m/s s. kant chemicals pvt. ltd. manufacturing of bulk...

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New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient S. Kant Chemicals Pvt. Ltd., Tarapur PFR for M/S S. Kant Chemicals Pvt. Ltd. Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 1 M/S S. KANT CHEMICALS PVT. LTD. PFR for Environmental Clearance (EC) of Proposed Greenfield project of Manufacturing of Bulk Drugs and Active Pharmaceutical Ingredients at Plot No.: W-5 and W-6, Tarapur MIDC, Tarapur, District: Palghar, Maharashtra © Goldfinch Environmental Engineering Systems Private Limited (‗Goldfinch‘), December 2016 This report is released for the use of the M/s Kant Chemicals Pvt. Ltd. (SKCPL). Regulators and relevant stakeholders solely as part of the subject EC of Proposed Greenfield project of Manufacturing of Bulk Drugs and Active Pharmaceutical Ingredients at Plot No.: W-5 and W-6, Tarapur MIDC, Tarapur, District: Palghar, Maharashtra. Information provided (unless attributed to referenced third parties) is otherwise copyrighted and shall not be used for any other purpose without the written consent of Goldfinch/SKCPL. QUALITY CONTROL Name of Publication Proposed Greenfield project of Manufacturing of Bulk Drugs and Active Pharmaceutical Ingredients, at Plot No. W-5 and W-6, Tarapur MIDC, Tarapur, District: Palghar, Maharashtra. Project Number GEC/SKCPL T/2016/11/ 06 Report No. 1 Versio n 1 Release d December, 2016 Prepared By Mr. Kamlesh Bagul & Dr. Nivedita Kulkarni Reviewed By Mr. K. N. Sharma Released By Mr. Anand Apte DISCLAIMER Goldfinch has taken all reasonable precautions in the preparation of this report as per its auditable quality plan. Goldfinch also believes that the facts presented in the report are based on information submitted by SKCPL and based on the technical expertise of Goldfinch as on the date it was written. However, it is impossible to dismiss absolutely, the possibility of errors or omissions. Goldfinch therefore specifically disclaims any liability resulting from the use or application of the information contained in this report. The information is not intended to serve as legal advice related to the individual situation.

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Page 1: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 1

M/S S. KANT CHEMICALS PVT. LTD.

PFR for Environmental Clearance (EC) of Proposed Greenfield project of

Manufacturing of Bulk Drugs and Active Pharmaceutical Ingredients at Plot

No.: W-5 and W-6, Tarapur MIDC, Tarapur, District: Palghar, Maharashtra

© Goldfinch Environmental Engineering Systems Private Limited (‗Goldfinch‘), December

2016

This report is released for the use of the M/s Kant Chemicals Pvt. Ltd. (SKCPL).

Regulators and relevant stakeholders solely as part of the subject EC of Proposed

Greenfield project of Manufacturing of Bulk Drugs and Active Pharmaceutical

Ingredients at Plot No.: W-5 and W-6, Tarapur MIDC, Tarapur, District: Palghar,

Maharashtra. Information provided (unless attributed to referenced third parties) is

otherwise copyrighted and shall not be used for any other purpose without the written

consent of Goldfinch/SKCPL.

QUALITY CONTROL

Name of

Publication

Proposed Greenfield project of Manufacturing of Bulk Drugs and

Active Pharmaceutical Ingredients, at Plot No. W-5 and W-6, Tarapur

MIDC, Tarapur, District: Palghar, Maharashtra.

Project

Number

GEC/SKCPL

T/2016/11/

06

Report

No. 1

Versio

n 1

Release

d

December,

2016

Prepared By Mr. Kamlesh Bagul & Dr. Nivedita Kulkarni

Reviewed By Mr. K. N. Sharma

Released By Mr. Anand Apte

DISCLAIMER

Goldfinch has taken all reasonable precautions in the preparation of this report as per

its auditable quality plan. Goldfinch also believes that the facts presented in the report

are based on information submitted by SKCPL and based on the technical expertise of

Goldfinch as on the date it was written. However, it is impossible to dismiss absolutely,

the possibility of errors or omissions. Goldfinch therefore specifically disclaims any

liability resulting from the use or application of the information contained in this report.

The information is not intended to serve as legal advice related to the individual

situation.

Page 2: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 2

Table of Contents

Executive Summary ................................................................... 5

1.0 INTRODUCTION OF THE PROJECT/BACKGROUND

INFORMATION ........................................................................... 6

1.1 Introduction of the Project and Project Proponent .............................. 6

1.2 Nature of the project ..................................................................... 6

1.3 Need for the project and its importance to the country and or region .... 7

1.4 Demands-Supply Gap .................................................................... 7

1.5 Imports vs. Indigenous Production ................................................... 7

1.6 Domestic /Export Markets .............................................................. 7

1.7 Employment Generation due to the project ....................................... 7

2.0 Project Description .............................................................. 8

2.1 Type of Project: ............................................................................ 8

2.2 Project Location: ........................................................................... 8

2.3 Alternate sites: ........................................................................... 10

2.4 Size or Magnitude of Operation ..................................................... 11

2.5 Process Description ..................................................................... 12

2.6 Raw Material requirement: ........................................................... 55

2.7 Availability of Resources ............................................................... 60

2.7.1 Water Requirement and Source ........................................................ 60

2.7.2 Power Requirement ................................................................. 61

2.7.3 Fuel Requirement ................................................................... 61

2.8 Quantity of wastes to be generated ............................................... 61

2.8.1 Waste Water Generation.................................................................... 61

2.8.2 Solid waste generation and Disposal ................................................... 62

Page 3: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 3

2.9 Schematic representations of the feasibility drawing which give

Information of EIA purpose. .................................................................. 62

3.0 Site Analysis ...................................................................... 64

3.1 Connectivity .................................................................................. 64

3.2 Land Form, Land use and Land ownership .......................................... 64

3.3 Topography ................................................................................... 64

3.4 Existing Land use Pattern ............................................................... 66

3.5 Existing Infrastructure ................................................................... 66

3.6 Soil classification .......................................................................... 66

3.7 Climatic data from secondary sources .............................................. 66

Climate Classification ............................................................................. 66

Temperature ......................................................................................... 66

Rainfall: ............................................................................................... 66

3.8 Social Infrastructure Availability ...................................................... 66

4.0 Planning In Brief ............................................................... 67

4.1 Planning Concept: ........................................................................ 67

4.2 Population Projection: ................................................................... 67

4.3 Land use planning: ....................................................................... 68

4.4 Assessment of Infrastructure Demand (Physical and Social): ............. 68

4.5 Amenities/ Facilities: .................................................................... 68

5.0 Proposed Infrastructure ................................................... 69

5.1 Industrial area ............................................................................. 69

5.2 Residential Area: ......................................................................... 69

5.3 Green Belt: ................................................................................. 69

5.4 Social Infrastructure:.................................................................... 69

5.5 Connectivity: ............................................................................... 69

Page 4: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 4

5.6 Drinking Water Management: ....................................................... 70

5.7 Sewage System: ......................................................................... 70

5.8 Industrial Water Management: ...................................................... 70

Standard Operating Procedure of Effluent Treatment Plant ....................... 70

5.9 Solid Waste Management .............................................................. 71

6.0 Rehabilitation and Resettlement (R & R) Plan ................. 72

7.0 Project Schedule & Cost Estimates .................................. 73

7.1 Estimated project cost along with analysis in terms of economic

viability

of the project .............................................................................. 73

8.0 Analysis of proposal (Final Recommendations) ............... 73

Page 5: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 5

Executive Summary

SK Group is serving the pharmaceutical industry with dedication since 1932.

Company has a proven track record and expertise in manufacturing, importing exporting

& distribution of Bulk Drugs, Fine chemicals and Pharmaceutical Formulations. The SK

Group is professionally managed by the fifth generation of entrepreneurs and employs

about 700 people.

S Kant Chemicals Pvt Ltd. purchased an Industrial Plot in MIDC, Tarapur from Kalpataru

Organic in 2016. Kalpataru was engaged in manufacturing of Metalic Stearates and

Waxes plans. S Kant will modify existing building set up for proposed manufacturing

facility of Bulk Drugs & Active Pharmaceutical ingredient. The company aims to produce

Anti Diabetic, Anti-Viral, Anti-Malarial & Antibiotic APIs.

S Kant proposed to set up new manufacturing unit at Plot no. W-5 and W-6, MIDC

Tarapur, District Palghar, Maharashtra.

Sr. No. Parameters Description

1 Category as per EIA Notification (5 f) B-1

2 Proposed Production Capacity 61 MT/M

3 Total Plot Area 2000 sq. m.

4 Green Belt Area 170 sq. m

5 Fresh Water Requirement 124 CMD

6 Effluent Quantity (Trade +

Domestic)

48 + 8 = 56 CMD

7

Trade Effluent Treatment

Effluent coming from proposed project will

be treated in ETP of capacity 65 CMD

having primary, secondary and tertiary

treatment. Treated water will be

discharged to CETP.

8

Boiler , Stack height

2 Nos. of 1 TPH capacity each (1 boiler

standby)

Stack Height : 30 m, combined stack for

both boilers

9 Fuel requirement LDO - 1248 kg/day for Boiler and HSD For

DG – 45 lit/hr.

10 Power Requirement Installed power: 250 KW

Operating power: 200 KW

11 DG Sets 1 no. of 200 KVA capacity

12 Work Force (Proposed) 150 Nos.

13 Total Capital Cost the project Rs. 6.84 Cr.

Page 6: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 6

1.0 INTRODUCTION OF THE PROJECT/BACKGROUND

INFORMATION

1.1 Introduction of the Project and Project Proponent

The objective of this pre‐feasibility study is to provide information for the Bulk Drugs and

Active Pharmaceutical ingredient manufacturing unit by M/s. S Kant Chemicals Pvt. Ltd.

at Plot No. W-05 and W-06, MIDC Tarapur, District Palghar, Maharashtra. Company will

manufacture Anti Diabetic, Anti-Viral, Antibiotics, Anti-Hypertensive products,

Parkinsons and Anti-Malarial Products which will be exported to Asia, Africa & Europe.

As per the EIA Notification No. S. O. 1533 promulgated on 14th September 2006,

proposed project has covered Synthetic Organic Chemical Industry as 5 (f) and need

prior environmental clearance. It is stated that 5(f) industries located in a notified

industrial area are classified under category B and would be appraised by State Level

Expert appraisal committee/ impact assessment authority. Based on the OM dated 16th

May 2014 by Director MoEF, Public Hearing is exempted for the Industrial Estates /

Parks which have taken Environmental Clearance.

