Annexure-Project feasibility report - Welcome to...
Transcript of Annexure-Project feasibility report - Welcome to...
1
PRE FEASIBILITY REPORT
for
PROPOSED BULK DRUGS MANUFACTURING
IN EXISTING PREMISES
of
M/s. NIVIKA CHEMO PHARMA P. LTD.
PLOT NO. 1808, 1809/2, 1811, 1812, 1813, 1814 & 1815,
GIDC ESTATE, ANKLESHWAR, DIST: BHARUCH-393002 (GUJ.)
2
CONTENTS
Sr. No. Description Page No.
1. Executive Summary 3
2. Introduction of the Project/Background information 13
3. Project Description 15
4. Site Analysis 16
5. Planning Brief 17
6. Proposed Infrastructure 18
7. Rehabilitation and resettlement (R & R) Plan 19
8. Project Schedule & Cost Estimates 20
9. Analysis of Proposal (Final Recommendations) 20
3
1.0 EXECUTIVE SUMMARY
1.1 Company Profile
M/s. Nivika Chemo Pharma P. Ltd. is an existing unit engaged in production of Ortho Toluene
Nitrite and Optical Brightening Agent at Plot No. 1808, 1809/2, 1811, 1812, 1813, 1814 & 1815,
G.I.D.C. Estate, Ankleshwar-393002, Dist: Bharuch (Guj.). It now also proposes to enter and
produce bulk drugs at this existing premises in GIDC Ankleshwar. At present India is importing
major APIs and hence to cater to the ever expanding market the proposal is to manufacture
various bulk drugs detailed as under.
1.2 Project Details
1.2.1 Products along with Production Capacity
SR.
NO PRODUCTS CAS NO
PRODUCTION CAPACITY (MT/MONTH)
EXISTING ADDITIONAL TOTAL
EXISITING PRODUCTS
1 OPTICAL BRIGHTENING AGENT 13001-39-3 1.0 0 1.0
2 ORTHO TOLUENE NITRITE 88-72-2 4.0 0 4.0
TOTAL (EXISITING PRODUCTS) 5.0 0 5.0
PROPOSED PRODUCTS
1 Darunavir
206361-99-1
5 5
2 Levosulpiride 23672-07-3 10 10
3 Montelukast Sodium 151767-02-1 5.5 5.5
4 Tramadol hydrochloride
36282-47-0
7 7
5 Nifedipine 21829-25-4 4.5 4.5
6 Quetiapinehemifumarate
111974-72-2
3 3
7 Furosemide 54-31-9 3.5 3.5
8 Risedronate Sodium 105462-24-6 4.5 4.5
4
9 Iohexol/Iopamidol/Iodixanol
66108-95-
0/60166-93-
0/92339-11-
0.0
6 6
10 Lauryl Pyridinium chloride 104-74-5 10 10
11 Vildagliptin 274901-16-5 4 4
12 Ambroxol Hydrochloride 23828-92-4 4 4
13 Pantaprazole Sodium 138786-67-1 7.5 7.5
14 Miconazole Nitrate 22916-47-8 4.5 4.5
15 Dorzolamide Hcl 130693-82-2 4 4
16 Bosentan 147536-97-8 5.5 5.5
17 Febuxostat 144060-53-7 10 10
18 Fesoterodine NDMF 286930-02-7 6 6
19 Rizatriptan 145202-66-0 2.5 2.5
20 Olanzapine 132539-06-1 4.5 4.5
21 Levocetirizine 130016-77-8 5 5
22 Revaroxaban 366789-02-8 7 7
23 Ciprofloxacin 85721-33-1 10 10
24 Agomelatine 138112-76-2 10 10
25 Brinzolamide 138890-62-7 2.5 2.5
26 Atorvastatin Calcium 134523-00-5 8.3 8.3
27 Capecitabine 154361-50-9 3.5 3.5
28 Diacerein 13739-02-1 3.5 3.5
29 Dabitgatran 211915-06-9 3 3
30 Vilazodone Hydrochloride 163521-08-2 2 2
31 Posaconazole 171228-49-2 5.5 5.5
32 Dapoxetine Hydrochloride 129938-20-1 3.5 3.5
33 Canagliflozin 842133-18-0 2.5 2.5
34 Bronopol(BP) 52-51-7 7 7
35 Carbamazepine 298-46-4 5.5 5.5
36 Cefsulodine Sodium 52152-93-9 6.5 6.5
5
37 Cilinidipine 132203-70-4
3.5 3.5
38 Nebivolol 99200-09-6
0.5
0.5
39 Nebivolol HCL 152520-56-4
40 Donepezil Hydrochloride 120011-70-3
41 Brimonidine Tartrate 70359-46-5
10
10
42 Captopril 62571-86-2
43 Cilostazol 73963-72-1
44 Clopidogrel bisulphate 120202-66-6
45 Entacapone 130929-57-6
46 Graniserton HCL 107007-99-8
47 Meloxicam 71125-38-7
48 Modafinil 68693-11-8
49 Piogltazone HCL 112529-15-4
50 Zaltoprofen 74711-43-6
51 Zonisamide 68291-97-4
52 Pregabalin 148553-50-8
53 Rampril 87333-19-5
54 Sodium Valroate 1069-66-5
TOTAL(Proposed) 0.0 210.8 210.8
TOTAL (EXISTING+PROPOSED) 5.0 210.8 215.8
1.3 Raw Material Requirement
List of Raw Materials and Their Capacity
EXISTING:
SR.
