Under Secretary to the Government of India
PI-Norms
Directorate General of Foreign Trade,Department of Commerce,(Shri R.C. Meena, Dy. DGFT),Udyog Bhawan, New Delhi.
XL- /2017-GC and F-DCMSMEO/o THE DEVELOPMENT COMMISSIONER (MSME)
(CHEMICAL DIVISION)7th floor, A Wing, Nirman Bhawan,
■ ̂ New DelhiDate: May, 2017
OFFICE MEMORANDDM
Subiect: Ratification of the norms in respect of advance authorization No0310792363 dated 24.01.20t4, un^er Para 4.7 of HBP obtained by WI/sNational Tube Industries, Wlumbai.
Director General of ForeignlTrade (DGFT) may refer to Its O.M /I.D Note
No. 01/82/050/254/AM16/DES.III/500 ' dated 24.08.2016 fonwardlng AdvanceAuthorization application No. 0310792363 dated 24.01.2014 of M/s National TubeIndustries, Mumbal requesting ratlflcatlori of the norms for the Export of- Slllcone oil 1.0and 2.0 cst. The application was examined and certain clarifications were sought fromM/s National Tube Industries. The application was re-examined In light of theclarifications provided. ^
the quantities of reactants have b^n worked out and may be recommended as
i Export
Product
Exp. Qty.
(Kg)
Import Inputs
(Reactants)
Quantity
Sought (Kg)
Quantity
allowed (Kg)
(I). Silicone Oil1.0 cst
(II) Silicone Oil2.0 cst
9350
4500
Silicone Oil of
0.65 cst 11
11082 9750
BRB CM ̂0 5181.5 5181.5 1t
1j11
rv^aii iivm ^
sought 2629.75 Kg Sulfonated slloxane as catalyst. It Is however observed thattechnically catalyst Is a substance, used | alter the rate of a chemical reaction but Itremain unchanged chemically at th4 fd of the reaction. Also technical literatureIs available which states that Sulfonatkl slloxane used as catalyst In polymerizationof slllcone oil can be reactivated by washing the catalyst with a low molecularweight slloxane medium. It Is lnforme|by M/s National Tube Industries that they areneither reactivating catalyst nor they have any technology and equipments for re-
J"
activation ■ There is no technical literature a«iiable to ascertain or verify the soughtquantity of catalyst. In view of this, norms ccmmittee may decide on the quantity ofSulfonated siloxane to be allowed.
^ This Issues with the approval of comoetent authority.
( H.S Bisht)-;"Director (Chemical)
Shri Nirmal Kumar,Dy. DirectorO/o Director General of Foreign Trade.DES-III Section. Room No. 414M/o Commerce and Industry,Udyog Bhawan,New Delhi
Q UF. No.35011/544/2014-PI (Norms)GoveiTiment of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan,New Delhi, the March, 2015
Office MemorandumSub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol 1)
2009-14 Case of M/s. RL Fine Chem.
The undersigned is directed to refer to DGFT U.O.No.01/82/50/714/AMI5/D"ES-3/721 dated the 21/10/14 vide which an applicationfrom M/s. R L Fine Chem was sent to this Department for fixation of normsunder para: 4.7 for the export of Methane Sulfonate of 10,ll,Dihydro-NNBetatrimethyl 5H Benzo (BP) Azepine-5 Propanamine. This department hasexamined the matter and the following comments are flimished under para 4.7of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import Item Qty. Recommended kg/kg.
1. 1 Bromo 3 Chloro 2 Methyl Propane 0.72
2. Iminodibenzyl 0.74
2. This issues with the approval of Director (PI).
(Barnali Khastgir)Under Secretary to the Government of India
Phone-23071162Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
2^
F. NO.35011/1/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
-3-o
7?
Udyog Bhawan, New Delhi,Dated: 1 June, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Voi.i) 2009-14 Case of Ws Suven Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/0185/>^M-16/DES-3/1653 dated the lS/2/16 vide which application from M/s Suven LifeSciences Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of (1-PhenyImethyl)-1H-lndeno[2,1-b]Pyrldine-6-Carbonitrile. Thisdepartment has examined the matter*
iFGG
DGFT is advised to call following details from .the firm viz:-
1. The import item is catalyst only for which no recovery or regeneration isshown. The firm may be advised to elaborate the recovery of importedcatalyst with technical justification.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. No.35011/2/2016-Pi (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi.Dated the December 14. 2016
Office Memorandum
Subject: - Application of M/s Porus Laboratories Pvt. Ltd., Hyderabad., for normsagainst export of SIVIKT:{S)-1.{{{1-{3-[2(EH7-Chloro2 quinollnyl)ethenyl)Phenyl1}}-3-[2-(1-hydroxy-1-methyl ethyl) Phenyl]-1-propanol.
The undersigned is directed to refer to DGFT U.O.No. 01/82/050/01755/AM-16/DES-3/1879 dated the 22/03/2016 and recent CM No. 01/82/162/29/AM16/DES-111/105 dated 19/09/2016, seeking comments of the DoP on the response of thecompany. It may be recalled that the DoP conveyed Its views vide this office letter ofeven number dated 1^' June 2016 informing that the product to be exported and itsraw material to be imported are same drug-intermediates for Montelukast and^omanufacturing activity appears to be involved: ^
2) Vide their letter dated 26'^ August 2016, M/s Porus Laboratories Pvt. Ltd.. haveprovided some information without indicating the actual percentage purity of thecrude input to be imported or that of the product to be exported. As such, as alreadyinformed the product to be exported is same as the input to be imported and nomanufact^ring_activitv is to be undertaken. The Norms Committee may like to take aview in the matter as deemed fit.
3) This issues with the approval of competent authority
(Barnali Khastgir)Under Secretary to the Government of India
Phone: 23323292
Email: [email protected] General of Foreign Trade.Department of Commerce.(Shri Nirmal Kumar. Dy DGFT).Udyog Bhawan. New Delhi
Email: [email protected]
F. NO.35011/74/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: June, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/siVIac Chem Products (india) Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1639/AM-16/DES-3/1811dated the 15/3/16 vide which application from M/s Mac Chem Products (india) Pvt. Ltd. was sent tothis Department for fixation of norms under paraj 4.7 for the export of Hydrocortisone SodiumSucclnate Bulk Sterile Lyophilized USP 37. This department has examined the matter and thefollowing norms are furnished under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14:-
S.No. Import item Norms Recommended for
1kg Export
1 Flydrocortisone IP/EP/USP 0.88kg
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:- 23071162
Directorate General of Foreign Trade.Department of Commerce.(Shri M.V. Singh, FTDO).Udyog Bhawan. New Delhi
F. NO.35011/781/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated; 26 April, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of M/s Sun Pharmaceutical Industries Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1295/AM-16/DES-3/1237 dated the 15/12/15 vide which application from M/s SunPharmaceutical Industries Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Clarlthromycin Carbomer Granules 43.75%/44%.This department has examined the matter and-
undsLpaEa^533fctisn4Seelu3tErQGfiGlures4VoU)-2009^^
DGFT is advised to call following details from the firm viz:-
1) Copy of valid DML for above export product.2) Copy of Master-Batch formula duly certified by Q.C. incharge.
2. This- issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan. New Delhi
GOVERNMENT OF INDIA
MINISTRY OF SCIENCE & TECHNOLOGY
DEPARTMENT OF BIOTECHNOLOGY
BT/IL/05/316/2010-PID
M<2Kil ̂ 3TIT
vn^ft
6qii«h-2, 7^ ^ "^0
1^^^-110003
Block-2, 7th Floor, C.G.O. ComplexLodhi Road, New.Deihi-110003
^ z-JJ-Date: 05.06.2017
OFFICE MEMORANHIIAA
Subject: Applications of M/s. Panacea Biotec Ltd New Delhi for fiY;^Hnn nf i/n m *the export of ■62/0-DTwP-HepB-Hib-Pentavalent VaccL
The undersigned is directed to refer to the Directorate General of Foreign Tradecommunications vide 1) HQ File Number 01/82/050/01127/AM15/-Dated-05 12 2014* 2) HQFile Number 01/82/050/01019/AM16/-Dated;28.10.2015- 3) HO >ile NiTmherDated-'zP 01/82/050/00709/AM17/-nf i /n M J fowarding applications of M/s. Panacea Biotec Ltd., New Delhi, for fixationof I/O Norms for the export of different quantities of '62/0-DTwP-HepB-Hib-PentavalentVaccine (Easyfive TT) (single dose vial of 0.5 ml presentation)' requiring three import inputsnamely i) punfied Dipthena Toxoid concentrate antigen bulk, i1) purified Tetanus ToxoidfurnNh d B 'T'" Bulk As per the informarionSth ' ''' '' cases/applications are fixedHih PentX.1»ni V ^ Vials (single dose vial of 0.5 ml presentation) of 'DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)', norm for the imported items are;
1. Purified Diptheria Toxoid concentrate antigen bulk (@ -2050 Lf/ml) = 13.64 Ltr2. Purified Tetanus Toxoid concentrate antigen bulk (@ -1900 Lf/ml) = 5 23 Ltr3. Inactivated whole cell pertussis bulk (@ -192 OU/ml) = 86 46 Ltr
This issues with the approval of Secretary, Department of Biotechnology.
Q>h
(Amit Parikh)Scientist 'D'
To,Shri Nfrmal KumarDeputyDGFTRoom No. 303, Directorate General of Foreign TradeMinistry of Commerce & IndustryUdyog Bhawan, New Delhi-01
Website : http://www.dbtindia,nic.in http://www.btlsnet.gov.ln^:Wrelephone : 24363012, 243G2329 ̂ ^Fax : 011-24362884
1-c?
no
F. NO.35011/776/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: June, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of iVI/s Shasun Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1253/AM-16/DES-3/1472 dated the 12/1/16 vide which application from M/s ShasunPharmaceuticals Ltd. was sent to this Department for fixation of norms under para:4.7 for the export of Gabapentin Tablets USP 800mg. This department has
Rnnk nf PrnnpHi itpq [\/n\ I) 9nnn -| mtSlicJ ui idei pdia 4 7 uf HaDGFT is advised to call copy of Master-Batch formula from the firm.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. No.35011/837/2015-Pl (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: 18 May, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s MSN Labs Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1357/AM-16/DES-3/1507 dated the 12/1/16 vide which application from M/s MSN Labs Pvt.Ltd. was sent to this Department for fixation of norms under para: 4.7 for the exportof Epierenone. This department has examined the matter.afld-tbeToHevvfng-fiofms
'-ufldor para 4.7-Qf44and-Eook of ProGedwe&-(VeU)-2e99-44^
DGFT is advised to call following details from the firm viz:-
1. Copy of technical literature in support of the yields claimed by the firm atvarious stages.
2. Past production vis-a-vis actual consumption of imported input duly certifiedby Central Excise Authorities.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,.Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
9?
F. NO.35011/781/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: 26 April, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Sun Pharmaceutical Industries Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1295/AM-16/DES-3/1237 dated the 15/12/15 vide which application from M/s SunPharmaceutical Industries Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Clarithromycin Carbomer Granules 43.75%/44%.This department has examined the matter and'tho following nofffls--ai:e-fum4sbed
DGFT is advised to call following details from the firm viz:-
1) Copy of valid DML for aboye export product.2) Copy of Master-Batch formula duly certified by Q.C. incharge.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. NO.35011/781/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: 26 April, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of WI/s Sun Pharmaceutical Industries Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1438/AI\/l-16/DES-3/1407 dated the 11/1/16 vide which application from M/s SunPharmaceutical Industries Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Clarithromycin Carbomer Granules 27.5/28%.This department has examined the matter, gnd the fo!k>wlng-4:tom^s--afe-4umishedunder para 4.7 QLHaiid-BQol^^f-Pfe6e4ures (Vnl l) 2009-14:-
DGFT is advised to call following details from the firm viz:-
1) Copy of valid DML for above export product.2) Copy of Master-Batch formula duly certified by Q.C. incharge.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi
Cji)
F. NO.35011/98/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi.Dated; February 16, 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Jodae-gxpeim (P) Ltd, forexport of Novatrizoate 76% (Diatrizoate Meglumine and DiatrizoateSodium Injection 600 mg i/ml and 760 mg/I ml)..
