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For TOR – New Projects

1. Basic Information of the Project: i Name & Address of the Project site Brichem Sciences Pvt Ltd (Complete details with plot no./Survey Plot no:140,GIDC,Opp.Paras no., Landmark etc. ) Pharmaceuticals,Kalol,Gandhinagar- 382721,Gujarat ii Name of the Applicant Rajesh Gami iii Address for correspondence Brichem Sciences Pvt.Ltd. A-114, Ganesh Meridian, Opp. Kargil Petrol Pump, S.G.Highway, Ahmedabad-380060 iv Contact no. and e-mail ID of the Applicant Mo. no.: +919427536568 e-Mail: [email protected] v Aerial distance of nearest Habitat (KM) vi Longitude & Latitude of the Project Site: A: 23°13’29.69” N 72°30’39.17” E (4 corners of the site) B: 23°13’30.20” N 72°30’40.28” E C: 23°13’28.93” N 72°30’40.87” E D: 23°13’28.48” N 72°30’39.94” E vii Total cost of Proposed Project @ Rs. 5.00 Crore (Rs. in Crores):

viii Total Plot area @ 1192.6 sq.m. ( sq. meter) ix Green belt area,/Tree Plantation area @300 sq.m ( sq. meter) x Category as per the Schedule to the EIA 5(f) Notification 2006 i.e. 1(d), 2(b), 5(f) etc. xi Applicability of General Conditions of Not applicable as proposed unit is EIA Notification 2006: i.e. within notified industrial estate. Ensure that I. Protected areas notified under the Wildlife (Protection) Act, 1972; II. CEPI areas III. Eco-sensitive areas and IV. Inter-state boundaries and international boundaries; are not located within 5 km or 10 km (as the case may be) area from the boundary of the proposed site. 2. Online application proposal no. : SIA/GJ/IND2/20969/2017 3. Date of application for TOR: 10th Nov 2017 4. Project status: New 5. Product profile: Sr. Quantity Name Of Product CAS Number End User No. ( Kg Per Month) Hydroxyprogesterone caproate(HPC) 630-56-8 Nandrolone Decanoate 360-70-3 1 Nandrolone Phenylpropanoate 62-90-8 750 Norethistrone 68-22-4

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Norethisterone Acetate 51-98-9 Norethisterone Enanthate 3836-23-5 Estrone 53-16-7 Ethinyl Estradiol 57-63-6 Dydrogesterone 152-62-5 Final Estradiol Valerate 979-32-8 Products 2 Estradiol 50-28-2 350 Being Bulk Levonorestrel 17489-40-6 Drugs(API) Lynestrenol 52-76-6 will be Desogestrel 54024-22-5 Utilized By Allylestrenol 432-60-0 Pharmaceu Testosterone 58-22-0 tical Units Testosterone Decanoate 5721-91-5 For Formulation Testosterone Propionate 57-85-2 3 400 Testosterone Phenylpropanoa 1255-49-8 Testosterone Enanthate 315-37-7 Testosterone Undecanoate 5949-44-0 Progesterone 57-83-0 4 Medroxyprogesterone Acetate 71-58-9 1000 Medroxy Progesterone 520-85-4 Mifepristone 84371-65-3 Dehydroepiandrosterone 53-43-0 Boldenone Undecylenate 13103-34-9 5 200 Tibolone 5630-53-5 Oxandrolone 53-39-4 Danazole 17230-88-5 TOTAL 2700

The project falls under Category B of project activity 5(f) as per the schedule of EIA Notification 2006. 6. Product wise Raw material consumption: Quantity Sr. Produc Product Quantity Quantity in Raw Material Name (Product) in No. t Group Name per Kg Kg/Month Kg/Month 17-Alphahydroxy 1.00 750.00 Progesterone Toluene 8.00 6000.00 Para toluene sulfonic acid 0.04 30.00 Hydroxyprog N-Caproic anhydride 1.00 750.00 esterone 1 Methanol 8.20 6150.00 caproate(HP Hydrochloric Acid 0.75 562.50 C) Dichloromethane 8.00 6000.00 Group Sodium Bicarbonate 0.30 225.00 750.00 No: -1 Di-Iso Propyl Ether 3.00 2250.00 Activated Carbon 0.04 30.00 Nandrolone 0.80 600.00 Deconyl chloride 1.10 825.00 Pyridine 0.10 75.00 Nandrolone 2 MDC 5.00 3750.00 Decanoate HCl 0.50 375.00 Methanol 2.00 1500.00 Activated Carbon 0.04 30.00

