PROJECT PRE-FEASIBILITY REPORT For Proposed Expansion Project For Manufacturing of Bulk

161 Pages·2017·4.32 MB·English

PROJECT PRE-FEASIBILITY REPORT

For

Proposed Expansion Project

For

Manufacturing of

Bulk drugs and Intermediates

AT

Plot No.1408, 1409,
GIDC Estate,
Ankleshwar
Dist- Bharuch

Project Proponent
CONTENTS
Chapters
S. No. Particulars Page No.
1 Executive Summary 1-4
2 Introduction Of The Project 5-6
2.1 Identification Of The Project And Project Proponent 5
2.1.1 Identification Of The Project 5
2.1.2 Details Of Project Proponent 6
2.1.3 Nature Of The Project 7
2.2 Need Of Project & Demand-Supply Gap 7
2.2.1 Imports vs. Indigenous Production 7
2.2.2 Domestic / Export Market 7
2.2.3 Employment Generation due to Project 7
3 Project Discription 8-30
3.1 Type & Location Of Project 8
3.1.1 Type 8
3.1.1.1 Location 8
3.2 Details Of Alternative Site 10
3.3 Size & Magnitude Of Operation 10
3.4 Project Discription With Process Details 10
3.5 Raw Material For Finished Products 10
3.6 Material Storage & Transportation 17
3.7 Resource Optimization& Availability 18
3.7.1 Land 18
3.7.2 Building 18
3.7.3 Equipment 19
3.7.4 Power & Fuel Requirement 20
3.7.5 Water 20
3.7.6 Man-Power 21
3.8 Quantity Of Waste To Be Generated 21
3.8.1 Wastewater Generation & Management 21
3.8.2 Wastewater Characteristics 25
3.8.3 Wastewater Treatment & Disposal 25
3.8.4 Air Emissions & Control 27
3.8.4.1 Process Emission 27
3.8.4.2 Utility Emission 27
3.8.4.3 Fugitive Emission 28
3.8.5 Hazardous/Non-Hazardous Wastes Management 28
3.8.6 Noise Control 29
3.9 Health And Safety Measures 29
3.10 Environmental Health & Safety Cell 30
3.11 Post Project Monitoring Plan 30
4 Site Analysis 31-29
4.1 Connectivity 31
4.2 Land Form, Land Use & Land Ownership 31
4.2.1 Land Form 31
4.2.2 Land Use Pattern 31
4.2.3 Land Ownership 31
4.3 Topography 31
4.4 Salient Features 31
4.5 Existing Infrastructure 32
i
S. No. Particulars Page No.
4.6 Soil Classification 32
4.7 Climate & Meterology 32
4.7.1 Temperature 33
4.7.2 Humidity 33
4.7.3 Cloud Cover 33
4.7.4 Rainfall 33
4.7.5 Wind Pattern 33
4.7.6 Social Infrastructure 33
4.7.7 Educational Facilities 33
4.7.8 Medical Facilities 34
5 Planning Brief 35-36
5.1 Planning Concept 35
5.2 Population Projection 35
5.3 Area Statement 35
5.4 Assesment Of Infrastructure Demand (Physical & Social) 35
5.5 Amenities/Facilities 36
5.5.1 Drinking Water Facilities 36
5.5.2 Power Supply Facilities 36
5.5.3 Communication & Banking Facilities 36
5.5.4 Transport Facilities 36
6 Proposed Infrastructure 37
6.1 Industrial Area 37
6.2 Residential Area 37
6.3 Greenbelt 37
6.4 Social Infrastructure 37
6.5 Connectivity 37
6.6 Drinking Water Management 37
6.7 Sewerage System 37
6.8 Industrial Waste Management 37
6.9 Solid Waste Management 37
6.10 Power Requirement & Source Of Supply 37
7 Rehabilitation & Resettlement ( R& R) Plan 38
7.1 Policy To Be Adopted 38
8 Project Schedule & Cost Estimates 39
8.1 Time Schedule Of The Project 39
8.2 Estimated Project Cost 39
9 Analysis Of Proposal 40
9.1 Financial & Social Benefits 40

