1
PRE - FEASIBILITY REPORT
for
PROPOSED EXPANSION OF BULK DRUG AND
BULK DRUG INTERMEDIATES IN
EXISTING UNIT
of
M/s. DARSHAN PHARMACHEM PVT. LTD.
PLOT NO. 3609, NEAR FICOM CHOKDI, GIDC ESTATE,
ANKLESHWAR-393002, DISTRICT: BHARUCH, GUJARAT
NABL Accredited Testing Laboratory
ISO 9001:2008 Certified Company
Aqua-Air Environmental Engineers P. Ltd.
403, Centre Point, Nr. Kadiwala School, Ring
Road, Surat - 395002
Prepared By:
NABL Accredited Testing Laboratory
ISO 9001:2008 Certified Company
Aqua-Air Environmental Engineers P. Ltd.
403, Centre Point, Nr. Kadiwala School, Ring
Road, Surat - 395002
NABL Accredited Testing Laboratory
ISO 9001:2008 Certified Company
Aqua-Air Environmental Engineers P. Ltd.
403, Centre Point, Nr. Kadiwala School, Ring
Road, Surat - 395002
Prepared By:
2
CONTENTS
Sr. No. Description Page No.
1. Executive Summary 3
2. Introduction of the Project/Background information 31
3. Project Description 32
4. Site Analysis 40
5. Planning Brief 42
6. Proposed Infrastructure 43
7. Rehabilitation and resettlement (R & R) Plan 44
8. Project Schedule & Cost Estimates 45
9. Analysis of Proposal (Final Recommendations) 45
3
1.0 EXECUTIVE SUMMARY
1.1 Company Profile
M/s Darshan Pharmachem Pvt. Ltd. proposes expansion of manufacturing of Bulk Drugs and
Bulk Drug intermediates at Plot No. 3609, Nr. Ficom Chokdi, GIDC Estate, Ankleshwar-393002,
District: Bharuch, Gujarat.
1.2 Project Detail
1.2.1 Products along with Production Capacity
Sr
No Product Cas No.
Existing
Capacity
(MT/Month)
Additional
Capacity
(MT/Month)
Total
Capacity
(MT/Month)
Existing Products
1.
1-(4-Hydroxy Phenyl)
Piperazine
Hydrochloride
0056621-48-8 10 -- 10
2. 2-Chloro Ethyl Amine
Hydrochloride 0000870-24-6 10 -- 10
3.
N,N, Bis (2-Chloro
Ethyl) Amine
Hydrochloride
0000821-48-7 7 -- 7
Total 27 -- 27
Proposed Products
1.
1-(3-Chlorophenyl)-4-
(3-chloropropyl)
piperazine
hydrochloride
52605-52-4
-- 30 30
2.
N-methyl-N-benzyl-3-
hydroxy
acetophenone
suphate ( MAAP
Sulphate)
120410-24-4
3. N-Acetyl-Thiazolid-4-
carboxylic acid
5025-82-1
4.
1-Acetyl-4-(4’-
Hydroxyphenyl)
Piperazine
67914-60-7
5. Dorepenem 148016-81-3
6. Candesartan & 139481-59-7
4
intermediates
7. Celecoxib &
intermediates 169590-42-5
8. Clopidogrel Besilate & intermediates
113665-84-2
9. Ketaconazole &
intermediates 65277-42-1
10. Levo cetirizine dihydrochloride
130018-87-0
11. Levetiracetam &
intermediates 102767-28-2
12. Pantoprazole Magnesium & intermediates
102625-70-7
13. Phenylephrin Hydrochloride
61-76-7
14. Prasugrel
Hydrochloride 389574-19-0
15. Quetiapine fumarate 111974-72-2
16. Rabeprazole Sodium 117976-90-6
17. Solifenacin 242478-37-1
18. Tamsulosin Hydrochloride
106463-17-6
19. Telmisartan 144701-48-4
20. Bortezomib 179324-69-7
21. Trimebutine Maleate 34140-59-5
22. Caberogoline 81409-90-7
23. Mycophenolat Mofetil
& intermediates 128794-94-5
24.
Raloxifene
Hydrochloride
& intermediates
82640-04-8
25. Febuxostat &
intermediates 144060-53-7
26. Pregabline &
intermediates 148553-50-8
27. Rosuvastatin Calcium
& intermediates 147098-20-2
28. Biperidine
Hydrochloride 514-65-8
5
29. Donepizil
Hydrochloride 120011-70-3
30. Domperidone &
intermediates 57808-66-9
31. Carisoprodole 78-44-4
32. Topiramate 97240-79-4
33. Valsartan 137862-53-4
34.
Moxifloxacin
Hydrochloride &
intermediates
354812-41-2
35. Cinnarizine 298-57-7
36. Cyano diol base 103146-25-4
37. Dextromethorphan
Hydrobromide 125-69-9
38. 2-Amino-5- Methyl
Thiazol 7305-71-7
Total
(Proposed Products) -- 30 30
Total
( Existing+ Proposed) 27 30 57
By-Products
1. 4-Nitro Toluene 99-99-0
--
13.8 13.8
2. 4-Nitrobenzyl Alcohol 619-73-8 3.8 3.8
3. Ammonium Sulphate 7783-20-2 7.17 7.17
4. Butane-1-thiol 4779-86-6 2.52 2.52
5.