NO. Name of Products
Raw Materials
Quantity
(KG/KG)
[1] OPTICAL BRIGHTENING AGENT
Ortho toluene nitrile 2.66
Chlorine gas 4.00
Trimethyl phosphate 1.78
6
OCBC 1.33
Orthoxylene 1.11
Terpthaldehyde ester 0.45
Sodium methoxide 1.60
Dimethyl formamide 2.22
[2]
Ortho toluene Nitrite
OTA 2.33
Sulphuric acid 0.83
Urea 1.67
Soda ash 0.50
Caustic lye 1.00
PROPOSED:
Sr.
No. Name of Product Raw Materials
Quantity
(KG/KG)
[1]
Darunavir
(3aS,4S,6aR)-4-METHOXY terahydrofuro-[ 0.628 Hydrochloric Acid 0.145 Sodium Borohydride 0.870 Hydrogen 0.007 Ethyl Acetate 2.300 Tetrahydrofuran 5.020 Sodium Hydroxide 0.130 isobutyl benzenesulfonamide 1.430 Disucinimidyl carbonate 0.963 Sulphuric acid 0.100 2-Methyl2-Butanol 0.600 Methylene Chloride 3.000 Cyclohexane 2.400 Sodium bicarbonate 0.020 Sodium chloride 0.010 Sodium sulphate 0.010 Sodium hydroxide 0.008 Activated carbon 0.020
[2] Levosulpiride
Monoethylene Glyco 1.000
2-Methoxy-5-Sulphomyl Benzoate 0.750
S-1-Ethyl 5- Amino methyl Pyrolidine 0.390 [3]
Motelukast Sodium 2-[2-[3(s)-[3-[2-(7-chloro-2-quinoliny1) -Ethanl
]pheny1]-3-hydroxypropy1]pheny1-2
propanol 1.326
2-[1-(Sunfonyl methy1) 0.423
7
Cyclopropy1]acetic acid
Methane sulfonyl chloride 0.332
Sodium hydroxide 0.182
N,N-Diisopropylethylamine 0.007
Hydrochloric acid 0.046
Sodium chloride 0.007
Acetic acid 0.013
Toluene 1.000
Acetonitrile 0.867
Methanol 1.333
n Hexane 1.733
Activated Carbon 0.013
[4] Tramadol Hydrochloride Isopropyl Alcohol 2.069
Cyclohexanone 0.345 Para Formaldehyde 0.103 Dimethyl amine Hcl 0.281 Caustic Lye 0.414 Tetrahydrofuran 1.034 Manganese Turning 0.086 Catalyst 0.003 M bromo Anisole 0.069 Hcl 0.345 Toluene 2.758 Methanol 1.724 Nitric Acid 0.217 IPA Hcl 0.638
[5] Nifedipine Methyl Aceto Acetate 2.250 Methanol 13.700 ONBA 1.500 Acetic Acid 3.200 Liquid Ammonia 1.100
[6] Quetiapine hemifumarate Dibenzo - (1,4)- thiazepine - 11 (10H) one 3- 2.780 Fumaric acid 0.402 Thionyl chloride 0.050 Hydrochloric acid 0.023 Sodium hydroxide 0.025 Sodium Carbonate 0.300 Toluene 7.000 Ethanol 8.500 Activated Carbon 0.050
[7] Furosemide Lasamide 1.300
Furfuryl amine 2.100
8
Iso propyl Alcohol 4.850
Caustic soda 0.600
Citric acid 0.100
EDTA 0.010
Hydrose 0.010
Hyflow 0.150
Acetic Acid 0.500
[8] Risedronate Sodium 3-Pyridyl Acetic Acid 2.446
Diethyl carbonate 0.750
Caustic soda lye 0.050
Phosphorous trichloride 0.025
Methane sulphonic Acid 0.500
Isopropyl alcohol 5.800
Sodium hydroxide flakes 0.309
Hyflow 0.050
Activated carbon 0.050
Hydrochloric acid 0.220
[9]
Iohexol/Iopamidol/
Iodixanol
L-Acetoxy propionyl chloride 1.200
5- amino-2, 4, 6- Tri iodoisophthaloyl di
chloride
1.500
2-Amino-1, 3-propanediol 1.200
Sodium Hydroxide 0.350
Isopropyl Alcohol 4.000
[10]
Lauryl Pyridinium Chloride
Lauryl chloride 0.722
Pyridine 0.560
Methyl Ethyl ketone 4.000
Acetone 2.000
[11] Vildagliptin KSM I 0.770
KSM II 0.720
DMF 5.400
Methylene dichloride 15.000
Potassium Carbonate 2.600
Isopropyl Acetate 5.040
Sulphate 3.750
Sodium chloride 0. 630
Acetone 12.500