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 List of Raw Materials 10
3.2 List of Proposed Equipment 20
3.3 Power & Fuel Requirement 20
3.4 Total Water Consumption (kl/day) 21
3.5 Man-Power Requirement 21
3.6 Category Wise Waste Water Generation 22
3.7 Expected Characteristics of Composite Waste Water To ETP 25
3.8 Existing ETP Unit Details 27
3.9 Details of Process Emissions 27
3.10 Details of Utility Emissions 27
3.11 Details of Hazardous And Solid Waste Generation And Its Management 28
3.12 Safety Details 29
3.13 Environmental Monitoring Plan 30
4.1 Salient Features of The Project Site 31
4.2 Summary Meteorological Data At Nearest Imd Station- Bharuch 32
5.1 Distribution of Population 35
5.2 Area Stattement 35
8.1 Total Capital Cost Projection 39
8.2 Recurring Cost Provision For EHS 39

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 Plant Layout 19
3.4 Water Balance Diagram - Existing Scenario (in kl/day) 23
3.5 Water Balance Diagram - Proposed Scenario (in kl/day) 24
3.6 Flow Diagram of Existing Effluent Treatment Plant 26

List of Annexures
Sr. No. Description
Annexure 1(a) Copy of Existing EC dated 9th August, 2007
Annexure 1(b) Forwarding Letter Submitted for EC Compliance Report
Annexure 2 Copy of Existing CC&A
Annexure 3 Process Technology
Annexure 4 Storage & Transportation of Material
Annexure 5 Characteristics of Material
Annexure 6 Land Document
Annexure 7 TSDF Membership Certificate

iii
Project Pre-feasibility report

CHAPTER – 1
EXECUTIVE SUMMARY
The project is summarized in the below table:
Table 1.1: Project Summary
PARTICULARS DETAILS
Name of the unit M/s. Abhilasha Pharma Pvt. Limited
Occupier Mr. M.D. Soni (Director)
Products Sr. Name of Products Quantity T/Month
No. Existing Proposed Total
Existing Products
1. 1:1 Di Methylbigumide Base (Metformin) 50 ---- 50
2. N-[4-[2-(3- Ethyl -4 methyl-2 –oxo-3-pyrroline -1- 0.05 ---- 0.05
Carboxamido) Ethyl Benzene Sulfonamide
(Glimepiride)
OR
3. 4-Hydroxy -9(H) Carbazole (Carvidilol) 0.9 ----- 0.9
4. 4-2-s (Chloro 2 –MethoxyBenzamido Ethyl)
PehenylSulphonamide (Glibenclamide)
5. DipheylHydanation (Phenytion Sodium)
6. N- Methyl -4-(8-Chloro-5,6 Di Hydro -1 (H)
Benzo (5,6) Cyelohepta (1,2B) Pyrideine -11
YlidinePiperidine (Lorataine)
7. 1-[2-Amino-1-P-Methoxyphenyl Ethyl]
Cyclohexanol Hydrochloride (Venalafixine)
8. 2,4 Difluro -2 (1H-1-2-4, Triazole -1-yl
Acetophenone) (Fluconazole)
9. 5-fluro -2 –Hydroxyl Acetophenone (Nebivilol)
10. 3-Methylamino -1 Phenyl -1-Propanol
(Fluoxetine)
11. 3-Ethyl [5- Methyl –(4RS) 2-/ (2 Aminoethoxy)
Methyl ]4-(2- Chlorophyl)-6-Methyl-1-4-Di-
Hydropyridine -3,5 Discarboxylate
Proposed Products
12. Metformin Hydrochloride --- 100 100
13. Glimepiride --- 0.2 0.2
14. Pioglitazone Hydrochloride --- 7.0 7.0
15. 5-[[4-2-(5-ethyl-2-pyridinyl) ethoxy]
Phenvlimethyl]-2.4-thiazolidinedione (Piobase)
16. 5-{[2-(5-ethyl-2-pyridyl) ethoxy]Benzylidene}-2,4-
Thiazolidinedione (Benzylidene)
17. Desloratadine --- 0.1 0.1
18. Glibenclamide --- 0.5 0.5
19. Loratadine --- 0.8 0.8
20. Nebivilol Hydrochloride --- 0.2 0.2
21. Chlorohexidine --- 4.0 4.0
22. Clopidogrel Bisulfate --- 2.0 2.0
23 Fluconazole --- 0.5 0.5
24. Fluoxetine HCl --- 0.5 0.5
25. Nicoumalone (Acenocoumarol) --- 0.066 0.066
26. Fluphenazine Decanoate --- 0.0125 0.0125
27. Crotamiton --- 1.25 1.25
28. Bupivacaine Hydrochloride --- 0.083 0.083
29. Ropicaine Hydrochloride --- 0.041 0.041
Total 50.95 117.2525 168.2025