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Nandrolone 1.00 750.00 Phenylpropanoyl Chloride 1.30 975.00 Nandrolone Pyridine 0.10 75.00 3 Phenylpropa Dichloromethane 5.00 3750.00 noate HCl 0.50 375.00 Methanol 2.00 1500.00 Activated Carbon 0.04 30.00 19-norandrostenedione 0.90 675.00 Acetyline gas 0.20 150.00 4 Norethistrone Potassium Hydroxide 0.20 150.00 THF 5.00 3750.00 Acetone 2.00 1500.00 Norethisterone 1.00 750.00 Acetyl Chloride 1.20 900.00 TEA 0.10 75.00 Norethisteron 5 Dichloromethane 5.00 3750.00 e Acetate HCl 0.50 375.00 Methanol 2.00 1500.00 Activated Carbon 0.04 30.00 Norethisterone 1.00 750.00 Enanthyl Chloride 1.00 750.00 TEA 0.10 75.00 Norethisteron 6 Dichloromethane 5.00 3750.00 e Enanthate HCl 0.50 375.00 Methanol 2.00 1500.00 Activated carbon 0.04 30.00 ADD (Androstadienedione) 1.00 350.00 PTSA Catalyst 0.03 10.50 Triethyl Orthoformate 0.50 175.00 Triethylamine 0.06 21.00 Ethylene Glycol 0.50 175.00 MDC 5.00 1750.00 1 ESTRONE THF 5.00 1750.00 Biphenyl Methane 0.56 196.00 Sodium metal 0.36 126.00 Hydrochloric Acid 1.30 455.00 Methanol 2.72 952.00 Activated carbon 0.06 21.00 Acetone 7.00 2450.00 Group Estrone 350.00 1.00 350.00 No: -2 Acetyline Gas 0.20 70.00 Ethinyl 2 Potassium Hydroxide 0.10 35.00 Estradiol THF 3.00 1050.00 Acetone 2.00 700.00 Progesterone 1.00 350.00 Mono ethylene glycol 0.50 175.00 Paratoluene sulfonic acid 0.00 0.07 Methylene dichloride 5.00 1750.00 Dydrogestero 3 Methanol 10.20 3570.00 ne Cyclohexane 15.50 5425.00 N,N-dibromohydantoin 0.44 154.56 Sodium carbonate 0.20 70.00 2,3,4-S-Collidine 0.84 294.00 SEAC, Gujarat [TOR – New Projects] SEAC, Gujarat : Page 4 of 11