Introduction of the Project Proponent

Established in 1932 by a young, dynamic and uncompromising individual Mr. Sevantilal

K. Shah, the SK Group today is a multi-faceted company that has evolved as a leading

Importer, Exporter, Distributor and Manufacturer of Bulk Drugs, Chemicals and

Pharmaceutical formulations. S Kant Chemicals is one of the companies of SK group.

Key Management personnel

Name Designation

Mr. Gaurav Satish Shah Managing Director

Mr. Bharat Nemchand Shah Managing Director

Mr. Rohan Mahesh Shah Managing Director

Mr. Vivek Bipin Shah Jt. Managing Director

1.2 Nature of the project

The proposed project will be on Plot No. W-05, W-06 at MIDC Industrial area Tarapur

with land admeasuring 2000 Sq. m. Preliminary Layout Plan is attached as Annexure -

I. The land is already in demarcated as ―Industrial‖ in a notified industrial area and is

not a prime Agricultural land. Thus there is no change in the land use status.

Proposed project is to manufacture bulk Drugs and Active Pharamaceutical Ingredient

products having high therapeutic value in the categories of Anti Diabetic, AntiViral,

AntiMalarial & Antibiotic APIs and general medicines. Production capacity of the

proposed expansion project will be of 61 MT/M.

Page 7: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 7

1.3 Need for the project and its importance to the country and or region

India's pharmaceutical industry is the third largest in the world in terms of volume. Its

rank is 14th in terms of value. India is also one of the top five active pharmaceutical

ingredients (API) producers (with a share of about 6.5%). The ever-increasing demand

for Bulk Drugs and Intermediated in India and abroad as well as changing market

conditions requisite Indian pharmaceutical industries to grow further.

M/s S. Kant Chemicals Private Limited aims to set up a new project in order to cater to

Domestic & International markets. These products will serve to cut the supply of imports

from foreign countries thus saving currency and at the same time will earn valuable

foreign currency by export of the proposed products.

1.4 Demands-Supply Gap

Competition in the Indian pharmaceutical market swelled in recent years, with

increasing generic penetration. This had many companies opting out of low-margin

segments, as competition resulted in lower prices. This created a gap between demand

and supply. Such unusual price hikes take place when there is withdrawal of some of the

key competitors, which leads to demand override and as a consequence prices start

soaring in a free-pricing market.

1.5 Imports vs. Indigenous Production

The proposed products including third generation antibiotics are high in demand in the

export market. Also their demand is increasing in the domestic market. Production of

these drugs domestically reduces the need to import these in future along with

significant scope for export in these products.

1.6 Domestic /Export Markets

The finished goods will be sold in domestic market and would be largely exported to the

Regulated International Market as per demand.

1.7 Employment Generation due to the project

The activities under proposed industry would produce improvement in the socioeconomic

status of people in the study area in terms of local labor employment and contract basis

jobs. The proposed activity might provide employment opportunities to the local

populace, especially in business and other services like transportation activity.

It is expected to direct or indirect employ about 150 people of various skills will be

required during operation phase. 150 peoples will work in 3 shifts of 8 hr. each.

Page 8: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 8

2.0 Project Description

2.1 Type of Project:

Proposed project is to manufacture bulk Drugs and Advanced Intermediates. Production

capacity of the proposed project will be of 61 MT/M.

2.2 Project Location:

S Kant proposes manufacturing unit at Plot No. W-05 And W-06, MIDC Tarapur, District

Palghar, Maharashtra. Location map is shown at Figure – 1.

The proposed plant is well connected both to Mumbai Ahmedabad Highway at 20 Km

and Railway line at Boisar Rail Way Station at 3.5 Km. A total of about 2000 sq. m. of

land is acquired for the proposed project. Satelliet image of the proposed project is

shown below.

Figure 2.1 : Satellite Image of the Site

Page 9: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 9

Figure 2.2: Photographs of Site Location of proposed project of S Kant

Chemicals Pvt. Ltd.

Page 10: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 10

Specific location

Table 2.1

Specific location details

Location Plot No.: W-5 and W-6, MIDC Tarapur, Dist.:

Palghar, Taluka: Palghar, Maharashtra

Longitudes 72.737725° E

Latitudes 19.793312° N

Industry at east side Sumangal Silk Mills Pvt Ltd

Industry at west side Carlton Industries

Industry at north side Option Logistic

Industry at south side Indian Transformer

Connectivity

Road National Highway 1 km from site connecting

Gujarat, Rajasthan and north India

Rail Boisar railway station on Mumbai - Vododara-

Ahemedabad 4 km from site

Airport Mumbai 110 km

Land Form:

The project site is situated in MIDC Tarapur. It is a notified industrial area where the

land is owned by Maharashtra Industrial Development Corporation (MIDC) and leased to

the Company. The land is meant for industrial activity.

Land Ownership: Land is owned by Maharashtra Industrial Development Corporation

(MIDC) and leased to the Company for 99 years.

2.3 Alternate sites:

Current site is in approved chemical zone of MIDC and is well connected to get raw

material by road / railway and carry on the proposed manufacturing activities.

Since the proposed site has sufficient land available and owned by proponent. The

following points were considered for selecting the proposed site:

Location is within the established notified industrial estate

Availability of common infrastructural facilities of the industrial estate

Page 11: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 11

Availability of water supply in the industrial estate

Availability of un-interrupted power supply in the industrial estate

In close vicinity of sister industry for the transportation of finished goods

2.4 Size or Magnitude of Operation

The products manufactured and their capacities proposed are shown in below Table

2.2

Table 2.2

Sr. No. Product Name Quantity

MT/Month

1. Anti-Diabetic Products

1.1 Gliclazide 3.5

1.2 Glibenclamide 1

1.3 Glimipride 1

1.4 Glipizide 1

2. Anti-Viral Products

2.1 Aciclovir 4

2.2 Ganciclovir 2

2.3 Valganciclovir 0.5

2.4 Fluconazole 2

3. Anti – Malarial

3.1 Sodium Sulfanilamide 5

3.2 4,7 Dichloroquionoline 2

3.3 Amodiaquine 2

3.4 Piperaquine Phosphate 1

3.5 Hydroxy Chloroquine Sulfate 1

3.6 Atovaquone 0.25

3.7 Sulfadimethoxine 3

3.8 Sulfa Salazine 2.5

3.9 Sulfadoxine 2.5

3.10 Artemether 2

3.11 Artesunate 0.75

3.12 Lumefantrine 3

Page 12: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 12

2.5 Process Description

1. 4, 7-DICHLOROQUINOLINE

Chemical Name: 4,7-dichloro- Quinoline

CAS No: 86-98-6

Molecular weight: 198

Synthetic Route

Cl NH2

EtO

COOEt

COOEt

+

Cl NH

COOEt

COOEt

Cl N

COOH

OH

Cl N

Cl

3.13 Pyrimethamine 1

4. Parkinsons

4.1 Entacapone 1

5. Antibiotics

5.1 Pyrazinamide 5

5.2 Ambroxol HCL 3

5.3 Moxifloxacin 2

5.4 Erythromycin 5

6. Anti-Hypertensive

6.1 Losartan Potassium 4

Total/Month 61

Total/Year 732

Page 13: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 13

Chemical Reaction

Process Description:

3-Chloroaniline on condensation with ethyl ethoxymethylene malonate gives

-carbethoxy- -m-chloroanilinoacrylate)

Stage I on heating cyclizes and on further treatment with sodium hydroxide gives

stage II(7-Chloro-4-hydroxy-3-quinolinecarboxylic acid

Stage II after decarboxylation and chlorination gives 4,7-dichloro quinoline

MASS BALANCE

MASS BALANCE FOR 0.067 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 m-chloroaniline 0.078 PRODUCT 0.067

2 Ethyl

ethoxymethylenemalonate 0.141

Recovered

skellysolve 0.797

3 Dowtherm 1.21

Recovered

dowtherm 1.21

4 Skellysolve 0.885 Handling Losses 0.162

5 Sodium hydroxide 0.076 Effluent Generated 2.44

6 Hydrochloric acid 0.195 Solid waste 0.623

7 Phosphorus oxychloride 0.274 -- --

8 Water 2.44 -- --

TOTAL 5.299 TOTAL 5.299

Summary

Fresh water 2.44 MT/day required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 2.44

2 Organic losses through

vent

0.162

3 Solid Waste 0.623

Page 14: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 14

2. ACICYCLOVIR

Chemical Name: 6H-Purin-6-one, 2-amino-1, 9-dihydro-9-[(2-

hydroxyethoxy)methyl]-

CAS No: 59277-89-3

Molecular weight: 225

Synthetic Route

HN

NN

N

HN

O

O

OAc

HN

NN

N

H2N

O

O

OH

Ac

Chemical Reaction

Process Description:

Diacetyl acicyclovir on hydrolysis gives Acicyclovir

MASS BALANCE

MASS BALANCE FOR 0.134 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 Diacetyl acicyclovir 0.201 PRODUCT 0.134

2 40% Methylamine soln 1.77 Recovered methanol 1.7

3 Methanol 1.89 Recovered MeNH2 1.61

-- -- Handling Losses 0.001

-- -- Solid waste 0.402

TOTAL 3.861 TOTAL 3.861

Page 15: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 15

Summary

Fresh water not required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent NIL

2 Organic losses through

vent

0.001

3 Solid Waste 0.402

3. AMBROXOL HYDROCHLORIDE

Chemical Name: 4-[(2-amino-3,5-dibromophenyl)methylamino] cyclohexan-1-ol

hydrochloride

CAS No: 23828-92-4

Molecular weight: 414.5

Synthetic Route

NH2

Br

Br

O

HO

NH2

NH2

Br

Br

N

OH

+

NH2

Br

Br

NH

OH

NH2

Br

Br

NH

OH

IPA.HCl

.HCl

NaBH4

CH3OH

Page 16: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 16

Chemical Reaction

Process Description:

Stage I

2-amino-3,5-dibromobenzaldehyde, 4-aminocyclohexanol and methanol are

charged in flask

Heat the reaction mass to reflux

Maintain for 8-10 hours. Cool the reaction mass and use for stage II

Stage II

Sodium borohydride was added to stage I at 15 °C

Reaction maintained for 10 – 12 hours

Methanol distilled off and water added to reaction mass

Filter the reaction mass and dry to yield stage II

Stage III

Charge stage II, IPA and HCl

Stir for 2 hours and filter to give stage III

OVERALL MASS BALANCE

PRODUCT QUANTITY 0.100 MT/DAY

INPUT MATERIAL OUTPUT MATERIAL

Sr.

No.