Project: Project for manufacturing of Bulk drugs and Intermediates 1 | P age
Project Pre-feasibility report

PARTICULARS DETAILS
Location Plot No. 1408, 1409, GIDC Industrial Estate, Ankleshwar-393002, Dist. -
Bharuch, Gujarat.
Nature of Proposed expansion project for manufacturing of Bulk drugs and Intermediates
project
RESOURCES
Resource type Requirement Source
Land Existing: 5787 m2 GIDC Ankleshwar
Proposed additional:
NIL
Water Existing Operations: GIDC water Supply
Domestic: 1.5 kl/day
Industrial: 18.6 kl/day
Gardening: 1.0 kl/day
Total: 21.1 kl/day (Fresh – 15.5 +
Recycle – 5.6 kl/d)
After Proposed Expansion Project:
Domestic: 3.0 kl/day
Industrial: 52 kl/day
Gardening: 1.5 kl/day
Total: 67.0 kl/day (Fresh – 56.5 +
Recycle – 10.5)
Power Existing: 100 kVA Dakshin Gujarat Vij Co. Ltd. (DGVCL)
Proposed additional: 200 kVA
Fuel Existing:  Natural gas is/will be supplied
Natural gas: 270 SCM/day through Gujarat Gas Company
Diesel: 11 liter/hr. Limited.
After Proposed Expansion Project:  Diesel is/will be purchased from
Natural gas: 2625 SCM/day local market.
Diesel: 11 liter/hr
POLLUTION POTENTIAL & MITIGATION MEASURES
Parameter Potential Mitigation
Wastewater Existing Operations:  The total wastewater generated
Domestic: 1.3 kl/day from the existing operations is 7
Industrial: 5.67 kl/day kl/day (Domestic: 1.3 kl/day &
Total: 6.97 kl/day Industrial: 5.7 kl/day).
After Proposed Expansion Project:  Domestic wastewater is disposed
Domestic: 2.5 kl/day through septic tank/ soak pit
Industrial: 29.5 kl/day system.
Total: 32 kl/day  The streams like process effluent,
plant washing water & utility
streams like boiler blowdown,
cooling tower blowdown & DM
regeneration plant about 5.7 kl/day
effluent is treated in in-house ETP
and treated in RO.
 Permeate from RO @3.9 kl/day is
recycled as cooling tower makeup
& 1.7 kl/day RO reject is sent to
evaporator.
 From evaporator, 1.65 kl/day
condensate is further recycled as
cooling tower makeup & salt is
disposed to TSDF.
 After proposed expansion projects,
about 32 kl/day wastewater will be
generated (Domestic: 2.5 kl/day &
Project: Project for manufacturing of Bulk drugs and Intermediates 2 | P age
Project Pre-feasibility report

