06 May 2017 221509117EF8XS16XAnnexure-Prefeasibilityreport PDF

PROJECT PRE FEASIBILITY REPORT
For
Application for TORs
Of
Proposed expansion project for

manufacturing of bulk drugs and drugs
intermediates
At
Plot No. 3103,
GIDC Estate, Panoli,
Dist: Bharuch.
Project proponent
M/s. Vasudev Drug Intermediates.
CONTENTS
Chapters
S. No. Particulars Page No.
1 EXECUTIVE SUMMARY 1-4
2 INTRODUCTION OF THE PROJECT 5-7
2.1 IDENTIFICATION OF THE PROJECT AND PROJECT PROPONENT 5
2.1.1 IDENTIFICATION OF THE PROJECT 5
2.1.2 PROJECT PROPONENT 6
2.1.3 NATURE OF THE PROJECT 6
2.1.4 NEED OF PROJECT & DEMAND-SUPPLY GAP 6
2.1.5 IMPORTS VS. INDIGENOUS PRODUCTION 6
2.1.6 EXPORT POSSIBILITY 6
2.1.7 DOMESTIC / EXPORT MARKET 7
3 PROJECT DISCRIPTION 8-19
3.1 TYPE & LOCATION OF PROJECT 8
3.1.1 TYPE 8
3.1.1.1 LOCATION 8
3.2 DETAILS OF ALTERNATIVE SITE 11
3.3 SIZE & MAGNITUDE OF OPERATION 11
3.4 PROJECT DISCRIPTION WITH PROCESS DETAILS 11
3.5 RAW MATERIAL FOR FINISHED PRODUCTS 12
3.6 HAZARDOUS CHEMICAL STORAGE & HANDLING 12
3.7 RESOURCE OPTIMIZATION& AVAILABILITY 12
3.7.1 LAND & BUILDING REQUIREMENT 12
3.7.2 EQUIPMENT 12
3.7.3 POWER REQUIREMENT 13
3.7.4 FUEL REQUIREMENT 13
3.7.5 WATER REQUIREMENT 13
3.7.6 MAN-POWER REQUIREMENT 14
3.8 QUANTITY OF WASTE TO BE GENERATED 15
3.8.1 WASTE WATER GENERATION & MANAGEMENT 16
3.8.2 WASTE WATER CHARACTERISTICS 16
3.8.3 AIR EMISSIONS & CONTROL 16
3.8.3.1 PROCESS EMISSION 16
3.8.3.2 UTILITY EMISSION 17
3.8.3.3 FUGITIVE EMISSION 17
3.8.4 HAZARDOUS/NON-HAZARDOUS. WASTES MANAGEMENT 17
3.8.5 NOISE CONTROL 18
3.9 HEALTH AND SAFETY MEASURES 18
3.10 ENVIRONMENTAL HEALTH & SAFETY CELL 18
3.11 POST PROJECT MONITORING PLAN 19
4 SITE ANALYSIS 20-22
4.1 CONNECTIVITY 20
4.2 LAND FORM, LAND USE & LAND OWNERSHIP 20
4.3 TOPOGRAPHY 20
4.4 SALIENT FEATURES 20
4.5 EXISTING INFRASTRUCTURE 20
4.6 SOIL CLASSIFICATION 20
4.7 CLIMATE & METEROLOGY 21
4.7.1 TEMPERATURE 22
4.7.2 HUMIDITY 22
i
S. No. Particulars Page No.
4.7.3 RAINFALL 22
4.7.4 WIND PATTERN 22
4.8 SOCIAL INFRASTRUCTURE 22
4.8.1 EDUCATIONAL FACILITIES 22
4.8.2 MEDICAL FACILITIES 22
5 PLANNING BRIEF 23-24
5.1 PLANNING CONCEPT 23
5.2 POPULATION PROJECTION 23
5.3 AREA STATEMENT 23
5.4 ASSESMENT OF INFRASTRUCTURE DEMAND (PHYSICAL & 23
SOCIAL)
5.5 AMENITIES/FACILITIES 24
5.5.1 DRINKING WATER FACILITIES 24
5.5.2 POWER SUPPLY FACILITIES 24
5.5.3 COMMUNICATION & BANKING FACILITIES 24
5.5.4 TRANSPORT FACILITIES 24
5.5.5 APPROACH TO VILLAGES 24
6 PROPOSED INFRASTRUCTURE 25-25
6.1 INDUSTRIAL AREA 25
6.2 RESIDENTIAL AREA 25
6.3 GREENBELT 25
6.4 SOCIAL INFRASTRUCTURE 25
6.5 CONNECTIVITY 25
6.6 DRINKING WATER MANAGEMENT 25
6.7 SEWERAGE SYSTEM 25
6.8 INDUSTRIAL WASTE MANAGEMENT 25
6.9 SOLID WASTE MANAGEMENT 25
6.10 POWER REQUIREMENT & SOURCE OF SUPPLY 25
7 REHABILITATION & RESETTLEMENT ( R& R) PLAN 26-26
7.1 POLICY TO BE ADOPTED 26
8 PROJECT SCHEDULE & COST ESTIMATES 27-27
8.1 TIME SCHEDULE OF THE PROJECT 27
8.2 ESTIMATED PROJECT COST 27
9 ANALYSIS OF PROPOSAL 28-28
9.1 FINANCIAL & SOCIAL BENEFITS 28
ii
List of Tables
Table No. Topic Page No.
1.1 PROJECT SUMMARY 1
2.1 LIST OF PRODUCTS 5
2.2 LIST OF DIRECTORS 6
3.1 AREA STATEMENT 11
3.2 LIST OF RAW MATERIALS ---
3.3 DETAILS OF HAZARDOUS CHEMICALS/MATERIALS STORAGE AND 12
HANDLING
3.4 LIST OF EQUIPMENT/MACHINERIES 12
3.5 CATEGORY WISE FRESH WATER REQUIREMENT 14
3.6 MAN-POWER REQUIREMENT 14
3.7 WASTE WATER GENERATION 15
3.8 EXPECTED CHARACTERISTICS OF COMPOSITE WASTE WATER 16
3.9 DETAILS OF UTILITY EMISSIONS 17
3.10 HAZARDOUS AND NON-HAZARDOUS WASTE GENERATION AND ITS 17
MANAGEMENT
3.11 SAFETY DETAILS 18
3.12 ENVIRONMENTAL MONITORING PLAN 19
4.1 SALIENT FEATURES OF THE PROJECT SITE 20
4.2 SUMMARY METEOROLOGICAL DATA AT NEAREST IMD STATION- 21
BHARUCH
5.1 DISTRIBUTION OF POPULATION 23
5.2 AREA STATTEMENT 23
8.1 TOTAL CAPITAL COST PROJECTION 27
8.2 RECURRING COST PROVISION FOR EHS 27
List of Figures
Sr. No. Description Page No.
3.1 LOCATION OF THE PROJECT SITE 9
3.2 SATELLITE IMAGE OF THE PROJECT SITE 10
3.3 SITE LAYOUT PLAN 11
3.4 WATER BALANCE DIAGRAM FOR EXISTING SCENARIO 15
3.5 WATER BALANCE DIAGRAM FOR PROPOSED SCENARIO 16
3.6 ORGANOGRAM OF EHS MANAGEMENT CELL 18
List of Annexures
Sr. No. Description
Annexure 1 Process details
Annexure 2 Land possession documents
Annexure 3 Existing CC&A
Annexure 4 List of raw-materials
iii
Project Pre-feasibility report
CHAPTER – 1
EXECUTIVE SUMMARY
The project is summarized in the below table:
Table1.1: Project Summary
PARTICULARS DETAILS
NAME OF THE M/s. Vasudev Drugs Intermediates.

UNIT
PRODUCTS The list of products are as follows:
Sr. Capacity T/month

Product
No
Existing Proposed Total
1 Para Nitro Benzyl Bromide 10.00 - 10.00
2 Rosuvastatin -
3 Aripirazole -
4 Itopride -
5 Venlaflaxine -
6 Amlodipine - 1.000 1.000
7 Rupatidine -
8 Chlorhexidine Acetate -
9 Glibenclamide -
10 Terazosin -
11 Pranlukast -
12 Loratidine -
13 Valsartan -
14 Losarton-K -
15 olanzapine -
16 CHHCl -
0.300 0.300
17 Desloratidine -
18 Nebivolol -
19 Cilastazole -
20 Nateglinide -
21 Telmisartan -
22 Atovaquone
23 Carvedilol - 0.200 0.200
24 CHBase - 5.000 5.00
25 CHGluconate - 20.000 20.00
Total Capacity 10.00 26.500 36.500
Proposed Expansion project for manufacturing of bulk drugs and drugs intermediates. Page | 1
PARTICULARS DETAILS
By-Product
1 HBr (30 to 35 %) 26.00 - 26.00
2 NaBr 0.50 - 0.50
3 KBr - 25.50 25.50
4 Spent Acetic acid - 5.50 5.50
LOCATION Plot No. 3103, GIDC Estate, Panoli, Dist. Bharuch.
NAME OF Proposed expansion project for manufacturing of bulk drugs and drugs intermediates.
PROJECT
RESOURCES
Resource type Requirement Source
Land Existing land: 3000 m2 The existing site is located in GIDC Estate,
Vapi
No additional land will be required for
proposed expansion. Necessary
modifications will be done in the
existing infrastructure.
Water Existing Scenario: Total kl/day The fresh water is/will be supplied by GIDC
 Domestic: 0.30 kl/day water supply department.
 Industrial:0.50 kl/day
 Gardening: 0.30 kl/day
After proposed expansion: Total

kl/day
 Domestic: 3.50 kl/day
 Industrial: 19.25 kl/day
 Gardening: 0.30 kl/day
Power Existing: 75 kVA The power supply is/will be supplied by

Dakshin Gujarat Vij Co. Ltd.
After proposed expansion: 250 kVA
Fuel Existing: Flue is/will be sourced locally.

 Natural gas 6.87 m3/hr.
OR
 Wood: 200 kg/day.
After proposed expansion:

 Wood: 2000 Kg/Day.
POLLUTION POTENTIAL & MITIGATION MEASURES
Parameter Potential Mitigation
PARTICULARS DETAILS
Wastewater Existing: Total kl/day In existing the domestic wastewater is

disposed of through Soak pit/Septic Tank
 Domestic: 0.25kl/day and there is no effluent discharge since the
 Industrial: 0.00 kl/day unit is zero discharge.
After proposed expansion: Total
For the proposed expansion in-house ETP
kl/day
will be developed and treated effluent from
 Domestic: 2.50 kl/day ETP after confirming the inlet norms will be
 Industrial: 9.95 kl/day sent to PETL for final disposal.
Air Emissions Existing: In existing Boiler (600 kg) is attached as

Utility.
Utilities: Steam boiler- 600 kg. (1 No.)
For the proposed project, 1 Nos. of Boiler (3
After proposed expansion: T), TFH (2 T) and D.G. Set (250 kVA) new
utilities will be installed and existing utilities
Utilities: Steam boiler- 3 Ton. (1 No.)
will be removed.
TFH- 2 Ton. (1 No.)
D.G. Set- 250 kVA (1 No.)
Hazardous & Existing: Used oil is/will be sent to Registered Re-

solid waste refiners.
Used Oil: 0.012 KL/annum
Discarded containers/bags is/will be sold to
Discarded containers/ Bags/ Liners: Authorized recycler.
240 Nos./annum
ETP sludge, Inorganic Process Salt,
After Proposed Expansion: Distillation residue, will be disposed to TSDF
site, BEIL, Ankleshwar.
Distillation Residue : 215.00 T/annum
Used Ni catalyst will be sold to GPCB/ CPCB
Process waste: 85.00 T/annum
approved vendor.
Spent Carbon: 15.00 T/annum
Used Palladium catalyst will be sent back to
party for reactivation.
Used Nickel Catalyst: 4.00 T/annum
Process waste (from iron powder) will be
Used Palladium Carbon: 3.00
sent to BEIL, Ankleshwar for disposal.
T/annum
Spent Carbon will be sent for incineration. At
Inorganic Process Waste: 15.00
BEIL, Ankleshwar.
T/annum
Used Oil: 0.12 kl/annum
Discarded containers/ Bags/ Liners:

250 T/annum
PARTICULARS DETAILS
Noise Expected levels  Regular maintenance of the machinery

is/will be carried out.
 Within the premises: <75dB(A)
during day time and <70 dB(A)
during night time.
CHAPTER – 2
INTRODUCTION OF THE PROJECT
2.1 IDENTIFICATION OF THE PROJECT AND PROJECT PROPONENT
2.1.1 IDENTIFICATION OF THE PROJECT

M/s. Vasudev Drug Intermediates is unit for manufacturing of bulk drugs and drugs intermediates, at plot
no. 3103, G.I.D.C Estate, Panoli, Dist. Bharuch. The company has obtained CC&A vide consent order no.
AWH-55875 dated 29/07/2013 for its existing products. M/s. Vasudev Drug Intermediates has proposed the
project expansion for manufacturing of bulk drugs and drugs intermediates.
Table-2.1: List of products
Sr. Capacity T/month
Product
No
Existing Proposed Total
1 Para Nitro Benzyl Bromide 10.00 - 10.00
2 Rosuvastatin -
3 Aripirazole -
4 Itopride -
5 Venlaflaxine -
6 Amlodipine - 1.000 1.000
7 Rupatidine -
8 Chlorhexidine Acetate -
9 Glibenclamide -
10 Terazosin -
11 Pranlukast -
12 Loratidine -
13 Valsartan -
14 Losarton-K -
15 olanzapine -
16 CHHCl -
0.ca300 0.300
17 Desloratidine -
18 Nebivolol -
19 Cilastazole -
20 Nateglinide -
21 Telmisartan -
22 Atovaquone
23 Carvedilol - 0.200 0.200
24 CHBase - 5.000 5.00
25 CHGluconate - 20.000 20.00
Total Capacity 10.00 26.500 36.500

By-Product
1 HBr (30 to 35 %) 26.00 - 26.00
2 NaBr 0.50 - 0.50
3 KBr - 25.50 25.50
4 Spent Acetic acid - 5.50 5.50
(Source: M/s. Vasudev Drug Intermediates.)
2.1.2 PROJECT PROPONENT

The company is promoted by 2 Partners. List of Partners with name, residential address is provided in below
table:
Table 2.2: List of Directors
Sr. Name Residential Address
No
1 Mr. Chimanbhai S. Plot No. 1105/5, G.I.D.C New Colony, Near Kohinoor Complex, Opp Arti
Jagani Colony Ankleshwar
2 Mrs. Ilaben C. Plot No. 1105/5, G.I.D.C New Colony, Near Kohinoor Complex, Opp Arti
Jagani Colony Ankleshwar
(Source: M/s. Vasudev Drug Intermediates.)
2.1.3 NATURE OF THE PROJECT

