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PROJECT FEASIBILITY REPORT FOR OBTAINING PRIOR ENVIRONMENT CLEARANCE FOR EXPANSION IN THE EXISTING SET UP OF M/s. BCJ PHARMA LLP LOCATED AT: Plot No.: 7102, Road No. 71, Sachin-GIDC, Sachin, Tal.: Choryasi, Dist.: Surat, State: Gujarat.

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Page 1: PROJECT FEASIBILITY REPORT - …environmentclearance.nic.in/writereaddata/FormB/TOR/PFR/16_Mar... · PROJECT FEASIBILITY REPORT FOR OBTAINING PRIOR ENVIRONMENT CLEARANCE ... Activated

PROJECT FEASIBILITY

REPORT

FOR OBTAINING

PRIOR ENVIRONMENT CLEARANCE

FOR

EXPANSION

IN THE EXISTING SET UP

OF

M/s. BCJ PHARMA LLP

LOCATED AT:

Plot No.: 7102, Road No. 71, Sachin-GIDC, Sachin, Tal.: Choryasi, Dist.: Surat, State: Gujarat.

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1. EXECUTIVE SUMMARY

M/s. BCJ PHARMA LLP is new unit located at Plot No.: 7102, Road No. 71, Sachin-GIDC, Sachin, Tal.:

Choryasi, Dist.: Surat, State: Gujarat. will involve to manufacture of drugs.

Project is located within GIDC area. The unit is going for production of synthetic organic chemicals. Therefore,

project falls under category B of schedule 5(f), as per the EIA Notification, September 2006. Therefore, it requires

prior Environment Clearance.

There shall be no forest, wild life sanctuary, eco sensitive area present within 10 km area from the project site.

Electric power requirement for proposed project will be 1000 KVA, which will be procured from DGVCL.

One Boiler of Capacity 1 TPH and One Thermo pack of capacity 4 TPH will be installed. Imported Coal will be used

as a fuel in Boiler and Thermopack. Therefore, Multi Cyclone Separator and Bag Filter & water scrubber will be

installed as Air Pollution Control System. Water scrubber followed by alkali scrubber and Ammonia Recovery

System will be attached with Reaction vessel as Air Pollution Control System.

For proposed project activity, water required for domestic & industrial purpose will be sourced from GIDC.

Domestic effluent shall be disposed in to Septic tank / Soak pit system. Industrial waste water after primary

Treatment in to ETP and confirming to the CETP inlet norms shall be disposed to CETP for its further treatment

and final disposal.

Hazardous/solid waste generated from the process and other industrial activity will be stored in a separate

hazardous waste storage area and then it will be disposed at nearest TSDF site for secured land filling. Unit will get

TSDF membership after getting EC but before starting of production.

Proper safety will be provided during storage, handling and use of hazardous substance. Portable Fire

Extinguishers shall be provided at key location.

Total area of project site is 1295.00 m2. Approx. 155.00 m2 (Outside of premises) area will be developed as a

green belt.

Due to proposed project, total employment generation will be 32 (30 men + 2 women).

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2. INTRODUCTION OF PROJECT / BACKGROUND INFORMATION

2.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT

M/s. BCJ PHARMA LLP is new unit located at Plot No.: 7102, Road No. 71, Sachin-GIDC, Sachin, Tal.:

Choryasi, Dist.: Surat, State: Gujarat. and manufacturing of Drugs.

PROJECT PROPONENT

M/s. BCJ PHARMA LLP is a Partnership firm. Mr. Pragnesh Thummar is a Managing Director of the

company.

2.2 NATURE OF THE PROJECT

M/s. BCJ PHARMA LLP is a small scale unit. It covers under the category 5(f) of synthetic organic

chemical industry.

2.3 NEED FOR THE PROJECT

M/s. BCJ PHARMA LLP will engage in production of Drugs. Due to need of intermediate products in market, unit proposes to produce product intermediate products.

2.4 EMPLOYMENT GENERATION (DIRECT & INDIRECT) DUE TO THE PROJECT

Due to proposed project, employment will be generated. The unit will hire local people from the nearby villages.

Due to proposed project, approx. 32 people (30 men + 2 women) will be required. Therefore, Total employment from this project will be 32 (30 men + 2 women).

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3. PROJECT DESCRIPTION

3.1 TYPE OF PROJECT

The unit will involve in manufacturing of Drugs.

3.2 LOCATION

The site is located at about 21° 5'39.45"N latitude and 72°51'33.39"E longitude.

LOCATION OF THE PROJECT

3.3 DETAILS OF ALTERNATE SITES

No alternative sites examined as proposed project is located within GIDC area

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3.4 DETAILS RAW MATERIAL AND PRODUCT

3.4.1 LIST OF PRODUCT

Sr. No.