2,3-Dichloro-5,6-
Dicyano
benzoquinone
84-58-2
8.6 8.6
6. Triphenyl phosphine
oxide 791-28-6
7.5 7.5
7. Tert-butyl fluoro
dimethyl silane --
3.4 3.4
8. Methoxy Ethanol 109-86-4 6.5 6.5
9. Dimethyl Sulfide 75-18-3 2.1 2.1
Total (By-Products) -- 55.4 55.4
6
Raw Material Requirement
List of Raw Materials And Their Capacity:
EXISTING PRODUCTS:
Sr.No. Raw Material Quantity (KG/KG)
1. 1-(4-Hydroxy Phenyl) Piperazine Hydrochloride
Bis HCL 1.88
PAP 1.18
NaOH 0.29
EDC 3.53
Acetic anhydride 1.13
Methanol 1.82
Toluene 0.59
2. 2-Chloro Ethyl Amine Hydrochloride
Monoethanolamine 0.63
Thionyl chloride 1.38
NaOH 0.16
EDC 1.88
3. N,N, Bis (2-Chloro Ethyl) Amine Hydrochloride
DiEthanolamine 0.63
Thionyl chloride 1.38
NaOH 0.16
EDC 1.88
7
PROPOSED PRODUCTS:
Sr. No. Raw Materials Quantity
(KG/KG)
1. 1-(3-Chlorophenyl)-4-(3-chloropropyl) piperazine hydrochloride
MCA 2
Bis HCL 1.2
Toluene 20
Triethylamine 0.67
MDC 20
NaOH 0.27
Hydrochloric Acid (36%) 0.67
1-Bromo 3-chloro propane 1.17
Ethyl Acetate 33.33
Isopropyl Alcohol 23.33
Hexane 11.67
2. N-methyl-N-benzyl-3-hydroxy acetophenone suphate ( MAAP Sulphate)
M-Hydroxy Acetophenone 2.03
N-Methyle amine 0.47
Di isopropyl ethylamine 0.43
Toluene 10
Bromine 30
Palladium Carbon 2
n-Heptane 8
Hydrogen gas 0.03
Hydrochloric Acid 1.2
NaOH 1.33
Ethyl Acetate 110
8
3. N-Acetyl-Thiazolid-4-carboxylic acid
Bi cyclic ketone (BCK) Acetophenone 1.2
Amino Ethane thiol 0.28
Di-Isopropyl Amine
0.4
Hydrochloric Acid (36%) 0.36
Acetonitrile 19
MDC 6
Formamidine 0.18
Para toluene sulfonyl chloride 0.36
Sodium Hydroxide 0.23
Hydrochloric Acid 0.22
Ethyl Acetate 18.74
Activated Carbon 0.1
Acetic anhydride 3.46
Hydrogen 0.06
Methanol 17.34
Hexane
8.6
4. 1-Acetyl-4-(4’- Hydroxyphenyl) Piperazine
Bis-(2-Chloro ethyl)amine HCl 2.5
P-Amino phenol 1.55
Methanol 10
Sodium acetate trihydrate 3
Acetic anhydride 2.5
Sodium hydroxide(47%)
7.13
9
5. Dorepenem
Methyl Vinyl Phosphate 1.5
Mercapto Pyrrolidine Chain 0.9
Acetonitrile
30
N-Ethyl Diispropyl Amine
0.5
DMF 15
NaOH 0.4
HCl (36%) 1
Palladium Carbon (10%)
1.65
Tetrahydrofuran 15
6. Candesartan & intermediates
Trityl Candisartan 1.9
Dimethyl form amide 10.35
Potassium Carbonate 1.05
Cyclohexyl,1-Chloro ethyl carbonate
0.58
Ethyl Acetate 65.4
Sodium Chloride 1.05
Sodium Sulphate 1.08
Cyclo hexane 25
MDC 6.5
Methanol 10.4
Formic Acid 0.09
Sodium Bicarbonate 1.25
Isopropyl alcohol
4.3
10
7. Celecoxib & intermediates
Trifluro Acetic Acid 0.56
Methanol 3.5
Sulfuric Acid 0.02
4-Methyl Acetophenone 0.58
Sodium Methoxide 0.3
Hydrochloric Acid (35%) 0.65
Toluene 15.95
4-Amino benzene Sulfonamide 1
Hydrochloric Acid (32%) 3
Sodium Nitrite 0.4
Sodium Hydroxide 0.52
Sodium metabisulfite 1.2
Isopropyl Alcohol 2
Ethyl Acetate 1.5
Activated Carbon 0.23
8. Clopidogrel Besilate & intermediates
2-Thophene Ethyl Amne 0.5
Formaldehyde 0.2
Sodum Sulphate 0.38
DMF 2
Hydrochlorc Acd (25%) 0.52
Toluene 9
Acetone 12.26
PA 3.2
Bromo Ester 0.9
Sulphurc Acd 0.28
Potassum carbonate
0.4
11
Methanol 7.05
L(-)Camphor sulphonc acd 0.66
Soda Ash 0.5
MDC 28.65
MBK 3.3
Ethyl Acetate 1.36
Sodum bcarbonate 0.25
Sodum bsulphate 0.18
Benzene sulfonc acd 0.38
MTB Ether 5.55
Hexane 2.27
Activated Carbon 0.1
9. Ketaconazole & intermediates
Cs-2-(2,4-dchlorophenyl)2-(1H-mdazol-1-yl-methyl)-1,3-
doxolane-4-methanol 1.0
Para Toluene Sulfonyl Chlorde 0.58
Sodum Carbonate 0.2
Methanol 9.4
Methylene Dchlorde 7
Trethyl Amne 0.35
