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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.
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
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
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
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.
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.
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.
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
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.
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
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
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
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
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
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
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
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
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 18
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
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 19
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
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 20
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
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 21
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
New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient
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PFR for M/S S. Kant Chemicals Pvt. Ltd.
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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
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.
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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.
New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient
S. Kant Chemicals Pvt. Ltd., Tarapur
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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 )
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.
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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.
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.
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Figure 3.1: Toposheet Showing Project site and 10Km of area
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.
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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.
New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient
S. Kant Chemicals Pvt. Ltd., Tarapur
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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.
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.
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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.
New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient
S. Kant Chemicals Pvt. Ltd., Tarapur
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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.
New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient
S. Kant Chemicals Pvt. Ltd., Tarapur
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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.
New project for manufacturing of Bulk drugs and Active Pharmaceutical Ingredient
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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.
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.
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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.
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.
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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
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.
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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