The proposed expansion project involves manufacturing of bulk drugs and drugs intermediates which falls
under the item no. “5(f) category i.e. Synthetic organic chemicals” and Category B as per the EIA
notification, 2006 (as amended time to time). But due to the applicability of general conditions i.e. located
within the 5km distance from critically polluted area (Ankleshwar), the proposed expansion project is
categorized as ‘Category A’ and needs to obtain environmental clearance from MoEF&CC.
2.1.4 NEED OF PROJECT & DEMAND-SUPPLY GAP

M/s. Vasudev Drug Intermediates is planning to manufacture bulk drugs and drugs intermediates. Since the
population and economy is growing the demand for our products is poised to show an upward trend.
Many drug intermediates which are imported at present to cater to domestic demand will be manufactured at
the present site and hence valuable foreign exchange will be saved. Continuous growth in population is
accelerating the demand of products in all segments of pharma.
2.1.5 IMPORTS VS. INDIGENOUS PRODUCTION

Many drug intermediates which are imported at present to cater to domestic demand will be manufactured at
the present site and hence valuable foreign exchange will be saved.
2.1.6 EXPORT POSSIBILITY

The company has secured its market by tying up with Nova International, M/s. Prakash Chemical Pvt. Ltd &
M/s. Adroit Pharma who already have an established export market. Hence, there will be no problem of
establishing the market for the proposed products (Drug Intermediates).
2.1.7 DOMESTIC / EXPORT MARKETS

Since, the proposed products are Bulk drugs and drugs intermediates; there are lots of pharmaceutical
industries manufacturing Bulk Drugs in Panoli and Ankleshwar itself like M/s. Cadila Pharmaceuticals, M/s.
Glenmark Pharmaeuticals, M/s. Cadila Healthcare etc. Hence, local market is already available.
In addition, the company has secured its market by tying up with Nova International, Prakash Chemical Pvt.
Ltd & M/s. Adroit Pharma, M/s. Rohit Exports who already have an established export market. Hence, there
will be no problem of establishing the market for the proposed products.
CHAPTER – 3
PROJECT DESCRIPTION
3.1 TYPE & LOCATIONOF THE PROJECT
3.1.1 TYPE
The proposed expansion project involves manufacturing of bulk drugs and drugs intermediates. The proposed
expansion is to be carried out on existing site located in GIDC estate of Panoli. Necessary modifications will
be done in the existing infrastructure.
3.1.1.1 LOCATION
The project site is located in the GIDC notified industrial area of Panoli. The existing site selection was guided
by many factors like infrastructure, availability of land, water sources, fuel transportation and power
availability. Specific site selection criteria are as follows:
 Availability of trained and skilled manpower nearby because of the proximity to various industrial areas
and city/town.
The location of the project site is provided in figure 3.1, satellite image of the project site is provided in figure
3.2 and the site layout plan of the project site in figure 3.3. The area statement is provided in table 3.1.
Figure 3.1: Location of the project site
Project site
(Source: Google.co.in)
Figure 3.2: Satellite image of the project site
(Source: Google Earth)
Figure 3.3: Site layout plan
(Source: M/s Vasudev Drug Intermediates.)
Table: 3.1 Area Statement

Particulars Unit Area
Built up area m2 1000.00
Open area m2 1523.00
Greenbelt area m2 477.00
Total Area m2 3000.00
3.2 DETAILS OF THE ALTERNATIVE SITE

The proposed expansion will be carried out on the existing site. No additional land will be required for the
proposed expansion.
3.3 SIZE & MAGNITUDE OF OPERATION

Total production after the proposed expansion for bulk drugs and drugs intermediates will be @36.5 T/month.
3.4 PROJECT DESCRIPTION WITH PROCESS DETAILS

The proposed expansion project involves manufacturing of bulk drugs and drugs intermediates. The process
details for existing and proposed products are attached as Annexure-1.
3.5 RAW MATERIAL FOR FINISHED PRODUCTS

The list of raw-materials required is attached as Annexure-4.
3.6 HAZARDOUS CHEMICAL STORAGE & HANDLING

The list of hazardous chemicals/materials storage, handling and transportation details are as follows:
Table 3.3: Details of hazardous chemicals/materials storage and handling
Sr. Name of chemical/ Means of storage and Handling Transportation
No. material
1 PNT Drum - 2 x 200 kg Truck
2 Br2 Bottle - 400 x 5 kg Truck
3 PNBB Bag-200 x 25 kg Truck
4 Acetic Acid Drum- 10 x 200 kg Truck
5 Sodium Acetate Drum-10 x 200 kg Truck
6 Sodium Hydroxide Solution Tank – 10 kL Tanker
7 IPA Drum- 5 x 200 kg Truck
3.7 RESOURCE OPTIMIZATION& AVAILABILITY

The main resources for the proposed expansion project will be raw-materials, utility, power, fuel, water, man-
power etc.
3.7.1 LAND & BUILDING REQUIREMENT

The existing land is 3000 m2. Necessary modifications will be done in the existing plant. No additional land
will be required for the proposed expansion. The land document is attached as Annexure-2.
3.7.2 EQUIPMENT
The list of equipment’s required for the proposed expansion project are as follows:
Table 3.4: List of equipment/machineries

Sr. No Description Quantity (Nos.)
Existing Scenario
Centrifuge
1 SS (48”) 2 Nos.
2 SS (36”) 1 Nos.
3 SS (24”) 1 Nos.
4 SS Jacketed reactor (3 kl) 2 Nos.
6 SS Jacketed reactor(6 kl) 4 Nos.
7 M S Auto cleave (10 kl) 1 Nos.
8 GLR (4 kl) 2 Nos.
9 GLR (2.5 kl) 1 Nos.
Dryer
10 Tray Dryer (196 Tray) 2 Nos.
11 ANFD (6000 Liter) 2 Nos.
Utility
12 Steam Boiler (600 Kg) 1Nos.
13 Cooling tower (50 TR) 1Nos.
Proposed Scenario:
1 SS (48”) 4 Nos.
2 SS (36”) 3 Nos.
3 MSRL(36”) 2 Nos.
4 MSRL (48”) 2 Nos.
5 Sparkler filter (1’ X 16 Plat) 2 Nos.
6 Steam Ejector (7.5 HP) 2 Nos.
7 Nutch Filter (7 kl) 4 Nos.
8 Scrubbing system (1.5 Ft X 8) 2 Nos.
9 Vacuum Pump (10 HP) 2 Nos.
13 M S Auto cleave (10 kl) 2 Nos.
14 GLR (4 kl) 8 Nos.
15 GLR(2.5 kl) 2 Nos.
16 GLR (0.625 kl) 1 Nos.
17 HVD (0.5 kl) 1 Nos.
18 HVD(1.2 kl) 1 Nos.
Dryer
19 Tray Dryer (196 Tray) 8 Nos.
20 FBD (60 kg) 1 Nos.
21 FBD(30 kg) 1 Nos.
22 Hot air dryer (196 tray) 1 Nos.
Utility
23 Steam Boiler (1 Ton) 1 Nos.
24 High thermo boiler (2 Ton) 1 Nos.
25 Cooling tower(100 TR) 1 Nos.
26 DG set (250 kVA) 1 Nos.
3.7.3 POWER REQUIREMENT

The existing power requirement is 75 kVA which will increase to 250 kVA after the proposed expansion. It is
sourced from Dakshin Gujarat Vij Company Limited. (DGVCL).
3.7.4 FUEL REQUIREMENT

For existing operations, natural gas @6.87 m3/hr. OR Wood @200 kg/day is used as fuel. After the proposed
expansion, Wood @2000 kg/day will be used as fuel.
3.7.5 WATER REQUIREMENT

Fresh water requirement is 1.10 kl/day, will increase to @23.05 kl/day after the proposed expansion. The
fresh water is/will be sourced from GIDC water supply department.
The category wise bifurcation of fresh water is given as follows:
Table 3.5: Category wise fresh water requirement

Particulars Existing operation (kl/day) After proposed expansion (kl/day)
Domestic 0.30 3.50
Gardening 0.30 0.30
Industrial
Process 0.40 4.70
Boiler 0.05 2.00
Cooling 0.05 9.30
Washing 0.00 3.00
Scrubber 0.00 0.25
Sub: Industrial 0.50 19.25
Total 1.10 23.05
3.7.6 MAN-POWER REQUIREMENT

In existing operations, the man-power requirement is 39 persons and after the proposed expansion project it
will be 69 persons for operational phase. The man-power will be employed locally. The bifurcation of man-
power is given as below:
Table 3.6: Man-power requirement

Existing Scenario:
Phase of project Type of No. of workers
Labour General 1st Shift 2nd Shift 3rd Shift
M F M F M F M F
During Construction Managerial - - - - - - - -
Skilled - - - - - - - -
Un-skilled - - - - - - - -
During operations Managerial 3 - 3 - 3 - 3 -
Skilled - 3 - 3 - 3 -
Un-skilled - 6 - 6 - 6 -
Proposed Scenario:
Phase of project Type of No. of workers
Labour General 1st Shift 2nd Shift 3rd Shift
M F M F M F M F
During Construction Managerial 10 - - - - - - -
Skilled 20 - - - - - - -
Un-skilled 30 - - - - - - -
During operations Managerial 6 - 5 - 5 - 5 -
Skilled - 6 - 6 - 6 -
Un-skilled - 10 - 10 - 10 -
3.8 QUANTITY OF WASTE TO BE GENERATED

The quantity wise bifurcation of waste water is provided below table.
Table 3.7: Waste water generation

Particulars Existing operation (kl/day) After proposed expansion (kl/day)
Domestic 0.25 2.50
Industrial
Process 0.00 4.20
Boiler blow down 0.02 1.00
Cooling blow down 0.00 1.50
Washing 0.00 3.00
Scrubber 0.00 0.25
Sub-total: Industrial 0.02 9.95
TOTAL 0.27 12.45
The water balance diagram for existing scenario is provided in figure 3.4 and for proposed scenario is
provided is provided in figure 3.5.
Figure 3.4: Water balance diagram for existing scenario
Figure 3.5: Water balance diagram for proposed scenario
3.8.1 WASTE WATER GENERATION & MANAGEMENT

In existing the domestic wastewater is disposed of through Soak pit/Septic Tank and there is no effluent
discharge since the unit is zero discharge. For the proposed expansion in-house ETP will be developed and
treated effluent from ETP after confirming the inlet norms will be sent to PETL for final disposal.
3.8.2 WASTE WATER CHARACTERISTICS

The expected characteristics of composite waste water are as follows:
Table 3.8: Expected characteristics of composite waste water

Sr. Parameters Expected Characteristics – Expected Characteristics – PETL
No. Untreated Treated Norms
1. pH 4.5-9.5 6.0-7.0 --
2. Total dissolved 10000-11000 9000-10000 --
solids (TDS)
3. COD 5000-6000 4500-5000 10000
4. BOD 1200-1800 1000-1200 3000
5. Oil & Grease 8-10 8-9 --
6. TSS 500-800 500-700 --
Note: All the values are in mg/l except pH.
3.8.3 AIR EMISSIONS & CONTROL

The details of air emissions are given as follows:
3.8.3.1 PROCESS EMISSION
After proposed expansion there will be emission of HCl, SO2, HBr, and NH3 gas. Adequate Scrubber will be
attached as control equipment.
3.8.3.2 UTILITY EMISSION

In existing operations, 1 No. of Steam Boiler (600 kg) is attached. After the proposed expansion new 1 Nos.
of Steam Boiler (1 T), TFH (2 T), and D.G. Set (250 kVA) will be installed and existing utilities will be removed.
The details of utility emissions are provided in table 3.11.
Table 3.9: Details of utility emissions
Installation Fuel Fuel Details of Pollution APCD
Consumption stack Parameters
Existing Scenario
Steam Boiler Natural 6.87 m3/hr. Stack height: PM,SO2, --
(600 kg) gas OR OR 11m NOx
Wood 200 kg/day.
Proposed Scenario
Steam Boiler Wood 1700 Kg/day Stack height: PM,SO2, --
(1 T) 11 m NOx
TFH (2 T) Wood 300 Kg/day Stack height: PM,SO2, --
30 m NOx
D.G. Set (250 HSD 2000 L/month Stack height: PM,SO2, --
kVA) 11 m NOx
Note:
3.8.3.3 FUGITIVE EMISSION

Minor quantity of fugitive emission is/will be occurred by the expansion project.
3.8.4 HAZARDOUS/NON-HAZARDOUS. WASTES MANAGEMENT

The details of hazardous waste generation and its management are provide in table 3.12.
Table 3.10: Hazardous and non-hazardous waste generation and its management
Sr. Type of waste Quantity Mode of disposal
No. Existing After
proposed
expansion
1. Used Oil 0.012 0.12 Collection, storage, transportation, disposal by
kl/annum kl/annum selling to registered Re-refiners.
2. Discarded 240 250 Collection, storage, transportation,
containers/ bags/ Nos./annum T/annum Decontamination, Disposal by selling to
Liners Authorized Recyclers.
3 Distillation -- 215.00 Distillation residue will be disposed to TSDF
Residue T/annum site, BEIL, Ankleshwar.
4 Process Waste -- 85.00 Process waste will be sent to BEIL, Ankleshwar
T/annum for disposal.
5 Spent Carbon -- 15.00 Spent carbon will be sent to BEIL, Ankleshwar

T/annum for incineration.
6 Used Nickel -- 4.00 Used Ni catalyst will be sold to GPCB/ CPCB
Catalyst T/annum approved vendor.
7 Used Palladium -- 3.00 Used Palladium catalyst will be sent back to
Carbon T/annum party for reactivation.
8 Inorganic Process -- 15.00 Inorganic Process waste will be disposed to
Waste T/annum TSDF site, BEIL, Ankleshwar.
3.8.5 NOISE CONTROL

There is/will be no major noise generation. Industry has/will take adequate measures for control of noise
levels and also regular maintenance is/will be carried out.
3.9 HEALTH AND SAFETY MEASURES

The details of safety measures provided and safety procedure followed at our unit are as below:
Table 3.11: Safety details
Sr. Particulars Remarks/ Details
No.
1. Manual call bells Yes
2. Emergency Control Room At main gate security office
3. Emergency Sirens Yes
4. Assembly Point 1 point
5. First Aid facility Provided at prominent places by trained persons.
6. Personal Protective Hand gloves, gum boots, safety shoes, dust masks, safety goggles,
Equipments and apron.
7. Health Check ups Regular health checkups at every six months.
8. Regular Training Provided
9. Safety & Health Records Maintained as per Factory Act.
10. MSDS MSDS available at prominent places for ready references.
3.10 ENVIRONMENTAL HEALTH & SAFETY CELL