PARTICULARS DETAILS
Industrial: 29.5 kl/day).
 The streams like domestic (septic
tank overflow), scrubber, process
effluent & plant washing water
about 21 kl/day will be treated in in-
house ETP.
 Total 21 kl/day will be discharged
to NCT/ CETP for final treatment &
ultimate disposal to deep sea.
 Remaining 11 kl/day effluent
generated from utility streams like
boiler blowdown, cooling tower
blowdown & DM plant regeneration
will be treated in RO.
 Permeate from RO @7.5 kl/day will
be recycled as cooling tower
makeup & 3.5 kl/day RO reject will
be sent to evaporator.
 From evaporator, 3.0 kl/day
condensate will further be recycled
as cooling tower makeup & salt will
be disposed to TSDF.
Existing Installations:  Natural gas is used as fuel in
 Boiler 800 kg/hr - 1 No. existing utility installation as well as
 D.G. set (125 kVA) - Stand by after proposed installation.
 Adequate stack height is/will be
Proposed Installations: provided.
 Steam Boiler (1000 kg/hr) - 1 No.  Process gases are/ will be
 DG Set (125 KVA) – 1 No. generated in form of HCl, NOx,
 Thermic Fluid Heater (1 SO2, Cl2, NH3, from manufacturing
lakh.kCal/hr.) - 1 No. process.
 Thermic Fluid Heater (50000  Twin scrubber is/will be provided to
kCal/hr.)- 1No. scrub out gases generated from
the process using water and
caustic soda solution.
 Raw Materials & Products are/ will
be stored in properly designated
storage area and under good
storage conditions to prevent any
volatilities.
 Regular monitoring is/ will be done
of piping and fittings for checking of
any leakages.
 Good housekeeping will be
maintained in the plant.
Hazardous & Hazardous Waste  Used oil is/will be disposed by
solid waste  ETP (Cat. 34.2) : 60 T/Annum selling to GPCB authorized
 Discarded containers/ barrels/ reprocessors.
liners (Cat. 33.1): Bag/Liner -  Distillation residue, Date Expired &
46,800 nos./ Annum, Drums - Off Specification product & Process
18000 Nos./ Annum, Carboys - waste is/will be disposed by
7200 Nos./Annum incineration at BEIL or co-
 Used Oil (Cat. 5.1): 12 liter/Annum processing in cement Industries.
 Distillation Resideu (Cat. 28.1): 18  Spent Carbon is/will be disposed
T/Annum by incineration at BEIL.
 ETP sludge & MEE Salt is/will be
Project: Project for manufacturing of Bulk drugs and Intermediates 3 | P age
Project Pre-feasibility report

PARTICULARS DETAILS
 Spent Carbon (Cat. 28.3): 3 disposed at TSDF, BEIL.
T/Annum  Discarded Container/ Barrels/
Hazardous Waste After Proposed Liner is/ will be disposed by reuse
Expansion Project & decontamination
 ETP (Cat. 34.2) : 180 T/Annum  Spent solvent will be sent for
 Discarded containers/ barrels/ recovery.
liners (Cat. 33.1): Bag/Liner -
80922 nos./ Annum, Drums - 3340
Nos./ Annum, Carboys -2630
Nos./Annum
 Used Oil (Cat. 5.1): 22 liter/Annum
 Distillation Resideu (Cat. 28.1):
159 T/Annum
 Spent Carbon (Cat. 28.3): 19
T/Annum
 Date Expired & Off Specification
product (Cat.28.4/ 28.5): 0.07
T/Annum
 MEE Salt (Cat. 34.2): 6 T/ Annum
 Process Waste (Cat. 28.1): 6 T/
Annum
 Spent Solvent (Cat. 28.6): 105 T/
Annum
Noise Plant premises  Regular maintenance is/will be
 <75 dB(A) during day time done to reduce the noise levels.
 <70 dB(A) during night time  D.G. set is/will be provided with
acoustic enclosures
 Ear plugs are/will be provided to
operating personnel.
(Source: Abhilasha Pharma Pvt. Ltd., Ankleshwar)

Project: Project for manufacturing of Bulk drugs and Intermediates 4 | P age
Project Pre-feasibility report