Hydrochlorc Acd (30%) 0.5
Ethyl Acetate 8.3
n-Hexane 5
Actvated Carbon 0.2
AHPP 0.55
Dmethyl Sulfoxde 2.96
SMO Powder
0.14
12
CS Flakes 0.15
Acetone 5
10. Levo cetirizine dihydrochloride
p-chloro benzo phenone 1.2
Ammonum formate 0.35
Hydrochlorc acd 0.25
Toluene 16
Actvated carbon 0.1
Sodum hydroxde 0.25
Tartarc acd 0.32
MDC 16.5
para toluene sulphonyl chlorde 0.52
n,n-bs( 2-chloro ethyl)amne 0.5
HCl 0
Sodum Hydroxde 0.25
Ethyl d sopropyl amne
0.28
Methanol 4
Hydro bromc acd 0.23
Acetc acd 0.15
Chloro ethanol 0.2
Trethyl amne 0.247
Sodum mono chloro acetate 0.27
Hydrochlorc acd 0.17
D methyl formamde 1
13
Actvated Carbon 0.1
Acetone 1.0
11. Levetiracetam & intermediates
(S)-2-Amnobutanamde hydrochlorde 1.25
4-Chlorobutyryl chlorde 1.4
Sodum Sulphate 1.5
Potassum Hydroxde Powder 2.57
Tetrabutyl ammonum bromde 0.09
Ethyl acetate 6.07
Methylene Dchlorde 9.7
12. Pantoprazole Magnesium & intermediates
Maltol 0.85
Dmethyl sulphate 0.45
Potassum carbonate 0.47
Acetone 10
Ammonum Carbonate 0.65
Toluene 3
Phosphorous oxy chlorde 0.35
Sodum Hydroxde 0.92
Methylenedchlorde 3
Hydrogen peroxde (30%) 0.5
Acetc acd 0.45
Methanol 8.75
MDC 7
Acetc Anhydrde 0.45
Chloroform 2
Thonyl chlorde 0.39
Methylenedchlorde 8.5
5-dFluoromethoxy-2-mercapto-benzmdazole 0.7
14
Sodum Hydroxde flakes 0.37
Toluene 5
Sodum hypochlorte (4%) 5.1
Methylenedchlorde 10
Actvated Carbon 0.1
Magnesum chlorde (5%) 3
13. Phenylephrin Hydrochloride
3-Hydroxy Acetophenone 1
Ethyl Acetate 6
Bromne 0.6
Aluminum Chlorde 0.02
Toluene 11
10% Sodum bcarbonate 1
Sodum Sulphate 0.1
N-Methyl Benzyl Amne 0.75
IPA-HCl 2
IPA 1
Methanol 10
10% Palladum Carbon 0.15
Hydrogen gas 0.03
Actvated Carbon 0.12
Lq.Ammona 3.7
L(+) Tartarc acd 2.44
PA 8
PA HCl 4
Acetone 3
14. Prasugrel Hydrochloride
2-Bromo-1-Cyclopropyl-2-(2-Fluorophenyl) Ethanone 0.88
15
5,6,7,7a-Tetrahydrotheno [3,2-c] Purdne-2(4H)-one 0.54
Potassum Hydroxde 0.22
Methanol 8.76
Acetc Anhydrde 0.32
Methyl Ethyl Ketone 2.94
Hydrogen Chlorde 0.12
Acetone 3.12
15. Quetiapine fumarate
2-Amnbphenylsulphate 0.63
Phenylchlorofumarate 0.54
Toluene 5.75
phosphorc acd 0.23
Acetone 2
Pperazne 0.205
Chloro ethoxy ethanol 0.30
Fumarc acd 0.28
Methanol. 2
16. Rabeprazole Sodium
2,3-Lutdne 0.46
Hydrogen Peroxde (50%) 0.33
Ntrc acd 0.3
Sulphurc acd 1.08
Acetc acd 0.46
3-Methoxy-1-Propanol 0.4
Sodum Hydroxde 0.67
Toluene 13.5
DMSO 2
Acetc anhydrde 1.5
Hydrochlorc acd 0.2
16
Thonyl Chlorde 0.53
MDC
13.5
Sodum Sulphate 0.1
2-Mercaptobenzmdazole 0.53
Sodum Hypochlorte (8%) 3.27
Acetone 1.5
Sodum hydro sulphate 0.12
MMA n Methanol 0.1
Isopropyl Alcohol 3
Actvated Carbon 0.1
17. Solifenacin
2-Phenyl ethyl amne 0.6
Benzoyl chlorde 0.7
Tr ethyl amne 0.75
Chloroform 6
N-Hexane 2.75
Phosphorus pentoxde 0.76
Phosphorus oxy chlorde 0.82
Toluene 5
MDC 17
NaOH flakes 1.26
Sodum boro hydrde 0.278
Methanol 6
D(-)-Tartarc acd 0.72
PA 8.4
Sodum Hydroxde 0.38
18. Tamsulosin Hydrochloride
(S)-5-(2-amnopropyl)-2- methoxybenzene sulfonamde 0.62
2-(O-Ethoxy phenoxy)ethyl bromde 0.91
17
Methanol 16.02
n-Hexane 3.73
50% lye soluton
0.4
Ethyl acetate 14.28
Ethanol 99% 7.45
Ethanol HCl 1.24
Absolute ethanol
5.58
19. Telmisartan
OTBN 0.45
Ethylene glycol 0.15
Potassum Hydroxde 0.37
Hydrochlorc acd 0.09
D methyl sulphate 0.30
Potassum Carbonate 0.32
D bromo d methyl hydanton 0.67
Acetone 12.52
Cyclohexane 1.8
Actvated Carbon 0.35
MDC 10
2-n-Propyl-4-methyl-6-(1- methylbenzmdazole-2-