The company promotes environmental protection and insists on complying with all applicable environmental
regulations. Every measure is taken for the prevention of pollution.
Figure 3.6: Organogram of EHS management cell
3.11 POST PROJECT MONITORING PLAN

The proposed post-project monitoring plan to ensure effective implementation of EHS Management system
is given below:
Table 3.12: Environmental Monitoring Plan
Component Parameter Frequency
Air – Ambient SPM, RSPM, SO2, NO2 Every six month
Process Stack -- Quarterly
monitoring
Noise monitoring Noise levels in decibels Quarterly at all noise generating
equipments & plant boundary
Work place VOC – Toluene, Ethyl Acetate, Ethylene Di Quarterly
monitoring Chloride, Methanol.
Haz. Waste Maintaining records of generation, receipt & Daily
management disposal in Form-3
Filing of annual returns in Form-4 for Haz. Yearly
Waste handling
Maintaining records of transportation in Form- While sending for disposal
9
Submission of returns of used oil in Form-13 Yearly
CC&A Obtaining consent to operate (and renewal) Before expiry of validity
under Air & Water Acts and authorization
under HW rules.
Water cess Filing of annual returns for cess incurred on Yearly
water consumption
Environmental Submission of audit statement in form-V Yearly
Statement
Compliance of Submission of compliance reports Half yearly on 1st June & 1st
EC conditions Dec
CHAPTER – 4
SITE ANALYSIS
4.1 CONNECTIVITY
This proposed expansion project is located at Plot No. 3103, GIDC Estate, Panoli, Dist. Bharuch. The site is
Approx. 1.60 km (E) from National highway. The land and infrastructure is already available. And the raw
material is easily available through the easy transport via road connectivity. The nearest Railway station is
Panoli railway station which is 2.09 km (SW) and Surat Airport is 53 km (SW) from the project site.
4.2 LANDFORM, LAND USE & LAND OWNERSHIP

The existing land is about 3000.00 m2. No additional land will be required for the proposed expansion project.
The existing plot is located in the industrial estate of GIDC, Panoli designated for the industrial purpose.
Hence, there will be no change in the land-use pattern of the area. The land is owned by the company.
4.3 TOPOGRAPHY
The topography of Ankleshwar is relatively flat terrain with series of deeply incised creeks of river. There are
generally levee deposits on the bank of river.
4.4 SALIENT FEATURES

The salient features of the project site is provided in table 4.1.
Table 4.1: Salient Features of the Project Site
Particulars Details
Co-ordinates Latitude: 21°32'56.00"N Longitude: 72°59'29.00"E
Village/Town Panoli
Taluka/ Tehsil Ankleshwar
District Bharuch
Nearest Water body River Narmada ≈ 15.70 km (N), Gulf of Cambay ≈ 43 km(W)
Nearest Highway NH-8 ≈ 1.60 km (E)
Nearest Railway station & Railway line Panoli Railway Station ≈ 2.09 (SW)
Nearest Airport/ Airbase Surat ≈ 53 km (SW)
State/ National borders Daman (Union territory) ≈ 120 km (S)
Protected Area/ Sanctuaries None within 15km radial periphery
CRZ applicability No
Seismicity Seismic Zone – III (Moderate)
Note: All the above mentioned distances are the aerial distance from the project site.
4.5 EXISTING INFRASTRUCTURE

The proposed expansion is to be carried out in the existing site. The company has the required infrastructure.
4.6 SOIL CLASSIFICATION
The soil of the area is mostly very fine to fine, Montmorillonitic, hyperthermicTypicChromusterts which is at
few places calcareous in nature mixed with Udicchromusterts and VerticUstochrepts. This are deep to very
deep, moderately well drained fine soils on very gently sloping alluvial plain with moderate erosion and slight
to moderate salinity associated with very deep moderately well drained calcareous, very fine to fine soils with
moderate erosion.
In the Northern part of the study area near to the river, Fine, mixed (calcareous), hyperthermic Fluventic
Ustochrepts with fine-loamy Udic Ustochrepts are present. This are deep, well drained, calcareous, fine soils
on very gently sloping alluvial plain with slight erosion and slight salinity, associated with very deep,
imperfectly drained, calcareous, fine-loamy soils with slight erosion.
4.7 CLIMATE & METEROLOGY

The year can be divided into four seasons. Climate is warm and dry from mid-March to June, during season
of summer, climate remains warm and dry, while during rainy season, from mid-June to end of September
climate is humid and pleasant. From October to November mild warm climate prevails, and from December
to February climate is cold.
The Table 4.2 indicates the summary of meteorological pattern at the nearest observatory of IMD, Bharuch
published by IMD.
Table 4.2: Summary Meteorological Data at nearest IMD Station –Bharuch
Location: Bharuch Gujarat (Lat: N 21o42’, Long: E 73o 00’)
Aerial Dist. from Project Site: Approx. 15 km (N)
Height of installation: 17 m above MSL.
Month Temperatur Relative Cloud Mean Pre- Rainfall
e (oC) Humidity Cover Wind dominant (mm)
(%) (Oktas) Speed Wind
Max Min. Mor Eve. Mor Eve. (km/h) Direction
. . .
January 31.3 11.3 71 38 0.8 0.8 6.0 NE 1.2
February 33.5 14.0 64 34 0.8 0.5 6.5 NE 1.4
March 37.7 18.6 65 29 1.1 0.8 7.3 SW 0.2
April 39.9 23.1 66 31 1.4 1.1 9.3 SW 0.5
May 39.6 25.8 74 39 1.7 0.6 13.3 SW 9.2
June 35.7 26.3 81 58 4.3 3.1 16.3 SW 108.5
July 32.1 25.3 89 74 6.6 5.9 14.5 SW 290.4
August 31.4 24.9 90 79 6.7 6.1 12.4 SW 279.1
September 32.5 24.4 87 68 4.8 4.7 9.4 SW 182.7
October 35.9 21.9 76 46 1.5 1.9 6.1 SW 16.8
November 34.7 16.7 73 42 1.0 1.0 4.8 NE 21.9
December 31.5 12.6 74 44 1.1 1.0 5.4 NE 0.2
Seasonal Average Values
Period Temperat Relative Cloud Mean Avg. PDW Total
ure (oC) Humidity Cover Wind Direction Rainfall
(%) (Oktas) Speed (mm)
Av Av Av Av Avg Avg (km/h)
g g g g Mor Eve
Ma Mi Mo Ev
x n r e
Summer 39. 22. 68. 33. SW
0 5 3 0 1.4 0.8 9.9 9.9
Winter 32. 12. 69. 38. NE
1 6 6 6 0.9 0.5 5.9 2.8
Monsoon 32. 25. 86. 69. SW
9 2 7 7 5.6 4.9 13.1 860.7
Post 35. 19. 74. 44. SW/NE

monsoon 3 3 5 0 1.2 1.4 5.4 38.7
Annual Total 34. 20. 76. 49. 2.7 2.3 9.3 SW 912.1
or Mean 6 4 0 0
Note: Winter: December, January & February, Summer: March, April & May, Monsoon: June, July,
August & September, Post monsoon: October & November
(Source: Book “Climatological tables of Observatories in India (1961 - 1990)” published by IMD)
4.7.1 TEMPERATURE
The climate of Bharuch is warm and dry during the summer months but humid and pleasant during the
monsoon months. The south-west monsoon from June to September brings copious rain to the territory. The
winter months are generally pleasant. May is generally the hottest month with the mean daily maximum
temperature recorded at 39oC and mean daily minimum temperature recorded at 22.5oC. January is the
coldest month with the mean daily maximum temperature as 32.1oC and mean daily minimum temperature
observed as 12.6oC.
4.7.2 HUMIDITY
Humidity is usually high during the monsoon months, generally exceeding 86.7 %. Humidity decreases during
the summer months. For rest of the year i.e. the period of October to February, the relative humidity ranges
around 66.7 - 71.5 %.
4.7.3 RAINFALL
About 95% of the annual rainfall is received during the southwest monsoon season i.e. from June to
September, July being the month with highest rainfall. The average annual rainfall observed from the data is
2182.8 mm.
4.7.4 WIND PATTERN

The annual predominant wind direction comes to West, followed by North and South-west. Winds blows
mostly from the West/North-West during summers and Monsoons are usually South-west. The post-monsoon
& winter seasons experience a change in the wind blowing from North and North-east.
The wind speed is high during summer and monsoon seasons, slightly moderate during winter and low during
post-monsoon phase.
4.8 SOCIAL INFRASTRUCTURE

The infrastructure available in the study area denotes the economic well-being of the Ankleshwar Taluka.
There are about 56 villages and 10 Towns in the Ankleshwar Taluka.
4.8.1 Educational Facilities

As per census of India, 70 Primary schools, 6 Secondary Schools. There were no Middle School, senior
secondary schools & Training institute found in 56 villages. The female literacy rate is 43%.
4.8.2 Medical Facilities

Out of the 56 villages, Primary health centers in 5 villages and Primary health sub center in 21 villages. There
was no Dispensary & hospitals found in 56 villages.
CHAPTER – 5
PLANNING BRIEF
5.1 PLANNING CONCEPT
The proposed expansion project is located at Plot No. 3103, GIDC Estate, Panoli Dist. Bharuch. The nearest
city is Bharuch which is a big hub for chemical & Pharmaceutical Products and also Ankleshwar itself is a big
industrial center. Major raw materials will be sourced locally.
The region is well planned with all the basic infrastructural facilities like internal roads, water supply,
arrangements for power, streetlights, solid waste disposal sites etc.
5.2 POPULATION PROJECTION

As per census 2011, the average household size is around 4 to 5 persons. The demographic profile of study
area of Ankleshwar taluka is presented below:
Table 5.1: Distribution of population
Sr. Particulars Observed values in Ankleshwar taluka
No.
1 Total Population 432086
2 No. of Households 95988
3 Avg. household size (person) 4-5
4 Male population 230732
5 Male population (in %) 53.4%
6 Female population 201354
7 Female population (in %) 46.6%
8 Sex ratio 873
(Source: Primary Census Abstract – Census of India, 2011)
5.3 AREA STATEMENT

The total area of the plot is 3000m2 out of which Greenbelt area of the plant is. 477m2 which is approx. 15.9
%. The bifurcation of the same is given below in table no. 5.2.
Table 5.2: Area Statement
Particulars Unit Area
Built up area m2 1000
Open area m2 1533
Greenbelt area m2 477
Total Area m2 3000
5.4 ASSESMENT OF INFRASTRUCTURE DEMAND (PHYSICAL & SOCIAL)

For proposed expansion project the company will acquire some plant and machinery so there will be some
demand of change in physical infrastructure and social infrastructure. As manpower requirement for the
proposed project shall be locally fulfilled, employment generation will lead to additional benefits to social
infrastructure.
5.5 AMENITIES/FACILITIES
5.5.1 DRINKING WATER FACILITIES
There were no Tap water available in 56 villages as per the Census 2011. 24 villages had Wells, 21 villages
had tanks/pond/lake and 34 had hand pumps. 24 Villages had River/Canal passing. Power supply was also
available in all the villages.
5.5.2 POWER SUPPLY FACILITIES

As per census 2011, all the villages have power supply facilities in the Ankleshwar Taluka.
5.5.3 COMMUNICATION & BANKING FACILITIES

Out of the 56 villages, Post Office is available in 2 villages, telephone facility exist in all the villages as per the
2011 census.
5.5.4 TRANSPORT FACILITIES
Bus service is available in the Ankleshwar Taluka and is the most preferable mode of transport in the
Ankleshwar Taluka. The villages are well connected with the State Highways. National Highway-8 also
passes from Ankleshwar. The Western railway line between Bombay to Ahmedabad passes from the
Ankleshwar Taluka and Ankleshwar Town has a railway station on the same.
5.5.5 APPROACH TO VILLAGES

As per census 2011, there are 18 villages have paved road and 4 Villages have mud road and 3 Villages
have foot path.
CHAPTER – 6
PROPOSED INFRASTRUCTURE
6.1 INDUSTRIAL AREA
The total area of the plot is 3000 m2 out of which 33.33m2 is the buildup area.
6.2 RESIDENTIAL AREA

In the said proposal no residential area has been proposed for workers and/or for staff.
6.3 GREENBELT
Maximum open land will be allotted for green belt development. If required, experts will also be consulted for
selection of species for the development of the greenbelt. Total greenbelt area is Approx 15.90 % of total plot
area and Approx 51.10% of the total open land area.
6.4 SOCIAL INFRASTUCURE

Existing infrastructure will be sufficient to accommodate the existing load from the proposed project which is
very low.
6.5 CONNECTIVITY
This proposed expansion project is located at Plot No. 3103, GIDC Estate, Panoli, Dist. Bharuch. The site is
Approx. 1.60 km (E) from National highway. The land and infrastructure is already available. And the raw
material is easily available through the easy transport via road connectivity. The nearest Railway station is
Panoli railway station which is 2.09 km (SW) and Surat Airport is 53 km (SW) from the project site.
6.6 DRINKING WATER MANAGEMENT

The source of drinking water is/ will be GIDC water supply.
6.7 SEWERAGE SYSTEM
Domestic waste water generated from the existing and proposed expansion is/will be disposed of through
soak pit/septic tank.
6.8 INDUSTRIAL WASTE MANAGEMENT
In existing the domestic wastewater is disposed of through Soak pit/Septic Tank and there is no effluent
discharge since the unit is zero discharge. For the proposed expansion in-house ETP will be developed and
treated effluent from ETP after confirming the inlet norms will be sent to PETL for final disposal.
6.9 SOLID WASTE MANAGEMENT

Hazardous wastes generated will be in the form of ETP waste from Effluent Treatment Plant, Used oil from
gear boxes of the machineries & D.G. Set, Process residue from manufacturing process, discarded drums &
bags from storage of raw materials. Company will provide adequate storage area for proper storage of wastes.
Details of solid waste generation are given in table 3.10
6.10 POWER REQUIREMENT & SOURCE OF SUPPLY

The power requirement for proposed expansion 250 kVA which will be sourced from Gujarat Electricity Board.
CHAPTER – 7
REHABILITATION &RESETTLEMENT (R &R) PLAN

7.1 POLICY TO BE ADOPTED
The proposed expansion project is to be developed in the land designated for industrial use. Hence, no
displacement of any population is proposed for the project. Therefore, detailed Social Impact Assessment
studies or R&R action study has not been proposed.
CHAPTER – 8
PROJECT SCHEDULE & COST ESTIMATES
8.1 TIME SCHEDULE OF THE PROJECT
The installation/ construction will be started after getting approval for Environmental Clearance and NOC from
authorities.
8.2 ESTIMATED PROJECT COST
Environment Protection has also been considered in planning the cost projection. Green belt development is
also considered. The estimated project cost will be approximately 5.0 Crores.
Table 8.1: Total Capital Cost Projection
Sr. Purpose Total Cost