Charcoal 0.050
[12] Ambroxol Hydrochloride Ambroxol Base 0.912
Isopropyl Alcohol 10.500
Activated Carbon 0.015
9
[13] Pantaprazole Sodium 2-Chloromethyl-3-4-dimethox pyridine
hydrochloride
0.770
5-difluoromethoxy-2-mercapto benzimidazole 0.740
Sodium Hydroxide 0.410
Isopropyl Alcohol 11.530
Sodium Hypochlorite (10%aqueous) 2.790
Acetone 6.230
[14] Miconazole Nitrate TCAP 1.059
Imidazol 0.424
Sodium Carbonate 0.848
Toluene 9.481
Sodium borohydride 0.069
TBAB 0.375
Caustic Soda flake 3.750
DCBC 0.917
Hydrose 0.010
Carbon 0.350
Nitric acid 0.300
Methanol 2.300
[15]
Dorzolamide Hcl
(+-)- Trans -5,6 - DIHYDRO-4H-4-Ethyl amino-
6-methyltheino[2,3-
2.990
N butanol 23.200
Methanol 30.200
Ethyl Acetate 14.500
Acetone 0.800
Activated carbon 0.300
Sodium Bicarbonate 1.500
Sodium Chloride 1.500
Sodium Hydroxide 0.258
Hydrochloric acid 0.336
[16] Bosentan 4,6 Dichloro 5 (2-Methoxyphenoxy)2,2
Bipsimidine
0.726
4 Tert Butylbenzene Sulfonamide 0.443
Hydrochloric Acid 0.179
Potassium Carbonate 1.206
Sodium Tert Butoxide 0.998
Ethylene Glycol 12.339
[17] Febuxostat KSM 1.547
Isobutyl Bromide 1.162
10
Potassium Carbonate 1.834
Ammonium Hydroxide Hcl 0.323
Sodium Carbonate 0.314
Sodium Hydroxide 0.297
Hydrochloric Acid 0.289
Acetone 0.750
[18] Fesoterodine NDMF Benzyl Amine DPTT 5.454
Sodium Carbonate 5.726
Ceric Ammonium nitrate 12.544
Barium Borohydrate (BaBH4) 0.774
Fumaric Acid 1.477
Hydrogen gas 0.013
Isobutyl Chloride 0.340
Triethylamine 0.301
[19] Rizatriptan Triazole Compound 1.250
Dimethyl amine Indole 2.000
Catalyst 1.120
Acetonitrile 5.000
Methanol 6.250
[20]
Olanzapine
Methyl Piperazinyl 1.060
Chloro-thiano benzodiazepine 0.933
N N DMA 5.330
Catalyst 0.130
Acetonitrile 4.000 [21]
Levocetirizine
1-[4Chlorophenyl) Phenyl methyl] piperizine
L-Tartaric acid
1.820
2-Chloroethoxy 0.620
Acetonitrile 1.450
Sodium Carbonate 0.350
Potassium Iodide 0.150
N-Butanol 2.250
Hydrochloric Acid 0.320
Ethyl Acetate 2.950
[22] Rivaroxaban (4-4-Aminophenyl)-morpholin-3-one 1.410
Glycidyl Phthalimide 1.640
4-Dimethylaminoopyridine (DMAP) 0.010
Carbonyldiimidazole 4.030
5-Chlorothiophene-2-cacoxylic acid 1.230
11
Sodium Acetate 1.480
Oxalyl Chloride 1.500
Methyl Amine(Aqueous) 1.630
Hydrochloric Acid 0.680
Acetic Acid 0.040
[23] Ciprofloxacin Flouro Quinolic acid 1.000
Piperazine 0.400
Dimethyl Sulphoxide 0.050
Causitc lye 0.950
Hydrochloric Acid 0.600
Methanol 1.400
[24] Agomelatine 2-(7-methoxy-1-napthyl-napthyl) Acetonitrile 1.000
Hydrogen Gas 0.020
Isopropyl Alcohol 0.740
Sodium Acetate (Anhydrous) 0.420
Acetic Acid (Anhydrous) 0.510
[25]
Brinzolamide
4(S)-4-hydroxy-6- sulfonamide dioxide 2.610
Methanol sulfonic anhydride 0.600
Ethyl amine 0.330
Ammonia liquor 0.200
Hydrochloric Acid 0.101
Sodium Hydroxide 0.110
Pyridine 0.200
Tetrahydrofuran 10.050
Isopropyl Alcohol 10.950
Sodium Bicarbonate 0.101
Activated Carbon 0.101
Hyflow 0.101
[26]
Atorvastatin calcium
1, 1--dimethyl ethyl-6-(2- aminoethyl) 0.770
4- Fluoro-2-methyl-1-oxopropyl 1.176
Cyclohexane 3.000