Name Quantity Name Quantity

1 4-amino-3,5-dibromo

benzaldehyde

0.075 Product 0.100

2 4-aminocyclo hexanol 0.035 Recovered methanol 0.336

3 Methanol 0.373 Recovered IPA 0.289

4 Sodium borohydride 0.011 Water of reaction 0.005

5 Water 0.336 Solid waste 0.04

6 IPA 0.321 Vent & handling

losses

0.069

7 HCl 0.024 Effluent generation 0.336

Total 1.175 Total 1.175

Page 17: M/S S. KANT CHEMICALS PVT. LTD. Manufacturing of Bulk ...environmentclearance.nic.in/writereaddata/Online/TOR/02_Jan_2017... · Manufacturing of Bulk Drugs and Active Pharmaceutical

New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient

S. Kant Chemicals Pvt. Ltd., Tarapur

PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 17

Summary

Fresh water required – 0.336 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent 0.341

2 Organic losses through

vent

0.069

3 Solid Residue 0.04

4. AMODIAQUINE DIHYDROCHLORIDE

Chemical Name: Phenol, 4-[(7-chloro-4-quinolinyl)amino]-2-[(diethylamino)methyl]-,

dihydrochloride

CAS No: 6398-98-7

Molecular weight: 464.5

Synthetic Route

NCl

Cl

H2N

OH

+

NCl

HN

OH

NCl

HN

OH

N

.2HCl

Chemical Reaction

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Process Description:

4,7-dichloroquinolineis treated with 4-aminophenol in acetic acid to give

intermediate

The intermediate on treatment with formaldehyde and diethylamine followed by

hydrochloric acid gives amodiaquine dihydrochloride

MASS BALANCE

MASS BALANCE FOR 0.067 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 4,7-dichloro quinoline 0.031 PRODUCT 0.067

2 4-Aminophenol 0.018 Handling Losses 0.013

3 Acetic acid 0.093 Effluent Generated NIL

4 32% formaldehyde 0.022 Solid waste 0.136

5 Diethylamine 0.017 -- --

6 HCl 0.035 -- --

TOTAL 0.216 TOTAL 0.216

Summary

Fresh water not required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent Nil

2 Organic losses through

vent

0.013

3 Solid Waste 0.136

5. ARTEMETHER

Chemical Name: 3,12-Epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin, decahydro-10-

methoxy-3,6,9-trimethyl-, (3R,5aS,6R,8aS,9R,10S,12R,12aR)-

CAS No: 71963-77-4

Molecular weight: 298.37

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Synthetic Route

O

OO

OCH3

H

HH

O

CH3

H3C

O

OO

OCH3

H

HH

HO

CH3

H3C

O

OO

OCH3

H

HH

H3CO

CH3

H3C

Chemical Reaction

Process Description:

Artemisinin is treated with sodium borohydride in methanol solvent to give

Dihydroartemisinin

Dihydroartemisinin on treatment with trimethylorthoformate in methanol solvent

in presence of hydrochloric acid gives artemether

MASS BALANCE

MASS BALANCE FOR 0.067 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 Artemisinin 0.090 PRODUCT 0.067

2 Sodium borohydride 0.016 Recovered methanol 0.862

3 Methanol 0.958 Effluent Generated 2.43

4 Water 2.43 Handling Losses 0.097

5 Acetic acid 0.030 Solid waste 0.219

6 Sodium bicarbonate 0.011 -- --

7 HCl 0.0006 -- --

8 Trimethylorthoformate 0.139 -- --

TOTAL 3.675 TOTAL 3.675

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Summary

Fresh water 2.43 MT/Day required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 2.43

2 Organic losses through

vent

0.097

3 Solid Waste 0.219

6. ARTESUNATE

Chemical Name: Butanedioic acid, 1-[(3R,5aS,6R,8aS,9R,10S,12R,12aR)-decahydro-

3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin-10-yl] ester

CAS No: 88495-63-0

Molecular weight: 384.42

Synthetic Route

O

OO

OCH3

H

HH

O

CH3

H3C

O

OO

OCH3

H

HH

HO

CH3

H3C

O

OO

OCH3

H

HH

O

CH3

H3C

O

HO

O

Chemical Reaction

Process Description:

Artemisinin is treated with sodium borohydride in methanol solvent to give

Dihydroartemisinin

Dihydroartemisinin on treatment with succinic anhydride in presence of

triethylamine in acetone solvent gives artesunate

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MASS BALANCE

MASS BALANCE FOR 0.025 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 Artemisinin 0.022 PRODUCT 0.025

2 Sodium borohydride 0.004 Recovered methanol 0.269

3 Methanol 0.2995 Recovered acetone 0.178

4 Water 0.884 Effluent Generated 0.884

5 Acetic acid 0.017 Handling Losses 0.054

6 Succinic anhydride 0.011 Solid waste 0.033

7 Acetone 0.198 -- --

8 Triethylamine 0.007 -- --

TOTAL 1.443 TOTAL 1.443

Summary

Fresh water 0.884 MT/Day required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 0.884

2 Organic losses through

vent

0.054

3 Solid Waste 0.033

7. ATOVAQUONE

Chemical Name: 1,4-Naphthalenedione, 2-[trans-4-(4-chlorophenyl)cyclohexyl]-3-

hydroxy-

CAS No: 95233-18-4

Molecular weight: 366.84

Synthetic Route

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O

O

Cl

Cl

HO

O

O

O

Cl

Cl

O

O

OH

Cl

+

Chemical Reaction

Process Description:

Ttrans-4-(4- chlorophenyl)cyclohexane-l-carboxylic acid , 2-chloro- l,4-

naphthoquinone and silver nitrate was taken in the solution of sulfolane,

acetonitrile and water. Reaction mixture was heated to reflux. Then ammonium

persulfate in water was added to the reaction mixture. After completion of

reaction, the mass was cooled to ambient temperature. The mixture of ethyl

acetate and cyclohexane was added and stirred. The solid was filtered to give 2-

[4-(4-chlorophenyl) cyclohexyl]-3-chloro- 1,4-naphthoquinone

2-[4-(4-chlorophenyl) cyclohexyl]-3-chloro- 1,4-naphthoquinone in methanol was

taken. A solution of potassium hydroxide in water was added in reaction mass

and heated to 58±2°C. After completion of reaction, the mass was cooled to 25-

30°C. Then, Hydrochloric acid was added to the reaction mass to adjust the

acidic pH. Reaction mass was filtered to give Atovoquone.

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MASS BALANCE

MASS BALANCE FOR 0.009 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1

trans-4-(4-

chlorophenyl)

cyclohexane-l-

carboxylic acid

0.033 PRODUCT 0.009

2 2-chloro- l,4-

naphthoquinone 0.032 Recovered methanol

0.211

3 Silver nitrate 0.009 Recovered Sulfolane 0.060

4 Sulfolane 0.067

Recovered

Acetonitrile 0.887

5 Acetonitrile 0.985

Recovered ethyl

acetate 0.121

6 Ammonium persulfate 0.053

Recovered

cyclohexane 0.121

7 Ethyl acetate 0.133 Recovered MDC 0.091

8 Cyclohexane 0.133 Effluent generated 0.335

9 MDC 0.101 Handling Losses 0.121

10 Methanol 0.234 Solid waste 0.183

11 KOH 0.006 -- --

12 HCl 0.018 -- --

13 Water 0.335 -- --

TOTAL 2.139 TOTAL 2.139

Summary

Fresh water 0.335 MT/DAY required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 0.335

2 Organic losses through

vent

0.121

3 Solid Waste 0.183

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8. ENTACAPONE

Chemical Name:2-Propenamide, 2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-

, (2E)-

CAS NO: 130929-57-6

Molecular Weight: 305.286

Synthetic Route:

CHO

OH

OH

O2N NC

N

O

+

OH

OH

O2N

CN

NO

Chemical Reaction:

Process Description:

3,4-dihydroxy-5-nitrobenzaldehyde,N,N-diethyl cyanoacetamide, piperidine and Toluene

were charged sequentially. The resulting reaction mixture was heated to reflux and

maintained with removal of water by azeotropically. After the completion of reaction the

solvent is recovered for further usage and the remaining mass is quenched into a cooled

solution of cyclohexane and water and stirred for 3 hrs. The precipitated solid is filtered

and dried to obtain entacapone

MASS BALANCE

MASS BALANCE FOR 0.034 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL QUANTIT

Y

OUTPUT MATERIAL QUANTIT

Y

1 3,4-dihydroxy-5-

nitrobenzaldehyde

0.034 PRODUCT 0.034

2 N,N – Diethyl -2-Cyano

Acetamide

0.033 Handling losses 0.006

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3 Cyclohexane 0.007 Effluent Generated 0.07

4 Piperidine 0.0015 Recovered Toluene 0.0061

5 Acetic acid 0.048 Recovered

Cyclohexane

0.0061

6 Toluene 0.007 Recovered methanol 0.0092

7 Methanol 0.010 Solid waste 0.0796

8 Water 0.07 -- --

Total 0.211 Total 0.211

SUMMARY

Fresh Water required 0.07MT/DAY Product output

SR.

NO.

Effluent and Vent losses MT/DAY

1 Liquid Effluent 0.07

2 Organic losses through vent 0.006

3 Solid waste 0.0796

9. ERYHTHROMYCIN

Chemical Name: (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-dideoxy-3-C-methyl-

3-O-methyl- -L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-

hexamethyl-6-[(3,4,6-trideoxy-3-dimethylamino- -D-xylo-hexopyranosyl)-

oxy]oxacyclotetradecane-2,10-dione (erythromycin A)

CAS No: 114-07-8

Molecular weight: 733.9

Synthetic Route

O

OH

O

OH

O

OO

HO

O

O

OH

OCH3

HO N

O

OH

O

OH

O

OO

HO

O

O

OH

OCH3

HO N

.HSCN

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Chemical Reaction

Process Description:

Charge Erythromycin thiocayante and MDC.

Charge NaOH solution and stir till clear solution

Separate layers. Distil off MDC to give Erythromycin Base

MASS BALANCE

MASS BALANCE FOR 0.167 MT / DAY OUTPUT

Sr. No. INPUT MATERIAL Quantity OUTPUT

MATERIAL Quantity

1 Erythromycin

Thiocyanate 0.209 PRODUCT

0.167

2 Methylene Chloride 1.507 Recovered MDC 1.356

3 Caustic Soda 0.019 Handling Losses 0.151

4 Water 0.32 Effluent Generated 0.33

-- -- -- Solid waste 0.051

TOTAL 2.055 TOTAL 2.055

Summary

Fresh water required – 0.32 MT/DAY product output

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 0.33

2 Organic losses through

vent

0.151

3 Solid Waste 0.051

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10. FLUCONAZOLE

Chemical Name: Fluconazole

CAS NO: 86386-73-4

Molecular weight: 306.271

Synthetic Route:

F

F

O

N

N

N F

F

N

N

N O

F

F

N

N

NOH

N

NN

Chemical Reaction:

Process Description:

2, 4- difluoro-2-(1H-1, 2, 4-troazol-1-yl) acetophenone when treated with

Trimethylsulfoxonium iodide gives the oxiranyl compound which on further reaction with

1,2,4-triazole in presence of potassium carbonate gives Fluconazole

MASS BALANCE

MASS BALANCE FOR 0.067 MT/DAY OUTPUT

Sr.