No. (Rs. in Lakhs)
1. Land 11.00
2. Plant & Machinery 250.00
3. Building 80.00
4. Electrical Installations & Misc. 20.00
5. Furniture, Fixtures & Office Equipments 10.00
6. Green belt development 10.00
7. Effluent Treatment Plant 100.00
8. Safety Systems 10.00
Total 491.00
Table 8.2: Recurring cost provision for EHS

Sr. Purpose Provision per Annum (Rs. in lakhs)
No.
1. ETP (Operation & maintenance) 55.00
2. Greenbelt maintenance 5.00
3. Environment & Safety Management System 7.00
TOTAL 67.00
CHAPTER – 9
ANALYSIS OF PROPOSAL
9.1 FINANCIAL & SOCIAL BENEFITS
M/s. Vasudev Drug Intermediates is located at Plot No. 3103, GIDC Estate, Panoli, Dist.: Bharuch.
The project will provide direct employment opportunity to 20 persons and indirect employment to
10 persons. The man-power required for the project will be employed locally from the nearby areas.
Annexure
Annexure-1 Process details
Existing Product:
PARA NITRO BENZYL BROMIDE
Proposed Products
(1) Pranlukast
In Put Out put

Raw Materials Kgs / Lit Product Kgs / Lit
MDC 8.812 SO2 0.31
PRN-119 1.519 HCl 0.175
DMF 0.065 Reactor Reaction mass 10.511
Thionyl chloride 0.600
Total 10.996 Total 10.996

MDC 8.412 Org Layer-1 17.308
Pyridine 1.139 Aq Layer 5.538
3A2HAcetophenone 0.745 Reactor Vapor loss 1.844
Reaction mass 10.511
HCl 3.882

Aq Layer 5.538 Org Layer-2 16.862
MDC 16.824 Reactor Aq Layer to ETP 5.500

Organic Layer- (1+2) 34.170 organic Layer 34.993
Sodium bicarbonate 0.971 Aq Layer to ETP 4.657
Water 4.706 Reactor Loss 0.196

Organic Layer 34.993 organic Layer 33.954
Nacl 0.912 Aq Layer to ETP 6.657
Water 4.706 Reactor

Organic Layer 33.954 Distilled MDC 30.705
Reaction mass 3.955
Reactor
33.954 Loss 0.294
34.954
Ethyl acetate 3.529 Reaction mass 7.484
Reaction mass 3.955 Reactor

Reaction mass 7.484 ML- 1 for recovery of EA 6.899
Ethyl acetate 1.294 CF Wet cake 1.879

Wet Cake 1.879 Dry material 1.553
Dryer Drying loss 0.326
(1). Pranlukast
Stage-2

DMSO 3.106 Reaction Mass 34.706
Sodium Methoxide 1.672 Loss 0.443
THF 4.659
PRN-02 1.553
THF 3.106 Reactor
Tert Ester 0.865
Methanol 15.529
HCl 4.659

Reaction mass 34.706 ML to ETP 34.104
Water 3.106 Loss 1.00
Reactor
Wet cake 2.708

Wet cake 2.708 Product 1.553
Dryer
Loss 1.155
(1). Pranlukast
Stage-3

Dimethyl formamide 10.094 Reaction mass 11.118
PRN-02 1.553 Solid waste(Process Waste) 0.941
Reactor
Charcoal 0.523 Loss 0.111

Reaction mass 11.118 Wet cake 2.096
Washing DMF 0.776 CF ML -2 for Recovery of DMF 9.798

Methanol 16.306 Filtrate ML 18.176
Wet cake 2.096 Solid waste (Process Waste) 0.400
TEA 0.357 Reactor Loss 0.339
Activated Carbon 0.155

Filtrate ML 18.176 Filtrate ML 18.165
Activated Carbon 0.155 Solid waste (Process Waste) 0.450
Reactor
Methanol 0.776 Loss 0.510

Filtrate ML 18.165 Reaction Mass 19.718
Methanolic HCl 1.553 Reactor

Reaction mass 19.718 Wet cake 1.180
Methanol 1.553 CF ML- 3 for recovery of Methanol 20.091

Wet cake 1.180 Dry Wt 1.00
Dryer loss 0.180
ML- 1 for recovery of EA 6.899 EA Recovery 4.63

Total 6.899 Distillation Residue 2.129
Losses 0.14
Total 6.899
ML -2 for Recovery of DMF 9.798 DMF Recovery 9.69

Losses 0.008
Total 9.798
ML- 3 for recovery of Methanol 20.091 Methanol Recovery 17.88

Losses 0.5
Total 20.091
(2) Loratidine
STEP 1
INPUT OUTPUT
Raw Material Input kg. Product Output Kg.
Reaction, Distillation & Centrifuge
2-2[2-(3-
Chlorophenyl/ethyl]nicotininit
rile 0.800 THF distilled 3.570
THF 4.000 Toluene distilled 5.350
Magnesium 0.220 Loss (THF) 0.030
N Methyl 4 Chloro Piperidine 0.400 Loss (Toluene) 0.050
HCl 6.000 ML to ETP 12.900
Toluene 6.000 Wet Cake 1.520
Water 6.000 Total 23.420
Total 23.420

Drying
Wet Cake 1.520 Dry Cake 1.000
Total 1.520 Loss on drying (water) 0.520
Total 1.520
STEP 2
INPUT OUTPUT
Reaction, Distillation &
Dry cake 1.000 Toluene distilled 14.920
Centrifuge
HF 2.680 Loss (toluene) 0.040
BF3 1.200 ML to ETP 22.080
Toluene 16.000 Wet Cake 1.600
KOH 2.200 HCl Gas 0.04
Total 38.680

Drying
Wet Cake 1.600 Final Product 1.000
Total 1.600 Loss on drying 0.600
Total 1.600
INPUT OUTPUT

8 chloro Azatidine 1.000 Reaction Distilled Toluene 1.000
Toluene 3.500 Evaporation Loss 0.410
Ethylchloroformate 0.250 Mass 3.490
Sodium Bicarbonate 0.150 ML to ETP 2.000
Water Wash 2.000 Total 6.900
Total 6.900
Mass 3.490 ML for toluene recovery 2.200

Filtration
Total 3.490 Wet Cake 1.290
Total 3.490

Wet Cake 1.290 Distillation Distilled Acetonitrile 1.900
Acetonitrile 2.000 Evaporation Loss 0.140
Charcoal 0.100 Cake to *Incinerator 0.100
Total 3.390 Wet Cake 1.250
Total 3.390

Wet Cake 1.250 Drying Loratadine 1.000
Total 1.250 Evaporation Loss 0.250
Total 1.250
ML for toluene recovery 2.200 Toluene Recover 1.700

Distillation
Total 2.200 Residue 0.400
Losses 0.100
2.200
(3) CARVEDILOL
STEP1 : CV-3 PREPARATION
INPUT :
Raw Material Input , Kgs OUTPUT :
2-(2-
Methoxyphenoxy)ethyl
Phthalamideride (CV-3) 3.319 Product Output , Kgs
DNS 11.617 Reaction and Cake to Incineration 1.000
Hydrazine Hydrate 0.820 Centrifuge ML 17.664
HCl 2.489 Losses 1.337

Ethanol 1.757 Total 20.001
Total 20.001
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output , Kgs
Water 13.940 Organic layer-I 36.905
ML 17.664 Extraction & Aqueous layer 20.587
Chloroform 24.893 Separation
NaOH 0.996
Total 57.492
Total 57.492

Chloroform 8.264 Chloroform Organic layer - II 7.938
Aqueous layer 20.587 wash to aqueous Aqueous layer *to ETP 7.258
layer Recovered Ethanol 1.680
Recovered DNS 11.150
Total 28.851 Losses 0.826
Total 28.852
INPUT : OUTPUT
Raw Material Input , Kgs Raw Material Input , Kgs
Organic layer-I & II 44.843 Chloroform distilled 31.972
Distillation
Total 44.843 CV-I 1.890
Losses 10.981
Total 44.843
STEP2:
INPUT : OUTPUT :
Raw Material Input , Kgs Product Output, Kgs
DNS 13.500 DNS distilled 4.000
4-hydroxy-9(H)-
Reaction &
carbazole 2.000 Residue 24.010
Distillation
Epichlorohydrin 9.550 Losses 2.700
NaOH 0.400 Total 30.710
Water 5.260
Total 30.710
INPUT : OUTPUT :
Residue 24.010 Crystaliztion & Wet cake 1.904
DNS 3.500 Centrifuge ML-1 for recovery 23.205
Total 27.510
INPUT : OUTPUT :
Wet cake 1.904 Dry cake (CV-2) 1.360
Drying
Total 1.904
INPUT : OUTPUT :
ML-1 for recovery 23.205 ML -1 Recovery DNS+ Epichlorohydrine di 21.000
Total 23.205
(3) CARVEDILOL
STEP 3 :
INPUT : OUTPUT :
4-oxyanylmethoxy-9(H)-
IPA distilled
Carbazole(CV-2) 1.360 6.968
2-(2- Reaction &
Methoxyphenoxy)ethyl Distillation
Phthalamideride (CV-1) 1.890 Residue 3.250
IPA 7.460 Losses 0.492
INPUT : OUTPUT :
Residue 3.250 Wet cake 1.904
Crystaliztion &
Toluene 17.190 ML forRecovery 27.026
Centrifuge
Cyclo hexane 5.331 Losses 2.853
Ethyl acetate 6.011 Total 31.783
Total 31.783
INPUT : OUTPUT :
Wet cake 1.904 Drying Dry cake (CV-3) 1.360
Total 1.904
STEP4 :
INPUT : OUTPUT :
Carvedilol crude(CV-3
Wet cake to incinerator
Crude) 1.360 Purification and 0.900
Ethyl acetate 19.584 Filtration Filterate 16.727
Charcoal 0.300 Losses 3.917
Hyflo 0.300 Total 21.544
Total 21.544
INPUT : OUTPUT :
Filterate 16.727 Crystaliztion & Wet cake 1.200
Ethyl acetate 3.672 Centrifuge ML -2 for recovery 18.648
Total 20.399
INPUT :
Raw Material Input , Kgs OUTPUT :
Wet cake 1.200 Drying Product Output , Kgs
Total 1.200 Carvidelo (Dry cake) 1.000
Loss on drying 0.200
Packing in drums Total 1.200
INPUT : OUTPUT :
ML-1 for recovery 23.205 Toluene distilled 16.500
ML -1 Recovery
Residue to Incinerator * 3.224
Total 23.205
INPUT : OUTPUT :
ML-3 for recovery 18.648 ML -2 Recovery Ethyl acetate distilled 15.316
Total 18.648
INPUT : OUTPUT :
ML-2 for recovery 27.026 ML -2 Recovery Toluene Distilled 22.674
Total 27.026
(4) Nebivilol
Step-5 NB5 PREPARATION
INPUT : OUTPUT :
Raw Material Input , Kgs Raw Material Output, Kgs
MDC 50.00 Reaction Losses 10.00
6-Fluoro-3,4-dihydro-2H-1-benzopyran 7.84 ML -1 for Recovery 59.89
Quenching
DMSO 8.43 Spent Cake (ProcessWaste) 7.84
Oxalyl Chloride 1.54 Organic Layer 52.00
&
HCl 1.33
Water (Recycled) 50.00 Layer Separation
Na HCO3 0.59
Sodium Sulphate 1.00
Total 120.73
Total 129.73
INPUT : OUTPUT :
NB5 52.00 Water distilled Recycle in next B 200.00
Sodium hydride 1.96 DMSO Recovery 33.00
NB6
TMSI 9.80 Reaction Methanol Recovery 7.38
DMSO 34.56 Work Up TMSI Recovery 9.31
Water ( Recycled) 147.00 & Residue 1.27
HCl 0.67 Washings Losses 0.68
Na HCO3 0.59 Mass 62.44
MDC 10.66
Ice 49.00
INPUT : OUTPUT :
Mass 62.44 Distillation MDC Recovery 55.00
MDC Recovery Losses 2.00
Residue 1.63
Product 3.81
Step-7 NB7 PREAPARATION
INPUT : OUTPUT :
NB6 3.81 Organic Layer 25.34
Methanol 18.00 Aq. Layer(ML-1) for Recovery 22.78
Benzyl Amine 0.86 NB7
EA 20.67 Reaction
HCL 1.73
Water (Recycled) 3.05
Organic Layer 25.34 Product 3.00

Total 25.34 EA Recovery 19.84
Distillation
Losses 0.30
Residue 2.20
Total 25.34
(4) Nebivilol
INPUT : OUTPUT :
NB7 3.00 Spent Pd/C 0.22
Methanol 15.76 Losses 2.40
Pd/C 0.22 NB8 Distilled MeoH 15.13
Total 18.98 Reaction Mass 1.23
Total 18.98

INPUT : OUTPUT :
Methanol 2.29 ML -3 for Rec. 3.60
NB8 1.23 Reaction Mass 1.13
IPA-HCL 1.21
INPUT : OUTPUT :
Raw Material Input , Kgs Drying Raw Material Output, Kgs
Mass 1.13 & Dry Cake 1.00
Milling Losses 0.13
ML-1 for Recovery 59.89 DMSO Recovered 8.09

Distilled water 51.70
Total 59.89
ML-2 for Recovery 22.78 Methanol Recovery 17.28

Total 22.78 Distillation Res. To Inc. * 4.60
Losses 0.90
Total 22.78
INPUT : OUTPUT :
Methanol Recovery 2.200
ML -3 3.60 IPA Recovery 1.16
Solvent Recovery
Res. To Inc. * 0.14
Losses 0.10
(5) Rosuvastatin
Stage-API: Manufacturing process flow diagram of RSV-F

Input Out put
7-[4[4-fluorophrnyl)-6-isopropyl-2-9N-
1.34 kg methyl]-N-methylsulfonylamino0pyrimidin-5-
yl)]-(3R,5S)-dihydroxyhept -6-enoic acid
Purification
0.14 Kg A. carbon
16 Water
0.15 Kg for
Carbon
incinration
cake wet
0.14 Kg Hyflo
Filtration
1.43 Water
2.86 lit Calcium chloride solu

Calcium formation
Centrifuge
Water ML 19 L to ETP
Drying
1.76 drying loss
Rosuvastatin calcium API

1 Kg dry product
21.91 Total Input 21.91 Total Output

(6) CH base
INPUT : Ce-1 Batch In put OUTPUT : Batch Out put
Raw Material Reaction Product
HMDA 0.35 Aq Layer to ETP 6.23
SodiumDicyanamide 0.53 Butanol + TEA 1.88
n-Butanol 5.4 Loss 0.27
TEA 0.1 Reaction Mass 5.79
HCL 0.9
NaOH 0.29
Water 5.56
PCA HCL 1.04
INPUT : Batch In put Crystilization Output Batch In put