Isopropyl Alcohol 2.501
Hydrochloric Acid 0.070
Acetonitrile 3.500
Sodium Hydroxide 0.146
Calcium Acetate 0.179
Hyflow 0.012
[27] Capectabine 2,3 di-o-actyl-5-dexy-5-fluorocytidine 1.247
12
n-Pentyl Chloroformate 0.570
Sodium Hydroxide 0.415
Sodium Bicarbonate 0.050
Hydrochloric Acid 0.075
Methylene Chloride(MDC) 4.000
Methanol 2.500
Ethyl Acetate 5.500
Activated Carbon 0.050
[28] Diacerein Aloe emodine 1.966
Sodium dichromate dihydro 2.168
Sulphuric Acid 0.814
Sodium Hydroxide 0.122
Tetrahydrofuran 22.000
Acetone 6.200
Acetic Anhydride 1.018
N Methyl pyrolidone 3.498
Methanol 2.200
Activated Carbon 0.200
Celite 0.200
[29]
Dabigatran
3-[(1-Methyl-2-{[4-(5-oxo-4,5-dihydro-[1,2,4]
oxadiazol-3-yl)-phenylamino]-methyl)-1H-
benzoimidazole-5-carbonyl)-pyridin-2-yl
amino]-propionic acidethyl ester
0.970
Para toluene sulphonic acid 0.250
Acetic acid 0.200
Ethanol 25.000
Hexa Chlorofomate 0.280
Acetone 12.000
Potassium Hydroxide 0.096
Hydrochloric acid 0.004
[30]
Vilazodone Hydrochloride
5-{4-(5-Cyano-1H-indol-3-yl)-butyl]-piperazin-
1-yl}-benzofuran-2carboxylicacid methyl ester 1.510
Ammonia 0.951
Methanol 16.100
Hydrochloric acid 0.110
Sodium Hydroxide 30% 0.122
Isopropyl Alcohol 12.000
Activated Carbon 0.200
13
[31]
Posaconazole
2-[2-[3(S)-[3-[2-(7-Chloro-2- Quinolinyl)
ethenyl ]pheny]-3 hydroxy propyl] phenyl-2-
Propanol
1.326
2-[1-(sulfonyl methyl) cyclopropyl} acetic acid 0.423
Methane sulfonyl chloride 0.332
sodium hydroxide 0.182
N,N-Disopropyletylamine 0.007
Hydrochloric acid 0.046
Sodium chloride 0.007
Acetic acid 0.013
Toluene 1.000
Acetonitrile 0.867
Methanol 1.333
n-Hexane 1.733
Activated carbon 0.013
[32] Dapoxetine Hydrochloride ᵦ- (dimethylamino) benzenepropanol 1.062
1-fluoronaphthalene 0.865
sodium hydroxide 0.357
Hydrochloric acid
0.325 Di methyl Sulphoxide (DMSO) 12.500
n-Propanol 10.000
Activated Carbon 0.250
[33] Canagliflozin 2-(5-bromo-2-methylbenzil)-5-(4-
flurophenyl)thiophene 2.123
silyl D-gloconolactone 2.770
Methanol 16.667
Acetone 25.000
Potassium Carbonate 0.333
[34] Bronopol(BP) Nitro Methane 0.333
Methanol 1.667
caustic 0.233
Formaldehyde 0.733
Carbon 0.017
Bromine 0.883
[35]
Carbamazepine
Methanol 1.014
Imino stilbene carbonyl Chloride 1.282
Ammonia Liquor 2.802
Acetone 6.504
Toluene 0.040
14
Caustic lye 0.406
Hyflow 0.013
Activated Carbon 0.012
[36]
Cefsulodine Sodium
RS-a-Sulfophenyl acetic acid 0.515
(S)-a-Methyl benzyl amine 0.288
Acetonitrile 6.150
1-Hydroxy benzotriazole 0.309
Methane sulphonyl chloride 0.261
Sodium bicarbonate 0.100
Methylene dichloride 5.125
Hexane 3.000
Sodium hydroxide 0,086
7-Amino cephalosporic acid 0.598
Boron triflouride etherate 1.875
Tert-butyl acetate 0.255
Hyflow 0.050
Zinc chloride 0.025
Triethyl amine 0.025
Ethyl acetate 1.025
Di isopropyl ether 0.500
Pyridine -4-carboxamide 0.242
Sodium Iodide 0.200
Dimethyl formamine 0.276
Hydrochloric Acid 0.025
Ethanol 1.750
Sodium hydroxide 0.027
DMF 1.500
Diethyl ether 2.250
[37]
Cilinidipine
Methanol 7.500
2 Methoxy Ethyl Acetoacetate 3.250
