MFPPLIGEN/2016/029 June 06,2016

To,

The Member Secretary, Industry-II,

Ministry of Environment, Forest & Climate Change

Vayu wing, Indira Paryawaran Bhawan,

Jor 8agh Road, Jor 8agh, New Delhi-110003

Subject: Online query raised regarding application submitted for the proposed expansion of

Synthetic Organic Chemicals Industry's expansion at manufacturing facility located at Plot

No. 31 to 35, 48 to 51, 1 to 5, 26 & K ,Gat No 201, Lakhmapur, Tal. Dindori, District:

Nashik, Maharashtra.

Ref: (a) Proposal No. IAlMHIIND2/50828/2016 dt 11.05.2016 & File No. J-11011/91/2016-IAII(I)

(b) Online query raised dt 11.05.2016

Dear Sir,

We are proposing to expand our existing Synthetic organic chemicals based product at

manufacturing facility located at Plot No. 31 to 35, 48 to 51, 1 to 5, 26 & K, Gat no 201,

Lakhmapur, Tal Dindori, Nashik district Maharashtra.

The proposed expansion activity falls under schedule 5(f) category A as per the EIA Notification of

14th September, 2006 and will require prior Environmental Clearance.

We have received online query as per following

Query 1 : whether existing unit has obtained Environmental clearance or not? If not please justify

the reason?

Reply : Megafine Pharma (P) Ud has taken over a unit called Superfine Laboratories (P) Ud-

copy of acquisition order from Honourable High Court Mumbai dt 22nd Jan 2006 is enclosed

herewith (Annexure I). Consent Order No. BO/RO-NsklPCI-1I943-07 R/CC-125 dt 30.03.2007 was

granted to us by Maharashtra Pollution Control Board post acquisition wherein the Total production

of APls at the time was 650.67 MTPA.

Copy of recent MPCB Consent to Operate (ref BO/JD-PAMS/NK-12418/R/CC-1911 dt 04.03.2012

valid upto 31.12.2017) is enclosed herewith which shows our production is lower than the earlier

sanctioned limits (production as per existing CTO is 338.45 MTPA as against 650.67 MTPA

earlier).

Megafine Phartna (P) Ltd.Website: www.megafine.in • CIN: U24239MH1995PTC092028

CORPORATE OFFICE:Sethna, 4th Floor,55, Maharshi Karve Road, Marine Lines,Mumbai - 400 002, Maharashtra, IndiaTel.: +91-22-61461111Fax: +91-22-61461109E-mail: info@megafine.in

PLANT:Plot No. 31 to 35 & 48 to 51,5,26 & K/201,Lakhmapur, Tal. Dindori,Dist. Nashik - 422 202, Maharashtra, IndiaTel.: +91-2557-250121 to 126Fax: +91-2557-250586E-mail: admin.nashik@megafine.in

PLANT:911 & 912, G.I.D.C.,III Phase, Vapi - 396195,Gujarat, IndiaTel.: +91-260-2400685Fax: +91-260-2424622E-mail: admin.vapi@megafine.in

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Query 2 : please attach adequate to po sheet as per defined scale (1 : 50000) within 10km radius?

Reply: we will be sending you copy of toposheet showing site and 10km vicinity shortly .

••

We trust the above is to your satisfaction and request you to grant us TOR at the earliest andoblige.

Thanking you,

Yours faithfully,

MIs Megafine Pharma (P) Itd

(H P Gandhi)DirectorEncl: as above

Megafine Pharma (P) Ltd.Website: www.megafine.in CIN: U24239MH1995PTC092028

CORPORATE OFFICE:Sethna, 4th Floor,55, Maharshi Karve Road, Marine Lines,Mumbai - 400 002, Maharashtra, IndiaTel.: +91-22-61461111Fax: +91-22-61461109E-mail: info@megafine.in

PLANT:Plot No. 31 to 35 & 48 to 51,5,26 & Kl201,Lakhmapur, Tal. Dindori,Dist. Nashik - 422 202, Maharashtra, IndiaTel.: +91-2557-250121 to 126Fax: +91-2557-250586E-mail: admin.nashik@megafine.in

PLANT:911 & 912, G.I.D.C.,III Phase, Vapi - 396195,Gujarat, IndiaTel.: +91-260-2400685Fax: +91-260-2424622E-mail: admin.vapi@megafine.in

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Clj!vll-'(~I'!)' I-'En:TIUI\I NO.'I·J.8 OF 201!i5CUMo,jU': TEiJ !>JITH

COt1P(-\NY APPLICATION NU.33!:.i UF 21?il!i5~ .