yl)benzmdazole 0.71
DMF 0.7
Methanol 6.8
20. Bortezomib
so Butyl Boronc Acd 0.8
N-Heptane 43.6
Pnanedol 1.8
Sodum Chlorde 0.12
Znc Chlorde 0.72
THF 26
18
N-Hexyl Lthum 9.5
D so Propyl Amne 0.54
MDC 73
Sulphurc acd
0.52
HMDS 0.8
DPE 2.7
Tr Fluoro Acetc Acd 0.46
Dsopropyl Ether 45
L-Phenyl Alanne 0.9
Thonyl Chlorde 0.7
Methanol 41.5
PA 4.5
Pyrazne Carboxylc acd 0.5
DMF 10
N-Hydroxy Succnamde 3
D Cyclohexyl Carbodmde 1
N-Methyl Morpholne 0.7
Ethyl Acetate 18
Acetone 4
Sodum Hydroxde 0.2
Hydrochlorc Acd 0.82
N-Hydroxysuccnamde 0.5
Dcyclohexyl dcarbodmde 0.8
D sopropyl ethylamne 0.9
Sodum bcarbonate 0.78
Bortezomb base 1.5
sobutyl boronc Acd 0.3
21. Trimebutne Maleate
Methyl-2-(d methyl amno)-2-phenylbutyrate 0.55
19
70%Vtrde Toluene soluton 1.02
Toluene 9
Sodum hydroxde flake
0.1
Sodum sulphate 0.05
3,4,5-Trmethoxy benzoc acd 0.47
Trphosgene 0.67
DMF
0.01
Methanol 5
Trethyl Amne 0.23
Sodum sulphate 0.07
Malec acd 0.23
22. Cabergolne
Lysergol 1.4
Trethyl amne 0.56
Tert-butyldmethyl slyl chlorde 0.84
4-Dmethyl amno pyrdne 0.2
DMF 8
Palladum carbon 0.04
MDC 22
N-Heptane 4
Hydrogen gas 0.01
Ntrogen Gas 0.04
Chloro ethyl formate 0.4
Methanol 13
Sodum bcarbonate 0.6
Sodum chlorde 0.2
Toluene 8
4-Dmethylamno pyrdne 0.4
D-tert-butyl dcarbonate 0.8
20
TBAF 0.2
Acetc acd 0.4
Acetontrle 8
THF 6
TEMPO 0.2
odobenzene dacetate 0.1
Sodum thosulphate 0.24
Thonyl chlorde 0.4
MDC 8
Allyl bromde 0.4
Sodum hydroxde 0.14
TEA 0.34
Hydrochlorc Acd 0.12
EDC Free base 0.42
Alumna 0.1
MTBE 6
Acetone 4
n-Heptane 2
Actvated carbon 0.2
23. Mycophenolate Mofetl
Mycophenolc acid 1
Methanol 6.4
Sulphuric acid 0.335
Morpholne ethanol 0.4
Znc oxde 0.048
Ethyl acetate 12
Sodum hydroxde 0.26
Sodum bcarbonate 0.1
Phosphorc acd 0.012
21
Actvated carbon
0.2
24. Raloxfene Hydrochlorde
4[2-(1-pperdnoethoxy)]benzoc acd hydrochlorde
1
Thonyl chlorde 0.416
Toluene 8
Heptane 6
6-Methoxy-2-(4-methoxyphenyl)benzo(b)thophene 0.9
MDC 12
Ntrogen Gas 0.1
Alumnum chlorde 0.6
Ethane thol 0.2
Methanol 18
Hydrochlorc acd (10%) 1.4
DMF 2
Actvated carbon
0.2
25. Febuxostat
2-(4- hydroxyphenyl)-4-methyl-5- thazole carboxylc Acid
ethyl ester 1.4
Polyphosphouric acid 1.8
Hexamethyl tetramanine 0.2
Acetic Acid 0.32
DMF 11
Potassum carbonate 0.57
sobutyl bromde 0.57
Hydorxyl amne Hydrochlorde 0.28
Formc acd 0.19
Sodum Formate 0.27
THF 25
Sodum hydroxde 0.16
Ethanol 15
22
Hydrochlorc Acd 0.14
Actvated carbon 0.1
26. Pregabalin
Isoveraldehyde 0.89
Diethyl malonate 1.68
Acetic acid 1.21
Di isopropyl amine 0.09
n-Hexane 1.64
Sodium cyanide 0.43
Ethanol 8.64
Toluene 4.55
Methanol 2
Potassium hydroxide 0.45
Raney nickel 0.27
IPA 3.18
Hydrogen gas 0.05
(S)-Mandelic acid 1.07
Isopropyl alcohol 8.73
27. Rosuvastatin Calcium
4-Fluoro benzaldehyde 0.52
4-Methyl-3-oxo-pentanoic acid 0.663
Potassium hydroxide 0.24
Methyl Iodide 0.6
Methanol 5.5
S-Methyl iso thio urea 0.35
2,3-Dichloro-5,6-dicyano 0.85
HMPA 1
MDC 8
Meta chloro peroxy benzoic acid 1.19
23
Methyl amine 0.10
Ethanol 2.5
Methane sulfonyl chloride 0.35
Sodium hydride (60%) 0.01
Di methoxy ethane 3
Hydrogen 0.01
DIBAL-H 0.01
Toluene 8
Methyl(3R)-3-(tert butyl di methyl silyloxy)-5-oxo-6-
triphenyl phosphoranylidene hexanoate 1.45
Triethyl amine 0.15
N,N-Dimethyl formamide 3
Hydrogen fluoride 0.05
Ethyl acetate 10.5
Diethyl methoxy borane 0.2
Sodium boro hydride 0.01
THF 5
Calcium chloride 0.13
28. Biperiden Hydrochloride
Cyclo pentadiene 0.3
Methyl vinyl ketone 0.32