Name Of Product Capacity (MT/Month)

Chemical Formula

Therapeutic use

1. Albendazole and/or 35 C12H15N3O2S Antihelmintics

2. Alendronate Sodium and/or 1 C4H13NO7P2 Bone Enhancers

3. Amisulpride and/or 4 C17H27N3O4S Psychotherapeutics 4. Duloxetine HCl and/or 1.5 C18H19NOS.HCL

5. Bisoprolol and/or 1.1 C18H31NO4

Anti hypertensive

6. Lacidipine Hydrochloride and/or 0.8 C26H33NO6

7. Losartan Potassium and/or 3 C22H23ClN6O

8. Nisoldipine and/or 1 C20H24N2O6

9. Olmesartan and/or 1.5 C29H30N6O6

10. Telmisartan and/or 3.5 C33H30N4O2

11. Dutasteride and/or 0.5 C27H30F6N2O2 BPH Agents

12. Tamsulosine HCl and/or 1.1 C20H28N2O5S

13. Fexofenadine Hydrochloride and/or 6 C32H39NO4. HCL Antihistamine

14. Loratidine and/or 3.5 C22H23ClN2O2

15. Gabapentin and/or 3 C9H17NO2 Anticonvulsants

16. Pregabalin and/or 4 C8H17NO2

17. Glimepiride and/or 1 C24H34N4O5S Antidiabetic agent

18. Larnoxicam and/or 2.5 C13H10ClN3O4S2 Anti-inflammatory

19. Lansoprazole and/or 3 C16H14F3N3O2S

Antiulcers 20. Omeprazole and/or 6 C17H19N3O3S

21. Pantoprazole Sodium and/or 8 C16H15F2N3O4S

22. Rabeprazole Sodium and/or 3 C18H21N3O3S

23. Phenylephrine Hydrochloride and/or

4 C9H13NO2

Decongestants

24. Prilocaine HCl and/or 0.5 C13H20N2O Anesthetic

25. Sertraline Hydrochloride and/or 1 C17H17Cl2N antidepressant

26. Simvastatin and/or 0.5 C25H38O5 Antilipemics

Note: The unit will produce any of the above Products individually / simultaneously having total production capacity shall not exceed 100 MT/Month.

3.4.2 LIST OF RAW MATERIALS

Sr. No.

Products Raw Material

Molecular formula Raw Material Consumption

Kg/Batch MT/Month

1. Albendazole

2-Nitro-4-thiocyano aniline C7H5N3O2S 420 26.72

n-Propanol C3H8O 1850 117.72

n-Propyl Bromide C3H7Br 180 11.45

Sodium Hydrosulphide NaHS 1720 109.45

Thiourea CH4N2S 239 15.20

Dimethyl Sulphate (CH3)2SO4 216 13.74

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Methyl Chloroformate ClCOOCH3 600 38.18

Sodium Hydroxide NaOH 835 53.13

Acetic Acid C2H4O2 195 12.40

Water H2O 550 35.0

DM water H2O 50 3.18

and/or

2. Alendronate Sodium

2-Pyrrolidinone C4H7NO 35.03 0.34

DM Water H2O 608.54 5.92

Methane sulphonic acid CH4O3S 248.70 2.42

Phosphorus Trichloride PCl3 69.30 0.67

Activated carbon C 0.75 0.0072

Hyflow (Celite) O2Si 5.0 0.048

Sodium Hydroxide NaOH 50.15 0.487

and/or

3. Amisulpride

AMT-III (4-amino-2- methoxy-5-ethyl thiomethoxy benzoate)

C10H11O3NS 243.99 9.76

Sodium hydroxide NaOH 265.01 10.60

Conc. Hydrochloric acid HCl 24.39 0.975

Water H2O 1189.6 47.58

Propanol C3H8O 220.77 8.83

Hydrogen peroxide H2O2 33.99 1.360

Sodium tungstate dehydrate Na2WO4.2H2O 0.14 0.0056

Methanol CH3OH 0.97 0.038

Triethyl amine (CH3CH2)3N 126.48 5.06

Ethyl chloroformate ClCO2C2H5 115.09 4.60

N-Ethy-2-aminomethyl pyrrolidine C7H16N2 97.92 3.91

Activated carbon C 2.79 0.111

Hyflow (Celite) O2Si 1.39 0.055

Acetone C3H6O 286.3 11.45

and/or

4. Duloxetine HCl

DTP Hydrochloride[(3-(dimethylamino)-1-(thiophen-2-yl) propan-1-one hydrochloride)]