Cinramyl Aceto Acetate 1.000
3 Nitro Benzaldehyde 0.750
Ammonium Carbonate 1.000
[38] NEBIVOLOL Benzopyran-2- Carboxaldehyde Deri 1.4
Trimethyl sulfoxonium Iodide 1.15
Potassium hydroxide 0.56
Benzylamine 0.4
Toluene 3.0
15
Ammonium formate 0.6
(Hydrogen source) Pd/C 0.01
Methanol 5.2
[39] NEBIVOLOL HCL NSR-19C 1.0
Methanol 7.6
Acetonitrile 3.0
Diisopropyl ether 6.0
HCl (CP) 0.6
Methanol 144.1
NSR-19D 0.3
IPA HCl (20%) 3.4
Hyflow 1.7
[40] DONEPEZIL
HYDROCHLORIDE
NSR-10A
1.61
NSR-10B 1.39
Sodium methoxide solution (30%) 1.57
Methanol 42.33
Hydrochloric acid 0.44
NSR-10C 0.78
Recycled NSR-10C from Donepezil
Hydrochloride crude (cycle-1) 0.06
Recycled NSR-10C from Donepezil
Hydrochloride crude (cycle-2) 0.12
Hydrochloric acid 2.00
Ammonia solution 16.39
Ethyl acetate 60.00
Hydrogen gas 1.11
Hyflo super cel 1.11
Methanol 147.22
Methanol 16.39
Methyl tertiary butyl ether 23.99
Activated charcoal 0.11
Hyflo super cel 0.28
Donepezil Hydrochloride seed 0.02
[41] BRIMONIDINE TARTRATE NSR-2A 5
Benzoyl chloride 3.8
NSR-2B 2.1
Acetone 15
Sodium Hydroxide Flakes 4.5
Hydrochloric acid 10
16
Hyflo supercel 5.1
Ethylenediamine 2.05
Chlorobenzene 55.5
Isopropyl alcohol 15
Hydrochloric acid 2
Sodium Hydroxide flakes 7.1
Ethylacetate 72
Hyflo supercel 138.6
[42] CAPTOPRIL NSR-5A 3.55
NSR-5B 4.36
Thionyl chloride 5.91
Methanol 1.82
Sodium hydroxide lye 22.73
NSR-5C 1.82
Methylene chloride 9.09
N,N-Dimethyl aniline 1.91
Hydrochloric acid 1.82
Ammonia solution 1.18
Hydrochloric acid 2.05
NSR-5D 0.28
Activated charcoal 0.03
Hyflo super cel 0.03
Sodium chloride 2.59
Ethyl acetate 14.77
[43] CILOSTAZOL NSR-7A 0.92
NSR-7B 0.70
Sodiumhydroxide 0.44
Sodiumsulphate 0.71
NSR-7C 0.03
Activated charcoal 0.01
Toluene 0.64
Methanol 3.21
Methanol 26.38
Activated carbon 0.09
hyflow 0.09
[44] CLOPIDOGREL BISULPHATE NSR-8A 5.43
Sodium bicarbonate 1.74
Sulphuric acid 0.83
Methanol 18.26
17
Chloroform 13.04
Mehtyl-Alpha-bromo-2-hlorophenyl acetate 5.00
Sodium bicarbonate 3.91
NSR-8B 3.22
Acetone 29.57
Chloroform 17.39
Methanol 28.26
NSR-8C 2.43
Clopidogrel seed-1 0.06
Sodium bicarbonate 1.83
Chloroform 22.17
Ethyl acetate 19.13
Activated charcoal 0.09
Hyflo super cel 0.17
Sulphuric acid 0.52
Clopidogrel seed-2 0.02
Sodium bicarbonate 2.74
Chloroform 22.17
Ethyl acetate 23.48
Activated charcoal 0.09
Hyflo super cel 0.17
Sulphuric acid 0.30
Clopidogrel seed-2 0.01
[45] ENTACAPONE NSR-11A 1.79
Nitric acid 1.60
Sulphuric acid 2.07
Methylenedichloride 12.50
5-Nitro Vanillin 1.19
NSR-11B 1.10
Pyridine 2.14
Methylenedichloride 8.93
Hydrochloric acid 7.62
DHNB 0.54
NSR-11C 0.60
NSR-11D 0.65
Isopropyl alcohol 6.65
Acetic acid 2.48
Methanol 1.07
Cyanoacetic acid 0.86
18
Diethylamine 0.81
NSR-11E 2.02
Tetrahydrofuran 5.60
Methylenedichloride 3.33
Acetic acid 0.29
[46] GRANISERTON HCL NSR-13A 1.13
Thionyl chloride 1.47
NSR-13B 0.03
n-Hexane 16.67
Stage-I 1.00
NSR-13C 0.92
Triethylamine 0.92
Methylenedichloride 35.00
Isopropyl alcohol 21.67
Sodiumbicarbonate 1.33
Hydrochloric acid 0.58