Ethyl Acetate 7.00 2450.00 Estrone 1.00 350.00 Valeric anhydride 1.01 353.50 Pyridine 0.10 35.00 Estradiol 4 Dichloromethane 5.00 1750.00 Valerate HCl 0.50 175.00 Methanol 2.00 700.00 Activated Carbon 0.04 14.00 Estrone 1.00 350.00 Methanol 1.00 350.00 Sodium Borohydride 0.10 35.00 5 Estradiol Sodium Hydroxide 0.18 63.00 Acetic Acid 0.35 122.71 Acetone 8.00 2800.00 Methoxy dienone 1.00 350.00 Tetra hydrofuran 4.00 1400.00 Acetylene gas 0.22 77.00 Potassium tert-butoxide 0.15 53.20 6 Levonorestrel Sulfuric acid 0.14 49.00 Methanol 5.00 1750.00 Hydrochloric acid 0.11 39.90 Sodium carbonate 0.12 43.40 Nandrolone 1 350.00 Ethane-1,2-dithiol 2 700.00 Boron trifluoride etherate 0.5 175.00 Na metal 0.12 42.00 7 Lynestrenol Liq. Ammonia 0.4 140.00 Jones reagent 0.098 34.30 Acetylene 0.15 52.50 Potassium tert-butylate 0.099 34.65 Acetone 2 700.00 11α-hydroxy-18- 1.00 350.00 methylnordione p-Toluene sulfonic acid 0.10 35.00 1,2-ethanedithiol 0.40 140.00 Methanol 12.50 4375.00 Acetone 5.00 1750.00 Dichloromethane 7.50 2625.00 Ethylene glycol 1.80 630.00 Triethyl orthoformate 1.40 490.00 Pyridine 0.09 31.50 Pyridinium dichromate 1.00 350.00 8 Desogestrel DMF 4.00 1400.00 Magnesium 0.17 59.50 Iodine 0.45 157.50 Chloromethyl 0.85 297.50 trimethylsilane Dibromo ethane 0.20 70.00 THF 5.65 1977.50 Toluene 5.00 1750.00 Ammonium chloride 1.00 350.00 solution 36% Aqueous HCI 0.10 35.00 SEAC, Gujarat [TOR – New Projects] SEAC, Gujarat : Page 5 of 11

Aqueous NaHC03 solution 0.15 52.50 KOtBu 1.00 350.00 Acetylene 1.00 350.00 tBuOH 0.15 52.50 Acetic acid 0.90 315.00 Sodium 0.10 35.00 Copper nitrate 0.02 7.00 Ammonia 2.00 700.00 Acetonitrile 0.25 87.50 Estrane-4-ene-17-one 1.00 350.00 Allyl Chloride 1.20 420.00 Mg Turnings 0.10 35.00 9 Allylestrenol THF 3.00 1050.00 MDC+Methanol 2.00 700.00 Activated Charcoal 0.04 14.00 4-Androstenedione (4-AD) 1.00 400.00 Triethyl orthoformate 2.00 800.00 Pyridine pTSA catalyst 0.01 5.60 Methanol 5.50 2200.00 1 Testosterone Sodium Hydroxide 0.28 112.00 Sodium Borohydride 0.07 29.20 Hydrochloric Acid 0.42 166.00 Dichloromethane 3.00 1200.00 Testosterone 1.00 400.00 Deconyl Chloride 1.20 480.00 Pyridine 0.10 40.00 Testosterone 2 Dichloromethane 5.00 2000.00 Decanoate HCl 0.05 20.00 Methanol 2.00 800.00 Activated carbon 0.04 16.00 Testosterone 1.00 400.00 Propanoyl Chloride 1.20 480.00 Pyridine 0.10 40.00 Testosterone 3 Group Dichloromethane 5.00 2000.00 Propionate 400.00 No: -3 HCl 0.50 200.00 Methanol 2.00 800.00 Activated carbon 0.04 16.00 Testosterone 1.00 400.00 Phenylpropanoyl Chloride 1.20 480.00 Testosterone Pyridine 0.10 40.00 4 Phenylpropio Dichloromethane 5.00 2000.00 nate HCl 0.50 200.00 Methanol 2.00 800.00 Activated carbon 0.04 16.00 Testosterone 1.00 400.00 Enanthyl Chloride 1.20 480.00 TEA 0.10 40.00 Testosterone 5 Dichloromethane 5.00 2000.00 Enanthate HCl 0.50 200.00 Methanol 2.00 800.00 Activated carbon 0.04 16.00 Testosterone Testosterone 1.00 400.00 6 Undecanoate Undeconyl Chloride 1.20 480.00 SEAC, Gujarat [TOR – New Projects] SEAC, Gujarat : Page 6 of 11