No.

INPUT MATERIAL QUANTITY OUTPUT

MATERIAL

QUANTITY

1 2, 4-difluoro-2-(1H-1, 2, 4-

triazol-1-yl)acetophenone

0.141 PRODUCT 0.067

2 Toluene 2.28 Handling losses 0.630

3 Trimethylsulfoxonium iodide 0.146 Effluent Generated 3.58

4 Cetyltrimethylammonium

bromide

0.013 Recovered toluene 2.05

5 Water 3.58 Recovered hexane 0.085

6 Carbon 0.021 Recovered IPA 1.369

7 Hexane 0.094 Recovered MDC 2.171

8 IPA 1.52 Solid waste 0.768

9 1, 2, 4 triazol 0.044 -- --

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10 Potassium carbonate 0.13 -- --

11 MDC 2.41 -- --

12 Citric acid 0.101 -- --

13 Sodium Chloride 0.203 -- --

14 Hyflo 0.021 -- --

Total 10.72 Total 10.72

SUMMARY

Fresh water required – 3.58 MT/DAY product output

SR. NO. Effluent and Vent losses MT/DAY

1 Liquid Effluent 3.58

2 Organic losses through vent 0.63

3 Solid waste 0.768

11. GANCICLOVIR

Chemical Name: 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[[2-hydroxy-1-

(hydroxymethyl)ethoxy]methyl]-

CAS No: 82410-32-0

Molecular weight: 255

Synthetic Route

HN

NN

N

O

NH

O

O O

O

O

O

HN

NN

N

O

H2N O OH

OH

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Chemical Reaction

Process Description:

Triacetyl ganciclovir on hydrolysis gives Ganciclovir

MASS BALANCE

MASS BALANCE FOR 0.067 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL Quantity OUTPUT MATERIAL Quantity

1 Triacetylganciclovir 0.103 PRODUCT 0.067

2 Sodium carbonate 0.062 Handling Losses Nil

3 Conc. Hydrochloric acid 0.0103 Effluent Generated 1.035

4 Carbon 0.005 Solid waste 0.1137

5 Water 1.03 -- --

6 Hyflo 0.0054 -- --

TOTAL 1.2157 TOTAL 1.2157

Summary

Fresh water 1.03 MT/day required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 1.035

2 Organic losses through

vent

NIL

3 Solid Waste 0.1137

12. GLIBENCLAMIDE

Chemical Name: Benzamide, 5-chloro-N-[2-[4-

[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy-

CAS No: 10238-21-8

Molecular weight: 494

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Synthetic Route

Cl

OCH3

NH

O

O2S

NH2

Cl

OCH3

NH

O

O2S

NH

NH

O

NCO

+

Chemical Reaction

Process Description:

5-chloro-N-[2-[4-[amino sulfonyl] phenyl]ethyl]-2- Benzamide and Cyclohexylisocyanate

are reacted in presence of NaOH in acetone solvent. The reaction mass is refluxed and

after completion of reaction the pH of the mass is adjusted with HCl to precipitate the

crude glibenclamide. The crude is purified from methanol and sodium methoxide.

OVERALL MASS BALANCE

PRODUCT QUANTITY 0.034 MT/DAY

INPUT MATERIAL OUTPUT MATERIAL

Sr.

No.

Name Quantity Name Quantity

1

5-chloro-N-[2-[4-

[aminosulfonyl] phenyl]ethyl]-

2- Benzamide 0.033

Product 0.034

2 Cyclohexylisocyanate 0.013 Recovered Acetone 0.147

3 Sodium hydroxide 0.004 Recovered methanol 0.073

4 Acetone 0.163 Vent & handling losses 0.034

5 Water 0.204 Effluent generation 0.209

6 Methanol 0.082 Solid waste 0.033

7 HCl 0.011

8 Sodium methoxide 0.010

9 Acetic acid 0.010

Total 0.53 Total 0.53

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Summary

Fresh water required – 0.204 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent 0.209

2 Organic losses through

vent

0.034

3 Solid Residue 0.033

13. GLICLAZIDE

Chemical Name: Benzenesulfonamide, N-[[(hexahydrocyclopenta[c]pyrrol-2(1H)

yl)amino]carbonyl]-4-methyl-

CAS No: 21187-98-4

Molecular weight: 323

Synthetic Route

N NH2.HClS

HNH2N

O O

O

CH3

+

S

HN

HN

O O

O

CH3

N

Chemical Reaction

Process Description:

Hexahydro-cyclopenta -2- pyrrolyl amine hydrochloride is reacted with p-toluene

sulfonyl urea(PTSU) in toluene and DMF to give crude product which on re-

crystallization gives pure Gliclazide

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MASS BALANCE

MASS BALANCE FOR 0.117 MT/DAY OUTPUT

SR. NO INPUT MATERIAL Quantity OUTPUT MATERIAL Quantity

1

N-amino-3-

azabicyclo[3,3,0]-octane

hydrochloride 0.074

PRODUCT 0.117

2 p-toluene sulfonyl urea 0.107 Recovered DMF 0.070

3 DMF 0.074 Recovered Toluene 0.289

4 Toluene 0.294 Solid waste Nil

-- -- Handling Losses 0.074

-- -- Effluent Generated 0.0

TOTAL 0.549 TOTAL 0.549

Summary

Fresh water not required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent NIL

2 Organic losses through

vent

0.074

3 Solid Waste Nil

14. GLIMEPIRIDE

Chemical Name: 1 H-Pyrrole-1-carboxamide, 3-ethyl-2,5-dihydro-4-methyl-N-[2-[4-

[[[[(trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-

CAS NO: 93479-97-1

Molecular Weight: 490.617

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Synthetic Route:

N

O

O

HN

S

O

O

NH2

NCO

CH3

N

O

O

HN

S

O

O

NH

NH

O

CH3

+

Chemical Reaction:

Process Description:

Tetrahydrofuran,,4[2-(3-Ethyl-4-methyl-2-carbonyl pyrrolidoneamido)ethyl]benzene

sulfonamide and potassium carbonate was added and refluxed for 6 hours.A solution of

trans -4-methylcyclohexyl isocyanate in toluene was added to the above reaction

mixture and the reaction mixture was refluxed, cooled and filtered. The pH was adjusted

by addition of aqueous HCl acid. The solid obtained was filtered and washed with water

to obtain glimepiride.

MASS BALANCE

MASS BALANCE FOR 0.034 MT/DAY OUTPUT

Sr.

No.

INPUT MATERIAL QUANTITY OUTPUT

MATERIAL

QUANTIT

Y

1 THF 0.43 PRODUCT 0.034

2 4[2-(3-ethyl-4-methyl-2-cabonyl

pyrrolidoneamido)ethyl]benzene

sulfonamide

0.028 Handling losses 0.118

3 Potassium Carbonate 0.017 Effluent Generated 0.057

4 Toluene 0.5243 Recovered Toluene 0.472

5 Trans-4-metylcyclohexyl

isocyanate

0.0146 Recovered THF 0.38

6 Water 0.057 Recovered

methanol

0.204

7 Methanolic ammonia 0.227 Solid waste 0.033

Total 1.298 Total 1.298

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SUMMARY

Fresh Water required - 0.057 MT/DAY Product output

Sr.

No.

Effluent and Vent losses MT/DAY

1 Liquid Effluent 0.057

2 Organic losses through vent 0.118

3 Solid waste 0.033

15. GLIPIZIDE

Chemical Name: 2-Pyrazinecarboxamide, N-[2-[4-

[[[(cyclohexylamino)carbonyl]amino] sulfonyl]phenyl]ethyl]-5-methyl-

CAS NO: 29094-61-9

Molecular Weight: 445.54

Synthetic Route:

O

HN

S

O

O

NH

N

N

H3C

NCOO

HN

S

O

O

NH2

N

N

H3C

NH

O

+

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Chemical Reaction:

Process Description:

Acetone and 4-[2-(5-methylpyrazin-2-carbox amide) ethyl] benzenesulfonamide was

refluxed. To this, solution of sodium hydroxide and cyclohexyl isocyanate was added and

reacted under reflux . Water was added and pH adjusted with HCl. Filtered and crystals

were washed with water to obtain glipizide

MASS BALANCE

MASS BALANCE FOR 0.034 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL QUANTITY OUTPUT

MATERIAL

QUANTIT

Y

1 4-[2-(5-methylpyrazin-2-

carboxamide)ethyl]benzenesulfona

mide 0.034

PRODUCT 0.034

2 Cyclohexylisocyanate 0.018 Handling losses 0.076

3 Acetone 0.758 Effluent Generated 0.373

4 Sodium hydroxide 0.048 Recovered Acetone 0.683

5 Water 0.363 Solid waste 0.079

6 Hyflo 0.003

7 HCl 0.021

Total 1.245 Total 1.245

SUMMARY

Fresh Water required - 0.363 MT/DAY Product output

Sr.

No.

Effluent and Vent losses MT/DAY

1 Liquid Effluent 0.373

2 Organic losses through vent 0.076

3 Solid waste 0.079

16. HYDROXY CHLOROQUINE

Chemical Name: Ethanol, 2-[[4-[(7-chloro-4-quinolinyl)amino]pentyl]ethylamino]-

CAS No: 118-42-3

Molecular weight: 335.87

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Synthetic Route

NCl

Cl

NCl

HN

+ H2NN

CH2OH

N

CH2OH

Chemical Reaction

Process Description:

4,7-dichloroquinolineis treated with 5-(N-ethyl-N-2-hydroxyethylamino)-2-

pentylamine in water in presence of potassium iodide and sodium hydroxide to

give hydroxychloroquine base, which on acidification with phosphoric acid gives

hydroxychloroquine diphosphate. Hydroxychloroquine diphosphate is then

converted to hydroxychloroquine base by treatment with ammonia.