Activated carbon 0.02
Solvent E 13.00
[47] MELOXICAM NSR-16A 1.08
NSR-16B 0.47
Meloxicam Crude 1.13
Sodium Hydroxide 0.15
Acetic acid 0.76
Methanol 1.95
Activated Carbon 0.12
Hyflow 0.25
Meloxicam Purified 1.07
Acetic acid 2.96
Meloxicam Purified 1.03
Toluene 4.90
Dimethylformamide 0.49
[48] MODAFINIL NSR-17A 1.21
Ethylene Dichloride 12.12
Triethyl Amine 0.73
Ethyl Chloroformate 0.80
NSR-17B 0.12
Methanolic Ammonia (20%) 16.36
Methanol 6.36
Modafinil Crude 1.03
19
Methanol 13.33
Activated Carbon 0.06
Hyflow 0.03
[49] PIOGLTAZONE HCL NSR-22A 1.23
Methane sulphonylchloride 1.07
Toluene 13.09
NSR-22B 1.06
Isopropyl alcohol 6.85
Sodium hydroxide 0.41
Methanol 18.52
NSR-22C 0.31
2,4-Thiazolidinone 0.87
Triethylamine 1.01
Potassium Carbonate 1.43
NSR-22D 0.12
NSR-22E 0.10
Dimethylformamide 17.78
Sodiumborohydride 0.31
Hydrochloric acid 1.65
Methanol 8.32
Hydrochloric acid 0.76
Activated charcoal 0.06
Hyflow 0.12
[50] ZALTOPROFEN NSR-27A 1.43
NSR-27B 5.71
Ethylene Dichloride 2.14
Acetone 4.29
Activated carbon 0.05
Hyflow 0.04
NSR-27C 5.36
Sodium carbonate 0.23
Denatured Spirit 2.79
NSR-27D 0.01
Acetic acid 0.82
[51] ZONISAMIDE NSR-28A 2.5
NSR-28B 3.8
NSR-28C 4.4
Methanol 25.0
Ammonia Solution 6.3
20
Hydrochloric Acid 7.5
Ethyl Acetate 6.3
Ethylene Dichloride 12.3
NSR-28D 2.2
1,4 Dioxane 1.6
Phosphorus Oxy chloride 8.2
Toluene 61.3
Ethyl Acetate 102.1
Activated Carbon 2.1
Hyflow Super cell 0.8
Sodium Chloride 4.4
Anhydrous ammonia 0.8
Acetone 8.3
Activated carbon 1.7
Hyflow supercel 0.4
[52] PREGABALIN 3-isobutylglutaric acid 2.2
acetic anhydride 1.2
Toluene 6.6
4-Dimethyl aminopyridine 0.01
(S)-(-)-phenyl ethylamine 2.84
caustic lye 2
Hydrochloric acid 2.92
Acetone 12.5
Triethylamine 1.09
Ethylchloroformate 1.03
Sodium Azide 1.4
Toluene 13
Methanol 0.5
70% sulphuric acid 24.8
Sodium Hydroxide lye 13
Iso Butanol 8.68
A. carbon 0.02
Hyflow 0.06
[53] RAMIPRIL ECPPA 0.88
Azabicyclo Benzylester 8.33
TEA 0.6
HOBT 0.5
DCC 0.67
MDC 16.67
21
Sodium Bicarbonate 1.67
Benzyl Ramipril 1.56
Ab. Alcohol 12.5
pd/C 0.16
Hyflow 0.1
Acetonitrile 7.8
[54] SODIUM VALROATE valporic acid 0.91
Acetonitrile 3.5
sodium Hydroxide 0.29
Activated carbon 0.005
hyflow 0.02
1.4 Water Requirement, Waste Water Generation and Treatment
Source of water will be met through Ankleshwar GIDC Water Supply. Total water requirement
will be 126 m3/day (Fresh Water: 60 KL/Day + Reuse water: 66 KL/Day). Total 93.1 m3/day (91.1
m3/day Industrial + 2.0 m3/day domestic) of effluent shall be generated. 2.5 m3/day Industrial
effluent generated from existing products will be treated in existing ETP to give primary
treatment and sent to ETL, Ankleshwar. 88.6 m3/day of Industrial effluent will be given primary
treatment in ETP & then sent to Solvent Stripper and in-house MEE for further treatment. ETP
sludge and MEE salt will be sent to common TSDF site of BEIL, Ankleshwar and MEE condensate
(66 KL/day) will be reused in industrial processes. Domestic Waste water will be disposed by
septic tank & soak pit.