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00068/AM-17/DES-3/120 dated 23/05/2016 and subsequent letter from M/s Jodas Expoim Pvt.Ltd., for fixation of norms against export of Novatrizoate 76% (DiatrizoateWieglumine and Diatrizoate Sodium Injection 600 mg l/ml and 760 mg/I ml).This department has examined the matter and following observation are made.
2. The application is incomplete and adequate details including DML, needed forworking out requirement of raw materials are not available.
3) In view of the above, the DGFT may direct the applicant to provide:(i) Application form prescribed for norms under para 4.7 of Handbook of Procedures.(ii) A copy of valid Drug Manufacturing License for the export products.(iii) The quantity of each type of vials to be exported.(iv) Method of calculation used to arrive at the quantity of Diatrizoic Acid for export ofeach vial of injections with different strengths.
(Barnali Khastgir)Under Secretary to the Government of India
Phone:23323292
Email: barn.khast(S)nic.inDirectorate General of Foreign Trade,Department of Commerce,(Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New Delhi
Email: [email protected]
[o 0
2^
F. NO.35011/866/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi.Dated: 18 May, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.I) 2009-14 Case of IVI/s Kopran Research Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1597/AM-16/DES-3/1743 dated the 2/3/16 vide which application from M/s Kopran ResearchLabs Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of Doripenem Sterile. This department has examined the matter and thefollowingjiiKiiis-afeTtmrshHdTmdef-^afa-4;?-oTHand-Bool^L^eedur-e^^ I)
DGFT is advised to call following details from the firm viz:-
1. Complete technical detail as per appendix-33 showing chemical reactions, %yield on molar basis etc.
2. Copy of technical literature in support of yields envisaged.3. Past production vis-a-vis actual consumption of imported inputs duly certified
by Central Excise Authorities.
This issues with the approval of competent authority.
(Rajkumar)- Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
(?(
1 0^
Case No.:37/15/82-
ALC4/20I3
HQ File
:01/82/050/00799/AMI4/
Party Name;AMINES &
PLASTICIZERS LIMITEDMeet No/Date: 18/82-
ALC4/2013
I9.I2.20I3
Lic.No/Date:03107495I613.09.2013
Status:Case
Approved
Defer Date:RLA File
- :03/94/040/00510/AM14/Decision :ln the light of written comments received from Department of Chemicais and.Petrochemicals vide their U.O No. 14010/61/2011-Ch 11 dated 02.12.2013, it was decided to
249 ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm,whichever is less:
Export product Exp.
Qty.
SI.No. Import items Qty. allowed
N-
FormylMORPHOLINEIkg 1.
MORPHOLINE0.810 kg
KA may take appropriate action as per the decisloh of Norms Committee.
[0
F. NO.35011/68/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
rfr
106
Udyog Bhawan, New Delhi,Dated: June, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of WI/s Fresenius Kabi Oncology Ltd.
The undersigned is directed to refer to DGFT U.Q.No. 01/82/50/1681/AM-16/DES-3/1829 dated the 15/3/16 vide which application from M/s Fresenius KabiOncology Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of Innotecan Hcl injections 500mg, SOOmg, lOOmg, 40mg. Thisdepartment has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
DGFT is advised to call following details from the firm viz:-
1) Complete technical details as per appendix-33 for the manufacture ofirinotecan Hcl 3H2O (API) showing moi.\Art., % yield on molar basis for eachstep.
2) Consumption-coefficient of R.M. for 1kg API.3) % wastage claimed on API in the manufacture of injections of different
strength/vial size.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government Of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
2^O
F. NO.35011/4/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated; 1 June, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of WI/s Morepen Labs Ltd.
■!? 01/82/50/1689/AM-lb/UbS-3/1815 dated the 15/3/16 vide which application from M/s Moreoen LabsL d^was sent to this Department for fixation of norms under para 4 7 for threxportdepartment has examined the matternorms are furn^sbed-ufldeH3ara-4JZ^f Hand Ropt^ef Proceduicc (Voi-|)-2009-44^
DGFT is advised to call following details from the firm viz:-
1. Description of import item SXS01 does not match with its chemicalconfiguration shown in step-1 reaction. Correct import description or itsstructure used in chemical reaction may be given alongwith revisedchemistry.2. Past production vis-a-vis actual consumption of all import inpurts dulycertified by central excise authorities may be furnished.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. NO.35011/138/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
o-
Udyog Bhawan. New Delhi,Dated: August. 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Optimus Drugs (P) Ltd.
°GFT U.O.No. 01/82/50/253/AM-
, L dated the 4/7/16 vide which application from M/s Optimus Drugs (P)Ltd. was sent to this Department for fixation of norms under para: 4 7 for the exportof Srmeprevir. This department has examined the matter
a/:eJumished-tmderpaFa-4:7j2fJiand-Boo)v0FfT-eGedmBs-{VGy)-2OO9-44^
DGFT is advised to call following details from the firm viz:-
1) Description of import item does not match with the description given in theprocess detail /chemistry.The correct description of import item may be given.
2) Past production vis-a-vis actual consumption of import inputs duly Certifiedby Central Excise Authorities may be furnished.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi.
F. No.35011/28/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: August. 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol I) 2009-14 Case of Mis Zim Labs Ltd. '
^-Q-No- 01/82/50/183G/AM-16/DES-3/20 dated the 4/4/16 vide which application from M/s Zim Labs Ltd wassent to this Department for fixation of norms under para: 4.7 for the export of
'^®P3'^^ent has examined
Ploceduffis4Vey)-20e9-t4:- ef^ara . eok of
DGFT is advised to call following details from the firm viz:-
Both the Export description as well as net content of prednisolone BP in each of thetwo export products do not match with the DML furnished by the firm.Technical justification alongwith revised details may be furnished by the firm.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO).Udyog Bhawan, New Delhi.
j oC
F. No.35011/241/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shaslri Bhawan, New Delhi,Dated: September 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures fVoI I) 2015 -90Case of M/s. Covalent Laboratories Pvt. Ltd.
3/361 dltedSTSfSbtr'VV'^®'' 0I/82/50/1789/AM-I6/DES-Ammo 3-VinyI-3-Cephem-4-CarbozyIic Acid fV-AVCA^ Thic + i
o7pTo::zt
S. No. Import ItemNorms Recommended for 1kg
Export
I.
7-PhenyIacetamideo-3-ChloroniethylCephalosporonic Acid Para Methoxybenzyl Ester(GCLE)
2.672kg2. Acetone
2.1375kgj>. Methylene Chloride
10.26kg4. Methanol
7.87kg5. Activated Carbon
0.1kg
2.) This issues with the approval of competent aiJthority.
,P(Parveen Kumar)Under Secretaiy to the Government of India
E-mail: parveen. [email protected]:-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mail: [email protected]
Ph: 23061562, Extn.269
F. NO.35011/154/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan. New Delhi,Dated; September. 2016
Office MemoranHiim
Subject: - Fixation of norms under para-4.7 of Hand Book of.Procedures (Vol.!) 2009-14 Case of IW/s Strides Shasun Ltd.
.on.A undersigned is directed to refer to DGFT U O No 01/82/50/1fi2 R,whiSrfplicatr^^^^^^^fnr 'his Department for fixation of norms under para- 4 7
DGFT IS advised to call copy of master-batch formula from the firm dulyauthenticated by their Q.C. incharge.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PFl:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi.
or
F. NO.35011/200/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi, )Dated: August, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of WI/s Fresenius Kabi Oncology Ltd.
■ 17/DES^W8TS"fh 01/82/50/250/AM-application from M/s Fresenius KabiOncology Ltd_was sent to this Department for fixation of norms under para- 4 7 for
This department has examined the
DGFT is advised to call following information/detail from the firm viz:-
1) Copy of Master-Batch formula duly certified by Q.C. Incharge.2) Consumption-coefficient of raw material for paclitaxel API3) Wastage claimed on API for the above export.
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh,.FTDO),Udyog Bhawan, New Delhi.
F.NO.35011/241/2016-PI (Norms)Government of IndiaMinistry of Chemical & Fertilizers
Department of Pharmaceuticals
Office IVremoranriiim
Shastri Bhawan, New Delhi,Dated; September l^Jt, 2017
Caseof M/s.™ien'^^^^^^ of Procedures (VoM) 2015-20
3/361 dated the 17/08/2^16 0I/82/50/1789/AM-16/DES-Ltd. was sent to this Department f^ifxa L oTn^" Laboratories Pvt.Am.no-3.VinyI-3-Cephem-4-CarbozSirrcid (7 rVCAf 4.7 for the export of 7-
S. No.Import Item
7^hM^d^^ii;^,ideo-3-ChIoro"S;S^Cephalosporonic Acid Para Methoxybenzyl Ester,GCLE)
Norms Recommended for 1 kgExport
2.672kg2. Acetone
2.1375kgMethylene Chloride
4. Methanol
5. Activated Carbon
10.26kg
7.87kg
0.1kg
2.) This issues with the approval of competent authority.
(Parveen'i&mar)Under Secretary to the Government of India
E-mail; parveen. [email protected]:-23352298
Directorate General" of Foreign Trade,Depaitment of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mail: [email protected]: 23061562, Extn.269
u o
1^^F. NO.35011/281/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Janpath Bhawan, New Delhi.Dated; September 15. 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2015-20 Case of M/s Sentiss Pharma Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/365 &616/AM-17/DES-3/427 & 509 dated the 19/08/2016 & 31/08/2016 vide whichapplication from M/s Sentiss Pharma Pvt. Ltd. was sent to this Department forhxation of norms under para: 4.7 for the export of Oftahist (Olopatadine EyeSolution 0.1% vial, of 5ml). This department has examined the matter and the
oniTon. Psra 4.7 of Hand Book of Procedures (Vol.i)
S.No. Import Item Norms Recommended1 Olopatadine FIcI 5.65mg for one eye/ear
drop of 5ml
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone:23352298
_ Email: [email protected] General of Foreign Trade.Department of Commerce,(Shri S.K. Panigrahi. Economic Officer. DES-lllPhone No: 23061562. (269),Udyog Bhawan, New Delhi
Email: [email protected]
\u
F. No.35011/145/2016-Pi (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: July, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Orbit Life Sciences (P) Ltd.
The undersigned is directed to refer to DGFT U.O.No. O'l/82/50/308/AM-17/DES-3/218 dated the 6/7/16 vide which application from M/s Orbit Life Sciences(P) Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of imipenem (Sterile I Technical / N-FormimidoyI I Thienamycin Hci). Thisdepartment has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
DGFT is advised to call following details/clarification from the firm viz:-
1) Whether the export item is sterile or technical grade.2) If sterile, please give details of conversion from tech. grade to sterile
alongwith yield etc.3) The DML furnished by the firm is only for export/manufacture imipenem (Non-
Sterile). How the firm will be manufacturing/exporting Sterile product.4) The import items at appendix-11A do not tally with ANF-4A.The correct and
revised list of import items may be furnished as many inputs have beenshown indigenous in appendix-11A
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:- 23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi.