Sodium hydroxide 0.35
Methanol 5
Piperdine Hydrochloride 0.5
Para formaldehyde 0.15
Isopropyl alcohol 10
Phenyl magnesium chloride 0.5
Hydrochloric acid 0.2
THF 5
1,4-Dioxane 4
24
Hydrochloric acid 0.15
29. Donepezil Hydrochloride
Ethyl isonipecotate 0.75
Benzyl chloride 0.62
Toluene 14
Potassium carbonate 0.35
Vitride 0.86
Dimethyl sulfoxide 0.3
Hydrobromic Acid (48%) 0.3
5,6-Dimethoxy indanone 0.57
Methanol 8
Raney Nickel (catalyst) 0.1
Hydrogen 0.02
Isopropyl alcohol 3
Hydrogen chloride 0.2
30. Domperidone
N-Carbethoxy-4-piperidone 1.6
Ammonia gas 0.56
Methanol 16
Raney Nickel 0.6
Hydrogen 0.1
2,5-Dichloro Nitrobenzene 1.56
Sodium Carbonate 0.6
Hydrogen 0.1
Toluene 7
Urea 0.4
Sodium Hydroxide (48%) 1.5
1-(3-Chloropropyl)-1,3-dihydro- 0.8
2H-benzimedazole-2-one 0
25
Sodium Carbonate 0.4
Methyl Isobutyl Ketone 24
31. Carisoprodol
2-Methyl-2-propyl-1,3-propane diol 0.78
Dimethyl carbonate 1.1
Toluene 8.1
Sodium methoxide 0.06
Isopropylamine 1.64
Sodium cyanate 0.315
Chloroform 6.3
Hydrochloric acid (35%) 1
Sulphuric acid 0.5
Carisoprodol (Tech) 1.12
Methanol 3.35
Activated carbon
0.15
32. Topiramate
Fructose 1.15
Sulfuric Acid 0.31
Acetone 4.2
Sodium Hydroxide 0.26
n-Hexane 0.1
Toluene 3.2
Pyridine 0.24
Ammonia gas 0.05
Sulfonyl Chloride 0.42
Sodium bicarbonate 0.01
n-Hexane 2.64
Sodium Chloride 0.01
Ethyl Acetate 3.22
26
Isopropyl Alcohol 2.83
33. Valsartan
L-Valine 0.45
Thionyl Chloride 0.457
Methanol 8
Toluene 25
4-Bromomethyl-biphenyl-2- carbonitrile 0.82
Potassium carbonate 0.45
Valeryl Chloride 0.34
TEA 0.2
Sodium bicarbonate 0.25
Sodium Sulphate 0.1
Sodium Azide 0.16
Tri butyl tin chloride 0.8
Hydrogen 0.005
Sodium hydroxide 0.2
Xylene 2.4
MDC 5
Acetic Acid 0.4
N-Hexane 2
Activated Carbon 0.1
34. Moxifloxacin Hydrochloride
Moxifloxacin Q-Acid 0.9
2,8-Diazobicyclo(4.3.0)nonane 0.4
Triethylamine 0.32
Acetone 4
Dimethylformamide 2
Moxifloxacin Base 1.06
Hydrochloric acid 0.2
27
Methanol 10
EDTA 0.02
Activated Carbon 0.1
35. Cinnarizine
1-Benzhydryl piperazine 1.06
Cinnamyl chloride 0.93
Potassium carbonate 0.64
Ethyl acetate 9.15
Methanol 1.9
Activated carbon 0.08
Hyflow 0.05
36. Cyano Diol Base
Para Bromo fluoro benzene 0.27
Magnesium turnings 0.10
Ethylene dibromide 0.04
THF 5.73
Dimethl amino propyl chloride 12.14
Potassium hydroxide 1.4
Sodium hydroxide 2.34
hydrochloric acid 1.4
Magnesium turnings 0.55
Iodine 0.17
5-Cyano phthalide 0.67
THF + Toluene 14.6
Uene 29.75
Acetic acid 3.4
37. Dextromethorphan Hydrobromide
PMPPA 4.94
CHEA 3.72
28
Phosphorous oxy chloride 4.57
Caustic lye 3.17
Toluene 25.89
Mandelic acid 0.61
Formic acid 0.15
Sodium methoxide powder 0.04
Phosphoric acid 16.28
Phosphorous pentoxide 0.59
Methanol 2.70
CS Lye 1.74
Formaldehyde 0.5
Acetone 1.79
Activated carbon 0.05
Hyflow 0.05
38. 2-Amino-5-Methyl Thiazol
Propionaldehyde 0.77
Sulphuryl Chloride 0.19
NaOH 0.02
Thiourea 0.42
29
1.4 Water Requirement, Waste Water Generation and Treatment
Source of water will be met through Anklehwar GIDC Water Supply. Total water requirement
will be 42.5 m3/day. Total 25 m3/day (24 m
3/day Industrial + 1 m
3/day domestic) of effluent
shall be generated. 4 m3/day = High COD & high TDS stream-I will be neutralized & then sent to
Common MEE, Ankleshwar for further treatment & disposal and 20 m3/day = low COD and low
TDS stream-II will be treated in ETP then sent it to ETL, Ankleshwar for further treatment and
disposal.