Raw Material Product
Mass 5.79 CH base Crude 1.88
Butenol 2.48 Butenol ML 6.36
Loss 0.03
INPUT : Batch In put Purification Output : Batch In put

Raw Material and Product
CH Base Crude 1.88 Centrifuge CH Base wet cake 1.19
Methanol 4.39 ML Methanol 4.99
Loss 0.09
INPUT : OUTPUT :
Raw Material Batch In put Product Batch In put
CH Base wet cake 1.19 Drying CH base 1
Total 1.19 Loss 0.19
Total 1.19
Butanol ML 6.36 Recovered Butanol 6.000

Total 6.36 distillation Residue 0.282
Losses 0.078
Total 6.36
Methanol ML 4.99 Recovered Methanol 4.21

Total 4.99 distillation Residue 0.736
Losses 0.044
Total 4.99
(7) CILASTAZOLE
INPUT : OUTPUT :
Caustic soda 0.180 Mass 16.783
6 HQ 0.559 HCl Gas to Scrubber 0.130
Sodium sulphate 0.653 Reaction
toluene 0.576
Tetrazole 0.847
TBAB 0.037
Water 14.061
INPUT : OUTPUT :
Mass 16.783 ML TO ETP * 17.925
Water 2.542 Centrifuge Cilastazole 1.400
INPUT : OUTPUT :
MeOH 1.695 Leaching Mass 3.095
Cilastazole 1.400
INPUT : OUTPUT :
MeOH 0.424 ML for Recovery -I 2.169
Mass 3.095 Centrifuge Mass 1.35
CL-1
INPUT : OUTPUT :
MeOH 9.492 distilled methanol 9.200
Hyflo 0.034 Purification Spent Charcol 0.137
Mass 1.350 Mass 1.200
Carbon 0.021 Loss 0.360
INPUT : OUTPUT :
MeOH 0.370 Centrifuge ML for Recovery -II 0.470
Mass 1.200 Mass 1.100
INPUT : OUTPUT :
Mass 1.100 Dryer Loss 0.100
Cilastazole pure 1.000
Packing In Drums
INPUT : OUTPUT :
ML for Recovery-I+II 2.639 Solvent Recovery Recovered Toluene 0.550
Recovered Methanol 1.959
Loss 0.010
Residue to incinerator 0.120
(8) CH -HCL
INPUT QTY OUTPUT QTY
Raw Material Kgs/ Lit Product Kgs/ Lit
Ch base W/C 1.4 CH -HCL wet cake 1.540
Methanol 6.98 Methanol ML 7.130
Reaction and CF ML to ETP 0.060
HCL- CP 0.49 Loss 0.140
Total 8.870
Total 8.870

Wet cake CH-HCL 1.54 Ch - HCL dry 1.000
Drying Methanol R 0.440
Losses 0.100
0 Total 1.540
Total 1.540
Methanol ML 7.130 Methanol Recovered 6.7

Losses 0.07
Total 7.13
(9) Rupatadine
In PUT Out Put

Raw Material Kgs / Lit Product Kgs / Lit
Carbon tetra Chloride 160.40 Mass 167.50
3,5- Lutidine 2.86 Reaction
N-bromosuccinimide
3.8
Azobis Iso butronate 0.44

Mass Carbon Tetrachloride layer
167.50 160.00
Filtration
Solid waste (Process Waste) 2.50
Loss 5.00
Step2-
OUTPUT :
CCl4 Layer 160.00 Mass 165.00
Desloratadine 1.71 Reaction Loss 0.30
TBAB 0.21
NaoH 0.53
Total 165.30

Organic Layer 165.00 Filtration Aq Layer to ETP 32.10
Water 28.60 Process Organic Layer 159.50
Sodium Sulphate 0.95 Salt (Process Waste) 1.00
loss 1.95
Total 194.550 Total 194.550

Organic Layer 163.00 Distillation Rec CCl4 159
O- Xyline 5.70 Mass 8.54
Loss 1.16

Mass 8.54 Mass 23.92
Acetone 15.96 Distillation Solid to incinerator 1.50
Silica gel 1 Loss 0.20
Acivated Carbon 0.12 Total 25.62
Total 25.62

Mass 23.92 Rec Acetone 15.5
Distillation Rec O- Xyline 5.5
Oil Mass 1.66
Total 23.92 Loss 0.32
Total 22.98
(9) Rupatadine
Step 3 -

Rupa -2 1.66 Mass 18.11
Acetone 8.30 Reaction
Methanol 7.68
Fumeric Acid 0.47

Mass 18.11 Mass ML -1 for recovery 16.60
Acetone 3.32 Filtration Crude 1.41

Crude 1.410 Acetone ML -2 for recovery 11.50
Acetone 11.62 Filtration Wet cake 1.30
and CF Loss 0.230

Wet cake 1.300 Dry WT 1.00
Drying Loss 0.30
ML -1 and ML- 2 for recovery 28.10 Recovered Methanol 6.985

Total 28.10 Recoverd Acetone 20
Distillation
Residue 1.1
Loss 0.015
Total 28.1
(10) Aripriparazole
ARP-1
In Put Qty Out Put Qty
Raw materials Kgs / lit Product Kgs / lit
Dimethyl formamide 2.08 Reaction mass 4.41
DCPP. HCl 0.69 Reaction
1-4 Di bromo butane 0.76
Potassium Carbonate 0.88

Reaction mass 4.41 Organic layer -I 5.00
Water 2.00 Aq layer 5.88
Process
Methylene dichloride 4.51 HBr Gas 0.04

Aq layer 5.88 Aq Layer with KBr/HBr for sale 5.67
Methylene dichloride 4.51 Process Organic Layer -II 4.72

Organic Layer - (I+II) 9.72 Organic layer 9.71
KOH solution 0.76 Aq layer with KBr for sale 7.00
Process
Water 6.25 HBr Gas 0.028

Organic Layer 9.71 Distilled Methylene dichloride 8.65
Distillation
Product 1.00
loss 0.06
ARP-2

Acetonitrile 10 Acetonitrile distilled 9.03
7- HQ 0.68 Process Reaction mass 2.94
Triethyl amine 0.3 loss 0.01
ARP-1 1.00

Reaction mass 2.94 Organic Layer 18.31
Water 3.44 Process Aq Layer with HBr for sale 4.86
Chloroform 16.80 loss 0.022

Organic layer 18.31 Organic Layer 18.31
Water 3.44 Process Aq Layer to ETP 3.44

Organic layer 18.31 Distilled chloroform 17.03
Methanol+Chloroform mix 1.00
Process
Methanol 5.00 Reaction mass 5.28

Reaction mass 5.28 CF ML - 1 for recovery 4.89
Process Wet cake 1.39
Methanol 1.00

Wet cake 1.39 Dry cake 1.14
Drying loss 0.25
ML-1 4.89 Methanol recover 4.5

Losses 0.09
Total 4.89
(11) Itopride HCL
Stage -1
In put Qty Out Put Qty
Kgs / Lit Raw Materials Product Kg/Lit
p-Hydroxy Benzaldehyde Wet Cake of Reney Nickle
0.990 Catalyst Back to Party 0.3
Recovered Toluene
0.730 NH3 gas 1.62
Process
Recovered Methanol
0.200 Reney Nickle 7.410
7.800 Methanol Mass 0.79
1.710 Toluene Loss 1
Water to ETP 0.150
11.430 Total NH3 Gas to Scrubber 0.16
Total 11.430
Stage-2
Kg/Lit Raw Materials Product Kg/Lit

0.790 ITP-1 Recovered Toluene 6.27
3,4 Dimethoxy benzoyl Recovered MDC
1.360 chloride 11.870
0.680 TEA Process HCl gas to scrubber 0.53
12.500 Dichloro Methane Loss 1.300
6.600 Toluene Mass 1.74
21.930 Total Filtrate to incineration 0.22
Total 21.930
Stage-3

Inorganic Material K2CO3 to
1.740 ITP-2 Incinerator 1.1
2-Dimethyl
0.970 aminoethyl chloride Recoved THF 1.9

Potassium Carbonate Reduction
1.000 Recoverd EA 7.6
0.800 Conc.Hcl CO2 0.32
2.000 THF Loss 1.280
8.000 EA Mass 1.99
14.510 Total HCl gas to scrubber 0.32
Total 14.510
Stage-4 0
1.990 ITP Recovered (IPA Hcl+IPA) 5.76
5.690 IPA Mass 1.85
Process
0.500 IPA Hcl (20%) Loss 0.57
8.180 Total Total 8.180
Stage-5
Qty Kgs Raw Materials Product Qty Kgs

1.850 ITP Hcl crude Activated Carbon 0.210
0.140 Activated Carbon ML for recovery 4.576
4.640 Acetonitrile Process Product 1.700
Loss 0.144
4.576 ML for recovery Acetonitrile Distillation Recovered Acetonitrile 4.00

4.576 Total Residue 0.526
Losses 0.05
Total 4.576
(12) VENLAFAXINE
Step 1 VF 1 PREPARATION
Sodium Methoxide 1.15 Mass 13.03
Methanol 7.25 Reaction
4- Methoxy Phenyl Acetonitrite 1.15
Cyclohexanone 1.75
Water 1.74

Mass 13.03 Centrifuge ML to ETP * 11.00
Mass 2.03

Mass 2.03 Washings ML for Rec. 2.78
N hexane 2.64 Mass 1.89

Mass 1.89 Drying Dry Cake(VF1) 1.60
Losses 0.29

ML 2.78 Recovery Distillate 1.81
Losses 0.42
Residue to Inc. * 0.56
Step 2 VF 2 PREPARATION

VF1 1.60 Reaction Mass 23.75
Acetic Acid 22.04
Palladium Charcoal 0.11

Mass 23.75 Filtration Spent Pd/ Ch. 0.13
Mass 23.62

Mass 23.62 Rec Acetic acid 20.94
Acetic Acid
Losses 0.69
Recovery
Mass 1.99
INPUT : OUTPUT :
Ethyl Acetate
Centrifuge &
Mass 1.99 Recovery 5.34
solvent Recovery
Ethyl Acetate 5.40 Residue to Inc * 0.50
Mass 1.55
INPUT : OUTPUT :
Mass 1.55 Drying Losses 0.30
mass 1.25
(12) VENLAFAXINE
Step 3 VENLAFLAXINE PREPARATION

VF2 Acetate 1.25 Reaction Mass 2.58
Formic Acid 0.50 CO2 1.82
Formaldehyde 0.15
Water 2.50
INPUT : OUTPUT :
Mass 2.58 pH Adjustment Aq. To ETP * 3.69
NaOH 1.46 & Mass 10.35
Water 1.00 Extraction
Ethyl Acetate 9.00

Mass 10.35 Filtration Cake to Inc. * 0.05
Charcoal 0.04 Mass 11.09
Ethyl Acetate 0.75

EA Recovery Distilled Ethyl
Mass 11.09 Acetate 8.70
Ethyl Acetate 1.50 Losses 2.79
Mass 1.10

Mass 1.10 Reaction Mass 2.10
IPA HCL 1.00

Mass 2.10 Centrifuge & EA Rec. 1.50
Ethyl Acetate 0.75 Solvent Recovery Mass 1.10

Mass 1.10 Drying Losses 0.10
VL 1.00
(13) Chlorhexidine Acetate

1.330 CH-Base Cake 1.13
Process
8.670 Water ML to ETP 9.15
0.280 Acetic Acid

1.343 Wet Cake Dry Cake 1.000
Drying
Loss 0.343
(14) CH Gluconate
VST-1.HCl
Kgs / Lit Raw material Material Kgs / Lit
0.080 Delta Glucone 1,5 Reaction CH - 1.000
Lacton Gluconate
0.110 CH - base
0.820 Water Handling loss 0.01

(15) Olanzapine
Step 1:- OL1 PREPARATION

Malanonitrile 1.35 Mass 12.53
Sulfur powder 0.66 Reaction
Propinaldehyde 1.43
TEA 1.26
DMF 7.83

Mass 12.53 Mass 85.43
Water 72.90 Quenching
Quanching
OUTPUT :
Mass 85.43 ML to ETP * 93.15
Water 9.25 Centrifuge Wet Cake 1.53

Wet cake 1.53 Drying VapourLoss 0.15
Dry Cake 1.38

Dry Cake 1.38 Mass 3.75
Leaching
Toluene 2.37
INPUT : OUTPUT :
Mass 3.75 Toluene Rec. 2.42
Centrifuge &
Toluene 0.13 Wet cake 1.46
Solvent Recovery
Step-2 OL2 PREPARATION

OL1 1.46 Mass 9.24
DMSO 5.23 Reaction
KOH 1.21
OFNB 1.34

water 47.60 Quenching
INPUT : OUTPUT :
Mass 56.84 ML To ETP * 25.50
Water 25.50 Centrifuge ML -1 for DMSO Recovery 54.45
Wet Cake 2.39
Total 82.34
Total 82.34

Wet Cake 2.12 Mass 4.51
Leaching
IPA 2.39

Mass 4.51 IPA recovered 2.74
Centrifuge &
IPA 0.267 OL2 Pure 2.04
Solvent Recovery
Residue to Inc * 0.31
(15) Olanzapine
Step-3 OL3 PREPARATION

OL2 2.04 Mass 33.09
Water 8.60 Reaction
HCL 8.52
Sn Cl 2 5.22
DMA 8.71 Miscible

Mass 33.09 ML to ETP * 31.35
Centrifuge Wet Cake 1.74

Wet Cake 1.74 Drying Vapours 0.26
Dry Cake 1.48
ML -1 for DMSO Recovery 54.45 Recoverd DMSO 5.02

Total 54.45 Distillation Losses 0.08
Water recovered recycled in
next batch 49.35
Total 54.45
Step -4 OL4 PREPARATION

OL3 1.48 Mass 6.37
TEA 0.59 Reaction NH3 Gas to Scrubber 0.09
Piperazine 2.36 HCl Gas to Scrubber 0.20
DMSO 2.23

Water 2.22 Precipitation
Methanol 12.87

Mass 21.46 Meoh Rec. 21.21
Methanol 1.16 Centrifuge & Wet Cake 1.41
Solvent Recovery

Wet Cake 1.41 Vapours 0.14
Dryer
Dry Cake 1.27
Step -5 OL-5 PREPARATION

Crude 1.27 Mass 6.93
Dissolution &
Ethyl Acetate 5.58
Purification
Charcoal 0.08
INPUT : OUTPUT :
Mass 6.93 Filtration Spent cake to Inc. * 0.16
Hyflow 0.07 Mass 7.70
Ethyl Aceate 0.86

Mass 7.70 ML to recovery 7.46
Ethyl Acetate 0.86 Centrifuge Wet Cake 1.10

Wet Cake 1.10 Dryer,Sifting & Vapours 0.10
Micronisation Dry Cake 1.00

ML 7.46 Ethyl Acetate Rec 6.36
ML Recovery Residue Incin. * 1.10
(16) Terasosin
INPUT QTY OUT PUT QTY