WITH

COI"IPANY rETI.f:rjJN·.NU.4lY ()F :Ni\,'i3

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Ir. ttH~ matteI" o'f Schemef~rna 19itfliii- t ion 0 f Sup e .''Lab~rator'ies Pvt. Ltd.Cai'ltef' PtH~.t'.i)la.ceL\ticals Pvt.iorith' M~~,<t -j:.:i'n.e PIlaf'llla PV\;·.

Super Fine Laooratutiesd Pvt.Ltcl. • ••• Pe); i 1.i un e i

WITH

.Gantt! r Pharinaceut i c •.•l sp~r~~Jt1~,..

WITH

ofFille

andLt:cI.

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MegM ~in~ Pha~ma Pvt.Ltd~

Ms.Alpana 131'1onelib Kail':}.1 u Co. for' l;Ile.PetU;ione,'.

1'lt'.C.J. Joyilb Dr.T.e.

with ~1f'•.H.C. r·la~tp.I'.t, ~11-.~1.~1. GO!'-"/iHTlX

K<il1sh i k +or- f'h~':)Lon a l . \:H 1"8(:b:l1', D<o!par'trnell1;

.HARASHTRA POLLUTION CONTROL BOARD24010437/24020781/24014701

\. 24024068 I 24023515

~OvY' . site: http://mpcb.mah.nic.in

6~ Iii: mpcb@vsnl.net

Kalpataru Point, 2nd- 4th Floor

Opp. Cine Planet Cinema,

Near Sion Circle, Sion (E)

Mumbai-400 022.

)/LSIsent No.BO/RO-Nsk/PCI-1/943-07/R/CC- 12-~ Date: 30/03/2007

Consent to Operate under Section 260f the Water (Prevention & Control ofiouunon) Act, 1974 & under Section 21 of the Air (Prevention & Control of Pollution)\ct, 1981 and Authorisation / Renewal of Authorisation under Rule 5 of thelazardous Wastes (Management & Handling) Rules 1989 a{ld Amendment Rules,003. [To be referred as Water Act, Air Act and HW(M&H)Rules respectively].----

CONSENTis hereby granted to :Mis. Mega Fine Pharma (P) Ltd.,Gut No. 201, Lakhmapur, Dindori,Nashik - 422 202

located in the area declared under the provisions of the Water Act, Air act andAuthorisation under the provisions of HW(M&H) Rules and amendments theretosubject to the provisions of the Act and the Rules and the Orders that may be madefurther and subject to the following terms and conditions:

1. The Consent to Operate is granted for a period upto - 31.12.2011

2. The consent is valid for the manufacture of -

Sr. No. Name of the Product Maximum Quantity

1 Disodium Pamoate 10 TIM2 PamoicAcid 6 TIM3 Pvrantel Citrate 1 TIM4 Pyrantel Pamoate . 1 TIM5 Morantel Citrate 1 TIM6 1,2-Dimethyl 1,4,5,6- Tetrahydro 4 TIM7 Thiophene-2-Aldehyde (T2A) 4 TIM8 3-Methyl- Th iophene-2-Aldehyde (3MT2A) 2 TIM9 4-Amino -1,2,4-Triazole (4AT) 6 TIM10 1,2,4-Triazole (TRZ) 2 TIM11 N-Methvl Diamino-1,3-Propane OR MAPA 5 TIM12 2-Acetyl Thiophene (2AT) 2 TIM13 5-Ethyl-4( -2-Phenoxyethyl)-2H-1,2,4- Triazole 3(4H)-one-(ETP) 1 TIM14 Xanthate Anhydride OR BIS 9Ethoxythio Carbonyl)Sulphide (I A) 1 TIM15 L-Aspartic Thiono Urethane (II A) 0.965 TIM16 L-Aspartic NTA(III A) 0.565 TIM17 Alitame Ptsa Salt (IV A) 1 MTIM18 D-Alanine Enamine Salt (IV B) 1.043 TIM19 Chloro Ethoxv Acetic Acid 1 TIM20 Ammonium Benzene Sulphonate (ABS) 2 TIM21 Pioerzine Citrate 0.5 TIM22 Fluconzole-B 0.05 TIM23 Carvedilol 0.1 TIM24 AmlodipineBesvlate 1 TIM

3. CONDITIONS UNDER WATER ACT:

(i) The daily quantity of trade effluent from the factory shall not exceed 18.4 m3•

(ii) The daily quantity of sewage effluent from the factory shall not exceed 2.4 m3

(iii) Trade Effluent:Treatment: The applicant shall provide comprehensive treatmentsystem consisting of primary/secondary and/or tertiary treatment as iswarranted with reference to influent quality and operate and maintainthe same continuously so as to achieve the quality of the treatedeffluent to the following standards: ~'"

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5.