C9H14ClNOS 293.44

6.81

Sodium borohydride NaBH4 65.73 1.52

Sodium hydroxide NaOH 116.37 2.70

Conc. Hydrochloric acid HCl 42.06 0.97

Sodium chloride NaCl 220.34 5.11

Methanol CH3OH 505.83 11.75

Dichloromethane CH2Cl2 285.86 6.64

Cyclohexane C6H12 1536.36 35.69

Water H2O 1112.61 25.85

1-Fluoronaphthalene C10H7F 152.85 3.55

Acetic acid CH3COOH 428.04 9.94

Sodamide NaNH2 53.07 1.23

Oxalic Acid dehydrate (COOH)2.2H2O 18.92 0.44

Dimethyl sulfoxide (CH3)2SO 93.69 2.17

Ethyl acetate C4H8O2 1368.9 31.80

Aq. Ammonia NH3 507.65 11.79

Dibenzoyl-L-tartaric acid C18H14O8 105.76 2.45

Di isopropyl amine 49.15 1.14

Phenyl chloroformate ClCOOC₆H₅ 74.44 1.73

Sodium bicarbonate NaHCO3 19.09 0.44

Ethyl acetate hydrochloride C4H8O2.HCl 72.77 1.70

Toluene C6H5CH3 257.16 5.97

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Activated carbon C 4.76 0.11

Celite O2Si 17.06 0.39

Acetone C3H6O 297.94 6.92

and/or

5. Bisoprolol

4 – Hydroxy Benzaldehyde C7H6O2 134.71 1.03

Sodium Borohydride NaBH4 115.20 0.88

Sodium Hydroxide NaOH 126.97 0.97

Water H2O 2531.71 19.50

Caustic flakes NaOH 44.45 0.34

Activated carbon C 12 0.092

Acetic acid CH3COOH 114.5 0.88

Toluene C7H8 650.76 5.012

2- Isopropoxy ethanol C5H12O2 212.44 1.636

Amberlyst resin - 97.00 0.747

Potassium Carbonate K2CO3 20.20 0.155

Epichlorohydrin (EPH) C3H5ClO 336.80 2.594

Mono Isopropyl amine (MIPA) C3H9N 363.73 2.80

IPA C3H6O 316.00 2.434

Fumaric acid C4H4O4 33.67 0.259

and/or

6. Lacidipine Hydrochloride

Bi phenyl compound -- 80.45 0.429

Succinic anhydride OCCH2CH2COO 22.72 0.121

Dichloro methane CH2Cl2 298.20 1.59

IPA C3H6O 149.10 0.795

Water H2O 220.50 1.176

Alluminium chloride AlCl3 17.85 0.095

Nitro compound -- 44.10 0.235

Methoxy derivative -- 29.19 0.155

Toluene C7H8 596.40 3.182

Methanol CH3OH 306.78 1.636

Activated carbon C 8.97 0.047

and/or

7. Losartan Potassium

Cyano biphenyl comp.( 4'-Methyl-2-cyanobiphenyl)

C14H11N 72.01

1.779

Dibromo adantine 53.35 1.318

Chloro benzene C6H5Cl 242.54 5.992

Immidazole C3H4N2 59.50 1.470

Sodium hydroxide NaOH 14.29 0.353

Toluene C7H8 673.65 16.64

Water H2O 910.43 22.49

Sodium borohydride NaBH4 12.37 0.305

Acetic acid CH3COOH 20.08 0.496

Methanol CH3OH 266.98 6.59

Sodium azide NaN3 21.20 0.523

Conc. Hydrochloric acid HCl 11.90 0.294

Potassium hydroxide KOH 16.40 0.405

Activated carbon C 7.36 0.181

and/or

8. Nisoldipine

3-Nitrobenzaldehyde C7H5NO3 102.14 1.277

Isopropyl alcohol C3H6O 808.33 10.109

Methyl aceto acetate C₅H₈O₃ 79.80 0.997

Piperidine C5H11N 6.38 0.0797

Acetic acid CH3COOH 4.78 0.0597

Methyl-3- aminocrotonate C₅H₉NO₂ 76.60 0.957

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Methanol CH3OH 616 7.703

Sodium hydroxide NaOH 47.60 0.595

Conc. Hydrochloric acid HCl 171.38 2.143

Carbon C 68.62 0.858

Water H2O 247.17 3.091

n-Benzyl-N-Methyl ethanolamine C10H15NO 54.26 0.678

Dichlorohexylcarbodiimide 17.41 0.217

Dimethylopropionic acid 3.19 0.039

Ethyl acetate C4H8O2 337.12 4.216

Acetone C3H6O 367.08 4.590

and/or

9. Olmesartan

4-(1-Hydroxy-1-methyl ethyl)-2-propyl-1H-imidazole-5 carboxylic acid ethyl ester

C12H20N2O3 105.0

0.622

5-(4’-Bromomethyl biphenyl-2-yl)-1-trityl-1H-tetrazole

C32H25N4Br 112.0

0.664

Potassium carbonate K2CO3 0.50 0.003

Sodium hydroxide Powder (NaOH Powder)