II 7^
F. NO.35011/382/2016-PI (Norms)Government of India
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Room No. 302, 3'^ Floor,Janpath Bhawan New Delhi,Dated: September 12, 2017
Office MemorandumSubject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-
14 Case of IW/s Softgel Healthcare (P) Ltd.
The undersignedus directed to refer to DGFT U.O. No. 01/82/050/00542/AM-17/DES-lli/566 dated the 07/10/2016 vide which application from M/s SoftgelHealthcare (P) Ltd. was sent to this Department for fixation of norms for the export ofSoft Gelatin Capsules Fish Oil 1000 mg (Omega-3 Capsules 1000 mg) Thisdepartment has examined the matter and the following norms are furnished againstthe export item:
Product to be Exported Raw materials to be importedDescription Quantity Description Quantity in gm
Soft Gelatin Capsules AspacardioQ10 - 30 mg (each capsules containco-enzyme Q10-30 mg).
1000 Nos. Ubidecarenone (Co-enzyme Q10)
30.60 gm
Soft Gelatin Capsules AspacardioMix Omega 3 + Q10-100 mg (eachcapsule contain co-enzyme QIC 100mg besides omeqa
1000 Nos. Ubidecarenone (Co-enzyme Q10)
102 gms
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone; 23352298
Email: [email protected] General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IIIPhone No: 23061562, (269),Udyog Bhawan, New Delhi
Email: [email protected]
V3'
F. NO.35011/344/2016-PI (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan.New Delhi,Dated the April 3, 2017
Office Memorandum
Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms ofAmylmetacresol Antiseptic Throat Lozenges Sugar Free Blackcurrantand Other Flavor and Amylmetacresol Antiseptic Throat LozengesLemon/Cherry and Other Flavor.
The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00582/AM-17/DES-3/520 dated the 05/09/2016 vide which application from M/s. J.B. Chemicals& Pharmaceuticals Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Amylmetacresol Antiseptic Throat Lozenges Sugar FreeBlackcurrant and Other Flavor and Amylmetacresol Antiseptic Throat LozengesLemon/Cherry and Other Flavor. Besides API the applicant also intends to importexcipients for which Master Batch Formula duly certified by the Quality Control In-Charge of the company is needed and the same is not provided with application.
2) In view of the above, the applicant may be advised to provide copy of Master BatchFormula duly certified by the Quality Control In-Charge of the company so that therequirement of excipients may be worked out.
Barnali Khastgir)Under Secretary to the Government of India
Phone: 23323292
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,
-(Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New Delhi
Email: [email protected]
F. NO.35011/343/2016-PI (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
0
Shastri Bhawan.New Delhi,Dated the August 24. 2017
Office Memorandum
Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms ofOxybutynin Chloride Extended Release Tablets 10 mg .
The undersigned is directed to/efer to DGFT U.O.No. 01/82/050/00586/AM-17/DES-3/536 dated the 05/09/2016 vide which application from M/s. J.B. Chemicals& Pharmaceuticals Ltd was sent to this Department for fixation of norms under para'4.7 for the export of Oxybutynin Chloride Extended Release Tablets 10 mg. Theapplication of the unit has been examined and following quantities are recommendedfor one tablet of lOmg Oxybutynin chloride Extended Release.
S. No. import Item Qty. Recommended1. Oxybutynin chloride USP 10.02mq/tablet2. Sentry Polyox WSR N80 FP NF 80.77mq/tablet3. Sentry Polyox WSR 303 NF 41.10mq/tablet
2. This issue is with the approval of Competent Authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri Panigrahi, Dy DGFT),Room No. 414, Udyog Bhawan, New Delhi
A, VIt y
159F. N0.35OII/379/2OI6-PI (Norms)
Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Room No. 302, 3'^'^ Floor.Janpath Bhawan New Delhi,Dated; September^, 2017
Office Memorandum ' v
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case of Wl/s J.B. Chemicals & Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/0G660/AM-17/DES-11I/552 dated the 03/10/2016 vide which application from M/s J.B. Chemicals &Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the export ofvarious medicated throat lozenges containing Benzocaine as one of the API. Thisdepartment has examined the matter and the following norms are furnished against theexport item:
Product to be Exported Raw materials to be imported
Description Quantity Description Quantity in gm
Benzocaine and Cetylpyridinium ChlorideAnesthetic Throat Lozenges Flavours
Black Current, Honey Lemon & OtherFlavours (Each lozenge containsBenzocaine 12 mg)
1000
lozenges
Benzocaine 12.240 gm
Benzocaine and Cetylpyridinium ChlorideAnesthetic Throat Lozenges Flavours lime
and lemon and Other Flavours (Each
lozenge contains Benzocaine 10 mg)
1000
lozenges
Benzocaine 10.20 gm
Benzocaine, Cetylpyridinium Chloride andDextromethorphan HydrobromideAnesthetic Throat Lozenges (Each lozenge
contains Benzocaine 1.25 mg)
1000
lozenges
Benzocaine 1.275 gm
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-lllPhone No: 23061562, (269), Udyog Bhawan, New DelhiEmail: sl<[email protected]
F. NO.35011/348/2016-PI -Norms
Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Office Memorandum
Shastri Bhawan,New Delhi, April 3, 2017
Subject: - Application from M/s Cadila Healthcare Ltd. for norms of FludarabinePhosphate Injection 50 mg/2ml.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00601/AM-17/DES-3/551 dated the 06/09/2016 vide . which application from M/s CadilaHealthcare Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of Fludarabine Phosphate Injection 50 mg/2ml. This department hasexamined the matter and the following norms are furnished:
Name of ExportProduct
Quantity 8.
No
Inputs recommended Quantity for 100vials
Fludarabine
Phosphate injection 50mg/2mi (each mlcontains Fludarabine
Phosphate 25 mg)
100 vials 1. Fludarabine Phosphate 5.500 gm
2. Glass Vial M Clear 20-mm
T-1, 6 ml CA7844 Glassvial 6 ml capacity
As per packingPolicy
3. Rubber Stoppers GreyBromobutyle
2) This issues with the approval of competent authority.
Directorate General of Foreign Trade,Department of Corhmerce,(Shri Nirmal Kumar. Dy DGFT),Udyog Bhawan, New Delhi
Email: [email protected]
Barnali Khastgir)Under Secretary to the Government of India
Phone: 23323292
Email: [email protected]
//?
F. No. 35011/315/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan. New Delhi,Dated; September 5, 2017
Office Memorandum
Sub. - Fixation of norms under para 4.7 of Hand Book of Procedrues (Vol.1) 2009-14, Case of M/s Reanon Pharmaceuticals.
The undersigned is directed to refer to DGFT U.O. No. 01/82/50/553/AM-17/DES-3/510 dated the 31/08/2016 vide which application from M/s ReanonPharmaceuticals. Was sent to this department for fixation of norms under para: 4.7for the export of Renongin injection. This department has examined the matter thefollowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol 1)2009-14:- . ^ ^
S. No. Import Product Norms Recommended1 Potassium Aspartate 474.6mg per vial of 10ml of Renongin
Iniection
2. This issue is with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23.352298Email: [email protected]
Directorate General of Foreign Trade,(Shri S.K. Panigrahi, Dy DGFT),Room No.414, Udyog Bhawan,New Delhi-110001
F. NO.35011/357/2016-P1 (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
(bZG3
-2^
Shastri Bhawan, New Delhi,Dated: august 31, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Styrax Pharma Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.Nor 01/82/50/635/AM-17/DES-3/556 dated the 26/09/2016 vide which application from M/s. Styrax PharmaPvt Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of 2,4DiFluoro-Alpha-(1-H1,2,4 Triazole 1-1y!) Acetophenone (D.F.T.A).This department has examined the matter and .the following norms are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S. No. Import Item Qty. Recommended kg/kg.
1. 1,3 Di Fluorobenzene' 0.60
2. 4 Amino Triazole 0.47
3. Methlene Di Chloride 1.41
4. Acetonitrile 1.65
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 011-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panlgrahi),Udyog Bhawan, New DelhiPh: 011-23061562, Extn.269
1/7
o
F.NO.35011/374/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Office Memorandum
Shastrl Bhawan, New Delhi,Dated; Septembers, 2017
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol I) 2009-14Application of M/s Cadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/50/639/AM-17/DES-3/549 dated, the 03/10/2016 vide which an application from M/s CadilaHealthcare Ltd. was forwarded to this Department for fixation of norms for theexport of Clopidogrei Besylate. This department has examined the matter and thefollowing norms are recommended against this application:-
S.No. Import Product Norms Recommended1 4,5,6,7-Tetrahydrothieno[3,2-C] Pyridine
Hcl0.626kg
2 L(-) Camphor Sulphonic Acid 0.6I3kgj Dichloromethane 1.348kg4 Acetone 4.932kg
5 Methanol 1.435kg
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
E-mail: parveen.19(§gov.inPh:-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mail: sl<.panigrahi(@nic.in
Ph: 23061562, Extn.269
F. NO.35011/333/2016-PI (Norms)Government of India
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Room No. 302, 3^^ Floor,Janpath Bhawan New Delhi,Dated: September 6, 2017
Office Memorandum
\
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of Wl/s Encube Ethicals Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/0055"6/AM-17/DES-III/528 dated the 05/09/2016 vide which application from M/s EncubeEthicals Pvt. Ltd. was sent to this Department for fixation of norms for the export ofNystatin & Triamclnolone Acetonide Cream In 15 gm, 30gm and 60 gm tubes.This department has examined the matter and the following norms are furnishedagainst the export item:
S.No Raw Materials Quantity allowed for 1000 tubes
15 gm tube 30 qm tube 60 gm tube1. Nystatin 1.53 BOU 3.06 BOU 6.12 BOU2. Thamcinolone Acetonide 15.30 gm 30.60 gm 61.20 gm3. Dried Aluminum Hydroxide
Gel/Powder
37.534 gm 75.068 gm 150.136 gm
4. Mono & Diglycerides NF 1949.220 gm 3898.44 gm 7796.88 qm5. Polyethylene Giycol 400
Monostearate-IH
224.910 gm 449.82 gm 899.64 gm
6. Simethicone emulsion 14.994 gm 29.988 gm 59.976 gm7. Petrolatum Jelly Yellow/White
bearing Brand/Tradename SuperWhite Protopet (R)
2249.100 gm 4498.2 gm 8996.4 gm
8. Polyoxyl 20 cetostearyl ether NF 999.847 gm 1999.694 gm 3999.388 gm9. Noncrystallizing Sorbitol Solution
NF
999.847 gm 1999.694 gm 3999.388 gm
10. Polysorbate 60 NF 299.880 gm 599.76 gm 1199.52 gm11. Nystatin and Thamcinolone one
Acetonide Cream
As per packing policy
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-HIPhone No: 23061562, (269), Udyog Bhawan, New Delhi
a-
F. No.35011/388/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi,Dated: September 5, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1)2009-14 Case of M/s BDR Pharmaceuticals Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/695/AM-17/DES-3/594 dated the 31/10/2016 vide which application from M/s BDRPharmaceuticals Pvt. Ltd. was sent to this Department for fixation of normsunder para: 4.7 for the export of Aprepltant Capsules 125mg/80mg. Thisdepartment has examined the matter and the following norms are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
Export Product Qty. Import Items Qty. in Kg.Pack of one capsule 125mg+ Two capsules of SOmgAprepitant
One pack Aprepitant 290.7mg
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
B-mail: [email protected]:-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mail: [email protected]
Ph: 23061562, Extn.269
F. NO.35011/358/2016-PI (Norms)Government of India
Ministry of Chemicai & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi,Dated; September 1, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of WI/s Vivimed Labs (Alathur) Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/654/AM-17/DES-3/554 dated the 26/09/2016 vide which application from M/s Vivimed Labs(Alathur) Pvt. Ltd. Ltd. was sent to this Department for fixation of norms under para:4.7 for the export of Losartan Pottasium Tablets DSP 25mg, 50mg, 100mg. Thisdepartment has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
S.No. Import item Norms Recommended for 1
Tablet
25mgTablet
50mgTablet
100mgTablet
1 Losartan Pottasium USP 25.5mg 51mg 102mg
2 Mannitol (Pearitol 160C) 101.9mg 203.8mg 407.6mg
3 Microcrystalline Cellulose (Avicel PH 102) 40.5mg 81.0mg 162mg
4 Crosscarmellose Sodium (Ac Di Sol) 7.19mg 14.38mg 28.76mg
5 Povidone K 29/32 3.61mg 7.22mg 14.44mg
6 Magnesium Sterate (Mallickrondt 2257) 1.8mg 3.6mg 7.2mg
7 Opadry white (03H28419) 3.6mg 7.2mg 14.4mg
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
E-mail: [email protected]:-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan. New Delhi.E-mail: [email protected]
Ph: 23061562, Extn.269
0.3^
F.N0.35OII/374/2OI6-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Office Memorandum
Shastri Bhawan, New Delhi,Dated: Septembers, 2017
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14,Application of M/s Cadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/50/639/AM-17/DES-3/549 dated the 03/10/2016 vide which an application from M/s CadilaHealthcare Ltd. was forwarded to this Department for fixation of norms for theexport of Clopidogrei Besylate. This department has examined the matter and-thefollowing norms are recommended against this application:-
S.No. Import Product Norms Recommended
I 4,5,6,7-Tetrahydrothieno[3,2-C] PyridineHcl
0.626kg
2 L(-) Camphor Sulphonic Acid 0.613kg3 Dichloromethane 1.348kg4 Acetone 4.932kg5 Methanol 1.435kg
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretaiy to the Government of India
E-mail: parveen. 19(@gov.inPh:-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mai 1: sk.panigrahi(§nic.in
Ph: 23061562, Extn.269
F. No.350n/420/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
CP
"V
Shastri Bhawan, New DelhiDated: the September 11. 2017
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2015-20 Caseof M/s Sun Pharmaceuticals Industries Ltd.