1.5 Air Pollution Source and Control Management
There will be flue gas emissions from Boiler, Thermic Fluid Heater and D.G. Sets however as
natural gas will be used as fuel in the boilers the emissions will be well within permissible norms
as natural gas is a clean fuel. Process gas emissions will be in the form of Chlorine, HCL, SO2 and
NH3 which will be controlled by Wet scrubber, alkali scrubber & Water + HCl Scrubber. Fugitive
emissions will be well within permissible norms as all precautionary measures for fugitive
emission will be taken.
1.6 Hazardous Waste
Type of waste Category Existing Additional
Total
(Existing+
Proposed)
Disposal Method
22
Used oil 5.1
120
liters/
annum
350
liters/
annum
470
liters/
annum
Collection, storage,
Transportation and sale to
registered refiners
Distillation and
process residue
20.3 and
28.1
1.2 MT/
Year
78 MT/
Year
79.2 MT/
Year
Collection, storage,
Transportation and
disposal at BEIL common
incinerator/
Co processing in cement
plant
Spent catalyst 28.2 0 MT/
year
5.0 MT/
year
5.0 MT/
year
Collection, storage,
Transportation and return
back to regenerator
Spent carbon 28.3 0 MT/
year
15.0 MT/
year
15.0 MT/
year
Collection, storage,
Transportation and
disposal at BEIL common
incinerator/
Co processing in cement
plant
Date expired
discarded and
off specification
drugs/medicines
28.4 and
28.5
0 MT/
year
1.0 MT/
year
1.0 MT/
year
Collection, storage,
Transportation and
disposal at BEIL common
incinerator/
Co processing in cement
plant
HCl (35%) -- 6.0 MT/
year --
6.0 MT/
year
Collection, Storage,
Transportation, Purification
& Sale to GPCB approved
vendors.
Discarded
Drums/
Bags/ Liners
33.1
3060
Nos/
year
3000
Nos/year
6060
Nos/year
Collection, Storage,
Transportation,
Decontamination & Sale to
GPCB approved vendors.
Spent solvents 28.6
0
MT/
year
650
MT/year
650
MT/year
Collection, Storage,
Transportation & Sale to
GPCB registered re-
processor.
ETP Sludge 35.3
2.4
MT/
year
84
MT/year
86.4
MT/year
Collection, storage,
Transportation and
disposal at BEIL TSDF
Ankleshwar
23
1.7 Green Belt
Total 5,835 sq. meter land area is available at site; out of this area about 1,750 sq. meter (30%
of the total land area) area will be developed as greenbelt and other forms of greenery.
1.8 Power & Fuel Requirements
FUEL:
Existing:
Natural gas= 140 SCM/day
Proposed:
Natural gas= 2400 SCM/day
HSD= 20 lit/hr for DG Sets.
ENERGY:
Existing:
Power supply is from DGVCL and its about 125 KVA.
Proposed:
After Proposed expansion, 600 KVA will be required from DGVCL.
Standby power supply will be from D.G. sets (250 KVA) in emergency.
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. Nivika Chemo Pharma P. Ltd. proposes to manufacture bulk drugs in existing premises at
Plot No. 1808, 1809/2, 1811, 1812, 1813, 1814 & 1815, G.I.D.C. Estate, Ankleshwar-393002,
Dist: Bharuch (Guj.).
List of Directors
Sr.
No.