MASS BALANCE

MASS BALANCE FOR 0.034 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 4,7-dichloro quinoline 0.026 PRODUCT 0.034

2

5-(N-ethyl-N-2-

hydroxyethylamino)-2-

pentylamine 0.038

Recovered MDC

0.188

3 Potassium iodide 0.0011 Recovered methanol 0.095

4 Sodium hydroxide 0.0021 Effluent Generated 0.136

5 Methanol 0.105 Handling Losses 0.042

6 Water 0.13 Solid waste 0.1292

7 Phosphoric acid 0.034 - --

8 Ammonia solution 0.079 -- --

9 MDC 0.209 -- --

TOTAL 0.6242 TOTAL 0.6242

Summary

Fresh water 0.13 MT/Day required

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Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 0.136

2 Organic losses through

vent

0.042

3 Solid Waste 0.1292

17. LOSARTAN POTASSIUM

Chemical Name:1H-Imidazole-5-methanol, 2-butyl-4-chloro-1-[[2'-(2H-tetrazol-5-

yl)[1,1'-biphenyl]-4-yl]methyl]-, potassium salt (1:1)

CAS NO: 124750-99-8

Molecular weight: 461.007

Synthetic Route:

Br

CN

+

NH

N

Cl

OHC

N

N

Cl

HOH2C

CN

N

N

Cl

HOH2C

N NH

NN

N

N

Cl

HOH2C

N NK

NN

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Chemical Reaction:

Process Description:

Br-OTBN on condensation with BCFI gives stage I, which on treatment with sodium azide

in presence of triethylamine hydrochloride gives losartan base which is then converted

to its potassium salt by KOH.

MASS BALANCE

MASS BALANCE FOR 0.134 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL QUANTITY OUTPUT

MATERIAL

QUANTITY

1 Bromo OTBN 0.114 PRODUCT 0.134

2 (2-Butyl-4-chloro-5-

formylimidazole)BCFI

0.079 Handling losses 0.334

3 TBAB 0.0068 Effluent

Generated

3.09

4 SBH 0.0057 Recovered

Toluene

1.43

5 Toluene 1.59 Recovered

Methanol

1.18

6 Methanol 1.312 Recovered ethyl

acetate

0.1341

7 NaOH 0.206 Recovered

acetone

0.267

8 Sodium azide 0.059 Recovered

TEA.HCl

0.106

9 TEA.HCl 0.163 Solid waste 0.7369

10 Sodium

metabisulphate(SMBS)

0.013 -- --

11 Ethyl acetate 0.149 -- --

12 Carbon 0.023 -- --

13 NaOH 0.248 -- --

14 H2SO4 0.034 -- --

15 KOH Flakes 0.023 -- --

16 Activated Carbon 0.0103 -- --

17 Acetone 0.297 -- --

18 Water 3.08 -- --

Total 7.412 Total 7.412

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SUMMARY

Fresh water required –3.08 MT/DAY product output

Sr. No. Effluent and Vent losses MT/DAY

1 Liquid Effluent 3.09

2 Organic losses through vent 0.334

3 Solid waste 0.7369

18. LUMEFANTRINE

Chemical Name: 1-((Z)-9-(4-chlorobenzylidene)-2,7-dichloro-9H-fluoren-5-yl)-2-

(dibutylamino)ethanol

CAS NO: 82186-77-4

Molecular Weight: 528.94

Synthetic Route:

O

Cl

Cl Cl

HC CH2

N

OH

HC

Cl Cl

HC CH2

O

+

NH

Cl Cl

HC CH2

N

OH

Cl

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Chemical Reaction:

Process Description:

2-(2,7-dichloro-9H-fluoren-5-yl)oxirane, n-Butanol and Di-N-butyl amine was refluxed.

Cool the reaction mass and Filtered and crystals were washed with Methanol to obtain 1-

(2,7-dichloro-9H-fluoren-5-yl)-2-(dibutylamino)ethanol. 1-(2,7-dichloro-9H-fluoren-5-

yl)-2-(dibutylamino)ethanol ,Methanol, Para chlorobenzaldehyde and Sodium Hydroxide

was refluxed. Cool the reaction mass and Filtered and crystals were washed with

Methanol to obtain Lumefantrine crude. Lumefantrine Crude was purified by using

Methylene dichloride, Purified water and Methanol.

MASS BALANCE

MASS BALANCE FOR 0.100 MT/DAY OUTPUT

Sr.

No.

INPUT MATERIAL QUANTITY OUTPUT

MATERIAL

QUANTIT

Y

1 2-(2,7-dichloro-9H-fluoren-5-

yl)oxirane 0.067

PRODUCT 0.100

2

n-Butanol 0.163

Recovered n-

Butanol

0.155

3

Di-N-butyl amine 0.035

Recovered

Methanol

0.977

4 Methanol 1.086 Recovered MDC 0.21

5

Para chlorobenzaldehyde 0.035

Handling & vapor

loss

0.151

6 Sodium Hydroxide 0.010 Effluent 0.52

7 Methylene dichloride 0.26 Solid waste 0.063

8 Purified water 0.52 -- --

Total 2.176 Total 2.176

SUMMARY

Fresh Water required –0.52 MT/DAY product output

Sr.

No.

Effluent and Vent losses MT/DAY

1 Liquid Effluent 0.52

2 Organic losses through vent 0.151

3 Solid waste 0.063

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19. MOXIFLOXACIN HYDROCHLORIDE

Chemical Name: 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)- octahydro-

6Hpyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

hydrochloride

CAS No: 186826-86-8

Molecular weight: 437.5

Synthetic Route

N

OCH3

F

F

O

O

O

N

OCH3

F

F

O

O

O

B

O O

OO

N

OCH3

N

F

O

O

OH

NHN

OCH3

N

F

O

O

OH

NH

.HCl

Boric acid

Nonane der.

Chemical Reaction

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Process Description:

Stage I

Charge propionic anhydride, boric acid and gati ester and heat to 100-105°C

After completion of reaction cool to RT

Add water and stir for 2 hours

Filter the reaction mass and wash with water. Dry at 50 °C to give stage I

Stage II

Charge stage I, acetonitrile, nonane and sodium carbonate and heat to 55°C

After reaction completion, charge charcoal and filter over hyflo

Distill the filtrate and charge water to the residue. Stir and charge HCl and stir for

one hour

Charge MDC and then adjust pH with ammonia. Separate layers and distil off

MDC to give stage II

Stage III

Charge stage II, methanol and HCl. Cool to 0°C and maintain for 4 hours

Filter the reaction mass to give stage III, which is dried at 60 °C

OVERALL MASS

BALANCE

Product Quantity 0.067 MT/Day

INPUT MATERIAL OUTPUT MATERIAL

Sr.

No.

Name Quantity Name Quantity

1 Gati ester 0.056 Product 0.067

2 Boric acid 0.011 Propionic acid 0.07

3 Propionic anhydride 0.083 Ethanol 0.009

4 water 3.22 Recovered methanol/water 1.11

5 Nonane der. 0.022 Recovered MDC 0.614

6 Sodium carbonate 0.036 Recovered acetonitrile 0.341

9 Charcoal 0.004 Water of reaction 0.0015

10 HCl 0.083 Solid waste 0.1615

11 Ammonia 0.105 Vent & handling losses 0.106

12 Hyflo 0.004 Effluent generation 3.22

13 Acetonitrile 0.379 -- --

14 MDC 0.683 -- --

15 Methanol 1.014 -- --

Total 5.7 Total 5.7

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Summary

Fresh water required – 3.22 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent 3.2215

2 Organic losses through

vent

0.106

3 Solid Residue 0.1615

20. PIPERAQUINE

Chemical Name: Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis[7-chloro-

CAS No: 4085-31-8

Molecular weight: 535.5

Synthetic Route

N

NH

HNCl

Cl

+

NCl

N

NH

NCl

N N N N

N Cl

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Chemical Reaction

Process Description:

4,7-dichloroquinolineis treated with piperazine in IPA solvent to get 7-chloro-4-

piperazinyl quinoline (stage I)

Stage I on condensation with 1,3-dibromopropane in IPA gives piperaquine

MASS BALANCE

MASS BALANCE FOR 0.034 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL Quantity OUTPUT MATERIAL Quantity

1 4,7-dichloro quinoline 0.046 PRODUCT 0.034

2 IPA 0.72 Recovered piperazine 0.039

3 Piperazine 0.059 Recovered IPA 0.648

4 Potassium iodide 0.019 Recovered MDC 0.205

5 Water 1.05 Handling Losses 0.094

6 Hydrochloric acid 1.05 Effluent Generated 1.563

7 MDC 0.223 Solid waste 0.763

8 Ammonia 0.16 -- --

9 1,3-dibromopropane 0.019 -- --

TOTAL 3.346 TOTAL 3.346

Summary

Fresh water 1.05 MT/day required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 1.563

2 Organic losses through

vent

0.094

3 Solid Waste 0.763

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21. PYRAZINAMIDE

Chemical Name: Pyrazine-2-carboxamide

CAS No: 98-96-4

Molecular weight: 123

Synthetic Route

N

N CN

N

N CONH2

Chemical Reaction

Process Description:

Stage I

Charge 2- cyanopyrazine, NaOH and water. Heat to reflux.

Cool and adjust pH with HCl. Filter and dry to give pyrazinamide

MASS BALANCE

MASS BALANCE FOR 0.167 MT/DAY OUTPUT

Sr.

No. INPUT MATERIAL Quantity

OUTPUT

MATERIAL Quantity

1 2- Cyanopyrazine 0.142 PRODUCT 0.167

2 Caustic Soda 0.0008

Handling Losses

(1%) 0.006

3 Hydro Chloric Acid 0.002 Effluent Generated 0.4618

4 Water 0.49 -- --

TOTAL 0.6348 TOTAL 0.6348

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Summary

Fresh water required – 0.49 MT/DAY product output

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 0.4618

2 Organic losses through

vent

0.006

3 Solid Waste Nil

22. PYRIMETHAMINE

Chemical Name: 2,4-Pyrimidinediamine, 5-(4-chlorophenyl)-6-ethyl-

CAS No: 58-14-0

Molecular weight: 248.71

Synthetic Route

Cl

CN

O

O

+

Cl

CN

O

Cl

CN

O

O

Cl

N

N NH2

NH2

Chemical Reaction

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Process Description:

4 - chloro benzyl cyanide in presence of sodium methoxide is reacted with

isopropyl propionate will give 2 – ethyl – 2 (4 chloro phenyl) keto nitrile.

2 – ethyl – 2 (4 chloro phenyl) keto nitrile is protected with Mono Ethylene Glycol

in the presence of Para Toluene Sulphonic Acid gives 2 – ethyl – 2 (4 chloro

phenyl) ketol.