The undersigned is directed to refer to DOFT U.O_.No. 01/82/50/780/AM-17/DES-3/634 dated the 30/04/2016 vide which an application from M/s Sun PharmaceuticalsIndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for theexport of Clarithromycin Carbomer Granules 27.5% / 27.75% / 28%. This departmenthas examined the matter and the following comments are furnished under para 4.7 of HandBook of Procedures (Vol.l) 2015-20:-
S.No. Import Item Qty. Recommended kg/kg.
1.Carbopol 974P' 0.20
2.
Claritliromycin OR Its raw materials as per
SIGN A-2263 on pro-rata basis. 0.2777
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
E-mail: parveen. [email protected]:23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mail: [email protected]
Ph: 23061562. Extn.269
;0 /82/050/00877/AM15/ :03/95/040/00292/AM15/ 110.07.2014
vision : In the light of earlier decision taken in meeting no. 8/82 dated 25.09.2014, itdecided to ratify norms under Para 4.7 of HBP vl as per details given below or as
)Iied by the firm, whichever is less;
)rt product
temether
Exp.Qty.
1Kg
SI.No.
1.
import items
Artemlsinin
Qty, allowed
may take appropriate action as per the decision of Norms Committee1.235 kg
0 se No.:26/9/82-ALC4/2014
296 fFile0 /82/050/00823/AM15/
Parly Name:ALMELO PVTLTD
RLA File
:09/24/040/00188/AM15/
Meet No/Date: 11/82-ALC4/20I4
26.11.2014
Lic.No/Date:09I0060660
11.07.2014
$tatiis:I>efreredand Re-lndezed
Defer
Date:22.12J014
ision:: It was decided to defer the case for 22.12.2014 for comments ofDepartmentPharmaceuticals
i No.:65/9/82-ALC4/2^4
I File
1/82/050/00862/AMI5/
Party Name: AMINES &plasticizers limited
RLA
Fi!e:03/94/040/00298/AM15/
297
Meet No/Date: 11/82-
ALC4/2014
26.11.2014
Lic.No/Date:031078681314.07.2014
Status:
Approved
Defer Date:
cision : in the light of written comments received from Department of Chemicals and Petrochemicalsvi le their U.O No. 14Q10/61/2013/Ch II dated 11.11.2014, it was decided to ratify norms under Para 4.7HBP vl as per details given below or as applied by the firm, whichever Is less:
Export Product
l-PIPERIDINOETHANOL "
Export
Quantity
licg
S.NO
2.
Import Product
PIPERIDINE
R , may take appropriate action as per the decision of Norms Corhmittee
Quantity
Allowed
0.694 kg
2S6
C ise No.:88/9/82-ALC4/2014
298 fiQFile
1/82/050/00885/AM15/
Party NamerMAC CHEMPRODUCTS (INDIA)PRIVATE LIMITED
RLA File
:03/95/040/0{)302/AM15/
Meet No/Date: 11/82-
ALC4/2014
26.11.2014
Lic.NQ/Date:0310786782
14.07.2014
Statiis:Deflered
and fo-lndexed
Defer
Date:22.12.2014
ecision : It was decided to defer the case for 22.12.2014 for comments ofDepartmentPharmaceuticals.
29S
(Qase No.: 108/9/82-4/2014
!Q Filell/82/050/00905/AM15/
Party Name:NECTARLIFESCIENCES LIMITED,
RLA File
:22/24/040/00083/AM14/
Meet No/Date: 11/82-
ALC4/2014
26.11.2014
Ljc.No/Date:22I0015019
15.07.2014
StatusiDeffered
and Re-Indexed
Defer
Date:22.1220]4
^ecision: It was decided to defer the case for 22.12.2014 for comments ofDepartment'Phaimaceuticals.
udyog
1 2--^
F. No.35011/394/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi,Dated: September 8, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!)2009-14 Case of M/s J.B. Chemicals & Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/697/AM-17/DES-3/587 dated the 31/10/2016 vide which application from M/s. J.B.Chemicals & Pharmaceuticals Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of IVY Syrup 100ml bottle. Thisdepartment has examined the matter and the following nonns are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2015-20:-
S.No. Import Item Qty.I IVY Leaf Powder Extract 0.714gms per 100ml
bottle
2.) This issues with the approval of competent authority.
(Parveen Kumar)Under Secretaiy to the Government of India
E-mail: [email protected]:-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.
E-mail: [email protected]
Ph: 23061562, Extn.269
-2r§3-
F. 'No.35011/395/2016-PI (Norms)Government of India
Ministry of Chemicai & Fertiiizers
Department of Pharmaceuticals
Room No, 302, 3'" Floor,Janpath Bhawan New Delhi,
Dated; September/, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s J.B. Chemicals & Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00696/AM-
17/DES-III/586 dated the 31/10/2016 vide which application from M/s J.B. Chemicals& Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the
export of Medicated lozenges containing Cetylpyridinium Chloride,Benzydamine Hydrochloride and Phoicodine as APIs. This department hasexamined the matter and the following norms are furnished against the export item:
Product to be Exported Raw materials to be imported
Description Quantity Description Quantity ingm
Cetylpyridinium Chloride, BenzydamineHydrochloride and Phoicodine lozengesSugar free, Black currant and otherflavours (each lozenge contain 5.50 mgPhoicodine, Benzydamine Hydrochloride 1.50mg and Cetylpyridinium Chloride 1.33 mg)
1000
lozengesPhoicodine 5.61 gm
Benzydamine 1.53 gm
CetylpyridiniumChloride
1.3566 gm
Isomalt ST-M 2466 gm
Phoicodine and Cetylpyridinium Chloride,lozenges sugar free orange/lemon andother flavours (each lozenge contain 5.50mg Phoicodine, and Cetylpyridinium Chloride1.33 mg)
1000
lozengesPhoicodine 5.61 gm
CetylpyridiniumChloride
1.3566 gm
Isomalt ST-M 2466 gm
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IIIPhone No: 23061562, (269),Udyog Bhawan, New Delhi
Email: [email protected]
"Vuo
F. NO.35011/416/2016-PI (Norms)
Government of India
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Room No, 302, 3'" Floor,Janpath Bhawan New Delhi,
Dated: September 15, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!)' 2009-14 Case of M/s Rhydburg Pharmaceuticals Ltd.
The undersigned Is directed to refer to DGFT U.O. No. 01/82/050/0G769/AM-
17/DES-III/613 dated the 23/11/2016 vide which application from M/s RhydburgPharmaceuticals Ltd. was sent to this Department for fixation of norms for the export
of Sitagliptin 100 mg tablets. This department has examined the matter and it is
submitted that the application Is grossly incomplete in even a copy of DML is notprovided and the application is not as per prescribed format.
2. In any case considering the standard export product being composed of
Sitagliptin Phosphate Monohydrate (Molecular weight 523.32) equivalent to 100 mg
Sitagliptin (Molecular weight 407.31), in line with SIGN A-412 following norms are
provisionally recommended subject to the RLA verifying the availability of a
valid DML for the export product.
Product to be Exported Raw materials to be Imported
Description Quantity Description Quantity
Sitagliptin 100 mg tablets (each tabletcontains Sitagliptin PhosphateMonohydrate equivalent to 100 mgSitagliptin)
1000
tablets
Sitagliptin PhosphateMonohydrate
131.051 gm
3. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IIIPhone No: 23061562. (269).
Udyog Bhawan, New Delhi
GOVERNMENT OF INDIA
MINISTRY OF SCIENCE & TECHNOLOGYDEPARTMENT OF BIOTECHNOLOGY
«nTfl
^ 3117
^TR>-2, 7^ •'StO ̂
cTrat '^f IqcmVnooosBlock-2, 7th Floor, C.G.O. ComplexLodhI Road, New Delhi-110003
BT/IL/05/316/2010-PIDDate: 05.06.2017
OFFICE memorandum
fhoil''*' for of '/O Norms forthe export of 62/0-DTwP-HepB-Hib-PentavaIent Vaccine (Easyfive TT)*
The undersigned is directed to refer to the Directorate General of Foreign Tradecommunications vide 1} HQ File Number 01/82/050/01127/AM15/-Dated:05 12 2014' 2) HOFile Number 01/82/050/01019/AM16/-Dated:28.10.2015: 3) HQ File Number
Number 01/82/050/00709/AM17/-
f f/n M ^ forwarding applications of M/s. Panacea Biotec Ltd., New Delhi, for fixationof I/O Norms for the export of different quantities of '62/0-DTwP-HepB-Hib-PentavalentVaccine (Easyfive TT) (single dose vial of 0.5 ml presentation)' requiring three import inputsnamely 1} punfied Dipthena Toxoid concentrate antigen bulk, ii) purified Tetanus Toxoidconcentrate antigen bulk and iii) Inactivated whole cell pertussis Bulk. As per the informationfurnished by the applicant, the I/O norms for the above four cases/applications are fixedherewith.
For export of 1 million vials (single dose vial of 0.5 ml presentation) of 'DTwP-HepB-Hib-Pentavalent Vaccine (Easyfive TT)', norm for the imported items are;
1. Purified Diptheria Toxoid concentrate antigen bulk (@ -2050 Lf/ml) = 13.64 Ltr2. Purified Tetanus Toxoid concentrate antigen bulk (@ -1900 Lf/ml) = 5.23 Ltr3. Inactivated whole cell pertussis bulk (@ -192 OU/ml) = 86.46 Ltr
This issues with the approval of Secretary, Department of Biotechnology.