NaOH 9.0

0.0533

4-chloro methyl-5-methyl-2-oxo-3-dioxolene

C5H5O3Cl 93.0

0.551

Sodium Chloride(NaCl) NaCl 2.0 0.011

Toluene C7H8 200.0 1.185

Acetone C3H6O 300.0 1.778

and/or

10. Telmisartan

Bibenzimidazole C19H20N4 106.26 2.926

Bromo methyl ester C15H13BrO2 106.62 2.936

Sodium methoxide CH3ONa 18.45 0.508

Dimethyl formamide HCON(CH3)2 552.28 15.209

Acetone C3H6O 168.08 4.628

Water H2O 1131.43 31.159

Potassium Hydroxide KOH 43.34 1.193

Methanol CH3OH 477.04 13.137

Acetic acid CH3COOH 268.05 7.381

Activated Carbon C 7.45 0.205

Celite O2Si 5.01 0.138

and/or

11. Dutasteride

3-oxo-4-androstene -17 beta –carboxylic acid

4.0

0.333

2,5-bis (Trifluoromethyl) aniline (CF3)2C6H3NH2 4.0 0.333

Potassium Permanganate KMnO4 0.012 0.001

Sodium Carbonate Na2CO3 0.1 0.0083

Ethylene Glycol C2H6O2 0.1 0.0083

Acetic Acid C2H4O2 40.0 3.333

and/or

12. Tamsulosine

(S)-5-(2-aminopropyl)-2- methoxybenzene sulphonamide

C10H16N2O3S 8.68

0.668

2-(O-Ethoxy Phenoxy)ethyl Bromide C10H13BrO2 12.74 0.981

Methanol CH3OH 226.5 17.447

n-Haxane C6H14 52.22 4.022

50% NaOH NaOH 5.60 0.431

Ethyl acetate C4H8O2 200.0 15.406

Ethanol CH3CH2OH 182.42 14.051

Ethanolic HCl CH3CH2OH.HCl 17.36 1.337

DM Water H2O 371.68 28.630

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and/or

13. Fexofenadine Hydrochloride

2-[4-(4-Chlorobutanoyl)phenyl-2-methyl propionic acid

83.35

7.191

Methanolic Hydrochloric acid CH3OH.HCl 333.24 28.752

Sodium bicarbonate NaHCO3 0.40 0.034

Toluene C7H8 216.77 18.703

Water H2O 752.67 64.941

Azacyclonol C18H21NO 76.42 6.593

Potassium bicarbonate KHCO3 35.38 3.052

Potassium Iodide KI 0.74 0.063

Methyl-iso-butyl ketone(MIBK) C6H12O 410.53 35.421

De-natured Spirit (DNS) C2H5OH 98.69 8.515

Sodium borohydride NaBH4 7.32 0.631

Sodium Hydroxide NaOH 45.38 3.915

Hydrochloric acid HCl 52.22 4.505

Methanol CH3OH 515.96 44.517

Acetone C3H6O 219.60 18.947

Isopropyl alcohol C3H6O 332.59 28.696

Ethyl acetate C4H8O2 478.75 41.307

and/or

14. Loratidine

3-(3 Chlorophenylethyl )-2- Cyanopyridine

C₁₄H₁₁ClN₂ 142.24

3.892

4-Chloro-N- methylpiperidine C6H12ClN 78.28 2.142

Magnesium Mg 14.26 0.390

Hydrochloric acid HCl 21.39 0.585

Tetrahydrofuran C4H8O 706.72 19.340

Toluene C7H8 2641.07 72.273

Acetone C3H6O 494.70 13.537

Water H2O 1870.55 51.187

1,2-dibromomethane C2H4Br2 35.33 0.966

Poly phosphoric acid H3PO4 51.24 1.402

Caustic lye NaOH 75.37 2.062

Methylene dichloride CH2Cl2 464.12 12.700

Cyclo hexane C6H12 225.79 6.178

Ethylchloroformate ClCO2C2H5 54.36 1.487

Triethylamine (CH3CH2)3N 126.56 3.463

Activated carbon C 8.22 0.225

Acetonitrile CH3CN 507.36 13.884

and/or

15. Gabapentin

Isopropyl alcohol C3H8O 760.48 28.521

Ammonia NH3 109.38 4.102

CDAA 160.44 6.017

Hydrochloric acid HCl 441.65 16.563

Water H2O 1327.49 49.787

Sodium Hydroxide NaOH 239.90 8.997

Bromine Br2 140.78 5.280

MDC (Methylene dichloride) CH2Cl2 1771.88 66.453

Ethanol CH3CH2OH 751.94 28.201

Ethyl acetate C4H8O2 719.96 27.00

Tri ethylamine (CH3CH2)3N 48.76 1.828

Activated carbon C 3.19 0.119

Acetone C3H6O 1350.34 50.644

and/or

16. Pregabalin CMH ((+)-3-(carbamoylmethyl)-5- C9H17NO3 267.90 18.753

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methyl hexanoic acid)