2 – ethyl – 2 (4 chloro phenyl) ketol is condensed with Guanidine hydrochloride

in Methanol to give Pyrimethamine

OVERALL MASS BALANCE

PRODUCT QUANTITY 0.034 MT/DAY

INPUT MATERIAL OUTPUT MATERIAL

Sr.

No.

Name Quantit

y

Name Quantit

y

1 p-chlorobenzyl cyanide 0.043 Product 0.034

2 Isopropyl propionate 0.033 Recovered toluene 0.191

3 Toluene 0.21 Recovered methanol 0.031

4 Water 0.49 Vent & handling losses 0.025

5 Mono ethylene Glycol 0.017 Effluent generation 0.507

6 Methanol 0.034 Solid waste 0.1842

7 Guanidine HCl 0.027 -- --

8 Carbon 0.0026 -- --

9 Sodium methoxide 0.031 -- --

10 PTSA 0.048 -- --

11 HCl 0.034 -- --

12 Hyflo 0.0026 -- --

TOTAL 0.9722 TOTAL 0.9722

Summary

Fresh water required – 0.49 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent 0.702

2 Organic losses through

vent

0.009

3 Solid Residue 0.005

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23. SODIUM SULFANILAMIDE

Chemical Name: 4-aminobenzenesulphonamide sodium salt

CAS No: 10103-15-8

Molecular weight: 194.18

Synthetic Route

NH2

SO2NHNa

NH2

SO2NH2

Chemical Reaction

Process Description:

Charge sulfanilamide and NaOH solution. Heat to 70°C.

Distill off water and add IPA. Cool and filter to get sodium salt of sulfanilamide

OVERALL MASS BALANCE

PRODUCT QUANTITY 0.167 MT/DAY

INPUT MATERIAL OUTPUT MATERIAL

Sr. No. Name Quantity Name Quantity

1 Sulfanilamide 0.154 Product 0.167

2 Water 0.585 Recovered water 0.556

3 NaOH 0.034 Recovered IPA 0.68

4 IPA 0.754 Vent & handling

losses

0.124

-- -- -- Effluent generation NIL

-- -- -- Solid waste NIL

Total 1.527 Total 1.527

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Summary

Fresh water required – 0.585 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent NIL

2 Organic losses through

vent

0.124

3 Solid Residue NIL

24. SULFADIMETHOXINE

Chemical Name: Benzenesulfonamide, 4-amino-N-(2,6-dimethoxy-4-pyrimidinyl)-

CAS No: 122-11-2

Molecular weight: 310.33

Synthetic Route

N

N

OCH3H3CO

NH2

NHCOCH3

SO2Cl

+

N

N

OCH3H3CO

HN

O2S NH2

Chemical Reaction

Process Description:

4-(Acetylamino)benzenesulfonyl Chloride was added to a solution of 4-amino-2,6-

dimethoxypyrimidine in pyridine and toluene and the mixture was heated. The

condensation product was saponified in NaOH. After cooling, Carbon treatment and

acidifying with HCl, sulfadimethoxine is obtained.

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OVERALL MASS BALANCE

PRODUCT QUANTITY 0.100 MT/DAY

INPUT MATERIAL OUTPUT MATERIAL

Sr. No. Name Quantit

y

Name Quantity

1 4-amino-2,6-

dimethoxypyrimidine 0.09 Product 0.100

2

4-

(Acetylamino)benzenesulfonyl

Chloride

0.15 Recovered toluene 0.27

3 Pyridine 0.15 Recovered pyridine 0.135

4 Toluene 0.299 Vent & handling losses 0.045

5 Sodium hydroxide 0.028 Effluent generation 0.691

6 Carbon 0.0017 Solid waste 0.1827

7 Water 0.68 -- --

8 Hydrochloric acid 0.022 -- --

9 hyflo 0.003 -- --

Total 1.4237 Total 1.4237

Summary

Fresh water required – 0.68 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent 0.691

2 Organic losses through

vent

0.045

3 Solid Residue 0.1827

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25. SULFADOXINE

Chemical Name: 4-Amino-N-(5,6-dimethoxy-4-pyrimidinyl)benzenesulfonamide

CAS No: 2447-57-6

Molecular weight: 310

Synthetic Route

NH2

SO2NHNa

N N

Cl

OCH3

Cl

N N

Cl

OCH3

HN

S

NH2

O O

N N

H3CO

OCH3

HN

S

NH2

O O

Chemical Reaction

Process Description:

Stage I

Charge 4,6-dichloro-5-methoxy pyrimidine(DCMP), DMF and sodium

sulfanilamide. Heat to 70°C. Monitor by HPLC.

Charge water and adjust pH. Filter and wash with water. Dry in oven at 60°C to

get stage II

Recover unreacted sodium sulfanilamide from filtrate by adding caustic solution

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Stage II

Charge stage I, methanol and NaOH. Heat to reflux and monitor by HPLC.

Cool and add water and charcoal. Filter through hyflo bed.

Charge filtrate and adjust pH with acetic acid. Filter and wash with water to

obtain crude sulfadoxine

Sulfadoxine final

Purify crude sulfadoxine from water, methanol and HCl

OVERALL MASS BALANCE

MASS BALANCE FOR 0.084 MT/DAY PRODUCT OUTPUT

INPUT MATERIAL OUTPUT MATERIAL

Sr. No. Name Quantity Name Quantity

1 Na-sulfanilamide 0.177 Product 0.084

2 DCMP 0.069 Recovered

sulfanilamide

0.054

3 DMF 0.35 Recovered DMF 0.279

4 Water 3.03 Vent & handling

losses

0.1

5 HCl 0.113 Effluent generation 3.056

6 Methanol 0.449 Solid waste 0.8

7 NaOH 0.057 -- --

8 Acetic acid 0.102 -- --

9 Charcoal 0.013 -- --

10 Hyflo 0.013 -- --

Total 4.373 Total 4.373

Summary

Fresh water required – 3.03 MT/day

Sr. No. Effluent and vent

losses

MT/day

1 Liquid effluent 3.056

2 Organic losses through

vent

0.10

3 Solid Residue 0.8

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26. SULFASALAZINE

Chemical Name: Sulfasalazine

CAS NO: 599-79-1

Molecular Weight: 398.394

Synthetic Route:

H2N

S

NH

O

O N COOH

OH

+

N

S

NH

O

O N

N

HO

HOOC

Chemical Reaction:

Process Description: Sulfa pyridine is diazotized with sodium nitrite and hydrochloric

acid and then reacted with salicylic acid to give Sulfasalazine

MASS BALANCE

MASS BALANCE FOR 0.084 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL QUANTITY OUTPUT

MATERIAL

QUANTIT

Y

1 Sulfa pyridine 0.084 PRODUCT 0.084

2 Conc. HCL 1.93 Handling losses 0

3 Sodium nitrite 0.028 Effluent Generated 1.793

4 Salicylic acid 0.050 Solid waste 2.245

5 Potassium hydroxide 0.35 -- --

6 Water 1.68 -- --

Total 4.122 Total 4.122

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SUMMARY

Fresh Water required –1.68 MT/DAY Product output

Sr. No. Effluent and Vent losses MT/DAY

1 Liquid Effluent 1.793

2 Organic losses through vent Nil

3 Solid waste 2.245

27. VALGANCICLOVIR

Chemical Name: L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-

hydroxypropyl ester

CAS No: 175865-60-8

Molecular weight: 354

Synthetic Route

HN

N N

N

O

H2N

O

O

OHN

OH

COOCH2C6H5

HN

N N

N

O

H2N

O

O

ONH2

OH

Chemical Reaction

Process Description:

Mono benzylcarbonyl valine ganciclovir on reduction with Pd/C gives

Valganciclovir

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MASS BALANCE

MASS BALANCE FOR 0.017 MT/DAY OUTPUT

Sr. No. INPUT MATERIAL Quantity OUTPUT MATERIAL Quantity

1 Mono benzylcarbonyl

valine ganciclovir 0.024 PRODUCT 0.017

2 10% Pd/C 0.006 Recovered IPA 0.478

3 HCl 0.0028 Recovered Pd/C 0.006

4 Water 0.073 Handling Losses 0.055

5 IPA 0.53 Effluent Generated 0.0798

TOTAL 0.6358 TOTAL 0.6358

Summary

Fresh water 0.073 MT/day required

Sr. No. Effluent and vent

losses

MT/DAY

1 Liquid effluent 0.0798

2 Organic losses through

vent

0.055

3 Solid Waste NIL

2.6 Raw Material requirement:

Raw Materials:

The basic raw material for this key product capacity are submitted herein below and for

the details are given for all reactants, solvents and work up support chemicals.

Source for Raw Material Procurement: Raw Material is easily available in the local

market; some of the raw materials will be procured from the International Market.

Mode of Transport of Raw Materials: Few of the raw materials will be transported

locally and few will be imported from the International Market.

Storage at the site: Raw Materials will be stored in storage yard at the project site.

Location of storage yard is demarcated in Layout Plan.

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Table 2.3 List of Raw Materials

Sr. No. Raw Material Monthly consumption (T)

1. m-chloroaniline 2.34

2. Ethyl ethoxymethylene malonate 4.23

3. Dowtherm 36.3

4. Skellysolve 26.55

5. Sodium hydroxide 2.28

6. Hydrochloric acid 5.85

7. Phosphorus oxychloride 8.22

8. Water 73.2

9. Diacetyl acicyclovir 6.03

10. 40% Methylamine soln 53.1

11. Methanol 56.7

12. 4-amino-3,5-dibromo benzaldehyde 2.25

13. 4-aminocyclo hexanol 1.05

14. Methanol 11.19

15. Sodium borohydride 0.33

16. Water 10.08

17. IPA 9.63

18. HCl 0.72

19. 4,7-dichloro quinoline 0.93

20. 4-Aminophenol 0.54

21. Acetic acid 2.79

22. 32% formaldehyde 0.66

23. Diethylamine 0.51

24. HCl 1.05

25. Artemisinin 2.7

26. Sodium borohydride 0.48

27. Methanol 28.74

28. Water 72.9

29. Acetic acid 0.9

30. Sodium bicarbonate 0.33

31. HCl 0.018

32. Trimethylorthoformate 4.17

33. Artemisinin 0.66

34. Sodium borohydride 0.12

35. Methanol 8.985

36. Water 26.52

37. Acetic acid 0.51

38. Succinic anhydride 0.33

39. Acetone 5.94

40. Triethylamine 0.21

41. trans-4-(4- chlorophenyl) cyclohexane-

l-carboxylic acid 0.99

42. 2-chloro- l,4-naphthoquinone 0.96

43. Silver nitrate 0.27

44. Sulfolane 2.01

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45. Acetonitrile 29.55

46. Ammonium persulfate 1.59

47. Ethyl acetate 3.99

48. Cyclohexane 3.99

49. MDC 3.03

50. Methanol 7.02

51. KOH 0.18

52. HCl 0.54

53. Water 10.05

54. 3,4-dihydroxy-5-nitrobenzaldehyde 1.02

55. N,N – Diethyl -2-Cyano Acetamide 0.99

56. Cyclohexane 0.21

57. Piperidine 0.045

58. Acetic acid 1.44

59. Toluene 0.21

60. Methanol 0.3

61. Water 2.1

62. Erythromycin Thiocyanate 3.96

63. Methylene Chloride 28.56

64. Caustic Soda 0.36

65. Water 6.06

66. 2, 4-difluoro-2-(1H-1, 2, 4-triazol-1-

yl)acetophenone 4.23

67. Toluene 68.4

68. Trimethylsulfoxonium iodide 4.38

69. Cetyl trimethylammonium bromide 0.39

70. Water 107.4

71. Carbon 0.63

72. Hexane 2.82

73. IPA 45.6

74. 1, 2, 4 triazol 1.32

75. Potassium carbonate 3.9

76. MDC 72.3

77. Citric acid 3.03

78. Sodium Chloride 6.09

79. Hyflo 0.63

80. Triacetyl ganciclovir 3.09

81. Sodium carbonate 1.86

82. Conc. Hydrochloric acid 0.309

83. Carbon 0.15

84. Water 30.9

85. Hyflo 0.162

86. 5-chloro-N-[2-[4-[aminosulfonyl]