O0^
(Amit Parikh)Scientist 'D'
To,Shri Nirmal Kumar
Deputy^lDGFTRoom No. 303, Directorate General of Foreign TradeMinistry of Commerce & IndustryUdyog Bhawan, New Delhi-01
s
Website: http://wvvw.dbtindla.nlc.ln http://www.btisnet.gov.jn^:WrBlephone : 24363012, 243G2329 "^Fax : 011-24362884
ISO
1^'
F. NO.35011/409/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Room No. 302, 3^^ Floor,Janpath Bhawan New Delhi,
Dated: September 14, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14Case of Wl/s Aculife Healthcare Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00723/AM-17/DES-III/620 dated the 23/11/2016 vide which application from M/s AculifeHealthcare Pvt. Ltd. was sent to this Department for fixation of norms for the export ofIntravenous Fat Emulsion 10% w/v in 500 ml bottles. This department has examinedthe matter and the following norms are furnished against the export item in line withSIGN A-206 for injections above 10 ml and comparing with past consumption trend forproduction of Intravenous Fat Emulsion 10% w/v.
Product to be Exported Raw materials to be imported
Description Quantity Description Quantity
Intravenous Fat Emulsion 10%w/v in 500 ml bottles (each 100ml contains Soybean Oil-10 gm,Egg Lecithin-1.20 gm andGlycerol~2.25 gm)
100
bottles
1. Egg Lecithin 610 gm
2. Glycerol 1150 gm
3. Soyabean Oil 5100 gm
4. Glass Bottlel USP II 500 Ml As perpackingpolicy
5. 32 mm Ruber Stopper GreyBrb
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone:23352298
Email: parveen. [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IPhone No: 23061562, (269),Udyog Bhawan, New Delhi
)V
F. NO.35011/318/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi,Dated: September 4, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14Case of Wl/s J.B. Chemicals & Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00395/AM-17/DES-1II/339 dated the 17/08/2016 vide which application from M/s J.B. Chemicals &Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the export ofHexylresorcinol Sore Throat Relief Dual Action Lozenges Blackcurrant/Honey &Lemon/Black Cherry and other flavours. This department has examined the matterand the following norms are furnished against the export item:
Name of Export Product Quantity Inputs recommended Quantity for100 lozenqes
Hexylresorcinol Sore Throat ReliefDual Action LozengesBlackcurrant/Honey & Lemon/BlackCherry and other flavours (eachlozenge contains 4-Hexylresorcinol 2.4 mg)
100
lozenges
4-Hexylresorcinol(Hexylresorcinol)
0.2448 gm
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IPhone No: 23061562, (269),Udyog Bhawan, New Delhi
Email: [email protected]
n-2-
F. NO.35011/353/2016-PI (Norms)
Government of India
Ministry of Chemical & Fertilizers
Department of Pharmaceuticals
Room No. 302, 3^^ Floor,Janp'ath Bhawan New Delhi,
Dated: September 6. 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.l) 2009-14Case of WI/s Biotech Opthalmics Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00673/AM-
17/DES-III/580 dated the 31/10/2016 vide which application from Wl/s BiotechOpthalmics Pvt. Ltd. was sent to this Department for fixation of norms for the export of
Gloderm SOL, 1ml Pre-Filled Syringes (PFS) containing Sodium Hyaluronate 3%.
This department has examined the matter and the following norms are furnished against
the export item:
Product to be Exported Raw materials to be Imported
Description Quantity S.No Description Quantity pervial
Gloderm 30 L 3 % in 1
ml PFS vials (eachvial contain 30 mgcross linked Sodium
Flyaluronate)
100 vial 1. Cross Linked Sodium
Flyaluronate3.30 gm
2. Barrels /101 Nos. M3. Plunger Stopper 101 Nos.
4. Flypodermic Needle h 101 Nos.
5. Tyvek Lid v 101 Nos. 16. Blister ^ ^,101 Nos. /
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government-of India
Phone:23352298
Email: parveen.19(aiqov.in
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-lilPhone No: 23061562, (269), Udyog Bhawan, New Delhi 1 ^Email: [email protected] I ^
13^
pi\F.NO.35011/270/2016-P1 (Norms)
Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: October, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case of M/s Granules India Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/452 & 594/AM-17/DES-3/497 & 549 dated the 24/8/2016 & 6/9/2016 vide which application from M/sGranules India Ltd. was sent to this Department for fixation of norms under para: 4.7 forthe export of Ledipasvir Acetone Solvate. This department has examined the matterand the following norms are furnished under para 4.7 of Hand Book of Procedures(Vol.1) 2009-14:-
S.No. Import item Norms Recommended
for Ikq Export
1 (6S)-6-[5-[7-[2-(1R.3S,4S)-2-Azabicyc!o [2.2.1] hept-■3-y!-1H-benzimidazoI-6-yl]-9,9-difluoro-9H-f[uoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro [2.4] heptane Hcl(1:4)
0.965kg
2 N-Methoxy carbonyl-L-valine 0.70kg
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shh M.V. Singh, FTDO),Udyog Bhawan, New Delhi.
F. NO.35011/135/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated; July, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14Case of M/s Satya Deeptha Pharmaceuticals Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/245/AM-17/DES-3/196 dated the 4/7/16 vide which application from M/s Satya Deeptha PharmaceuticalsLtd. was sent to this Department for fixation of norms under para: 4.7 for the export of(1S,4R)-4-[(2-amino-6-chloro-5-formamido-4-pyrlmidlnyl) amino]-2-cyclo pentene-1-methanol. This department has examined the matter and the following norms arefurnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import item Norms Recommended
for 1kg Export
1 N-(2-amino-4.6-dichloro-5-Dvrimidinvl) formamide 0.764kg
2 (+)-2-azabicyclo [2.2.1] hept-5-en-3-oneWincelactam)
1.298kg
3 D(-) tartaric acid 0.78kq
4 Sodium borohydride 0.226kp
5 Isopropyl alcohol 4.18kq.
6 Methanol 4.75kg
7 L(+) tartaric acid 0.519kg
2. This issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:-23071162
Directorate General of Foreign Trade.Department of Commerce,(Shh M.V. Singh, FTDO), Udyog Bhawan, New Delhi.
F. NO.35011/343/2016-PI (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan.New Delhi,Dated the August 24, 2017
Office Memorandum
Subject: - Application from M/s J.B. Chemicals & Pharmaceuticals Ltd. for norms ofOxybutynin Chloride Extended Release Tablets 10 mg .
The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00586/AM-17/DES-3/536 dated the 05/09/2016 vide which application from M/s. J.B. Chemicals &Pharmaceuticals Ltd was sent to this Department for fixation of norms under para: 4.7 forthe export of Oxybutynin Chloride Extended Release Tablets 10 mg. The applicationof the unit has been examined and following quantities are recommended for one tabletof lOmg Oxybutynin chloride Extended Release.
S. No. Import Item Qty. Recommended
1. Oxybutynin chloride USP 10.02mg/tablet
2. Sfintry Pnlyox WSR N80 FP NF 80.77mg/tablet
3. Sentry Poiyox WSR 303 NF 41.10mg/tablet
2. This issue is with the approval of Competent Authority.
(Parveen Kumar)
Under Secretary to the Government of IndiaPhone:23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri Panigrahi, Dy DGFT),Room No. 414, Udyog Bhawan, New Delhi
F. NO.35011/132/2017-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi,Dated: April 13. 2017
Office Memorandum
Sub: - Fixation of norms under para 4.7- Application of M/s Cadila Pharmaceuticals Ltd.,for export of Clindamycin Capsules 150 mg.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/1050/AM-17/DES-3/1046 dated 02/03/2017 and subsequent letter from M/s Jubilant GenericsLtd.. for fixation of norms against export of Clindamycin Capsules 150 mg. Theapplicant has requested for import of relevant bulk drug i.e. Clindamycin Hydrochlorideonly as approved in the DML.
2. The SIGN for tablets are published vide S. No. A-412 and the application may beprocessed accordingly.
3. This issues with the approval of competent authority
(Barnali Khastgir)Under Secretary to the Government of India
Phone: 23323292
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shrl Nirmal Kumar, Dy DGFT),Udyog Bhawan, New DelhiEmail: [email protected]
F. NO.35011/404/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Room No. 302, 3^^ Floor,Janpath Bhawan Ne\w Delhi,Dated: September 12, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14Case of M/s Zim Labs Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00760/AM-17/DES-III/630 dated the 23/11/2016 vide which application from M/s Zim Labs Ltd. wassent to this Department for fixation of norms for the export of NicardipineHydrochloride SR Pellets 50 mg. This department has examined the matter and thefollowing norms are furnished against the export item:
Product to be Exported Raw materials to be imported
Description Quantity Description Quantity
Nicardipine Hydrochloride SRPellets 50 mg (230 mg SR Pelletscontain 50 mg NicardipineHydrochloride)
1 kg NicardipineHydrochloride
0.2196 kg
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-IPhone No:-23061562, (269),Udyog Bhawan, New DelhiEmail: [email protected]
11^
'2,53'
F. No.35011/41/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Janpath Bhawan, New Delhi,Dated: November 18, 2016
Office Memorandum
Sub: - Fixation of norms under para 4.7-Application of M/s Sentiss Pharma (P) Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/01717/AM-16/DES-3/1883 dated 22/03/2016 and subsequent letter from M/s Sentiss Pharma (P) Ltd. for fixation ofnorms against export of Inokain Eye Drops. This department has examined the matter and
Product to be Exported Raw materials to be Imported
8.
No
Description Quantity Description Quantity for100 vials
1. Inokain Eye Drops 5 ml vial(each ml contains BenoxinateHydrochloride 4 ma)
100 vials Benoxinate
Fiydrochloride2.1 gm
2 This issues with the approval of Director (Pharma Industry).(Barnali Khastgir)
Under Secretary to the Government of IndiaPhone: 23323292
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri Nirmai Kumar, Dy DGFT),Udyog Bhawan, New DelhiEmail: [email protected]
F. NO.35011/516/2015-P1 (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan.New Delhi,Dated the August 30, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures about request of M/s J.B. Chemicals Pharma Ltd.
The undersigned is directed to refer to various representations submitted by M/s J. B.Chemicals Pharma Ltd. to the DGFT and copies endorsed to the DoP, requesting foramendment in the description of export product and inputs-to be imported against export of (i)Bupivacaine Hydrochloride 0.5% in Dextrose Injection in 4 ml Ampoules and (II)Buplvacalne with Adrenaline Injection In 20 ml Ampoules.
2) A glance through the representation arid calculations undertaken in the Department, there isa need felt for amendment in the description of export products as well as the correspondingraw materials recommended to be imported. Considering different level of wastage permissiblefor injections up to 10 ml vials and above 10 ml vials, the norms conveyed earlier may bereplaced as follows: -
S. No Export Product ImportProduct
QuantityRecommended
1. Bupivacaine Hydrochloride 0.5%in Dextrose Injection in 4 mlAmpoules (each ml contains 5 mgBupivacaine Hydrochloride)
BupivacaineHydrochloride
22 mg per vial of 4 ml
2. Bupivacaine with AdrenalineInjection in 20 ml Ampoules(each ml contains 5 . mgBupivacaine Hydrochloride and0.0091 mg of AdrenalineBitartarate)
1) BupivacaineHydrochloride
105 mg per vial of 20 ml
2) AdrenalineBitartarate
0.1911 mg per vial of 20mi
4) This issues with the approval of competent authority.
(Raj Kumar)Under Secretary to the Government of India
Phone: -23071162
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
Case No.: 15/19/82-
ALC4/2013
Party NameiAMINES &PLASTICIZERS LIMITED
Meet No/Date: 19/82-
ALC4/2013
02.01.2014
Status:Case
Approved
HQ File
:0I/82/050/00960/AM14/
RLA File
:03/94/040/00661/AM14/
Lic.No/Date:031075688
1
06.11.2013
Defer Date:
23
0
Decision : In the light of written comments received from- Department of Chemicalsand Petrochemicals vide their UO No. 14010/61/2011-Ch II dated 02.01.2014, it wasdecided to ratify norms under Para 4.7 of HBP vl as per details given below or asapplied by the firm, whichever is less:
\
Export product Exp.Qty.