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1 pH Betwenn 5.5 to 92 SuspendedSolids Not to exceed 100 mg/L3 BOD3 days 27 Deg. C Not to exceed 30 mg/L4 COD Not to exceed 250 mg/L5 Oil & Grease Not to exceed 10 mg/L6 T.D.S. Not to exceed 2100 rnq/L7 Chlorides Not to exceed 600 mg/L8 Sulphates Not to exceed 1000 rnq/L9 % Sodium Not to exceed 60 % mg/L10 PhenolicCompound Not to exceed 5 rnq/L

(iv) Trade Effluent Disposal The treated trade effluent shall be recycled/reused to the maximum extent using forced evaporation system andremaining shall be used on land for gardening / plantation within ownpremises only. ••

(v) Sewage Effluent Treatment : The applicant shall provide comprehensivetreatment system as is warranted with reference to influent quality andoperate and maintain, the same continuously so as to achieve the quality oftreated effluent to the following standards.(1) Suspended Solids Not to exceed 100 mg/1.(2) BOD 3 days 27 Deg. C. Not to exceed 100 mg/1.

(vi) Sewage Effluent Disposal : The treated domestic effluent shall be soakedinto soak pit which shall be got cleaned periodically. Overflow if any shall beused on land for gardening / plantation within own premises only.

(vii) Non-Hazardous Solid Wastes·'Tvne of waste . 'Ouantitv DlsnosalM.S.drums/Fiber Drums ;60 nos./month Sale to authorized partyHDPEBaas 250 nos.zrnontn

(viii) Other conditions : The industry should monitor effluent quality regularlyfrom MoEF approved laboratory.

The applicant shall comply with the provisions of the Water ( Prevention & Control ofPollution) Cess Act, 1977 ( to be referred as Cess Act) and Rules thereunder:The daily water consumption for the following categories is as under:

i Domestic 2.9 CMDii Industrial Processing 15.0 CMDiii Industrial Cooling 7.0 CMDiv Agriculture/Gardening Nil CMD

The applicant shall regularly submit to the Board the returns of water consumption inthe prescribed form and pay the Cess as specified under Section 3 of the said Act.

CONDITIONS UNDER AIR ACT:(i) The applicant shall install a comprehensive control system consisting of control

equipments as is warranted with reference to generation of emission andoperate and maintain the same continuously so as to achieve the level ofpollutants to the following standards:Control Equipment: Air pollution control equipments of sufficient capacityshall be provided to limit the emissions.Conditions for D.G. Set :-

l]Noise from the D.G. Set should be controlled by providing an acoustic enclosureor bytreating the room acoustically.

21lndustry should provide acousticenclosurefor control of noise. The acousticenclosure/acoustictreatment of the room should be designedfor minimum 25 dB(A)insertion lossor for meeting the ambient noisestandards, whichever is on higher side. Asuitable exhaust muffler with insertion lossof 25 dB(A) shall also be provided. Themeasurementof insertion loss will be done at different points at 0.5 metres from acousticenclosure/room and then average.

3]The industry shall take adequate measures for control of noise levels from its ownsourceswithin the premises in respectof noise to less than 55 dB(A) during day timeand 45 dB(A) during the night time. Day time is reckoned between 6 a.m. to 10 p.mand night time is reckoned between 10 p.m to 6 a.m.

4]Industry should make efforts to bring down noise level due to DGset, outside industrialpremises,within ambient noise requirementsby proper siting and control measures.

5]lnstallation of DGSet much be strictly in compliancewith recommendationsof DGSetmanufacturer.

6]A proper routine and preventive maintenanceprocedure for DGset should be set andfollowed in consultation with the DGmanufacturer which would help to prevent noiselevelsof DGset from deteriorating with use.