Pyridine 0.10 40.00 Dichloromethane 5.00 2000.00 HCl 0.50 200.00 Methanol 2.00 800.00 Activated carbon 0.04 16.00 4-Androstenedione 1.00 1000.00 Sodium Methoxide 0.55 550.00 Dimethyl Sulfoxide 1.50 1500.00 Acetylene Gas 0.18 180.00 THF 1.50 1500.00 Sulphuric Acid 0.20 200.00 1,4-Dioxane 7.60 7600.00 Copper Sulphate Alumina 0.20 200.00 1 Progesterone Acetic Acid 2.50 2500.00 Toluene 7.59 7591.50 Isopropyl Alcohol 0.20 200.00 Triethyl Amine 0.24 240.00 Formic Acid 0.11 106.00 Palladium Carbon 0.05 50.00 Methanol 5.55 5550.00 Activated Carbon 0.03 30.00 Medroxyprog Medroxyprogesterone 1 1000.00 Group 2 esterone Acetic acid 1000.00 3 3000.00 No: -4 Acetate Acetic anhydride 1.1 1100.00 17-α Hydroxy progesterone 1 1000.00 Benzene 5 5000.00 Ethylene glycol 1.8 1800.00 p-Toluenesulfonic acid 0.04 40.00 Pyridine 0.15 150.00 Chloroform 5 5000.00 Anhydrous sodium 1.264 1264.00 Medroxy carbonate 3 Progesterone Anhydrous sodium sulfate 1.264 1264.00 Anhydrous sodium acetate 0.075 75.00 solution of peracetic acid Magnesium shavings 1.03 1030.00 Tetrahydrofuran 5 5000.00 Iodine 3.6 3600.00 H2SO4 1.5 1500.00 Acetone 2 2000.00 Dienedione 1 200.00 Ethylene glycol 0.4 80.00 TosOH 0.04 8.00 MDC 4 800.00 1-Propynylmagnesium 1.2 240.00 bromide 1 Group Mifepristone H2O2 200.00 0.2 40.00 No: -5 THF 8 1600.00 4- Dimethylaminophenylmagn 0.8 160.00 esium bromide HCl 0.1 20.00 2 Dehydroepia 4-Androstenedione (4-AD) 1.00 200.00 SEAC, Gujarat [TOR – New Projects] SEAC, Gujarat : Page 7 of 11

ndrosterone Tertiary butanol 7.50 1500.00 Potassium tertiary butoxide 0.98 196.00 Acetic acid 0.57 114.00 Methylene chloride 5.00 1000.00 Sodium ascorbate 0.35 70.00 Methyltetrahydrofuran 1.00 200.00 Pottasium phosphate buffer 0.50 100.00 6.5pH Sodium bicarbonate 0.05 10.00 Ethyl acetate 2.50 500.00 Boldenone 1.00 200.00 UndecenoylChloride 1.20 240.00 Pyridine 0.10 20.00 Boldenone 3 MDC 5.00 1000.00 Undecylenate HCl 0.50 100.00 Methanol 2.00 400.00 Activated carbon 0.04 8.00 Nandrolone 1.00 200.00 Isopropyl acetate 3.50 700.00 p-Toluenesulfonic acid 0.04 8.00 Isopropenyl acetate 0.50 100.00 Triethylamine 0.05 10.00 Isopropanol 4.00 800.00 DMF 3.00 600.00 N-Bromosuccinimide 0.45 90.00 Lithium carbonate 0.20 40.00 Lithium bromide 0.10 20.00 Acetic acid 0.70 140.00 Tetrahydrofuran 4.00 800.00 Methyl-magnesium chloride 0.25 50.00 37% Hydrochloric acid 0.10 20.00 Heptane 2.20 440.00 Toluene 2.00 400.00 Methanol 8.00 1600.00 Copper(II) bromide 1.50 300.00 4 Tibolone Aqueous sulphuric acid 0.50 100.00 Aqueous sodium chloride 0.24 48.00 Aqueous potassium 0.24 48.00 hydroxide EDTA 0.24 48.00 Isopropanol 5.00 1000.00 Liquid ammonia 1.80 360.00 tert-Butyl methyl ether 6.50 1300.00 2-Propanol 1.10 220.00 Calcium metal 0.30 60.00 Ammonium chloride 1.00 200.00 tert-Butanol 0.30 60.00 THF 3.10 620.00 Hepten 0.75 150.00 2,6-di-tert-Butyl-4- 0.65 130.00 methylphenol Benzaldehyde 0.35 70.00 Aluminium tri-tert-butoxide 0.12 24.00 SEAC, Gujarat [TOR – New Projects] SEAC, Gujarat : Page 8 of 11