Sl.No. Import items Qty. allowed |
N-METHYL
MORPHOLrNE fNMM)I kg 2.
Morpholine 1.001kg j
RA may take appropriate action as per the decision of Norms Committee.
1^1
F. No.35011/570/2013-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Phannaceuticals
New Delhi, the 24^'* December, 2013
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/sCadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/281/AM-14/DES-3/383 dated ̂ e08/08/13 vide which application from M/s. Cadila Healthcare Ltd was sent to this Department for fixationof norms under para: 4.7 for the export of Potassium Citrate Extended Release Tablets. Thisdepartment has examined the matter and the following norms are furnished under para 4.7 of Hand Bookof Procedures (Vol.1) 2009-14;-
Udyog Bhawan,
For Export of 1 Million No.Tablets.
S.No. Import Item 5m Eq 10.0m Eq 15.0m Eq
1. Potassium Citrate USP 550.8 kg 1101.60 kg 1652.40 kg
2. Carnauba Wax (EZ-COAT CWM) NF 137.85 275.70 290.0
3 to 7. Bottles and Caps Relevant, as per packing policy.
This issues with the approval of Director (Cost).
(Raj Kumar)
Under Secretary to the Government of IndiaPI-Norms
Directorate General of Foreign Trade,Department of Commerce,(Shri R.C. Meena, Dy. DGFT), Udyog Bhawan, New Delhi.
F. NO.35011/347/2016-P1 (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
*****
Shastri Bhawan.New Delhi.Dated the April 3, 2017
Office Memorandum
Subject: - Application from M/s Cadila Healthcare Ltd. for norms of Pyridostigmine BromideTablets 60 mg.
The undersigned is directed to refer to DGFT U.O.No. 01/82/050/00602/AM-17/DES-3/541 dated the 06/09/2016 vide which application from M/s. Cadila Healthcare Ltd. was sent tothis Department for fixation of norms under para: 4.7 for the export of Pyridpstigmine BromideTablets 60 mg. This department has examined the matter and the following norms are furnished:
Product to be Exported Raw materials to be Imported
Description Quantity S.
No.
Description Quantity for1000 tablets
PyridostigmineBromide Tablets
60 mg (eachtablet containsPyridostigmineBromide 60 mg)
1000
tablets
1. Pyridostigmine Bromide 61.200
2. Hvdroxy Propyl Cellulose 4:880-9m.
3. Lacfose Anhydrous 297.37Q-gm--
4. Bottle 75CC White HDPE -As-pei;-paekmgPolicy^
5. 33 mtb -400 PP CRC CAP (White HS 123Liner)\\
6. Desicc'^nt Canister 2 g7. Packin^sert (Pyridostigmine Bromide
Tablets) \
2) This issues with the approval of competent authority.
Barnali Khastgir)
Under Secretary to the Government of IndiaPhone: 23323292
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,
• (Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New DelhiEmail: [email protected]
F. NO.35011/119/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan. New Delhi,Dated: July, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case ofWl/s Anuh Pharma Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/116/AM-17/DES-3/99dated the 23/5/16 vide which application from M/s Anuh Pharma Ltd. was sent to thisDepartment for fixation of norms under para: 4.7 for the export of Dexamethasone SodiumPhosphate. This department has examined the matter and the following norms are furnishedunder para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import item Norms Recommended for
Ika ExDort
1 Dexamethasone 0.78kg
2. This issues with the approval of competent authority.
(Rajkumar)
Under Secretary to the Government of IndiaPH:- 23071162
Directorate General of Foreign Trade.Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. NO.35011/123/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan. New Delhi,Dated: July, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case ofWl/s Envee Drugs Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/88/AM-17/DES-3/130dated the 23/5/16 vide which application from M/s Enyee Drugs Pvt. Ltd. was sent to thisDepartment for fixation of norms under para: 4.7 for the export of Clobetasole propionateBP/USP. This department has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import item Norms Recommended forIka ExDort
1 Betamethasone I.OOkq
2. This issues with the approval of competent authority.
(Rajkumar)
Under Secretary to the Government of IndiaPH:-23071162
Directorate General of Foreign Trade,Department of Commerce.(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. NO.35011/130/2017-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Mo
Shastri Bhawan, New Delhi,Dated: April 12 2017
Office Memorandum .
Sub: - Representation against norms allowed in respect of an Application from M/s^^&^yt^__L^l>^Ltd., forexport of Atovaquone
The undersigned is directed to refer to DGFT U. 0. No. 01/82/050/379/AM16/DES-3/1020 dated23.02.2017 forwarding a representation against norms allowed against export of Atovaquone Bulkdrug. The applicant has requested to increase the quantity of various inputs based upon a certificateissued by the Superintendent of Custom & Central Excise, Kazipally Range, Secunderabad.
2) It may be recalled that norms as given below were permitted based on DoP's comments. The normsas per CE Certificate are indicated in last column of the following table:
V-
8. No. Import Item
Qty. Recommendedkg/kg.
Quantities as per CE
Certificate
^1.
4~(4-ChlorophenyI) Cylohexyl CarboxylicAcid 2.00 1 3.577
• 2. 2-Chloro-1,4-Naphthoquinone 1.62 3.605
Setphotane M:00
T0lueRe=f' ^^:4e -mTess-
5. Acetonitrile --6:65 -4§:663
DictiloTOIgthane^
7. MethanDt==^ ' -76:686-
3) It is also to be pointed out that the certificate has been issued based upon a Chartered EngineerCertified Data and at the request of the company. It is also stated that norms equivalent to thoseallowed to M/s Mylan Laboratories Ltd. have also been adopted while processing other applications fromdifferent Pharma companies for the same export product.
4) In view of the foregoing, there is no ground for higher norms based upon the CE certified figures thathas been merely issued based upon data provided by a Chartered Engineer and as per request of thecompany without any objective assessment of manufacturing process or accounting for valid recoveriesof solvents etc.
5) This issues with the approval of competent authority
(Barnali Khastgir)Under Secretary to the Government of IndiaPhone: 23323292/Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri Nirmal Kumar, Dy DGFT),Udyog Bhawan, New Delhi/Email: [email protected]
F. NO.35011/353/2016-P1 (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
j
Room No. 302, 3^^ Floor,Janpath Bhawan New Delhi,Dated: September 6, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case ofWI/s Biotech Opthalmics Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/050/00673/AM-17/DES-111/580 dated the 31/10/2016 vide which application from M/s. Biotech Opthalmics Pvt. Ltd. wassent to this Department for fixation of norms for the export of Gloderm SOL, 1ml Pre-FllledSyringes (PFS) containing Sodium Hyaluronate 3%. This department has examined thematter and the following norms are furnished against the export item:
Product to be Exported Raw materials to be Imported
Description Quantity S.No Description Quantity pervial
Gloderm 30 L 3 % in 1
ml PFS vials (eachvial contain 30 mgcross linked SodiumHyaluronate)
100 vial 1. Cross Linked Sodium
Hyaluronate
3.30 gm
2. Barrels 101 Nos.
3. Plunger Stopper 101 Nos.
4. Hypodermic Needle 101 Nos.
5. Tyvek Lid 101 Nos.
6. Blister 101 Nos.
2. This issues with the approval of competent authority.
(Parveen Kumar)Under Secretary to the Government of India
Phone: 23352298
Email: [email protected]
Directorate General of Foreign Trade.Department of Commerce,(Shri S.K. Panigrahi, Economic Officer, DES-lllPhone No: 23061562, (269), Udyog Bhawan, New DelhiEmail: [email protected]
F. No.35011/206/2014-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
lyw'?
New Delhi, the
Udyog Bhawan,October, 2014
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/sCTX Life Sciences Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1195/AM-14/DES-3/ dated the26/03/14 vide which application from M/s. CTX Life Sciences' Pvt Ltd was sent to this Department forfixation of norms under para: 4.7 for the export of Irbesartan. This department has examined the matterand the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
I
S.N^ Import Item Qty. Recommended kg/kg.
2-cyano-4-bromomethyl biphenyl 1.02
Petassium-earbenate- 2:09
2-n-butyl-l,3-diazospiro[4,4] non-4-ene HCL 0.88
4^TrrethyTammeTfGL 0 89
—Sedium-azide- 0 49
—Sodium_nitnt^ 0.48
—■EtltyPaeet-ate 2.86
—Ax ti vate d-carben—^ 0.1^0
This issues with the approval of Director (Cost).
(Bamali Khastgir)Under Secretary to the Government of India
Directorate General of ForeignTrade,Department of Commerce,(Shi'i M.V. Singh, FTDO),Udyog Bhawan, New Delhi
Sub:
F. No.35011/494/2012-PI (Norms)Govermiient of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan,New Delhi, the 1?"'October, 2012.
Office Memorandum
Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-Hetero Labs Ltd.
14 Case of M/s
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/197/AM13/DES-3/325 dated the28/05/12 vide which an application from M/s Hetero Labs Ltd was sent to this Department for fixation ofnorms under para; 4.7 for the export of Lisinopril. This department has examined the matter and thefollowing comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import Item Qty. Recommended kg/kg.
1.
N2-[(lS)-Ethoxy carbonyl-3-phenyl-propyl]-N6-Trifluoroacetyl-L-Lysine 1.92
2.L-Proline0.927
3.N,N-Carbonyldiimidazole 0.400
4.Methanol2.82
5.Methylene Chloride 9.59
6.Isopropyl alcohol 2.77
2. This issues with the approval of Director (Cost).
(N.N.Ahuja)Section Officer
PI-Nonns
Directorate General of Foreign Trade,Department of Commerce,(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
I 'll
kaVF. NO.35011/96/2012-PI (Norms)
Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan,New Delhi, the July, 2012.
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-Ranbaxy Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1091/AM12/DES-3/1615 datedthe 16/01/12 vide which an application from M/s Ranbaxy Labs Ltd was sent to this Department foifixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 27.5% /department has examined the matter and the following comments are ftirmshed under para 4.7 of HandBook of Procedures (Vol.1) 2009-14;-
14 Case of M/s
S. No. Import Item Qty. Recommended kg/kg.
1.Carbopol 974P 0.20
2.
Clarithromycin OR Its raw materials as per SIGNA-2263 on pro-rata basis. 0.2777
2. ' This issues with the approval of Economic Advisor.
(N.N.Ahuja)Section Officer
PI-Norms
Directorate General of Foreign Trade,Department of Commerce,(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi. / 3
/
,•9^
/
i) f <5
- /i.f- ■' ——-
Sub:
F. No.35011/296/2012-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
New Delhi, the
Office Memorandum
Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-Kopran Ltd.
Udyog Bhawan,September, 2012.
14 Case of M/s
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1181/AM12/DES-3/1755 datedthe 13/02/12 vide which an application from M/s Kopran Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of Pregabalin. This department has examined the matter and thefollowing comments are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import Item Qty. Recommended kg/kg.
1.(±) 3-(Carbamoyl Methyl)-5-Methylhexanoic Acid 2.94
2.Chloroform 4.75 Ltr/kg
3.R(+)-Methyl Benzyl Amine 0.114 kg/kg
4.Iso Propyl Alcohol 0.96 Ltr/kg
This issues with the approval of Director (Cost).
(N.N.Ahuja)Section Officer
PI-Norms
Directorate General of Foreign Trade,Department of Commerce,(Mrs. Lalita Maini, FTDO), Udyog Bhawan, New Delhi.