Domestic Waste water will be disposed by septic tank & soak pit.
1.5 Air Pollution Source and Control Management
There will be flue gas emission from Boiler, Thermic Fluid Heater and D.G. Sets and process gas
emission from process vent only. Company will install Multi cyclone separator, Bag Filter and
Two stage Scrubber to reduce air pollution.
1.6 Hazardous Waste
Sr.
No
Category
No.
Type of
waste Existing Proposed Total Disposal Method
1 33.1
Discarded
Containers
6
MT/ year
4
MT/ year
10
MT/ year
Collection, Storage,
Transportation & Disposal by
selling to registered recycler
2 5.1
Used/
Spent Oil
0.01
MT/ year
0.01
MT/ year
0.02
MT/ year
Collection, Storage,
Transportation & Disposal by
selling to registered recycler
3 35.3 ETP sludge -- 10
MT/ year
10
MT/year
Collection, Storage,
Transportation and dispose
common TSDF site.
4 B36 Salts of
Per-Acids
420
MT/year --
420
MT/year
(Collection, Storage,
Transportation and disposal)
Sodium Sulphide (30% Sol):
Disposal by sell out to
authorized users who is having
valid CCA and Rule 9
permission to receive this
waste.
30
1.7 Green Belt
Total 10,360 sq. meter land area is available at site; out of this area about 4,662 sq. meter area
(45% of total land area) will be developed as greenbelt and other forms of greenery.
1.8 Power & Fuel Requirements
FUEL:
Existing:
Natural gas = 500 sm3/Day,
Diesel = 27 Lit/ Hr.
Proposed:
Agrowaste = 15 MT/Day
Diesel = 10 Lit./ Hr (Only for emergency).
ENERGY:
Existing:
Power required from DGVCL is 150 KVA .
1 DG Set = 250 KVA (for Emergency case only)
Proposed:
Power required from DGVCL will be 500 KVA.
1 DG Set = 125 KVA (for Emergency case only)
5 28.1 Organic
Residue --
20
MT/year 20 MT/year
Collection, Storage,
Transportation & sent to
cement industries for co-
processing or incineration in
CHWIF.
6 28.3 Spent
Carbon --
5
MT/year
5
MT/year
Collection, Storage,
Transportation and sent for co-
processing in cement industries
or Disposal at common
incineration site.
7 --
Inorganic
Solid
Waste
-- 13
MT/year 13 MT/year
Collection, Storage,
Transportation and dispose
common TSDF site.
8 26.3 Spent Acid -- 84.7
MT/year
84.7
MT/year
Collection, Storage,
Transportation &
sale to authorize vendor.
31
2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION
2.1 Identification of the project and project proponent. In case of mining project, a copy of
mining lease/letter of intent should be given.
Identification of the project and project proponent
M/s. Darshan Pharmachem Pvt. Ltd. proposes expansion of manufacturing of Bulk Drugs and
Bulk Drug intermediates at Plot No. 3609, Nr. Ficom Chokdi, GIDC Estate, Ankleshwar-393002,
District: Bharuch, Gujarat.
List of Directors:
Sr. No. List of Directors
1. Ms. Lilaben Rameshbhai Dobariya
2. Mr. Jitendra Gordhanbhai Dobaria
3. Mr. Rasikkumar Jadavbhai Dobaria
4. Mr. Rasilaben Rasikbhai Dobariya
2.2 Brief description of nature of the Project
Proposed expansion of Bulk Drugs and bulk drug intermediates manufacturing unit in existing
premises.
2.3 Need for the project and its importance to the country and or region
The demand for products intended to be manufacture is increasing in the country by setting up
this unit, Company will be able to meet the demand of various products locally. The project will
save forex as certain products import will be reduced. This will also generate direct and indirect
employment opportunity for various levels of people.
2.4 Demands-Supply Gap
Based on our informal survey of the market with our current customers and various traders, we
have found that there is a big potential for the range of the products we are planning.
2.5 Imports vs. Indigenous production
32
Based on the current cost of indigenous raw materials and the non availability of some
materials, we will have to import some of the key raw materials as they are not available
indigenously. This will make us very competitive against imported finished products and we will
export of our finished products in the international market.
2.6 Export possibility
We shall explore the possibility of export the products.
2.7 Domestic/Export Markets
Our products have good demand in domestic & international markets. We shall explore the
possibility of export the products.