Kgs / Lit Raw Materials Product Qty / Lit
4-Amino, 2-
11.26 chloro,6,7,dimethoxyl Process Mass 219.19
Quinazolin
N-(2-Tetrahydrofuroyl)
12.43 HCl gas to Scrubber 1.5
piperazine
197.00 2-Methoxy Ethanol Total 220.69
220.69 Total
219.19 Mass ML for recovery 217.49

Terazocin
Total Filtration Monohydrochloride Di-
219.19 Hydrate 1.7
Total 219.19
Terazocin
Monohydrochloride Di- Mass
1.7 Hydrate 103.2
100 Water Dissolution and
1.5 Carbon Purification Total 103.2
103.2 Total
ML 101.50
103.2 Mass Filtration Cake to Incinarator 1.7
101.50 ML Chilling & Mass 101.50

101.50 Total Crystalization Total 101.50
101.50 Mass ML to ETP 79.80

Centrifuge
101.50 Total Mass 21.7
Total 101.50
21.7 Mass Product 21.5

Drying
21.7 Total EV. Loss 0.2
Total 21.7
217.49 ML for recovery 2- MethoxyEthanol Rec. 189.12

217.49 Total Distillation Residue 28.17
Losses 0.2
Total 217.49
(18) LOSARTON-K
STEP 1 : LK-1 PREPARATION:
INPUT : OUTPUT :
Toluene 19.2 Aqueous layer to ETP 2.750
Tetrazole 4.718 LK-1 Preparation Organic layer 25.700
Imidazole 1.308 HCl Gas to Scrubber 0.250
TBAB 0.040 Total 28.700
KOH 0.555
Water 2.880
Total 28.700
INPUT : OUTPUT :
Raw Material Input , Kgs Water wash Product Output , Kgs
Organic layer 25.700 Aqueous layer to ETP 5.000
Water 4.800 Organic layer 25.500
Total 30.500
Total 30.500
INPUT : OUTPUT :
Organic layer 25.500 Wet Cake 4.800
Water 7.400 Reaction and ML-1 For Recovery 22.947
Sodium borohydride 0.159 Centrifuge ML to ETP 7.40
Toluene 2.088
INPUT : OUTPUT :
Wet cake 4.800 Drying Dry cake 4.000
Total 4.800
INPUT : OUTPUT :
ML for Rec 30.274 ML for Recovery Toluene Rec 20.500
Residue to Incin. 9.564
Total 30.274
(18) LOSARTON-K
STEP 2 :
INPUT : OUTPUT:
MeOH 34.139 Losarton-K Cake for incinerator 0.268
KOH 0.428 Preparation Filterate 35.028
LK-1 3.964 Losses 3.414
Charcoal 0.179 Total 38.710
Total 38.710
Filterate OUTPUT :
INPUT : Product Output,Kgs
Raw Material Input , Kgs MeOH distilled 25.604
Filterate 35.028 Distillation Acetonitrile distilled 1.600
Acetonitrile 2.000 Losses 5.554
Total 37.028 Reaction mass 4.269
Total 37.028
INPUT : OUTPUT :
Reaction mass 4.269 Centrifuge Wetcake 1.400
Acetonitrile 0.400 ML -2 for Recovery 2.842
Total 4.669
INPUT : OUTPUT :
Wet cake 1.400 Drying Dry cake 1.000
Total 1.400
INPUT : OUTPUT :
ML for Rec. 22.947 ML for Recovery Toluene recovered 20.430
Residue to inc. 2.207
Total 22.947
INPUT : OUTPUT :
ML for Rec. 2.842 ML for Recovery Aceto Nitrile Rec. 2.060
Residue to inc. 0.498
Total 2.842
(19) Glibenclamide
Stage-1 Ester Preparation
Raw Materals Kgs/Lit Material Kgs/Lit
Butanone 2.185 CO2 Gas 0.189
5-Chlor salicyclic Acid 0.789 Buatanone distillate 1.971
Reaction
K2CO3 1.354 Mass 3.268
Dimethyl sulphate 1.314 Loss 0.214
Mass 3.268 Aqus. Layer to ETP 2.954

Water 1.000 Organic Layer 5.766
Reaction
EDC 3.138
Dimethyl sulphate 1.314
Organic Layer 5.766 Layer Aqus. Layer to ETP 1.493

Water 0.717 Saperation Organic Layer 4.990
Organic Layer 4.990 EDC 2.914

Ester 0.729
Distillation
Loss 0.998
Residue*Incineration on 0.349
Stage-2 Amide Preparation

Ester 0.729 Methanol Distilatted 0.182
Beta phenyl ethylamine 0.491 Aqus. Layer to ETP 1.221
Sodium Metal 0.008 Organic Layer 5.757
Methanol 0.144 Reaction Loss 0.401
EDC 5.409 HCl Gas to Scrubber 0.140
HCL 0.055
Water 0.865
Organic Layer 5.757 Aqus. Layer to ETP 1.642

Water 1.442 Separation Organic Layer 4.981
Loss 0.576
Organic Layer 4.981 EDC 2.308

Distillation Amide Solution 1.926
Loss 0.747
Chlorosulphonic Acid 3.220 Sulphonamide Wetcake 2.078

Amide Solution 1.926 ML to ETP 16.335
Liquor Ammonia 11.458 Reaction Loss 1.338
EDC 3.607 Recovered EDC 3.460
Water 3.000
Sulphonamide Wetcake 2.078 Sulphonamide dry cake 1.293

Drying
Loss on Dyeing 0.785
Stage-3 CHIC Salt Preparation & Purification

Sulphonamide 1.296 Solids to *Incineration 0.097
NaoH 0.149 CHIC Wet Salt 1.800
CHIC 0.493 ML-1 for Recovery 8.646
Ammonia 0.123 Reaction Loss 2.105
Hyflow 0.036
Carbon 0.029
Acetone 10.522
Methanol 23.453 Solids to *Incineration 0.216

CHIC Salt 1.763 CHIC Wet Salt 1.429
HCI 0.649 ML-2 for Recovery 17.775
Reaction
Water 15.873 Loss 4.691
Hyflow 0.072 ML ot ETP 17.772
Carbon 0.072
Glibenclamide Wet cake 1.429 Glibenclamide Dry Cake 1.000

Drying
ML-1 for Recovery 8.646 Acetone + Water distilled 11.004

Distillation
Water 3.571 Loss 1.213
ML-2 for Recovery 17.775 Methanol Distilled 16.500

Distillation Loss 1.075
Residue to Incinerator 0.200
(20) Desloratadine

Raw Materals Kgs/Lit Material Kgs/Lit
Methanol 11.040 Mass 14.200
Na-OH flakes 1.760 Reactor CO2 0.200
Loratadine 1.600
Reaction Mass 14.200 Mass 15.370

Sparkler
hy flow 0.133 Waste hyflow 0.069
Filteration
Methanol 1.106 Total 15.439
Total 15.439
Reaction Mass 15.370 Mass 37.884

Distillation &
Water 23.585 Distilled (Methanol) 1.060
Crystalisation
Distillation loss 0.011
Mass 37.884 Wet Cake 1.477

Water 10.110 Centrifugation ML to ETP 46.017
Loss 0.500
Mass 1.477 Wet Cake 1.266

Water 87.354 Purification ML to ETP 87.576
HCL CP 0.011
Wet Cake 1.266 Product 1.160

Drying Solvent (Water)to ETP 0.060
Loss on Drying 0.046
(22) AMLODIPINE
STEP 1 : Pthaloyed Amlodipine PREPARATION

INPUT : OUTPUT :
Hydroxy Ethyl Phthalamide 1 PHEMAA 2.400
Ethyl - 4- Chloroacetoacetate 1.4 Reaction Total 2.400
Total 2.400
INPUT : OUTPUT :
AD-2 2.400 A. Acid Distillation 0.320
Morpholine 0.078 Reaction & IPA Mass 3.072
Acetic acid 0.333 distillation
Ortho Chlorobenzaldehyde
0.581 Total 3.392
Total 3.392

Bach mass 3.072 Cake 1.516
Reaction & ML for sale ( A.Acid)
Acetic acid 3.033 Centrifuge 5.464
MAC ( AD2A) 1.027 Losses 0.152
0 Total 7.132
Total 7.132

Wet cake 1.516 CF Meoh ML 5.63
Methanol 5.652 Wet cake 1.300
Total 7.168
INPUT :
Raw Material Kgs/ Lit OUTPUT :
Wet cake 1.300 1.3 Product Kgs/ Lit
Total 1.300 Dryer Dry cake 1.210
Total 1.300
Stage -2 AD Base

AM-3 1.210 Cake 1.230
Monomethanolamine 4.037 Reaction & ML to incinaration 7.289
Water 3.526 Centrifuge Loss 0.254
STEP 3 : AD-5 PREPARATION

Water 1.708 Wet cake 1.914
AD-4 1.230 Reaction & ML to ETP * 3.817
Benzene sulphonic acid 0.534 Centrifuge
Washing 2.533 Losses 0.274

Total 1.914 Drying Loss on drying 0.754
Total 1.914
STEP4 : PURIFICATION

IPA 5.800 Clarification &
Crude 1.160 Filteration Mass 6.960
Water 0.116 Losses 0.116

Mass 6.960 Centifuge Wet cake 1.083
IPA 0.580 ML for recovery 6.207
Total 7.540

Total 1.083 Drying Loss on drying 0.082
Total 1.083
ML for Recovery 6.207 Recovered IPA 6.00

Distillation
Loss 0.007
Total 6.207
(23) Telmisarten
Step-TL-1 A PREPARATION
INPUT : OUTPUT :
Raw Material Input , Kgs Reaction Product Output, Kgs
Mono Ethyl Glycol 10.26 Mass 12.66
2 cyano 4 methyl Biphenyl 1.87 NH3 Gas to Scrubber 0.16
Potassium hydroxide 0.60
Process water 0.09
Mass 12.66 Precipitation Reaction mass 25.36

Water 9.33
HCl 3.37
Reaction mass 25.36 TL 1 A product 1.84

Water wash 18.66 Filtration & drying Mono ethyl glycol 10.06
Aqueous Layer to ETP 31.72
Loss 0.40
Step-TL-1 B PREPARATION
INPUT : OUTPUT :
Reaction &
Acetone 21.77 Mass 5.08
distillation
TL 1 A product 1.84 Acetone rec 20.69
Potassium carbonate 1.32 Loss 0.43
Diethyl sulphate 1.27
Mass 5.08 Reaction mass 7.60

Hexane 6.06 Aq layer to ETP 21.60
Inorganic Process Waste (Sodium
Water for wash 5.51 sulphate) 0.27
Extraction &
Sodium bicarbonate 0.59 Total 29.47
Filtration
Water for Sodium bicarbonate 6.54
Water wash 5.51
Sodium sulphate 0.18
Total 29.47
Reaction mass 7.60 TL 1 B product (Liq) 1.75

Total 7.60 Hexane- rec 5.69
Distillation
Loss 0.16
Total 7.60
Step-TL-1 C PREPARATION
INPUT : OUTPUT :
Raw Material Input , Kgs Reaction Product Output, Kgs
MDC 11.58 Mass 14.42
TL 1 B product 1.75 HBr Gas to Scrubber 0.24
1-3 Dibromo 5,5 Dimethyl Hyda 1.15
Azo Bis- Isobutynotrile(Catalyst 0.18
Mass 14.42 Reaction mass 15.09

Water for wash 10.53 Extraction & Aq layer to ETP 24.02
filtration Inorganic Process Waste (Sodium
Sodium bisulphate 0.18 sulphate) 0.27
Water for Sodium bisulphate 3.51
Water wash 3.51
Sodium chloride 0.42
Water for Sodium sulphate 3.51
MDC wash 2.32
Reaction mass 15.09 Distillation & Reaction mass 4.25

Hexane lot I 1.16 Filtration MDC- rec 12.78
Hexane lot II 2.32 Hexane - rec 1.16
Loss 0.38
Reaction mass 4.25 TL 1 B product (Liq) 1.93

Distillation
Hexane washing 0.58 Hexane- rec 2.75
Loss 0.15
(23) Telmisarten
Step-TL-1 PREPARATION
INPUT : OUTPUT :
N, N dimethyl formamide 8.97 Mass 12.79
Bibenzimidazole (BIM) 1.25
Reaction
KOH 0.64
TL-1C (85%) 1.93
Mass 12.79 Mass 30.79

Water 25.00 Aq layer 1 -KBr for Sale 33.97
Ethyl acetate 28.85 Extraction & Aq layer to ETP 27.38
Water wash 3 nos 25.50 filtration Process Waste to Incinerator 0.75
Reaction mass 30.79 Reaction mass 8.81

Distillation &
Ethyl acetate 5.91 Ethyl acetate- rec 29.29
crystallization
Hexane 29.70 Loss 0.30
Recovered Hexane 28.00
Reaction mass 8.81 Filtration Wet cake 1.88

Ethyl acetate 1.64 Ethyl acetate+ Hexane- rec 7.92
Wet cake 1.88 PL 1 Dry 1.33

Ethyl acetate 7.25 Slurry wash drying ML for recovery 9.67
ML for recovery 9.67 Recovered Ethyl Acetate+ Hexane 9.03

Losses 0.18
Total 9.67
Step-TL PREPARATION
INPUT : OUTPUT :
TL-1 1.33 Mass 33.41
HCl 13.56
Methylene dichloride 3.52 Reaction
Water 15.00
Mass 33.41 Mass 37.42

Caustic flakes 4.33 Aq layer to ETP 60.36
Water for caustic dilution 11.33 Process Waste to Incinerator 1.24
Methylene dichloride 36.96 MDC -rec 5.60
Acetic acid 4.20 Extraction &
Water 13.33 filtration
Activated carbon 0.13
Hyflo 0.13
Reaction mass 37.42 Reaction mass 39.22

Acetone 35.81 Methylene dichloride- rec 33.26
Distillation &
Loss 0.75
crystallization
Reaction mass 39.22 PL 1.00

Filtration & Acetone -rec 34.40
drying Loss 3.82
(24) Velsarten
VST-1.HCl
1.31 L-Valine Recovered methanol 9.40
3 Thionyl Chloride Recovered Toluene + Thionyl Chloride 2.84
Reaction
11.06 Methanol Recovered (Acetone + Toluene Traces) 5.70
1.94 Toluene Loss 1.79
5.9 Acetone SO2 Gas to Scrubber 1.61
23.21 Total Output 1.86
Total 23.21
VST-2