F. NO.35011/168/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Office Memorandum
Shastri Bhawan, New Delhi.Dated: March 27, 2017
Sub: - Fixation of norms under para 4.7- Application of M/s BDR Pharmaceuticals International (P)Ltd.
The undersigned is directed to refer to DGFT U.O. No. 01/82/50/00320/AM-17/DES-3/264dated the 08/07/2016 vide which an application from M/s BDR Pharmaceuticals International (P) Ltd.was sent to this Department for fixation of norms against export of Tamoxifen Tablets BP 10 mg &20 mg. The application has been examined and following norms are recommended
Product to be Exported Raw materials to be Imported
S. No. Description Quantity Description Quantity for1000 Tablets
1. Tamoxifen Tablets BP 10 mg (eachuncoated Tablet contains: TamoxifenCitrate equivalent to Tamoxifen 10 mgj_
1000 tablets Tamoxifen Citrate 15.473 gm
Tamoxifen Tablets BP 20 mg (eachuncoated Tablet contains: TamoxifenCitrate equivalent to Tamoxifen 20 mg)
1000 tablets Tamoxifen Citrate 30.946 gm
2) The above norms are being conveyed subject to verification of availability of valid DrugManufacturing License for both compositions of the export product by the RLA. This isprovided in view of the fact that copy of DML available with the application do not have the list ofapproved medicines.
3) Considering the fact that, the referred compositions of Tamoxifen are standard formulations, basedon the molecular weight co-relation for Tamoxifen base and its citrate salt and allowing admissiblewastage as per SIGN A-412, above quantities of Tamoxifen Citrate, against respective applicationsrecommended as Norm for 1000 tablets of 10 mg & 20 mg against this application, may also beconsidered for publication as SIGN for the above two export products.
4) This issues with the approval of competent authority.Barnali Khastgir)
Under Secretary to the Government of IndiaPhone: 23323292
Email: [email protected]
Directorate General of Foreign Trade,Department of Commerce,(Shri Nirmal Kumar, Dy DGFT).Udyog Bhawan, New DelhiEmail: [email protected]
F. No.35011/13/2014-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
New Delhi, the
Udyog Bhawan.September, 2014
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Nectar Life Sciences Ltd.
The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/408/AM-14/DES-3/950 dated the 26/11/13 vide whichapplication from M/s. Nectar Life Sciences Ltd was sent to this Department for fixation of norms under para: 4.7 for the export ofCefixime Trihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Bookof Procedures (Vol.1) 2009-14:-
S. No. Import Item Qty. Recommended kg/kg.
U' 1. GCLE 1.507
2. Sodium bromide 0.3628
J. Tri Phenyl Phosphine 0.820
v--4. DMF 1.869
5. Methylene Chloride 1.546 .
6. Formaldehyde 1.118
7. Methanol 5.117
8. Phenol 0.3808
U- 9. Butyl Acetate 0.302
V-10. Eno Carbon 0.100
11. Acetone 0.793
0.0182
" 13. MICA Ester 0.820
U4,—Aeetie-Aeid— 0.030
15. Triethylamine (TEA) 0.2717
Eth)4-Acetate ■ 0.376
This issues with the approval of Director (Cost).
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
(Barnaii Khastgir)
Under Secretary to the Government of IndiaPl-Norms
F. No.35011/293/2014-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
New Delhi, theUdyog Bhawan.November, 2014
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s Dr.Reddy's Labs Ltd.
The undersigned is directed to refer to DOFT U.O.No. 01/82/50/213/AM-15/DES-j/78 dated the08/05/14 vide which application from M/s. Dr. Reddy's Labs Ltd was sent to this Department for fixation ofnorms under para: 4.7 for the export of Capecitabine. This department has examined the matter and thefollowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.Tlo. Import Item Qty. Recommended kg/kg.
1. 2,3-Di-0-acetyl-5-deoxy-5-fluorocytidine 1.19
2. N-Pentyl Chloro Formate 0.813
Methylene Chloride 4.20
This issues with the approval of Director (Cost).
(Barnali Khastgir)Under Secretary to the Government of India
Directorate General of Foreign Trade,Department of Commerce,(Shi-i M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F.NO.35011/378/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Office Memorandum
Shastri Bhawan, New Delhi,
Dated: September 8, 2017
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2009-14,Application of M/s Morepen Laboratories Ltd.
■ The undersigned is directed to refer to DGFT U.O. No. 01/82/50/632/AM-17/DES-3/548 datedthe 03/10/2016 vide which an application from M/s Morepen Laboratories Ltd. was forwarded to thisDepartment for fixation of norms for the export of Atorvastatin Calcium. This department hasexamined the matter and the following norms are recommended against this application:-
S.No. Import Product Nonns Recommended
1 (4R-Cis)-l,l-Dimethylethyl-6-Cyanomethyl-2,2-Dimethy 1-1,3 -Dioxane-4-Acetate
0.708kg
2 4-Fluoro-alpha-[2-methyI-l-osopropyl]-gamma-oxo-N-beta-diphenyl benzenebutanamide
1.15kg
3 Methanol 6.42kg
4 Methyl Tert-Butyl Ether (M20F) 2.78kg
5 Tetrahydrofliran 0.80kg
6 Methylene Chloride 4.48kg
7 Diisopropyl ether 3.90kg
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Under Secretary to the Government of IndiaE-mail: parveen.19(ggov.in
Ph;-23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.E-mail: [email protected]'
Ph: 23061562, Extn.269
r
F. No.35011/729/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: 27 April, 2016
Office Memorandum
Subject; - Fixatiory^f norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of WI/sAnuh PKamfa Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/709/AM-16/DES-3/781 datedthe 10/8/15 vide which application from M/s Anuh Pharma Ltd. was sent to this Department forfixation of * norms under para: 4.7 for the export ofBetamethasone Valerate BP/USP/EP/IP. This department has examined the matter and thefollowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No.^ Import Item Norms Recommended
for 1kq Export
C1^ Betamethasone BP/USP/EP/IP 0.915kg
2— ^FBfflethyFGfth o - Va 1 o rato -Gr^ekg-
2. This issues with the approval of competent authority.
(Rajkumar)
Under Secretary to the Government of IndiaPH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
F. No.35011/814/2014-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan.New Delhi, the August, 2014
Office Memorandum
Subject:- Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Case of M/s Intas Pharma Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/825/AM-14/DES-3/982 dated the 26/11/13 vide whichapplication from M/s. Intas Pharma Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of LithiumCarbonate FC Tablets 250mg and 400mg . This department has examined the matter and the following norms are furnished underpara 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S.No. Import Item
For Export of 1000 Tablets
250 mg tablets 400 mg tablets
1. Lithium Carbonate PH. EUR./USP 0.255 kg 0.408 kg
2. Hypromellose 0.0107 0.0172
J. Magnesium Stearate 0.005 0.008
4. Maize Starcdh 0.0683 0.1092
5. Sodium Starch Glycolate 0.010 0.016
6. Ethanol 0.2791 0.4505
7. Lactose Monohydrate 0.130 0.208
8. Povidone 0.020 0.032
9. 5Ply Plain Shipper Relevant, As per packing policy.
10. HOPE Bottle
11. PP CR Closure
This issues with the approval of Director (Cost).
Directorate General of Foreign Trade,Department of Commerce,(Sliri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
(Raj Kumar)
Under Secretary to the Government of IndiaPI-Norms
F. N0.35OII/222/2OI6-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Shastri Bhawan, New Delhi.Dated: September 11, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2015-20 Case of M/s XJt^kfiaxLaboratories Pvt. Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/386/AM-17/DES-3/440 dated the19/08/2016 vide which application from M/s Unimax Laboratories Pvt. Ltd. was sent to this Department forfixation of norms under para: 4.7 for the export of Betamethasone Dipropionate BP 2009/BetamethasoneDipropionate. This department has examined the matter and the following norms are fiirnished under para 4.7of Hand Book of Procedures (Vol.1) 2015-20:-
S.No. Import item Norms Recommended
for 1kg Export
1 Betamethasone 0.868kg
2.) This issues with the approval of competent authority.
(Parveen Kumar)
Under Secretary to the Government of IndiaE-mail: parveen. [email protected]
Ph: 23352298
Directorate General of Foreign Trade,Department of Commerce,(Shri S.K. Panigrahi),Udyog Bhawan, New Delhi.E-mail: [email protected]
Ph: 23061562. Extn.269
15^
F. No.35011/28/2013-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan,New Delhi, the April, 2015
Office Memorandum
Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case olM/s. VhaHbabsTtdT
The undersigned is directed to refer to DGFT U.O.No. 0I/82/50/670/AM13/DBS-3/831dated the 22/01/15 vide which an application from M/s. Vital Labs Ltd was sent to thisDepartment for fixation of nonns under para: 4.7 for the export of Methyl Cobalamin J.P(Mecobalamin). This department has examined the matter and the following comments arefurnished under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14:-
S. No. Import Item Qty. Recommended kg/kg.
1. Vitamin B 12 (Cyanocobalamin) 0.95
2. This issues with the approval of Director (PI).
(Barnali Khastgii")Under Secretary to the Government of India
Phone-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
/T9
F.NO.35011/209/2016-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhav\/an, New Delhi,Dated: September, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.!) 2009-14 Case of WI/sDivi's Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/505/AM-17/DES-3/336 datedthe 17/8/2016 vide which application from M/s Divi's Labs Ltd. was sent to this Department for fixationof norms under para: 4.7 for the export of Naproxen. This department has examined the matter andthe following norms are furnished under pa>a 4.7 of Hand Book of Procedures (Vol.!) 2009-14:-
S.No. Import item Norms Recommendedfor 1kg Export ■
1 DL-Naoroxen 1.17kg
2 N-Octyl-D-Glucamine 0.0882kg
3 Methanol 2.02kg
4 . Acetic acid 0.54kg
5 Toluene 0.84kg
2. This issues with the approval of competent authority.
(Rajkumar)
Under Secretary to the Government of IndiaPH:-23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi.
fCo
F. NO.35011/289/2016-P1 (Norms)Government of India
Ministry of Ghemicai & FertilizersDepartment of Pharmaceuticals
^ !
Janpath Bhawan, New Delhi,Dated: September 15, 2017
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2015-20 Case of WI/sCadila Healthcare Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/356/AM-17/DES-3/333 datedthe 17/08/2016 vide which application from M/s Cadila Healthcare Ltd. was sent to this Departmentfor fixation of norms under para: 4.7 for the export of Acebutolol Zydus 200mg, 400mg Tablets;This department has examined the matter and the following norms are furnished under para 4.7 OfHand Book of Procedures (Vol.1) 2015-20:-
S.No. Import Item Norms Recommended
200mg 400mg
1 Acebutolol Hcl PH EUR 204mg per tablet 408mg per tablet
2.) This issues with the approval of competent authority.
Directorate General of Foreign Trade.Department of Commerce.(Shri S.K. Panigrahi, Economic Officer. DES-IPhone No: 23061562, (269).Udyog Bhawan. New DelhiEmail: [email protected]
(Parveen Kumar-
Under Secretary to the Government of IndiaPhone: 2335229S
Email: [email protected]
1^;
F. NO.35011/97/2015-PI (Norms)Government of India
Ministry of Chemicals & FertilizersDepartment of Pharmaceuticals
0^\y\
Udyog Bhawan,New Delhi.Dated the August, 2015
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.1) 2009-14 Case of M/s SnamLabs Pvt Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1047/AM-15/DES-3/1069 dated the13/01/15 vide which application from M/s. Sriam Labs Pvt Ltd was sent to this Department for fixation o.norms under para: 4.7 for the export of (lS,4R)-4-Amino-2-Cyelopentene-l-MethanoI Tartrate (Cap-2). Thisdepailment has examined the matter and the following norms are furnished under para 4.7 of Hand Book oiProcedures (Vol.1) 2009-14:-
S.No. Import Item Qty. Recommended kg/kg.