2.8 Employment Generation (Direct and Indirect) due to project.
M/s. Darshan Pharmachem Pvt. Ltd. will give direct employment to local people based on
qualification and requirement. In addition to direct employment, indirect employment shall
generate ancillary business to some extent for the local population.
3.0 Project Description
3.1 Type of Project including interlinked and interdependent projects, if any.
No interlinked project has been submitted.
• Location (map showing general location, specific location and project boundary & project
site layout) with coordinates.
• Map showing general location.
33
PROJECT
SITE
34
Specific location and project boundary
• Project Site (Google Map)
37
• Plant Layout
38
3.3 Details of alternate sites considered and the basis of selecting the proposed site,
particularly the environmental considerations gone into should be highlighted.
Looking to the international market demand of the products it was decided by M/s. Darshan
Pharmachem Pvt. Ltd. to expand existing facility.
Major factors involved in the selection of site are listed below:
• Minor site clearance activities shall be carried out to clear shrubs and weed.
• The project site is located on level ground, which does not require any major land filling
for area grading work.
• Proximity to Raw Material suppliers.
• Site is very well connected by road and railway.
• Availability of Fuel, Power, CETP, TSDF, etc. within the estate.
Modern infrastructure support and amenities at par in other global markets, including:
� Efficient transport facilities.
� Environment-friendly zone.
� Uninterrupted power supply.
3.4 Size or Magnitude of Operation
Please refer Section-1.2.1, Page No. 3.
3.5 Project Description with process details (a schematic diagram/flow chart showing the
project layout, components of the project, etc. should be given)
Please refer Please refer Form-I, Annexure-III.
3.6 Raw Material required along with estimated quantity, likely source, marketing area of
final product/s, mode of transport of raw material and Finished product.
For raw material required along with quantity; Please refer Section-1.3, Page No. 3. We shall
procure the raw material as much as possible from domestic market and if there is no
39
availability of any raw material we will import. We shall explore the possibility of export the
finished products.
3.7 Resource optimization/recycling and reuse envisaged in the project, if any, should be
briefly outlined.
Company will explore the possibility of reuse & recycle.
3.8 Availability of water its source, energy/power requirement and source should be
given.
Water Source
Total water requirement shall be met through Ankleshwar G.I.D.C Water Supply.
FUEL:
EXISTING:
Existing:
Natural gas = 500 sm3/Day,
Diesel = 27 Lit/HR
PROPOSED:
Agrowaste = 15 MT/Day
Diesel = 10 Lit./HR (Only for emergency).
ENERGY:
EXISTING:
Power required from DGVCL is 150 KVA
1 DG Set = 250 KVA (for Emergency case only)
PROPOSED:
Power required from DGVCL will be 500 KVA.
1 DG Set = 125 KVA (for Emergency case only)
3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their
management/disposal.
Please refer Please refer Form-I, Annexure-IV & VI.
40
3.10 Schematic representations of the feasibility drawing which give information of EIA
purpose.
4.0 Site Analysis
4.1 Connectivity
• Site is very well connected by road
• Availability of fuel, power, CETP, TSDF, etc. within the estate.
4.2 Land Form, Land Use and Land Ownership
Land Use will be incorporated in the EIA Study.
4.4 Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including
area under CRZ)), shortest distances from the periphery of the project to periphery of the
RECONNAISSANCE SURVEY OF EXISTING PLANT ANNUAL REPORT
MARKET ASSESSMENT
FINANCIAL REPORT
PROJECT REPORT
INTRODUCTION
MONITORING OF AIR, WATER & SOIL QUALITY & NOISE
LEVELS. DATA ON METEOROLOGY SOCIO-ECONOMIC
STATUS & BASIC AMENITIES. SITE VISITS BY AND
INTERVIEWS WITH LOCALS
BASELINE
ENVIRONMENTAL
STATUS
ENVIRONMENTAL INFORMATION CENTRE
CENTRAL GROUND WATER BOARD
GUJARAT POLLUTION CONTROL BOARD (GPCB)
PUBLIC HEALTH ENGINEERING DEPT.
AGRICULTURE DEPARTMENT
FOREST DEPARTMENT
IRRIGATION DEPARTMENT
EMPLOYMENT EXCHANGE
HEALTH CENTER
CENSUS DEPT.
INDIAN METEOROLOGICAL DEPT.
SOCIOECONOMIC
STATUS &
INFRASTRUCTURE
PROPOSED
PLANT
FACILITY DESCRIPTION
IMPACTS
METHODOLOGY OF
IMPACT
ASSESSMENT
IDENTIFICATION & ASSESSMENT OF IMPACTS
EVALUATION OF IMPACTS BY MATRIX METHOD
SOURCE OF INFORMATION OVERVIEW OF
E. I. A. STUDIES
ACTIVITIES
ENVIRONMENTAL
MANAGEMENT
PLAN
DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR
POLLUTION CONTROL, HAZARDOUS WASTE
MANAGEMENT, GREEN BELT DEVELOPMENT
MONITORING PROGRAM
RISK ANALYSIS
STUDIES &
DISASTER
MANAGEMENT PLAN
SAFETY, HEALTH & ENVIRONMENTAL POLICY, GUIDELINES BY
DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR. CONSEQUENCE ANALYSIS
PREPARATION OF DISASTER MANAGEMENT PLAN
41
forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from
HFL of the river), CRZ. In case of the notified industrial area, a copy of the Gazette
notification should be given.