R-(+)-1 Methyl benzyl amine C₈H₁₁N 143.60 10.052

methanol CH3OH 50.15 3.510

chloroform CHCl3 163.52 11.446

Sulfuric acid H2SO4 123.2 8.624

Water H2O 1181 82.674

Sodium hydroxide NaOH 24.00 1.680

Sodium hypochlorite NaOCl 127.34 8.914

Activated carbon C 4.62 0.323

Celite SiO2 0.83 0.058

Isopropyl alcohol C3H8O 393.00 27.511

and/or

17. Glimepiride

N-{4-[2-(3-ethyl-4-methyl-2-oxopyrroline)-1-caboxamido]ethyl} benzene sulphonamide

C16H21O4N3S

100.0

0.8

Trans-4-methylcyclohexyl isocyanate C8H13NO 52.0 0.416

Toluene C7H8 100.0 0.8

Acetone C3H6O 250.0 2.0

and/or

18. Larnoxicam

Pyridin-2-ylcarbamic chloride C6H5ClN2O 5.19 1.082

6-chloro-2-methyl-2H-thieno [2,3- e{1,2}thiazin-4-ol1,1- dioxide

C7H6ClNO3S2 8.40 1.751

Sodium methoxide CH3ONa 1.79 0.373

Methanol CH3OH 16.59 3.459

and/or

19. Lansoprazole

2-Chloromethyl-3-methyl-4-- 2,2,2 trifluoroethoxy Pyridine Hydrochloric acid

C9H8ONCl2F3 98.02 4.343

2-Mercapto BenzImidazole C7H6N2S 56.14 2.487

Sodium hydroxide NaOH 89.17 3.951

Methanol CH3OH 775.53 34.366

Water H2O 844.86 37.438

Sodium hypochlorite NaOCl 38.02 1.684

Sodium thiosulphate Na2S2O3 33.71 1.493

Ammonium acetate C2H7NO2 47.39 2.1

Diisopropyl ether C6H14O 430.68 19.084

Ethyl acetate C4H8O2 1751.08 77.595

Aq Ammonia NH4OH 8.24 0.365

Ethanol(denatured) CH3CH2OH 718.76 31.850

Acetone(denatured) C3H6O 1467.43 65.026

Potassium carbonate K2CO3 29.39 1.302

Activated carbon C 7.47 0.331

Celite SiO2 9.86 0.436

and/or

20. Omeprazole

2-Chloromethyl-- 3, 5 Dimethyl-- 4-methoxypyridine hydrochloride(Chloro compound)

C9H13Cl2NO 128.16 12.462

2-mercapto-5- methoxybenzimidazole (Mercapto compound)

C8H8N2OS 109.22 10.621

Sodium hydroxide NaOH 102.95 10.011

Methanol CH3OH 1805.1

175.536

Water H2O 1213.82

118.037

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Hydrogen peroxide H2O2 36.24 3.524

Ammoniummolybdate tetrahydrate (NH4)6Mo7O24.4H2O 0.60 0.0583

Sodium carbonate Na2CO3 1.44 0.140

Acetic acid C2H4O2 30.77 2.992

Triethyl amine (CH3CH2)3N 0.76 0.0739

Dichloro methane CH2Cl2 1304.01

126.808

Ammonium acetate C2H7NO2 25.48 2.477

Acetone C3H6O 50.97 4.956

and/or

21. Pantoprazole Sodium

HDMP (3,4- dimethoxypyridin-2-yl) methanol

C8H11NO3 70.38

8.316

Thionyl chloride Cl2OS 59.62 7.045

Methylene dichloride CH2Cl2 5161.78 609.95

Acetone C3H6O 165.90 19.604

Methanol CH3OH 664.31 78.50

DFMB (5-difluromethoxy -1H- benzimidazole-2-thiol)