1. Vincelactum 1.337
2. Sodium Borohydride 0.214
J. D (-)-tartaric Acid 0.90
Bamali Khastgir)
Under Secretary to the Government of IndiaPhone:23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
0 >
F. NO.35011/757/2015-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan, New Delhi,Dated: 2. May 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Fland Book of Procedures (Vol.1) 2009-14 Case of M/s Sriam Labs Pvt.Ltd.
The undersigned Is directed to refer to DGFT U.O.No. 01/82/50/1186/AM-16/DES-3/1299 dated the 16/12/15vide which application from M/s Sriam Labs Pvt.Ltd. was sent to this Department for fixation of norms under para: 4.7 for the exportofOiethyl (3,5-dimethoxy benzyl) phosphonate (ADDP-2).This department hasexamined the matter and the following norms are furnished under para 4.7 of FlandBook of Procedures (Vol.1) 2009-14:-
S.No. Import Item Norms Recommended
for 1kg Export1 3,5-dihvdroxv benzole acid 0.667kg■2 -T^otaSsiufn carbonate VF94kg3 Sodium borohydride 0.423kg4 Triethyl phosphite 0.932kg
2. This Issues with the approval of competent authority.
(Rajkumar)Under Secretary to the Government of India
PH:- 23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
\^j>
F. No.35011/226/2014-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
Udyog Bhawan,New Delhi, the October, 2014
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Caseof M/s Hetero Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/1233/AM-14/DES-3/39dated the 25/04/14 vide which application from M/s. Hetero Labs Ltd was sent to thisDepartment for fixation of norms under para: 4.7 for the export of Losartan Potassium. Thisdepartment has examined the matter and the following norms are furnished under para 4.7 ofHand Book of Procedures (Vol.l) 2009-14:-
S. No. Import Item Qty. Recommended kg/kg.
1. 2-butyl-4-chloro-5-formyl imidazole 0.50
2. 4-bromo methyl-2-cyano biphenyl 0.866
3. Sodium borohydride 0.048
4. Toluene 1.45
5. Methanol 0.85
6. n-methyl pyrrolidone 0.769
This issues with the approval of Director (Cost).
(Barnali Khastgir)Under Secretary to the Government of India
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
V /
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a>i'.
®fcii50|il35g9^-PI (Norms)Government of India
Ministry of Chemical & FertilizersDepartment of Pharmaceuticals
o I
Udyog Bhawan, New Delhi,Dated: 22 March, 2016
Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.I) 2009--14jCase^of-IV1/s_RA Chem Pharma Ltd. _
The undersigned is directed to refer to DGFT U.O.No. 01/82/50/839/AM-16/DES-3/923 dated the 8/9/15 vide which application from M/s RA Cham Pharma Ltd.was sent to this Department for fixation of norms under f5ara: 4.7 for the export ofEntacapone. This department has examined the matter and the following norms arefurnished under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14:-
S.No. Import Item Norms Recommendedfor 1kq Export
1 Vanillin 2.306kg
2 Pyridine 1.02kq
3 Diethyl Amine 1.437kq
4 Toluene 1.35kq
5 Methanol 0.62kg
6 Ethyl Acetate 2.56kgn nCUn
I 7 I Ethyl Cyano Actate
X
>' s
0
This issues with the approval of competent authority.
(Rajkumar)
Under Secretary to the Government of IndiaPH:- 23071162
Directorate General of Foreign Trade,Department of Commerce,(Shri M.V. Singh, FTDO),Udyog Bhawan, New Delhi
o m • X^ ••• I
: {. ••
i
Case No.:17/27/82-ALC4/2008 Party Name:ORGANICAAROMATICS PVT LTD
Meet No/Date: 15/82-
ALC4/2009
07.07.2009
Status:
Approved.
HQ File:01/82/050/01034/AM09/
RLA File
:07/24/040/00280/AM09/
Lic.No/Date:0710059944
19.09.2008
36
Decision : Committee considered case as per agenda and in light of written comments ofDept. of C & PC conveyed vide U.O. No. 14010/132/2004-Ch.Iir dated 19.3.2009decided to ratify norms under Para 4.7 of Handbook of Procedures as per details below oras applied for by firm whichever is lower
Export Product ExportQuantity
S.No. Import Item Quantity allowed
AlphaDamascone
1.00 Kg. 1 Citral 1.583 Kg.
Beta
Damascone
1.00 Kg. 1 Citral 1.583 Kg.
. RA concerned may take further necessary action as per above decision of NC.
GC
7.*
Government of IndiaMinistry of Chemicals and Fertilizers
Department of Chemicals and Petrochemicals %
Subject: 3PP"':ati°'Vfrom M/s. Tide Indusfries for the import of rawmatenal against the export of Rose Oxide etc.
- \u-v
norms Department recommends the followingnorms for the present Advance Authorization application.
*1. Item of Export QtvAldehyde C12 Laurie 1 kg
ucm sji inifJUl I
1. C-12 Fatty Alcohol(Lauryi Alcohol)Qty1.725 kg ■r7>
1. Item of ExportLauryl Nitrile
Qty.1 kg
item of Import1. Laurie Acid 1.22 kg
i yi cj/
I {'■
1. Item of ExportL- Rose Oxide
1. item of ExportRose Oxide
Qty.1 kg
Item of Import1. L Citronellol
Qty. Item of Importt kg 1. Citrai (Citral Synthetic)
This issues with the approval of competent authority.
Qty3.269 kg
Qty4.17 kg
♦••-A
(A.K. AGARWAL)Addl. Industrial Adviser
Tel. No. 011-23381430
Shrl Mahender Vikr-am Sinqh.FTDO fPES-lin O/n nnPT. Udvpg Rhnwan Npw n.inr _11Deptt. of C&PC U.O. No. 14010/40/2011-CH-ll dated 04.03.2016
'g- ItnF. No,35011/173/2016-PI-Norms -5^;;
Governmeni 01' IndiaMinistry of Chenilcal &. FertilizersDepartment of Pharmaceuticals
Shastri Rliav/an,• New Delhi, the- September 26. 2016
/ Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.!) 2009-14 Caseof Nils Aurobindo Pharma Ltd.
The utRiersigned is ciitected to refer to DGFT U.O. No. 01/82/50/1576/AM-16/DES-3/244 dated tlie 03/07/2010 vide whicti application from M/s Aurobindo Pharnia Lid. was sentto this Department for fixation of norms under para: 4.7 for the export of PGnicillin Vpotassium 600 ing Tablets and 250 mg Tablets. This department has examiped'the matterand the foilovv'ing norms arc furnished under para 4.7 of Hand Book of Procedures (Vol.!)2009-14: -
No Import Item - Norms Recommended
I ; _ ! ^500 mg • t 250,iTig iI 1. ; Phenoxymei'hyl Penicillin Pot"assiun-i 5'05.5nTg75M^^i . I ^Jassium)__ Tablet " i Tablet \
2) This issues wiij-i the approvul of compeleht authority.
Direciornte General of Foreign Trade,.Depcirlmenl oi Conimerce.
(Shri IvLV. Singh, FTDO),IJdyog Bhawan. New Delhi- ) ID011
(Ftaj Kumar)Under Secretary to ti'ie Government of India
Phone:-23071162
Email: [email protected]
F.NO.35011/351/2016-PI-Norms ^ ̂Government of inciid
^'"'®'7°fGhemicaUFer%ers ' 'Departmenjpf Pharmaceuiica^^
■ • Shastri Bhawan
^ ̂ r-- ■ - - ■ -ip ^ON.fpr
2) It may also ̂ be mentioned filat^^Barac^tamdi ^ - ^ \ " ' - . ^TOsseS:ThS5„,y„-j,j-g
KfSH?i ""«■ ™W'SNWMslSssS30m§s^ Quariiity
A-3488 f~u^— 1' JllP^Amino Phenol—
0.95 kq0.95 ko 0.91 kq,.(?l^ti^Anhyd7idi I^SST^ !
3) The applicani has claimed thai as anain.:f fhoreflected in the SION A-3488, the company fs achiS'""'! nSrSS ~Anhydride ©oIt 'S^'ytd ̂ af^TTrr"' "requirement works out to 0.80 kg of PAP and n yr . purification, theParacetamol. It is also worth pointing out that Ih/r Anhydride for each kg ofreported by some otherPharmaceuticals Ltd., in connection wilh their inwri? Jamisonhave been even lower lhan 0.75 kg/kg. appiications for Acetic Anhydride
.2/-
\ \
F No.3j011/351/2016-P|-Nomis ^ ̂- Government of (ndid
Mmistiy of Chemical S FeililizersDepartmenf ofPhirmaceutic# , • ,
■ . . . ...... -i Bhawan7,2017
2) It Wa^ also 'Pe menticinea tiial F ■ ' ■ -
Iff
A-3488 pTj^1 (2) smirniRMln
— -pMSjicA^^ S ^
■ --
re fcL?;S"sS ««? f' " o, PAP a„e ^p,»,„s p, Aoe„c A„p 2 ■r.rr,.r;,7 t" "••"consumption ,n the PAP route. . benchmarlr of raw mateiS
reported by so,me other n.a,u,facture,s i, Ir 2 o 1 """'f AnhydridePha,-mac.eut,cals Ltd. , in connection with tiebm no L '''' '^'rnsonhave been even lower than 0.75 kg/kg. ®® ^l^piications for Acetic Anhydride
.21-
17 o
-2-
5) In view of the foregoing, DGFT may consider amendment in the SIGN A-3488 as explainedabove. Simultaneously, the ghj"ntijy"6f A jn.SIGN A:343 niay also ,be revisedto 0.7.5 kg/kg in place of 0.95;kg/kg: thi's is,being recomiriended in view of the fact that AceticAnhydride is used in last stage of both of the processes for conversion of Para Amino Phenbltp^paxecetamoj. The revised .SipN.tpXepjdcl® ahd A-3488 Would be affollofe
SuahfityTyf:Paf^ T ■ Pflllgjp ̂3IW^Mag^ '7 T ',Quahiijy'pef'kg''.-TiilsiEyi.v.r-J2);;^t|iymil;^ .-e'.
i:7--Ar3488 , v ■M<g Y' ^[l);'|^m|^mihdWehbl '' ."' ' .T- :o.i80]eg=:;:_' -
.. .;j ;p.- V-,; ' - v i,;.': ■(2)i j^ti^Amhydnde -"T ' .,.■7 ' ■ ■ . 'DlTS^kg^ T.7 V -
6) bCFT may also consider .fo ufidertake-d rey^^ SlONs for conventional drugs andallied products; Jhis rfiay /be contempidfeJpp^ie^
, auye.iiC^iiiefits,; jn :pi;oauctipn of corresppiding c to be..exported as .alsothe/ihcremehtaFefficiericies exj^ctedio ap^ an exercise is relevantin .p|ti^'to'\;cheGk iypidibfe -.royeh.u^^quahdtief of corTesppf^ind to the disadvantage of localrhanu'factufers'of releyantihpuis. ■ \ '! • •
7) This issues v/ith the approval of competent authority
»! "il ,
Directorate General of Foreign Trade,De'"'2rtmen[ of Goi^imerce(Shri Nirmal Kumar, Dy DGFT),Uo'vog Bhawan. Now DelhiFI'Tiai 1! nirmal.kLtn"]arS5{'"7;i"iio.i11
("Barnalt Khastgir)Under Secretary to the Government of India
Phone; :23323292Email:[email protected]
)ii