7]D.G. Set shall be operated only-in caseof powe~e.8]The applicant should not causeany nUisanl:~r:5,~~~~rOUndingarea due to operation of

D.G.Set. r. • _... .I' . ,

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IAf A'l Al' A J"'1010437/4020781/4037124/403527324044532/4024063/4023510

Murnbai - fWO 022

Kalpataru Point, 3rll & 4th floor, Sian- Matunqa, cherneRoad No, 1.1.Opp Cine Planet Cinema. Ncarcion Circle, Sion (E),

Date:Oj /0.312013

enquiry@mpcb.gov,in

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'AmsentNQ:BOIJD-PAMSINl(-12418IRICC- ,'7";ollsentto Operate under Section: 26 .of the Watel~(Prevell~ion & ControlIf Pollution) Act, 1974 & uud er Section 21 of the Ail' (Prevention &Ionurol of Pollution) Act, 1981 and, L\.uthorizatio;l I Renel' al ofuthorization under Rule 5 of the Hazardous Wastes (Man eu eat,

_------.:xlalldling & Trans boundary Movement) Rules ZOOS . '.

[To be referred as Water Act, Air Act and HW (M&H) Ru11W',(is' .tively]................ " ',"!""\'CONSENT is hereby granted to "\ "-

MIs. Megafine Pharma (P) Ltd. ft '\

Gat No. 201. Lakh mapu r, Tal: .IJ'tptlO .•.·j ,D' t N 1'I' {- ..•

IS. as11(; " '" ~t ,_\ .~

located ill the area declared under the provisiotls of (; e Water Act, Air act andAuthorization under the provisions of HW(M&I-l). Ru),'fj: and amendments theretosubject to the provisions of the Act and th R, lel<'and the Orders that may bemade further and subject to the following ~ ~ d conditions:1. The Consentto Operateis grante·fb ertod up to: 31.12.2017.

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2, The Consentis valid for the ~t~ f<\d ire of -

2 Palipel1f1~~.,"' 0.53 py~~ttrate Zeolex 204 nQ15 pile 0.4-

5 I:tBQ~enYanMonohvdrate 10-

r, ~~,....~:Py)antelPamoate . 40. }"\ l(Sildanefil Oitrate InterrnediatetSl l.-H) 157 1', 4:;.,.-

8-' 0! Mirtazapine 2~l"" ! . ~

,9 ", '>.~.t. Darifsnacine Hydrobromide 0.210 Ammonium BenzeneSulphonate 1511 " Qnetiuvine Hemifumarate 412 t Thiophene-2 Aldehyde(T2A) 2513 Ziprasidone hydrochloride 0.2514 Erythromycine Oxime Base<EOB) 210 3-Methyl Thiophene -2 Aldehyde(3MT2A) 151.6 " 2 Acetyl Thiophene(2AT) 1..5

17 ~ Oxantal Pamoate 418 CL-7 319 ~ Donenezil hydrochloride O.G- 1'.,.

';HO NasltikJIIRJlJ51335000 ••

23 Amlodip ine Maleate24 N-Acet 1Pi erazine(NAP) 1.5

2(_) -I_Venlafaxine Hydrochloride21. DFTA22 Pamoic Acid

!5----20------j-----------201.

25 Vilda li tin 0.5

r2~6~------I~D~es~.~~~e~l~la=1=f~~x=u=·1~e~S~t=ic=c=in=a=t=e ~_I_.~l----------~r-2r_' rD~ie~n~e~c~r~y~8~ta=1=is~e~d~--------------4~--- ~

2a· ~ CincalcetHydroohloride • 0.129 Solifenacin Succinate 0.130 MorantelCitrate 2531 Meinantine Hydrochloride 0.532 1,2-Dimethyl

1,4,56-Tetrah droGO

33 Asena rinelvlaleateHP)

34 NBPCHO35 Prasu 1'e1H drochloride

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3. CONDITIONS UNDER WATER ACT: t ,.,.~\ 1.\ J -)/.. .,

(i) The daily quantity of trade effluent from the factol<~i~'"aij~lot exceed18.40M3.(ii) The daily quantity of sewage effluent from th ,,~fag~~i'V'!3halll1ot exceed 12.OM3,

I .,,/1\\"~ j)

(iii) Trade Effluent: '- "f" ,~""Treatment: The applicant shall "PI' '"\ii~~~"'comprehensive treatment systemconsistingof primary I secondary at. .t£rtiary treatment as is warranted with,reference to influent quality a 0})15 l~. and maintain the same continuously soas to achieve the quality of tb\\t; e~tl effluent to the following standards:

.--€''\'.,J11: )H "\J '\~llP 6.0-8.5

-

'j12 Oil & Gl'easE\f~',.". 10

J13./ BOD (3 ~i~~ItC) 100

M TotaOO ~Q1v.edSolids 2100

05 ~i~a~ ~st. 90% survival of fish after first 96 hrs ill

."i t,'<OJ 100% effluent

=3~!}{"'4<fditional Parameters

!\'fsenit ~ .. 0.20

~ t-.' Cyanide. \ . 0.101:., Phenolics (C6H5.oH) 1.0"ltt ~.