phenyl]ethyl]-2- Benzamide 0.99

87. Cyclohexylisocyanate 0.39

88. Sodium hydroxide 0.12

89. Acetone 4.89

90. Water 6.12

91. Methanol 2.46

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92. HCl 0.33

93. Sodium methoxide 0.3

94. Acetic acid 0.3

95. N-amino-3-azabicyclo[3,3,0]-octane

hydrochloride 2.22

96. p-toluene sulfonyl urea 3.21

97. DMF 2.22

98. Toluene 8.82

99. THF 12.9

100. 4[2-(3-ethyl-4-methyl-2-cabonyl

pyrrolidone amido)ethyl]benzene

sulfonamide 0.84

101. Potassium Carbonate 0.51

102. Toluene 15.729

103. Trans-4-metylcyclohexyl isocyanate 0.438

104. Water 1.71

105. Methanolic ammonia 6.81

106. 4-[2-(5-methylpyrazin-2-

carboxamide)ethyl]benzenesulfonamide 1.02

107. Cyclohexylisocyanate 0.54

108. Acetone 22.74

109. Sodium hydroxide 1.44

110. Water 10.89

111. Hyflo 0.09

112. HCl 0.63

113. 4,7-dichloro quinoline 0.78

114. 5-(N-ethyl-N-2-hydroxyethylamino)-2-

pentylamine 1.14

115. Potassium iodide 0.033

116. Sodium hydroxide 0.063

117. Methanol 3.15

118. Water 3.9

119. Phosphoric acid 1.02

120. Ammonia solution 2.37

121. MDC 6.27

122. Bromo OTBN 3.42

123. (2-Butyl-4-chloro-5-

formylimidazole)BCFI 2.37

124. TBAB 0.204

125. SBH 0.171

126. Toluene 47.7

127. Methanol 39.36

128. NaOH 6.18

129. Sodium azide 1.77

130. TEA.HCl 4.89

131. Sodium metabisulphate(SMBS) 0.39

132. Ethyl acetate 4.47

133. Carbon 0.69

134. NaOH 7.44

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135. H2SO4 1.02

136. KOH Flakes 0.69

137. Activated Carbon 0.309

138. Acetone 8.91

139. Water 92.4

140. 2-(2,7-dichloro-9H-fluoren-5-yl)oxirane 2.01

141. n-Butanol 4.89

142. Di-N-butyl amine 1.05

143. Methanol 32.58

144. Para chlorobenzaldehyde 1.05

145. Sodium Hydroxide 0.3

146. Methylene dichloride 7.8

147. Purified water 15.6

148. Gati ester 1.68

149. Boric acid 0.33

150. Propionic anhydride 2.49

151. water 96.6

152. Nonane der. 0.66

153. Sodium carbonate 1.08

154. Charcoal 0.12

155. HCl 2.49

156. Ammonia 3.15

157. Hyflo 0.12

158. Acetonitrile 11.37

159. MDC 20.49

160. Methanol 30.42

161. 4,7-dichloro quinoline 1.38

162. IPA 21.6

163. Piperazine 1.77

164. Potassium iodide 0.57

165. Water 31.5

166. Hydrochloric acid 31.5

167. MDC 6.69

168. Ammonia 4.8

169. 1,3-dibromopropane 0.57

170. 2- Cyanopyrazine 4.26

171. Caustic Soda 0.024

172. Hydro Chloric Acid 0.06

173. Water 14.7

174. p-chlorobenzyl cyanide 1.29

175. Isopropyl propionate 0.99

176. Toluene 6.3

177. Water 14.7

178. Mono ethylene Glycol 0.51

179. Methanol 1.02

180. Guanidine HCl 0.81

181. Carbon 0.078

182. Sodium methoxide 0.93

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183. PTSA 1.44

184. HCl 1.02

185. Hyflo 0.078

186. Sulfanilamide 4.62

187. Water 17.55

188. NaOH 1.02

189. IPA 22.62

190. 4-amino-2,6-dimethoxypyrimidine 2.7

191. 4-(Acetylamino)benzenesulfonyl

Chloride 4.5

192. Pyridine 4.5

193. Toluene 8.97

194. Sodium hydroxide 0.84

195. Carbon 0.051

196. Water 20.4

197. Hydrochloric acid 0.66

198. hyflo 0.09

199. Na-sulfanilamide 5.31

200. DCMP 2.07

201. DMF 10.5

202. Water 90.9

203. HCl 3.39

204. Methanol 13.47

205. NaOH 1.71

206. Acetic acid 3.06

207. Charcoal 0.39

208. Hyflo 0.39

209. Sulfa pyridine 2.52

210. Conc. HCL 57.9

211. Sodium nitrile 0.84

212. Salicylic acid 1.5

213. Potassium hydroxide 10.5

214. Water 50.4

215. Mono benzylcarbonyl valine ganciclovir 0.72

216. 10% Pd/C 0.18

217. HCl 0.084

218. Water 2.19

219. IPA 15.9

2.7 Availability of Resources

2.7.1 Water Requirement and Source

Proposed water requirement of the project for domestic and industrial activity during

operation phase will be 124 CMD. The water requirement will be sourced from MIDC.

The details of water requirement are given in Table 2.4

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Table 2.4: Water Balance

2.7.2 Power Requirement

Power requirement of proposed project will be made available through State Electricity

Board. Power requirement of proposed plant is as below:

Power requirement: 200 KW

Connected load: 250 KW

One D. G. set of capacity 200 KVA are proposed to meet emergency power requirement of

the plant.

2.7.3 Fuel Requirement

There will be 2 nos. of boilers having capacity 1 TPH each. One will be used as standby.

Fuel required will be around 1248 kg/day of LDO for one boiler. LDO will procure form

local sources.

2.8 Quantity of wastes to be generated

2.8.1 Waste Water Generation

Trade effluent generated will be 48 CMD. The trade effluent generated will be treated in

full-fledged effluent treatment plant having capacity of 65 CMD. It will be consists of

primary, secondary and tertiary treatment. Treated water ensuring parameters within

MPCB norms will be sent to CETP for further treatment.

The sewage generated due to domestic activities will be treated in combined ETP of 65

CMD capacity.

Particulars Consumption

(CMD) Loss (CMD)

Effluent

(CMD)

Domestic 10 2 8

Industrial Process 29 2 27

Cooling tower 72 54 18

Boiler 10 8 2

Floor washing 2 1 1

Gardening 1 1 --

Total 124 68 56

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2.8.2 Solid waste generation and Disposal

The types of Hazardous wastes generated from the project, method of disposal is shown

in below table 2.5

Table 2.5: Details of Hazardous Waste Generation

Sr.

No. Description Cat Unit Quantity

Method of

Disposal

1

Chemical sludge

from waste water

treatment

34.3 MT/M 6 MWML

2 Process waste

sludge/ residue 26.1 MT/M 240 MWML

3 Spent carbon

from Process 28.8 MT/M 1.5 MWML

4 Spent carbon

from ETP 35.3 MT/M 3 MWML

5

Discarded

containers /

Barrels/ Liners

contaminated

with hazardous

chemicals /

waste/

33.3 Nos. 50 Downstream

User

2.9 Schematic representations of the feasibility drawing which give

Information of EIA purpose.

The applicability of the 5.0 1533 for the proposed project was explored by

considering different possibilities & provision made in the said notification.

Considering the products & project location of the proposed project it is noticed

that the proposed project falls under Category 5 (f) "B" of the Schedule-I of EIA

Notification SO 1533.

As per the provision of the SO 1533 it is necessary to get Environmental Clearance by

applying to MoEF along with the Environmental Impacts Assessment Study Report

for the proposed project prior to commissioning of the project activities. Therefore

the EIA is required to conduct to comply with provisions of SO 1533 made for Category

5(f) "B" of schedule —I of the notification.

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Schematic representations of the feasibility drawing which give information of

EIA purpose.

Project Identification

What environmental impacts are normally associated with the type of project being

proposed?

Pre-feasibility Analysis

Is the Project feasible from an environment point of view?

Project Design

(a) What negative environmental impacts could arise if the proposed project is

implemented with proposed design? (b) Is there alternative design with less environmental impacts?

Project Appraisal

Have all the environmental concerns associated with the project been eliminated?

Project Implementation

What environmental concerns might arise at the implementation phase of the project?

Preparation of an Environment Monitoring and Evaluation Plan

(a) What environment monitoring indicators are required to ensure that

the implementation of components of the project will be executed within

environmentally

Sound limits? ( Identify monitoring indicators )

(b) What is required to ensure that the recommended environmental control

measures will be implemented and enforced?

(c)

(Prepare a comprehensive environment monitoring and management plan)

Post EIA Monitoring and Environment Audit

(a) Is the implementation of components of the project being executed in an

environmentally sound manner?

(b) Are all the recommended environmental control measures being implemented and

enforced?

(d) Are there any environmental impacts that were earlier not anticipated when

EIA was done?

( Identify gaps and corrective action )

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3.0 Site Analysis

3.1 Connectivity

M/s S. Kant Pvt. Ltd. is located at Plot no. W-5 and W-6, MIDC Tarapur, District

Palghar, Maharashtra.