80.99

9.570

Sodium chloride NaCl 42.62 5.036

Sodium Hydroxide NaOH 42.67 5.042

Cyclohexane C6H12 783.49 92.583

Water H2O 694.95 82.121

Sodium Hypochlorite NaClO 104.23 12.316

Sodium dihydrogen orthophosphate NaH2PO4 28.74 3.396

Sodium thiosulphate Na2S2O3 1.09 0.128

Ethyl acetate C4H8O2 1979.39 233.90

Diisopropyl ether (DIPE) C6H14O 2739.14 323.67

Ethanol CH3CH2OH 279.34 33.009

and/or

22. Rabeprazole Sodium

Chloro compound C11H17O2NCl2 136.87 6.065

2-Mercaptobenzimidazole C7H6N2S 79.39 3.518

Sodium hydroxide NaOH 170 7.533

Methanol CH3OH 518.8 22.989

Water H2O 838.32 37.148

Sodium hypochlorite NaClO 81.54 3.613

Sodium thiosulphate Na2S2O3 3.01 0.133

Acetic acid C2H4O2 75.28 3.335

Sodium chloride NaCl 75.28 3.335

Methylene dichloride CH2Cl2 1705.94 75.595

Ethyl acetate C4H8O2 988.60 43.807

Cyclohexane C6H12 931.88 41.294

Activated carbon C 3.61 0.1599

Celite SiO2 3.16 0.1400

Denatured Ethanol CH3CH2OH 427.51 18.944

DCM - 898.56 39.818

Di-isopropyl ether C6H14O 654.12 28.986

Toluene C7H8 624.03 27.652

and/or

23. Phenylephrine Hydrochloride

3-hydroxyAcetophenone HOC6H4COCH3 51.87 3.990

Ethyl acetate C4H8O2 129.22 9.941

Bromine Br2 31.12 2.394

Aluminium chloride AlCl3 1.03 0.079

Toluene C7H8 570.57 43.898

Sodium bicarbonate NaHCO3 51.87 3.990

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Sodium sulphate Na2SO4 5.18 0.398

Water H2O 1013.49 77.975

N-methyl benzyl amine C8H11N 38.90 2.992

IPA-HCl -- 311.22 23.944

Isopropyl alcohol C3H8O 466.83 35.916

Methanol CH3OH 245.69 18.902

10% palladium carbon - 7.78 0.598

Hydrogen gas H2 1.55 0.119

Activated carbon C 6.21 0.477

Liq Ammonia NH3 191.9 14.764

L(+)Tartaric acid C4H6O6 126.49 9.731

Acetone C3H6O 155.61 11.972

and/or

24. Prilocaine

Ortho Toluidine CH3C6H4NH2 10 0.185

2-Bromo Proponyl Bromide C3H4Br2O 10 0.185

O-Propyl Amine C3H9N 10 0.185

Toluene C7H8 200 3.703

Sodium Bi carbonate NaHCO3 0.7 0.012

Con. HCl HCl 2 0.037

Liq. Ammonia (25 %) NH3 50 0.9260

DCM -- 475 8.796

Acetone C3H6O 75 1.388

Isopropionic HCL -- 3 0.055

and/or

25. Sertraline Hydrochloride

4-(3,4 Dichlorophenyl) -,3,4- dihydro-1 2H – naphthalenone

C16H12Cl2O 69.35

1.123

Methylamine CH3NH2 7.38 0.119

Hexane C6H14 118.80 1.925

Toluene C7H8 118.80 1.925

Water H2O 712.8 11.550

Sodium borohydride NaBH4 8.33 0.134

Hydrochloric acid HCl 21.8 0.353

Methanol CH3OH 237.6 3.850

Activated carbon C 4.75 0.0770

Mandelic acid C6H5CH(OH)COOH 31.32 0.507

Sodium Hydroxide NaOH 15.84 0.256

Ethyl acetate C4H8O2 415.55 6.733

Sodium chloride NaCl 11.88 0.192

and/or

26. Simvastatin

Lovastatin C24H36O5 93.93 0.869

Potassium hydroxide (KOH) KOH 163.39 1.513

Catalyst SA -- 0.78 0.007

Conc. Hydrochloric acid HCl 394.38 3.652

BHT (Butylated hydroxy toluene) C15-H24-O 0.55 0.005

Immidazole C3H4N2 38.90 0.360

TBDMSi-Cl (tert- butyldimethylsilyl chloride)

C6H15ClSi 43.21

0.400

DMBC (2,2-Dimethyl Butylryl Chloride)

C6H11ClO 62.89

0.582

Tri ethyl amine (CH3CH2)3N 106.31 0.984

MSA (Methane Sulphonic Acid) -- 10.28 0.095

Sodium carbonate Na2CO3 11.49 0.106

Sodium chloride NaCl 33.86 0.313

Ammonia NH3 32.76 0.303

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Methanol CH3OH 1111.12 10.290

Toluene C7H8 1140.14 10.558

Ethyl acetate C4H8O2 1482.64 13.730

Water H2O 720.03 6.668

Ortho Phosphoric acid (OPA) H3PO4 24.79 0.229

Activated carbon C 12.87 0.119

Celite SiO2 2.82 0.026

MDC (Methylene dichloride) CH2Cl2 1195.74 11.073

Cyclohexane C6-H12 1227.75 11.370

Catalyst SB -- 0.30 0.0027

Catalyst SC -- 0.30 0.0027

3.6 MANUFATURING PROCESS AND FLOW DIAGRAM

For Manufacturing process and flow diagram with mass balance, please refer Annexure – 3 of EC application.