'--69 Sulphide-(asS) 2.0

~O PhosphatefasP) 5.0

/11 Suspended Solids 100_ -vfi COD' 250

-J1l/ Chloride 600

'\lA Sulphate 1000

(iv) Trade Effluent Disposal: : The treated effluent should be recycled! reused tomaximum extent using forced evaporation system and remaining should bedisposed on land for ga~denillg within own premises only. There should not beany discharge of effluenf outside factory premises, /.-;:::-;:=::.,

f/ r (II)" 0/ A''':~" ...J,··-~o··.;-;.?(.~r . J. .<-~~

)110 NashikfJ/RfU5 (33;O()O r~ <~<lt ) ~\I 2o, <" <.;j

______________________________ ~~~~~ ~~k/~--------~

(v) Sewage Efllueut Treatment: The applicant shall pro ide comprehensivetreatment system as is warranted with reference to influent quality and operateand maintain the same continuously so as to achieve the quality of treatedeffluent to the following standards.

(1) Suspended Solids r Not to exceed 100 mg/I.(2) BOD 3 days 270 C. Not to exceed 100 mg/l.

(vi) Sewage Effluent Disposal: The treated domestic effluent shall be soaked in asoak pit. which shall be got cleaned periodically. Overflow, if any; shall be used

..•.. on land for gardening I plantation only. .•• .••

(vii)Non-Hazardous Solid Wastes;

•MS Drume/fibie drum 60.00 NolMHDPE ba s .3.:..::5~O.:...::.0:..::0~_-+-N::..:...:::of1:.:;;.;::.1_....j....:::=:.::~~~~...r.:.::::.:.::.::.L1Boiler Ash 800.00 I( IDa

'..,

(viii)Other Coudttdons: Industry should monitor effluent qul:j.t:I[~: l~.l<lY.

4. The applicant shall comply with the provtslonsof th~f~C4ter (Prevention &Control of Pollution) CessAct, 1977; (to be t;a~rre<d' as Cess Act) andamendmentRules,2003 there under t .

The daily water consumption for the follo n 'G~ ~g(JLiesis as under(i) Domestic purpose . ,) 15.00 CMDOJ) Water gets Polluted & "Jt. t,.•.•'Jl~

... Pollutants areBiodegradable '"J1"~'; 15.90 CMD(m) Water gets Polluted, Pollutarlte \ I;.,:~.

are not Biodegradable & To.;ll~.:.-.,,',,"J 0.00 CMD(iv) Industrial Cooling, SPY\,: .iJ1~<',.."f,)'\

in mine pits 01' boiler t~ ~.4T·... 7.00CMDTh~ ap~licant s . g.. m:ly submit to the Board the retur~s of water

consumption m the' pi' 1'1 form and pay the Cess as specified underSection 3of the said~e

5. CONDITIONsUNDJi~t~!ACT: . .(i) : The applicant\..~~'hStal1 a comprehensive control system consisting of

control equip1lilBitV~-as is warranted with reference to generation of emission. and opeta~.,tl-~~aint~iIl the same continuously so as to achieve the level of

pollut tt'j~ \~ fblloWlllg standards:

a. Control .lpment: . '. .,{t _pollution control system of adequate capacity should be provided to

. - imit emissions and also to any other sotu'Cesof emissions.

. ufficient capacity of wet scrubber I bag filter shall be provided to limitthe emission

ur. There shall uct be any fugitive (secondary) emissions.b. Conditions for D.G.Set

a. Noise from the D.G. Set should be controlled by providing anacoustic enclosure or by treating the room acoustically.

b. Industry should provide acoustic enclosure for control of noise. Theacoustic enclos reI acoustic treatment of the room should bedesigned for minimum 25 dB (A) insertion loss or for meeting theambient noise standards. whichever is on higher side. A suitableexhaust muffler with insertion 10s8 of 25 dB (A) shall also beprovided. TIr measurement of insertion 1088 will be done at

•!;ltO Nashik!J/l\fL/5 I 335000

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