Existing land use pattern will be incorporated in the EIA Study. CRZ Clearance is not
applicable.
4.5 Existing Infrastructure
Processing Area (Plant facilities, ETP Area and Utility Services) = 2,500 m2
Non Processing Area (Raw material storage area, finished storage area, Workshop and Engg.
Store, Canteen, security cabin, green belt and open area) =7,860 m2
4.6 Soil Classification
Soil Classification will be incorporated in the EIA Study.
4.7 Climatic data from secondary sources.
Climatic data will be incorporated in the EIA Study.
4.8 Social infrastructure available.
Various Programs/ Projects related to Social & Economic development of surrounded area
has been planned, which are as follows.
A) Natural Resource Management – The main focus of this program will be to maximize the
yield returns of the farmers through efficient management of existing resources &
extension of new agricultural practices.
1) Integrated Agricultural Growth Project – For improvement and use of the modern
techniques and thereby would certainly contribute to prosperity in the agriculture
sector and reduce the rural poverty by programs like Farmers Training, Nursery
Growing Trainings, Modern agriculture equipment distribution programs etc.
2) Animal Husbandry Projects – Various programs like health checkups & treatment,
vaccination program, Anti sterility camps, breed improvement etc. will be carried
out.
B) Income Generation Program -
42
1) Establishment of Self help groups.
2) Rural Entrepreneurship Development Program
3) Handcrafts Development Program
4) Vocational Training
5) Business process outsourcing
C) Health, Education & Infrastructure
1) Aids Awareness Program
2) General Health Camps
3) Innovative Teaching Methods
4) Adult Education
5) Sanitation
6) Infrastructure Development Projects
5.0 Planning Brief
5.1 Planning Concept (type of industries, facilities, transportation etc) Town and Country
planning/Development authority classification.
Type of Industry: Proposed expansion of Bulk Drugs and bulk drug intermediates in existing
unit.
5.2 Population Projection
Population Projection will be incorporated in the EIA Study.
5.3 Land use planning (breakup)
Total Plot Area = 10,360 sq mt.
Processing Area = 2,500 sq mt
Non-Processing area = 7,860 sq mt
43
5.4 Assessment of Infrastructure Demand (Physical & Social)
• Employment would be as per prevailing norms of state government for skilled and
unskilled people for the proposed activity.
• Social Welfare
• Cordial relation with the villages shall be established and representation shall be made
to villagers for help for creation of facilities related to health, education, etc.
5.5 Amenities/Facilities
Details of amenities available in study area
Population Projection will be incorporated in the EIA Study.
6.0 Proposed Infrastructure
6.1 Industrial Area (Processing Area)
Processing Area (Plant facilities, ETP Area and Utility Services) = 2,500 m2
6.2 Residential Area (Non Processing Area)
Non Processing Area (Raw material storage area, finished storage area, Workshop and Engg.
Store, Canteen, security cabin, green belt and open area) =7860 m2
6.3 Green Belt
Total 10,360 sq. meter land area is available at site; out of this area about 4,662 (45% of
total land area) sq. meter area will be developed as greenbelt and other forms of greenery.
Green Belt: 4,662 m2
6.4 Social Infrastructure
• Water requirement will be met through G.I.D.C Water Supply.
• Power supply by DGVCL.
6.5 Connectivity (Traffic and Transportation Road/ Rail/Metro/ Water ways, etc.)
Major factors involved in the selection of site are listed below:
• Site is very well connected by road
44
• Proximity to Raw Material suppliers
• Availability of sufficient land free from cultivation
• Availability of power facilities
• Availability of fuel
6.6 Drinking water Management (Source & Supply of water)
Total water requirement shall be met through Ankleshwar, G.I.D.C. Water Supply.
6.7 Sewerage System
Sewage pipes are laid in entire company for the removal and disposal of mainly non-
harmful liquid wastes from the offices, canteen and domestic waste coming from different
section of industry. These liquid wastes are sent to septic tank & soak pit.
6.8 Solid Waste Management
Please refer Form-I, Annexure-VI.
6.9 Power Requirement & Supply/Source
Please refer Section 1.8, Page No. 5 of this report.
7.0 Rehabilitation and Resettlement (R & R) Plan
7.1 Policy to be adopted (central/state) in respect of the project affected including home
oustees, land oustees and landless laborers (a brief outline to be given)
There is no habitation on the proposed project activity area and it is open industrial land, so
R & R policy is not applicable to this project.
There shall not be displacement of any population in project area. Any major activity that
may lead to resettlement of the people is considered as permanent impact. Hence, there is
no permanent impact on this account. The increasing industrial activity will boost the
commercial and economical status of the locality up to some extent.
45
8. Project Schedule & Cost Estimates
8.1 Likely date of start of construction and likely date of completion (Time schedule for
the project to be given).
We shall start construction of proposed expansion project after getting EC and we shall start
production after applying for CCA.
8.2 Estimated Project cost along with analysis in terms of economic viability of the
project.
Total Project Cost for proposed project activity is Rs. 2.0 Crores.
9. Analysis of Proposal (Final Recommendations)
9.1 Financial and social benefits with special emphasis on the benefit to be local people
including tribal population, if any, in the area.
• Employment would be as per prevailing norms of state government for skilled and
unskilled people for the proposed project.
• Social Welfare shall be done.
• Cordial relation with the industry shall be established and representation shall be made
to villagers for help for creation of facilities related to health, education, etc.