3.7 RESOURCE OPTIMIZATION / RECYCLING AND REUSE

* Unit intense to produce 100 MT/Month from any of product as per Annexure No. 3. The maximum water consumption and waste water generation will be arising from product Omeprazole.

** Chilled out water will be totally reroute again in chilling Plant.

*** Softener backwash & regeneration will be done on every fifteen days.

**** DM plant regeneration & Backwash will be done at (after 20000 L DM water generations).

HCl & H2SO4 & Ammonia Solutions generated from reaction column will be scrubbed into water scrubber

followed by alkali scrubber. Recovered HCl (20-30%), and H2SO4 (50-70%) & Ammonia Solutions will be

sold to local manufacturer. Copy of Agreement / MOU to sale HCL, H2SO4 & Ammonia Solutions will take

after getting EC.

3.8 AVAILABILITY OF WATER, ITS SOURCE, ENERGY / POWER REQUIREMENT AND SOURCE

Energy / Power Requirement & Its Source

Electric power requirement for existing project is 1000 KVA, which is procured from DGVCL.

Water Availability & Its Source

Source of Water: GIDC water Source

The water consumption & generation at the different usages, please refer Annexure 5 of EC

Application.

Disposal of Wastewater:

Domestic effluent is disposed in to Septic tank / Soak pit system. Industrial effluent after primary Treatment in to ETP and confirming to the CETP inlet norms shall be

disposed to CETP for its further treatment and final disposal.

3.9 QUANTITY OF WASTES TO BE GENERATED (LIQUID AND SOLID) AND SCHEME FOR THEIR

MANAGEMENT / DISPOSAL

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Hazardous waste generated from the industrial activity will be stored in a separate hazardous waste

storage area and it will be disposed at nearest TSDF site for further treatment and disposal.

The municipal solid wastes generated during operation phase will be disposed to bin of GIDC.

4. SITE ANALYSIS

4.1 CONNECTIVITY

The project site is well connected with all infrastructures like National Highway, Railway, Airport, telephone, internet, fax, post, etc.

Nearest city is Surat located 9.5 km in NNW direction from the project site.

State Highway No. 6 is located 0.94 Km in NE direction.

National Highway No.8 located 12.13 Km in E direction.

Nearest railway station is Sachin located 2.37 km in ESE direction from the project site.

Nearest airport is Surat located 12.48 km in WNW direction from the project site.

4.2 LAND FORM, LAND USE AND LAND OWNERSHIP

The proposed unit will be developed in a GIDC. The land is already Non-Agriculture. The Proposed project

activity will be developed as per plan lay out shown in Annexure – 2 of EC Application in GIDC. The proposed

project will not cause any permanent or temporary change to land use.

4.3 TOPOGRAPHY

The project area is plain and flat surface with elevation 42 m above MSL. However, in the NE part the elevation is in the range of 41 – 43 m above MSL, in the SW part the elevation is in the range of 42 – 43 m above MSL & in NW part the elevation is in the range of 42 – 43 m above MSL. In the buffer zone towards W the elevation rises to 43 m above MSL & towards NE, E & SE, and the elevation descend to 41 m above MSL.

4.4 EXISTING LAND USE PATTERN, SHORTEST DISTANCE FROM THE PERIPHERY OF THE PROJECT TO PERIPHERY OF THE FOREST, NATIONAL PARK, WILD LIFE SANCTUARY, ECO SENSITIVE AREA, WATER BODIES (DISTANCE FROM THE HFL OF THE RIVER), CRZ

The land is non agriculture. The project site is located in GIDC area. There shall be no forest, wild life sanctuary, eco sensitive area within 10 km from the project site. The details of water bodies and nearest park are mentioned below:

Tapi River is 11.47 km in NNW direction. Arabian Sea is 16.90 km in WSW direction. Vansda National Park is 83.5 km in ESE direction. Purna Wildlife Sanctuary is 90.40 km in E direction. Dandi Eco-Sensitive Zone is 22.5 Km in S

4.5 EXISTING INFRASTRUCTURE

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The proposed project is located in a GIDC. DGVCL is provide power supply. pucca road,

telephone & other communication network & drainage network in the area was developed.

Skilled & unskilled manpower are available within area. Ambulance and emergency fire &

medical service available round the clock.