The nearest city from the site is Boiser at a distance of 3.5 Km

The nearest railway station is Boiser at a distance of 3.5 Km from the site.

The nearest airport is at Mumbai 110 km.

National Highway is Mumbai Ahmedabad Highway at a distance of 20 km.

3.2 Land Form, Land use and Land ownership

The proposed land for setting bulk drug unit is located in Notified Industrial Estate

having plot area 2000 sq. m. The land is acquired by S. Kant for establishing new

manufacturing facility.

3.3 Topography

The Geographical location of this industry is : 19.793312° N Longitude: 72.737725° E.

with an elevation of 11 m (36 ft.) above mean sea level.

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Figure 3.1: Toposheet Showing Project site and 10Km of area

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3.4 Existing Land use Pattern

The proposed land for setting new unit is located in Notified Industrial Estate. The land

is acquired by SKCPL Industries. The proposed site is an undeveloped land which does

not include agricultural, forestry, water bodies (including CRZ) etc.

3.5 Existing Infrastructure

The land is in a recognized MIDC industrial area.

All infrastructures are available.

Road Network connecting to Mumbai and Gujarat.

Air travel is readily available from Mumbai airport.

Water is available from MIDC.

Electricity is available from MSEDCL.

Membership of CETP for discharge of treated effluent

3.6 Soil classification

The basic type of soil found in the area varies from brown & black. The black type of soil is

found in the eastern part. The fertility of the soil increases as it goes from red to black.

3.7 Climatic data from secondary sources

The climate in proposed area is characterized by hot summer and general dryness

throughout the year except the south west monsoon season.

Climate Classification: Project site features a semiarid climate.

Temperature: Annual maximum and minimum temperature in Tarapur range from max

38°C min 11°C. The most comfortable time to visit in the winter October to February.

Rainfall: Most of the rainfall occurs in the monsoon season from June to September.

Average annual rainfall is 2488 mm.

3.8 Social Infrastructure Availability

Key infrastructure such as hospitals, schools, bank, places of worship and social/

community facilities such as park, market, playground etc. education, health care,

community development, income distribution, employment and social welfare are

available in nearby area of Maharashtra Industrial Estate.

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4.0 Planning In Brief

4.1 Planning Concept:

Proposed plant activities will be started after getting statutory clearance form related

authorities. The project will be completed within one year.

Further proposed project activities will take care of all the rules and regulation of

statutory authority and provide the control measure and devices to achieve the

standard norms

Tarapur MIDC has provided all infrastructure like assured electrical power, continuous

water supply with purification from water works like disinfection, the internal road

network, external approach road, and networking with CHWSTDF (Common Hazardous

Waste Storage Treatment and Disposal Facility), MWML at Taloja in vicinity established

with support of MIDC and MPCB.

All nearby villages are provided with drinking water from wells or Government Water

Supply Schemes. Hence we do not encroach upon their supply.

4.2 Population Projection:

Palghar has a population of 454,635 as per census 2011. It has more than 99,652

households of Maratha, Aagri, Koli, Muslim, Buddhist, and also includes SC, ST, OBC and

open categories community. The village has basically an agrarian economy and

industrial workers and farming is the main occupation of the villagers. The local self-

Government vests with a Grampanchayat having an elected body of headed by a

Sarpanch.

Population growth is being increased at alarming rate with their basic requirements.

Amongst, Medicine is one of the basic needs, which is very essential for everyone to live

happy life. So to fulfil their future basic need of Medicine for social community there is a

necessity to promote R & D Centre in each industrial sector. There will be in ratio of

population increase in similar way their need also increases so to fulfil their needs we

are going to set up a proposed unit which again generates employment.

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4.3 Land use planning:

The proposed project is in notified MIDC Industrial area, this is not a prime Agricultural

Land. The land-use is already as ―industrial‖. Thus there is no change in the status.

4.4 Assessment of Infrastructure Demand (Physical and Social):

M/s. S Kant Pvt Ltd. proposes new product of API (Bulk drug and intermediate) at the

Plot No. W-5 and W-6 at MIDC Industrial Area Tarapur, Dist.: Palghar, State:

Maharashtra. There will be demand of physical infrastructure and social infrastructure.

4.5 Amenities/ Facilities:

In proposed site many basic facilities like uninterrupted water supply, Power and Road

Network & solids disposal facility if feasible are available. This site is inside the campus

of the MIDC and means safe transportation, less need of utilities, less constructing

buildings and roads, less fuel, less water with optimization of infrastructure and

networking with CHWSTDF (Common Hazardous Waste Storage Treatment and Disposal

facility), MWML, Taloja in vicinity established with support of MIDC and MPCB.

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5.0 Proposed Infrastructure

5.1 Industrial area

Industrial Area (Processing area)

Utilities

Cooling towers

HSD unloading/storage area

Boilers

Non- Processing Area

Administrative Buildings

Security cabins

Workers restroom

Vehicle Shed

Water reservoirs

Temporary storage sites

Works block etc

5.2 Residential Area:

In M/s. S. Kant Chemicals Pvt Ltd. there is no any residential area has been proposed

5.3 Green Belt:

The project is built on an MIDC plot with plot area of 2000 sq. m. and green belt area

170 sq. m. In and around the industry, plantation is already done. Trees along with

some garden variety shrubs are already existed at the site. Near about 113 no. of new

trees and shrubs will be planted at new site.

5.4 Social Infrastructure:

The basic amenities within the study area include primary schools, dispensaries, water

supply, electric supply, public telephones, hotels, banks, post offices, petrol pumps, bus

services, technical training institute and entertainment etc.

5.5 Connectivity:

The proposed site is at Plot No. W-05 and W-06 at MIDC Industrial Area Tarapur. The

site is near from Mumbai city and 15 km from Boisar railway station. The land and

infrastructure is made available by MIDC and the raw materials are easily available

through easy transport via road connectivity. Proposed project site is 110 km away from

Mumbai Airport.

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5.6 Drinking Water Management:

The source of water supply is from MIDC. For proposed project 124 CMD of water will be

required.

5.7 Sewage System:

The domestic effluent will be treated in combined ETP

5.8 Industrial Water Management:

It will be treated in full fledge ETP having primary, secondary and tertiary treatment.

Table 5.1: Design Data & Performance projection

Sr. No. Parameters

mg/l

except pH

Inlet Effluent

Characteristi

cs

Outlet

Effluent

Characteristic

s

Effluent

discharge

standards

(MPCB)

1 pH 5-9 7-8 6.5 -9.0

2 TSS 300-350 50-80 <100

3 COD 5000-6000 200-240 <250

4 BOD 27oC

for 3 days

2000-3000 80-90 <100

5 TDS 2000-2100 1600-1900 <2100

6 O&G 20-25 5-6 <10

All values are in mg/L except pH and Flow

The ETP Process Details:

ETP shall be installed to treat 56 CMD of waste water. The capacity of the ETP will be 65

CMD and it will treat effluent till tertiary level.

Standard Operating Procedure of Effluent Treatment Plant

1. Effluent from all plants is received in the Screen chamber.

2. Oil & grease is removed from O & G chamber.

3. After removal of oil & grease the effluent is collected into the chamber Equalization &

neutralization.

4. Then for neutralization by adding HCL or caustic lye to bring pH as per standard.

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5. After neutralization, effluent is then transferred to Flash Mixture by Add alum in

effluent as coagulant, suspended solids get settled. Then primary settling tank (Clarifier)

& clear treated effluent is then overflow to Bioreactor Tank. And remaining dead bacteria

sludge is send to Sludge drying bed for solid waste disposal to Mumbai waste

management Taloja

6. The effluent from Bioreactor tank for biological treatment .Surface Aerator is bubbled

in it for aeration & then transfer to secondary settling tank.

7. In secondary settling tank suspended solids / sludge gets settle & clear treated

effluent is then pumped to Intermediate tank

8. The Biological treated effluent will be collected in a sump, where it will be imparted

small doses of flocculating and coagulating agents to coagulate any diffused biomass.

These solid will be removed by sedimentation in a settler fitted with tube settler media.

Clean Effluent liquid will be collected in a Tube settler. And remaining dead bacteria

sludge is send to Sludge drying bed for solid waste disposal to Mumbai waste

management Taloja.

9. The Clean Effluent are collected to Intermediate Tank & further passed through a

press Filtered effluent undergoes again filtration process by using Pressure sand &

carbon absorbent filter before sending to CETP.

10. The settled sludge & solids from clarifier is taken into the sludge drying beds

11. Solid waste sludge is collected in beds is air dried & then send to Mumbai Waste

Management Taloja for further processing & disposal.

5.9 Solid Waste Management

Hazardous solid waste generated from the process will be collected, stored, transported

and send to MWML, Taloja CHWTSDF as per Hazardous waste (Management, Handling

and Transboundry Movement) Rules 2008.

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PFR for M/S S. Kant Chemicals Pvt. Ltd.

Prepared by Goldfinch Engineering Systems Pvt. Ltd. Page 72

6.0 Rehabilitation and Resettlement (R & R) Plan

Rehabilitation & Resettlement (R&R) plan is not applicable to proposed project it is

proposed in notified industrial estate.

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PFR for M/S S. Kant Chemicals Pvt. Ltd.

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7.0 Project Schedule & Cost Estimates

Proposed project activities will be started after getting statutory clearance form related

authorities. The project will be completed within one year.

7.1 Estimated project cost along with analysis in terms of economic

viability of the project

The total investment envisaged is Rs. 6.84 Crore with the break-up as given in table no.

7.1

Table 7.1: Proposed Project Cost

Sr. No. Particulars Rs. lacs

1 Land 256

2 Building & Premises 78

3 Plant and Machinery & Equipment 300

4 Environmental Management 25

5 Other / Misc.* 25

Total Cost 684

8.0 Analysis of proposal (Final Recommendations)

Proposed activity will provide benefits to the local people in terms of financial

and social welfare.

Local people will get direct financial benefit by way of employment.

Local people will get some contract of supply and services to get indirect income.

Company will contribute in improving education and health facilities in nearby

area.

Application for ―ToR‖ January

2017 Finalization of EIA June 2017

SEAC/EAC meeting to

finalize ToR January 2017 Application for EC June2017

Environment Monitoring

February 2017

March 2017

April 2017

SEAC/EAC meeting

for EC July 2017

Collection of data from

FAEs April 2017 Consent to establish August 2017

Preparation of draft EIA May 2017 Consent to operate December 2017

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Annexure –I

Plot lay Out of Proposed Project of S. Kant Chemicals Pvt Ltd. at Plot no. W-5 and W-6,

M.I.D.C. Boiser Tarapur