2.33 Methyl Cyanobiphenyl Aqs. Layer to ETP 9.73
1.72 Dibromodimethyl hydantion Recovered MDC 8.31
0.23 AIBN Recovered E.Ac. (E.Ac.+ MDC Traces) 4.00
Reaction
9.23 MDC Loss 2.67
4.21 Ethyl Acetate Output 2.33
9.32 DM Water
VST-3

2.33 VST-02 Recovered Toluene + Water Traces 17.61
1.86 VST-01.HCl Filtrate to ETP 49.01
1.17 Potassium carbonate HBr Gas to Scrubber 0.70
13.2 DMF Reaction Loss 3.16
18.17 Toluene
1.34 HCl
34.97 DM Water Output 2.56
VST-4

2.563 VST-03.HCl Aqs.Layer to ETP 8.36
2.44 Sodium Bicarbonate Aqs.Layer to ETP 41.27
16.92 MDC Recovered DCM 14.38
1.15 Valeryl Chloride Reaction Spent Carbon 0.39
0.97 Triethylamine CF ML (Xylene) 6.62
1.77 HCl Loss 0.50
0.26 Activated Carbon HCl Gas to Scrubber 0.31
8.82 Xylene Output 2.56
39.49 DM Water Total 74.383
74.383 Total
VALSARTAN Final

2.56 VST-04 Recovered Xylene + Excess Tributyltinch Chloride 6.02
3.9 Tributyltinch Chloride Aqs. Layer to ETP 4.10
0.78 Sodiumazide Aqs. Layer to ETP 5.30
0.05 TBAB Recovered DCM 7.19
Reaction
1.03 Sodium Hydroxide Activated Carbon (Carbon + E.Ac.) 0.39
8.46 MDC Recovered (Ethyl Acetate + MDC) 3.89
0.26 Activated Carbon Loss 3.57
2.31 Ethyl Acetate Output 1.00
4.41 Xylene Total 31.45
7.69 DM Water
31.45 Total
(25) ATOVAQUONE (stage I)
Acid (0.98 kg) STAGE-1 FLOW-CHART
Amm.persulfate
(6.84 kg)
GLR
(Reflux for 6-8
Dichlone (0.92 kg) Recovered
hrs)
AgNO3 (1.71Kg) CH3CN 21.55 L
75-80 deg C
HPLC TEST
Water
Water(29.67
(22.5 L)
L),
CH3CN (29.67L)
CH3CN (22.8L)
Cooling to 0-5
deg C for 1 hr
Nutch Filtration MLR to ETP

35.45
Wet cake
DCM (68.4 L)
GLR (1 hr)
Filtration AgCl (1.368 kg) to

be recycle
Bicarbonate
(1.84 kg), Water filtrate
(18.4 L)
L)
Extraction Aqueous layer
(8hrs) twice 24.51 L to ETP
L to ETP
DCM layer in
GLR
Distilled MDC 62 L
CH3CN (11.55 L) Distillation
to recovery
10.98 L
Filtration MLR 17.93 L to Recovery CH3CN
6.95 L Dist.
Residue
220.87Total Input Dry Product
VTD (8 hr)
1.52 Kg 220.87 Total Output

65-70 deg C
Flow chart stage II
Methanol (27.47 L)
Stage I (1.52 Kg) SSR, Reflux at 70-75
deg C
KOH (0.987 Kg)
Water (15.26 L) 45.237
DCM ( 7.76 L) Cool to 12-15 deg C

52.997
52.
Layer Separation
Aq. Layer for
Methanol recovery
6.597 ( 46.9 L)
Methanol– 26.09 L
Acetic acid Neutralization & Cool Residue – 0.82
3.62 L to 0-5 deg C for 1hr Losses – 0.56
10.217 To ETP – 18.93 L
Filtration ML for DCM

recovery (8.21 L)
2.007
DCM – 7.37 L
VTD drying Residue – 0.3 L
Loss- 0.09 L
Dry product
ATQ crude
1.4 Kg
Loss - 0.607

ATQ Flow chart stage III
CH3CN (28 L) SSR

Stage II (1.4 Kg) Reflux at
75-78 deg C 29.4
SSR
Cooling to
0-5 deg C
Wash 3 ltr Filtration 32.4 MLR 30.9 L to

acetonitrile recovery
Recovered Acetonitrile–
1.5
29.76 L
Residue – 0.95 L
Losses – 0.5 L
VTD
ATQ final API
(1 kg)
(26) NATEGLINIDE
MATERIAL BALANCE
INPUT OPERATIONS OUTPUT
Trans-4-isopropyl cyclohexyl
Carboxylic acid (1.2 kg)
D-phenylalanine (1.22 kg)
Acetone (13.44 kg) Reaction

Triethylamine (0.78 kg)
HCl Gas to Scrubber (0.28 kg)
Ethyl chloroformate (0.84 kg)
Sodium hydroxide (0.30 kg) 19.06

Conc. HCl (1.28 kg)
Water (34.40 kg) Quenching
53.46
Aq. ML-1for recovery (51.66 kg)
Filtration
1.8
Drying
MeOH (7.36 kg)

Purification I
Conc. HCl (0.06 kg)
Water (18.4 kg)

INPUT OPERATIONS OUTPUT
AQ. ML-2 for recovery (26.01 kg)

Filtration
Drying
Hexane (16.8 kg)

Purification II
MDC (3.85 kg)
Filtration Solvent ML for distillation (21.03 kg)
Acetone (8.96 kg) Acetone ML for recvovery (8.00 Kg)

Aq. ML to ETP (12.11 Kg)
Water (11.2 kg)
Purification Nateglinide (1.0 kg)
TOTAL 120.09 kg TOTAL 120.09 kg
Aq. ML-1 for recovery 51.66 kg Recovered Acetone –12.90

Recovered Methanol- 0.253 Distillation
Losses – 0.041
ML to ETP – 38.466
Aq. ML-2 for recovery 26.01 kg Distillation Recovered Methanol- 7.0656

Losses – 0.0444
ML to ETP – 18.90
SolventML for recovery 21.03 kg Recovered Hexane-16.128

Distillation
Recovered MDC -3.696
Residue –1.082
Losses – 0.124
Solvent ML for recovery 8.00 kg Recovered Acetone-7.6
Distillation
Residue –0.3
Losses – 0.1
Annexure-2 Land Document
Annexure-3 Existing CC&A
GUJARAT POLLUTION CONTROL BOARD
PARYAVARAN BHAVAN
Sector 10-A, Gandhinagar 382010
~ Phone . (079) 23226295
~P""
GPCB Fax (079) 23232156
website· wwwgpcb.gov.in
BYR.P.A.D.
CCA NO· AWH- 55875
NO: GPCB/BRCH-CCA-1175/1D-27333/15 '1=i;'l""
In exercise of the power conferred under section-250f the Water (Prevention and
Control of Pollution) Act-1974, under section-21 of the Air (Prevention and Control of Pollution)
Act-19B! and Authorization under rule 3(c) & 5(5) of the Hazardous Waste (Management,
Handling and Trans-boundary Movement) Rule-200S, framed under the E (P) Act-1986.
And whereas Board has received consolidated application dated 24/05/2013 with
inward no. 68077 for the consolidated consent and authorization (CC& A) of this Board under
the provisions / rules of the aforesaid Acts Consent & Authorization is hereby granted as under.
CONSENTANDAUTHORISATION:
(Under the provisions / rules of the aforesaid environmental acts)
To,
M/s. VASUDEVDRUGINTERMEDIATES,
PLOT NO: 3103,
GIDCESTATE,PANOLI,
DlST: BHARUCH.
1. Consent Order No: AWH-55875, date ofIssue 29/07/2013.

2. The consent under Water Act -1974, Air Act - 1981 and Authorization under
Environment (Protection) Act, 1986 shall be valid up to 23/05/2018 to operate
industrial plant for manufacture of the following products:
Sr. No. PRODUCTS Quantity (MT/Month)

I- Para Nitro Benzvl Bromide 10
BYPRODUCTS
2. HBr r30 to 35 % 26
3. NaBr 0.5
3. CONDITIONUNDERTHE WATER ACT:
1. There shall be no generation & discharge of the industrial effluent from the
manufacturing process and other ancillary industrial operations, Hence the unit shall
strictly adhere to zero discharge.
2. The quantity of the domestic waste water (sewage) shall not exceed 250 Lit/Day.
3. The total water consumption for industrial process and other ancillary operations shall
not exceed SODLit/Day and water consumption for domestic purpose shall not exceed
300 Lit/Day as mentioned in form -D submitted consent application under Water Act-
1974.
Pag~ lot 5
Clean Gujarat Green Gujarat

ISO - 9001 - 2008 & ISO - 14001 - 2004 Certified Organisation
\
4. The unit shall affix of water meters as per Section 4 (1) of the water (Prevention and
Control of Pollution) Cess Act - 1977 for the purpose of measuring and recording the
quantity of water consumed at such places as may be required, within 15 days and it
shall be presumed that the quantity indicated by the meter has been consumed by the
industry until the contrary is proved.
5. Sewage shall be disposed through septic tank / soak pit system.
6. The GIDC drainage connection given by the GIDC for discharge of industrial
emuent shall be disconnected & the outlet shall be sealed.
4. CONDITIONSUNDERTHEAIRACT:
4.1 The following shall be used as fuel in furnace.
Sr. No. Fuel uanti

1. Natural Gas OR 6.87 M3 Hr
2. Wood ZOO K Da
4.2 The flue gas emission through stack attached to boiler shall conform to the following
standards:
Stack Stack Stack Height Parameter Permissible

No. Attached To in Meter Limit
1. Boiler 11 Particulate Matter 150 mg/NM3
S0, 100 ppm
NOx 50uum
4.3 The process emission through various stacks/vent of Reactors, Process and Vessels shall
conform to the following standards from the manufacturing process as well as any other
ancillary process.
Stack Stack Stack Height APCM Parameter Permissible

No. Attached To in Meter Limit
1. Reactor 11 Scrubber HCL 20mg/NW
S0, 40 mg/NM3
H,S 45 mg/NW
Bromine 2 m;iNW
4.4 The concentration of the following parameters in the ambient air within the premises of the
industry shall not exceed the limits specified hereunder:
Page20f5
GUJARAT POLLUTION CONTROL BOARD
" ...
PARYAVARAN BHAVAN
~ Phone : (079) 23226295
GPCB Fax (079) 23232156
'''oho;/o' gov.in
PERMISSIBLELIMIT(microgram ( ;
PARAMETERS
Annual 24 Hours Averae:e

Particulate Matter r PM1O) 60 100
Particulate Matter (PM25 40 60
Oxide ofSulphur( SOx 50 80
Oxide of Nitrogen NOx 40 80
HCL 200
CL2 100
Hvdrocarbon 160
, Ammonia 850
Bromine 20
• Annual arithmetic mean of minimum 10 measurements in a year ata particular

site taken twice a week 24 for hourly at uniform intervals .
• 24 Hourly or 08 hourly or 1 Hourly monitored values, as applicable ,shall be
complied with 98 % of the time in a year 2 % of the time they may exceed the
limits but not on two consecutive days monitoring.
4.5 The applicant shall operate industrial plant / air pollution control equipment very efficiently
and continuously so that the gaseous emission always conforms to the standards
specified in condition nO.4.2 & 4.4 above.
4.6 The consent to operate the industrial plant shall lapse if at any time the parameters of the
gaseous emission are not within the tolerance limits specified in the condition no. 4.2 & 4.4
above.
4.7 The applicant shall provide portholes, ladder, platform etc at chimney(s) for monitoring the
air emissions and the same shall be open for inspection to/and for use of Board's staff. The
chimney(s) vents attached to various sources of emission shall be designed by numbers
such as S-l, S-2, etc. and these shall be painted/displayed to facilitate identification.
4.8 The Industry shall take adequate measures for control of noise levels from its own sources
within the premises so as to maintain ambient air quality standards in respect of noise to
less than 75dB(a) during day time and70 dB(A)during night time. Daytime is reckoned in
between 6a.m. andIO p.m. and nighttime is reckoned between 10 p.m. and 6 a.m.
5. GENERAL CONDITIONS: -
5.1 Any change in personnel, equipment or working conditions as mentioned in the consents
form/order should immediately be intimated to this Board.
6. AUTHORISATION FOR THE MANAGEMENT & HANDLING OF HAZARDOUS WASTE

Form-2 (See rule 3 (C) & 5 (5).
6.1 Number ofauthorization:AWH-S587S, Date of issue: 29/07/2013.
Page30fS

\
Mis. V ASUDEV DRUG INTERMEDIATES, is hereby granted an authorization to operate
facility for following hazardous wastes on the premises situated at PLOT NO: 3103, GlDC
ESTATE, PANOLl, DlST: BHARUCH.
Sr. Waste category Quantity/ Facility

No. Year
1 Used oil 5.1 0.012 KL Collection, Storage, Transportation,
Disposal by Selling to Registered
Re-reflners
Z Discarded 33.3 240 Nos. Collection, Storage, Transportation,
Containers/ Decontamination, Disposal by
Bags/Liners Selling to Authorized Recycler.
63 The authorization is granted to operate a facility as above.
6.4 The authorization shall be in force for a period of Five years from the date of application.
6.5 The authorization is subject to the conditions stated below and such other conditions as
may be specified in the rules from time to time under the Environment (Protection) Act-
1986.
7. TERMS AND CONDITIONS OF AUTHORISATION:
7.1 The applicant shall comply with the provisions of the Environment (Protection) Act - 1986
and the rules made there under.
7.2 The authorization shall be produced for inspection at the request of an officer authorized by
the Gujarat Pollution Control Board.
7.3 The persons authorized shall not rent, lend, sell, and transfer of otherwise transport the
hazardous wastes without obtaining prior permission of the Gujarat Pollution Control Board.
7.4 Any unauthorized change in personnel, equipment or working conditions as mentioned in

the authorization order by the persons authorized shall constitute a breach of this
authorization.
7.5 It is the duty of the authorized person to take prior permission of the Gujarat Pollution
Control Board to close down the facility.
7.6 An application for the renewal of an authorization shall be made as laid down in rule 5 (6)
(iiJ.
7.7 Industry shall have to display the relevant information with regard to hazardous waste as
indicated in the Court's order in W.P. No. 657 of 1995 dated 14t' October 2003.
Page 40£5
I
y GUJARAT POLLUTION CONTROL BOARD
PARYAVARAN BHAVAN
Phone . (079) 23226295
GPCB
Fax (079) 23232156
website. wwwgpcb.govin
78 Industry shal1 have to display on-line data outside the main f.actory.gate with regard tO an.~
. nature of hazardous chemicals being handled in the plant, mcludmg.waste water an d 31
emission and solid hazardous waste generated within the factory premIses.
a e waste oil discarded containers etc., process waste as per

7.9 ~~~~~~ds~~:e~a:e 2t~o~aannJshall appl~ Authorization for all applicable waste as per
Amended Rules-2003 with 15 days.
7.10 Industry shall submit annual report within 15 days and sub sequently by 31,t January every
year.
For and on behalf of