CHAPTER – 2
INTRODUCTION OF THE PROJECT
2.1 IDENTIFICATION OF THE PROJECT AND PROJECT PROPONENT

2.1.1 Identification of the Project
M/s. Abhilasha Pharma Pvt. Ltd. is an operational manufacturing unit and manufacturing “Bulk
drugs and Intermediates” at Plot No.1408, 1409, GIDC Estate, Ankleshwar. Dist. - Bharuch.
Earlier the company had obtained EC for its existing plant at 9th August, 2007. The copy of same is
attached as Annexure – 1 (a) & a copy of forwarding letter of last submitted six monthly EC
compliance report is attached as Annexure – 1 (b). The company has obtained valid consolidated
consent and authorization (CC&A) vide No. AWH-75646 dated 26/01/2016 and valid up to
28/12/2020. The copy of existing CC&A is attached as Annexure - 2.
Now the company is planning for increase its production capacity from 50.95 T/Month to 168.2025
T/Month by adding similar category products.
Table 2.1: List of Proposed Products
Quantity MT/Month
Sr.
Name of Products Proposed
No. Existing Total
Additional
Existing Products
1. 1:1 Di Methylbigumide Base
50 ---- 50
(Metformin)
2. N-[4-[2-(3- Ethyl -4 methyl-2 –oxo-3- 0.05 ---- 0.05
pyrroline -1- Carboxamido) Ethyl
Benzene Sulfonamide (Glimepiride)
OR
3. 4-Hydroxy -9(H) Carbazole (Carvidilol)
4. 4-2-s (Chloro 2 –MethoxyBenzamido
Ethyl) PehenylSulphonamide
(Glibenclamide)
5. DipheylHydanation (Phenytion
Sodium)
6. N- Methyl -4-(8-Chloro-5,6 Di Hydro -1
(H) Benzo (5,6) Cyelohepta (1,2B)
Pyrideine -11 YlidinePiperidine
(Lorataine)

7. 1-[2-Amino-1-P-Methoxyphenyl Ethyl]

Cyclohexanol Hydrochloride 0.9 -----
0.9
(Venalafixine)

8. 2,4 Difluro -2 (1H-1-2-4, Triazole -1-yl
Acetophenone) (Fluconazole)
9. 5-fluro -2 –Hydroxyl Acetophenone
(Nebivilol)
10. 3-Methylamino -1 Phenyl -1-Propanol
(Fluoxetine)
11. 3-Ethyl [5- Methyl –(4RS) 2-/ (2
Aminoethoxy) Methyl ]4-(2-
Chlorophyl)-6-Methyl-1-4-Di-
Hydropyridine -3,5 Discarboxylate
Proposed Products
12. Metformin Hydrochloride --- 100 100
Project: Project for manufacturing of Bulk drugs and Intermediates 5 | P age
Project Pre-feasibility report

Quantity MT/Month
Sr.
Name of Products Proposed
No. Existing Total
Additional
13. Glimepiride --- 0.2 0.2
14. Pioglitazone Hydrochloride ---
15. 5-[[4-2-(5-ethyl-2-
7.0 7.0
pyridinyl)ethoxy]Phenvlimethyl]-2.4-
thiazolidinedione (Piobase)
16. 5-{[2-(5-ethyl-2-pyridyl)
ethoxy]Benzylidene}-2,4-
Thiazolidinedione (Benzylidene)
17. Desloratadine --- 0.1 0.1
18. Glibenclamide --- 0.5 0.5
19. Loratadine --- 0.8 0.8
20. Nebivilol Hydrochloride --- 0.2 0.2
21. Chlorohexidine --- 4.0 4.0
22. Clopidogrel Bisulfate --- 2.0 2.0
23 Fluconazole --- 0.5 0.5
24. Fluoxetine HCl --- 0.5 0.5
25. Nicoumalone (Acenocoumarol) --- 0.066 0.066
26. Fluphenazine Decanoate --- 0.0125 0.0125
27. Crotamiton --- 1.25 1.25
28. Bupivacaine Hydrochloride --- 0.083 0.083
29. Ropicaine Hydrochloride --- 0.041 0.041
Total 50.95 117.2525 168.2025
(Source: Abhilasha Pharma Pvt. Ltd., Ankleshwar)
2.1.2 Details of Project Proponent
The list of the board of directors are given below:
Table 2.2: List of Directors
Sr. Name of Directors Address
No.
1 Amrutlal N. Chaudhari A-3, Jalakamal Society No.1
New Coloney, GIDC, Ankleshwar 393 002
Ph No. 250061
2 Hiren A. Chaudhari A-3, Jalakamal Society No.1
New Coloney, GIDC, Ankleshwar 393 002
Ph No. 250061
3 Priyang Y. Chaudhari Old Post Building
Kansari Seri, Mansa.
Ph No. 270303
4 Bhargav M. Soni B.No.5, Navjeevan Society
Near Gattu School, Ankleshwar 393 002
Ph No. 253560
5 M. D. Soni
B.No.5, Navjeevan Society
Near Gattu School, Ankleshwar 393 002
Ph No. 253560
(Source: Abhilasha Pharma Pvt. Ltd., Ankleshwar)

Project: Project for manufacturing of Bulk drugs and Intermediates 6 | P age