5. PLANING BRIEF

5.1 PLANNING CONCEPT

The unit has proposed to manufacture Drugs. Proposed project activity will be carried out at

Plot No.: 7102, Road No. 71, Sachin-GIDC, Sachin, Tal.: Choryasi, Dist.: Surat, State: Gujarat. The Proposed project activity will be carried out in 1295 m2 unit area.

All the basic facilities like tap water, sanitation & drinking water, canteen & first aid box will

be provided within the premises.

The project site is well connected with the road, railway and airport. Finished product and

raw materials will be transported through road. There is no requirement for the development

of other road or railway.

5.2 POPULATION PROJECTION

During operation phase 32 people-Direct (30 men + 2 women), 32 employees

5.3 LAND USE PLANNING Please refer Annexure – 3 for land area.

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND (PHYSICAL & SOCIAL)

The proposed project is located in a GIDC. DGVCL is Provide power supply. Pucca road,

telephone & other communication network & drainage network in the area was developed.

Skilled & unskilled manpower are available within area. Ambulance and emergency fire &

medical service available round the clock.

Local people will be hired for new products and they will be trained within unit. Thus, no

social infrastructure will require.

5.5 AMENITIES / FACILITIES

All the basic facilities like tap water, sanitation & drinking water, will be provided within

premises.

First aid box, free medicines & doctor service (on call basis) will be provided.

Adequate PPE’s will be provided to all workers.

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6. PROPOSED INFRASTRUCTURE

The breakup of the land area is mentioned in the below table:

1. Industrial Area Total Area – 1295 m2

2. Residential Area Residential area is located 2.35 km in NNE direction.

Green Belt Proposed – 155 m2

4. Social Infrastructure Social infrastructure available within 10-15 km from project site.

5. Connectivity National Highway No. 8 is located 12.13 Km in E direction Nearest railway station – Sachin railway station is located 2.37 Km in ESE direction. Nearest Airport – Surat Airport 12.48 Km in WNW direction.

6. Drinking Water Management

Source of water for domestic & industrial purpose is from GIDC water.

7. Sewerage System Domestic effluent will be disposed in to existing Septic tank / Soak pit system. No Industrial effluent will be generated/ discharged.

8. Industrial Waste

Management

Discarded Containers/Bags – Collection, Storage, Decontamination and Disposal by selling to registered re-cyclers approved by GPCB/CPCB. Used Oil– Collection, Storage, Transportation, Disposal by selling to Registered Re-refiners approved by GPCB/CPCB.

9. Solid Waste Management MSW disposed to bin of nearby SMC.

10. Power Requirement &

Supply / Source

Source: Dakshin Gujarat Vij Company Ltd.

Proposed power requirement: 1000 KVA

7. REHABILITATION AND RESETTLEMENT (R & R) PLAN

The project is located within a GIDC therefore no Rehabilitation & Resettlement (R & R) plan is

involved in proposed project.

8. PROJECT SCHEDULE & COST ESTIMATES

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8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATE OF COMPLETION

Production of proposed product will be started after getting Environment Clearance (SEAC) and

CTE/CC&A from the GPCB.

8.2 PROJECT COST ESTIMATION Estimated cost for the proposed project is as under;

Details Description Approximate Recurring Cost Per Annum (Rs. in Lacs)

Approximate Capital Cost (Rs. in Lacs)

Land Adjacent GIDC plot will be required which was already purchased in past.

-- 110.00

Building , Raw Material & Finished Product Storage area

RCC G+1+1+1 floor and Roof type shed will be constructed. Existing roof type shed will be partly modified in RCC G+1+1+1 floor.

2.00 100.00

Plant & Machinery New machineries required for the proposed project.

-- 120.00

ETP & APCS New ETP will be provided. Bag filter will be provided in pulverizer section.

10.0 35.00

Green Belt Development

Proposed 155 m2 area will be developed as a green belt

0.50 3.00

CSR Activity Rain water harvesting will be developed nearby village Donate computer to nearby village school

-- 3.00

TOTAL

12.5 371.00

9. ANALYSIS OF PROPOSAL

9.1 FINANCIAL AND SOCIAL BENEFITS WITH SPECIAL EMPHASIS ON THE BENEFIT TO THE LOCAL PEOPLE INCLUDING TRIBAL POPULATION, IF ANY, IN THE AREA

Project is located in a GIDC. Therefore, No R & R plan involved in proposed project.

Due to proposed project, it is expected that employment will increase for people who reside nearby

project area. Approx. 30 men & 2 women will get employment directly.

Due to increase in raw material and product transportation activity, indirect employment will

generate.

As local people will get job, quality of living will be increase.

Due to green belt development, aesthetic value of local environment will improve.