Name of Directors
1. Mr. Satyan M. Patel
2. Mrs. Ramaben M. Patel
MEE Salt 35.3 --
600
MT/
year
600
MT/
year
Collection, Storage,
transportation and dispose
common TSDF site of BEIL,
Ankleshwar.
24
2.2 Brief description of nature of the Project
Proposed to manufacture bulk drugs in existing premises at Plot No. 1808, 1809/2, 1811, 1812,
1813, 1814 & 1815, G.I.D.C. Estate, Ankleshwar-393002, Dist: Bharuch (Guj.).
2.3 Need for the project and its importance to the country and or region
The demand for products intended to be manufactured is increasing in the country. APIs are
imported in the country and by manufacturing bulk drugs at this unit, company will be able to
meet the demand of various products locally. The project will save forex as imports 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, we have found that there is a big potential for the
range of the products we are planning. These products will be an addition to the current
products as they are directly related to health of the people and their well being.
2.5 Imports vs. Indigenous production
Based on the current cost of indigenous raw materials and the non availability of some
materials, we will have to import some of the raw materials as they are not available
indigenously. This will make us very competitive against imported finished products and we will
also export our finished products in the international market.
2.6 Export possibility
All possibilities of exports will be explored.
2.7 Domestic/Export Markets
Our products have good demand in international market. We shall explore the possibility of
exporting the products.
2.8 Employment Generation (Direct and Indirect) due to project.
M/s. Nivika Chemo Pharma P. Ltd. will give direct employment to local people based on their
qualification and requirement. In addition to direct employment, indirect employment will also
be generated. Ancilliary businesses will be developed to some extent for the local population.
25
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.
PROJECT
SITE
26
Specific location and project boundary
• Project Site (Google Map)
10
• Plant layout:
14
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 local and international market demand of the proposed bulk drug products,
Nivika Chemo Pharma P. Ltd. decided to set up its manufacturing facility at existing optical
brightening making unit in GIDC Ankleswar.
Major factors involved in the selection of site are listed below:
• No site clearance activities are required to be carried out.
• 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 water, Fuel, Power, CETP, TSDF and other infrastructures in the estate.
Modern infrastructure support and amenities at par with 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
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.
All possibilities of water reuse / recycle, energy conservation and environment friendly
operations will be explored and implemented.
15
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.
Power Requirements:
FUEL:
EXISTING:
Natural gas= 140 SCM/day
PROPOSED:
Natural gas= 2400 SCM/day
HSD= 20 lit/hr for DG Sets.
ENERGY:
Existing:
Power supply is from DGVCL and its about 125 KVA.
PROPOSED:
After Proposed expansion, 600 KVA will be required from DGVCL.
Standby power supply will be from D.G. sets (250 KVA) in emergency.
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.
3.10 Schematic representations of the feasibility drawing which give information of EIA
purpose.
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
16
4.0 Site Analysis
4.1 Connectivity
• Site is very well connected by road and rail
• Availability of water, fuel, power, CETP, TSDF and other infrastructure facilities in the
estate.
4.2 Land Form, Land Use and Land Ownership
Land Use will be incorporated in the EIA Study.
4.3 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
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.
4.4 Existing Infrastructure
Existing operating industry having Manufacturing plant, Adm. Bldg., Godown, etc.
4.5 Soil Classification
Soil Classification will be incorporated in the EIA Study.
4.6 Climatic data from secondary sources.
Climatic data will be incorporated in the EIA Study.
4.7 Social infrastructure available.
Various Programs/ Projects related to Social & Economic development of surrounded area
has been planned, which are as follows.
17
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 -
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 bulk drugs Manufacturing Unit in existing dyes unit.
5.2 Population Projection
Population Projection will be incorporated in the EIA Study.
18
5.3 Land use planning (breakup along with green belt etc.)
Total Area= 5,835 m2
Industrial Area (Processing Area)
Processing Area (Plant facilities, ETP Area and Utility Services) = 2,335 m2
Residential Area (Non Processing Area)
Non Processing Area (Raw material storage area, finished storage area, green belt and open
area) = 3,500 m2
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 expansion 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) = 2,335 m2
6.2 Residential Area (Non Processing Area)
Non Processing Area (Raw material storage area, finished storage area, green belt and open
area) = 3,500 m2
6.3 Green Belt
Total 5,835 sq. meter land area is available at site; out of this area about 1,750 sq. meter
(30% of the total land area) area will be developed as greenbelt and other forms of
greenery.
19
6.4 Social Infrastructure
• Water requirement will be met through Ankleshwar 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
• 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 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 expansion 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.
20
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 expansion project after getting EC & CTE 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. 25 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 expansion project.
• Social Welfare will be done with allocation of designated funds for this purpose as
percentage.
• 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.