Gujarat
Pollutioncootr:/
(K.~RY)
SR. ENVIRONMENT SCIENTIST
ISSUED TO:
Mis. VASUDEVDRUG INTERMEDIATES,
PLOT NO, 3103,
GIDC ESTATE, PANOLI,
DIST, BUARueU,
Page 50f5

Annexure-4 List of Raw-Material
LIST OF MATERIAL (Kg/Kg)
Product Raw-Material Kg/Kg

7-[4[4-fluorophrnyl)-6-isopropyl-
2-9N-methyl]-N-
methylsulfonylamino0pyrimidin- 1.34
5-yl)]-(3R,5S)-dihydroxyhept -6-
Rosuvastatin
enoic acid Sodiu salt solu
A. carbon 0.14
Hyflo 0.14
Calcium chloride solu 2.86
OR
Dimethyl formamide 2.08

DCPP. HCl 0.69
1-4 Di bromo butane 0.76
Methylene dichloride 9.03
Aripriparazole
KOH solution 0.76
Acetonitrile 10.00
Triethyl amine 0.30
Chloroform 16.80
Methanol 1.00
OR
p-Hydroxy Benzaldehyde 0.99

Reney Nickle 0.20
Methanol 7.80
Toluene 1.71
ITP-1 0.79
3,4 Dimethoxy benzoyl chloride 1.36
TEA 0.68
Dichloro Methane 12.50
Toluene 6.60
Itopride
ITP-2 1.74
2-Dimethyl aminoethyl chloride 0.97
Conc.Hcl 0.80
THF 2.00
EA 8.00
ITP 1.99
IPA 5.69
Acetonitrile 4.64
OR
Sodium Methoxide 1.15

Methanol 7.25
4- Methoxy Phenyl Acetonitrite 1.15
Cyclohexanone 1.75
N hexane 2.64
Acetic Acid 22.04
Palladium Charcoal 0.11
Ethyl Acetate 5.40
VF2 Acetate 1.25
Venlaflaxine
Formic Acid 0.50
Formaldehyde 0.15
NaOH 1.46
Ethyl Acetate 9.00
Charcoal 0.04
Ethyl Acetate 0.75
Ethyl Acetate 1.50
IPA HCL 1.00
Ethyl Acetate 0.75
OR
Hydroxy Ethyl Phthalamide 1.00

Ethyl - 4- Chloroacetoacetate 1.40
AD-2 2.40
Morpholine 0.08
Acetic acid 0.33
Ortho Chlorobenzaldehyde 0.58
Bach mass 3.07
Amolidipine
Acetic acid 3.03
MAC ( AD2A) 1.03
Methanol 5.65
Monomethanolamine 4.04
Benzene sulphonic acid 0.53
IPA 5.80
IPA 0.58
OR
Carbon tetra Chloride 160.40

3,5- Lutidine 2.86
N-bromosuccinimide 3.80
Azobis Iso butronate 0.44
Desloratadine 1.71
Rupatidine
TBAB 0.21
NaoH 0.53
Rupatidine O- Xyline 5.70
Acetone 15.96
Silica gel 1.00
Acivated Carbon 0.12
Acetone 8.30
Methanol 7.68
Fumeric Acid 0.47
Acetone 14.94
Crude 1.41
OR
CH-Base 1.33
Cholrhexidine Acetate
Acetic Acid 0.28
OR
Butanone 2.19
5-Chlor salicyclic Acid 0.79
K2CO3 1.35
EDC 3.14
Ester 0.73
Beta phenyl ethylamine 0.49
Sodium Metal 0.01
Methanol 0.14
EDC 5.41
HCL 0.06
Chlorosulphonic Acid 3.22
Amide Solution 1.93
Glibenclamide
Liquor Ammonia 11.46
EDC 3.61
Sulphonamide 1.30
NaoH 0.15
CHIC 0.49
Ammonia 0.12
Hyflow 0.04
Carbon 0.03
Acetone 10.52
Methanol 23.45
CHIC Salt 1.76
HCI 0.65
Hyflow 0.07
Carbon 0.07
OR
4-Amino, 2-chloro,6,7,dimethoxyl Quinazolin 11.26
N-(2-Tetrahydrofuroyl) piperazine 12.43
Terazosin 2-Methoxy Ethanol 197.00
Terazocin Monohydrochloride Di-Hydrate 1.70
Carbon 1.50
AND
MDC 34.05
DMF 0.84
Thionyl chloride 0.60
Pyridine 1.14
3A2HAcetophenone 0.75
HCl 8.54
Sodium bicarbonate 0.97
Nacl 0.91
Ethyl acetate 4.82
Pranlukast
DMSO 3.11
Sodium Methoxide 1.67
THF 7.76
Tert Ester 0.87
Methanol 34.16
Dimethyl formamide 10.09
Charcoal 0.83
TEA 0.36
Methanolic HCl 1.55
OR
2-2[2-(3-Chlorophenyl/0ethyl]nicotininitrile 0.80
THF 4.00
Magnesium 0.22
N Methyl 4 Chloro Piperidine 0.40
HCl 6.00
Toluene 25.50
HF 2.68
Loratidine
BF3 1.20
KOH 2.20
8 chloro Azatidine 1.00
Ethylchloroformate 0.25
Sodium by carbonate 0.15
Acetonitrile 2.00
Charcoal 0.10
OR
L-Valine 1.31
Thionyl Chloride 3.00
Methanol 11.06
Toluene 1.94
Acetone 5.90
Methyl Cyanobiphenyl 2.33
Dibromodimethyl hydantion
1.72
AIBN 0.23
MDC 9.23
Ethyl Acetate 4.21
VST-02 2.33
VST-01.HCl 1.86
Potassium carbonate 1.17
DMF 13.20
Toluene 18.17
Valsartan
HCl 1.34
VST-03.HCl 2.56
Sodium Bicarbonate 2.44
MDC 16.92
Valeryl Chloride 1.15
Triethylamine 0.97
HCl 1.77
Xylene 8.82
Tributyltinch Chloride 3.90
Sodiumazide 0.78
TBAB 0.05
Sodium Hydroxide 1.03
MDC 8.46
Activated Carbon 0.26
Ethyl Acetate 2.31
Xylene 4.41
OR
Toluene 19.2
Tetrazole 4.7175
Imidazole 1.308214286
TBAB 0.039642857
KOH 0.555
Sodium borohydride 0.158571429
Losarton-K
Toluene 2.088
MeOH 34.13928571
KOH 0.4275
Charcoal 0.178571429
Acetonitrile 2
Reaction mass 4.269214286
Acetonitrile 0.4
OR
Malanonitrile 1.35
Sulfur powder 0.66
Propinaldehyde 1.43
TEA 1.26
DMF 7.83
Toluene 2.37
Toluene 0.13
OL1 1.46
DMSO 5.23
KOH 1.21
OFNB 1.34
IPA 2.39
IPA 0.267
OL2 2.037
olanzapine
HCL 8.52
Sn Cl 2 5.22
DMA 8.71
OL3 1.48
TEA 0.59
Piperazine 2.36
DMSO 2.23
Methanol 12.87
Methanol 1.16
Ethyl Acetate 5.58
Charcoal 0.08
Hyflow 0.07
Ethyl Aceate 0.86
Ethyl Acetate 0.86
OR
Ch base W/C 1.40
Methanol 6.98
CH- HCl
HCL- CP 0.49
Methanol ML 7.13
OR
Methanol 11.04
Na-OH flakes 1.76
Loratadine 1.60
Deslora
hy flow 0.13
Methanol 1.11
HCL CP 0.01
OR
MDC 60.66
6-Fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol
7.84
DMSO 42.99
Oxalyl Chloride 1.54
HCl 1.33
Na HCO3 0.59
NB5 52.00
Nebivilol Sodium hydride 1.96
TMSI 9.80
HCl 0.67
Na HCO3 0.59
Methanol 36.05
Benzyl Amine 0.86
HCL 1.73
NB7 3.00
IPA-HCL 1.21
OR
Caustic soda 0.18
6 HQ 0.56
toluene 0.58
Tetrazole 0.85
Cilastazole TBAB 0.04
MeOH 1.70
Cilastazole 1.40
MeOH 10.29
Hyflo 0.03
Carbon 0.02
OR
Trans-4-isopropyl cyclohexyl Carboxylic acid 1.20
D-phenylalanine 1.22
Acetone 13.44
Triethylamine 0.78
Ethyl chloroformate 0.84
Sodium hydroxide 0.30
NATEGLINIDE
Conc. HCl 1.28
MeOH 7.36
Conc. HCl 0.06
Hexane 16.80
MDC 3.85
Acetone 8.96
OR
Mono Ethyl Glycol 10.26

2 cyano 4 methyl Biphenyl 1.87
Potassium hydroxide 0.60
HCl 3.37
Reaction mass 25.36
Acetone 21.77
Potassium carbonate 1.32
Diethyl sulphate 1.27
Hexane 6.06
Sodium bicarbonate 0.59
Water for Sodium bicarbonate 6.54
MDC 11.58
1-3 Dibromo 5,5 Dimethyl Hydatoin 1.15
Azo Bis- Isobutynotrile(Catalyst) 0.18
Sodium bisulphate 0.18
Water for Sodium bisulphate 3.51
Sodium chloride 0.42
Water for Sodium sulphate 3.51
Hexane lot I 1.16
Telmisartan Hexane lot II 2.32
N, N dimethyl formamide 8.97
Bibenzimidazole (BIM) 1.25
KOH 0.64
Ethyl acetate 28.85
Ethyl acetate 5.91
Hexane 29.70
Ethyl acetate 1.64
Hexane 0.48
Ethyl acetate 7.25
Hexane 2.16
HCl 13.56
Caustic flakes 4.33
Water for caustic dilution 11.33
Acetic acid 4.20
Activated carbon 0.13
Hyflo 0.13
Acetone 35.81
OR
Amm.persulfate 6.84
Dichlone 0.92
AgNO3 1.71
CH3CN 29.67
DCM 68.40
Bicarbonate 1.84
ATOVAQUONE
ATOVAQUONE
CH3CN 11.55
Methanol 27.47
KOH 0.99
DCM 7.76
Acetic acid 3.62
CH3CN 28.00
AND
2-(2-Methoxyphenoxy)ethyl Phthalamideride
3.319
(CV-3)
DNS 28.61
Hydrazine Hydrate 0.819793
HCl 2.48925
Ethanol 1.7567467
Chloroform 33.516
NaOH 1.396
4-hydroxy-9(H)- carbazole
2.000
Epichlorohydrin 9.550
Carvidelol
4-oxyanylmethoxy-9(H)-Carbazole(CV-2) 1.36
2-(2-Methoxyphenoxy)ethyl Phthalamideride1.89
(CV-1)
IPA 7.46
Toluene 17.1904
Cyclo hexane 5.3312
Ethyl acetate 6.0112
Carvedilol crude(CV-3 Crude) 1.36
Ethyl acetate 19.584
Charcoal 0.3
Hyflo 0.3
Ethyl acetate 3.672
AND
HMDA 0.35
SodiumDicyanamide 0.53
n-Butanol 5.4
TEA 0.1
CH Base HCL 0.9
NaOH 0.29
PCA HCL 1.04
Butenol 2.48
Methanol 4.39
AND
Delta Glucone 1,5 Lacton 0.08
Cholrhexidine Gluconate
CH - base 0.11

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06 May 2017 221509117EF8XS16XAnnexure-Prefeasibilityreport PDF

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PROJECT PRE FEASIBILITY REPORT

Application for TORs

Proposed expansion project for

NAME OF THE M/s. Vasudev Drugs Intermediates.

Sr. Capacity T/month

Resource type Requirement Source

After proposed expansion: Total

Power Existing: 75 kVA The power supply is/will be supplied by

Fuel Existing: Flue is/will be sourced locally.

After proposed expansion:

POLLUTION POTENTIAL & MITIGATION MEASURES

Parameter Potential Mitigation

Wastewater Existing: Total kl/day In existing the domestic wastewater is

Air Emissions Existing: In existing Boiler (600 kg) is attached as

D.G. Set- 250 kVA (1 No.)

Hazardous & Existing: Used oil is/will be sent to Registered Re-

Used Oil: 0.12 kl/annum

Discarded containers/ Bags/ Liners:

Noise Expected levels  Regular maintenance of the machinery

2.1.1 IDENTIFICATION OF THE PROJECT

Total Capacity 10.00 26.500 36.500

2.1.2 PROJECT PROPONENT

2.1.3 NATURE OF THE PROJECT

2.1.4 NEED OF PROJECT & DEMAND-SUPPLY GAP

2.1.5 IMPORTS VS. INDIGENOUS PRODUCTION

2.1.6 EXPORT POSSIBILITY

2.1.7 DOMESTIC / EXPORT MARKETS

Figure 3.1: Location of the project site

Figure 3.2: Satellite image of the project site

(Source: Google Earth)

Figure 3.3: Site layout plan

(Source: M/s Vasudev Drug Intermediates.)

Table: 3.1 Area Statement

3.2 DETAILS OF THE ALTERNATIVE SITE

3.3 SIZE & MAGNITUDE OF OPERATION

3.4 PROJECT DESCRIPTION WITH PROCESS DETAILS

3.5 RAW MATERIAL FOR FINISHED PRODUCTS

3.6 HAZARDOUS CHEMICAL STORAGE & HANDLING

3.7 RESOURCE OPTIMIZATION& AVAILABILITY

3.7.1 LAND & BUILDING REQUIREMENT

Table 3.4: List of equipment/machineries

13 Cooling tower (50 TR) 1Nos.

3.7.3 POWER REQUIREMENT

3.7.4 FUEL REQUIREMENT

3.7.5 WATER REQUIREMENT

The category wise bifurcation of fresh water is given as follows:

Table 3.5: Category wise fresh water requirement

3.7.6 MAN-POWER REQUIREMENT

Table 3.6: Man-power requirement

3.8 QUANTITY OF WASTE TO BE GENERATED

Table 3.7: Waste water generation

Figure 3.4: Water balance diagram for existing scenario

(Source: M/s Vasudev Drug Intermediates.)

Figure 3.5: Water balance diagram for proposed scenario

(Source: M/s Vasudev Drug Intermediates.)

3.8.1 WASTE WATER GENERATION & MANAGEMENT

3.8.2 WASTE WATER CHARACTERISTICS

Table 3.8: Expected characteristics of composite waste water

3.8.3 AIR EMISSIONS & CONTROL

3.8.3.1 PROCESS EMISSION

3.8.3.2 UTILITY EMISSION

3.8.3.3 FUGITIVE EMISSION

3.8.4 HAZARDOUS/NON-HAZARDOUS. WASTES MANAGEMENT