Aqueous solution of Lactic 0.22 44.00 acid Sodium hydrogen 0.12 24.00 carbonate Sodium chloride 0.04 8.00 Ethynyl magnesium 2.60 520.00 chloride Sodium chloride solution 0.10 20.00 Pyridine 0.01 1.20 Activated Carbon Darco 0.10 20.00 G60 Ascorbic acid 0.01 2.00 Ethanol 3.00 600.00 Hydrochloric acid 0.50 100.00 Aqueous potassium 0.00 0.00 acetate Mestanolone 1.00 200.00 IBX 1.50 300.00 Toluene:DMSO 2.00 400.00 Ethyl acetate 2.00 400.00 THF 5.00 1000.00 Acetone 2.00 400.00 N-methylmorpholine N- 1.20 240.00 oxide 1% aqueous solution of 0.50 100.00 5 Oxandrolone OsO4 Sodium metabisulphite 0.10 20.00 Dichloromethane 6.00 1200.00 Sodium metaperiodate 1.50 300.00 DMF 2.00 400.00 Sodium borohydride 0.20 40.00 1 N NaOH 0.02 4.00 3N Hydrochloric acid 0.02 4.00 solution DCM 4.00 800.00 17α-ethinyl-17β-hydroxy-3- 1 200.00 oxo-4-androstene Ethyl formate 1.2 240.00 NaOC2H5 0.1 20.00 Pyridine 0.1 20.00 6 Danazole NH2-OH 0.6 120.00 Na-OCOCH3 0.6 120.00 CH3COOH 0.2 40.00 Methanol 4 800.00 MDC 4 800.00

7. Water, Air and Hazardous waste management: Sr. Particulars Details no. A Water i Source of Water Supply GIDC,Kalol (GIDC, Bore well, Surface water etc...)

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Status of permission from the concern authority. -- ii Water consumption (KL/day)

Quantity (KL/day) Sr. No. Description Water Consumption 1 Domestic 0.8 2 Gardening 1.4 3 Industrial i Process 1.1 ii Washing 0.3 iii RO/DM Plant 1.5 IV Cooling make up 0.3 V Utility(Make of HWG) 0.5 TOTAL(3) 3.7 TOTAL(1+2+3) 5.9 iii Waste water generation (KL/day)

Quantity (KL/day) Remark Sr. No. Description Wastewater Generation 1 Domestic 0.6 To Septic Tank 2 Gardening 0.0 -- 3 Industrial i Process 1.4 Industrial waste of ii Washing 0.3 @ 2.1 KLD will be iii RO/DM Plant 0.4 sent to common IV Cooling make up 0.0 facility (MEE) after Utility(Make of V 0.0 required Treatment. HWG) TOTAL(3) 2.1 TOTAL(1+2+3) 2.7 iv Treatment facility with capacity Out of daily industrial wastewater, @ 2.1 (ETP, CETP, MEE, STP etc). KLD of wastewater will be sent to Common MEE after required treatment in our ETP, If required v Mode of Disposal & Final meeting point Domestic: 0.6 KLD Industrial: 2.1 KLD vi Reuse/Recycle details (KL/day) -- B Air i Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. - Source of Quantity Emission Stack Name Type of SR. emission of Fuel Standards Height of the APCM emissions no. With MT/hr & (meter) fuel i.e. Capacity MT/Day Hot water 1 -- Electricity N.R. -- -- Generator SEAC, Gujarat [TOR – New Projects] SEAC, Gujarat : Page 10 of 11

150 PM D.G.Set Diesel - 15 mg/Nm3 2 9 N.R. SO2 ( 65kVA) Liter/Hr. 100 ppm NO X 50 ppm ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.)

No Process Gas Emission from proposed project v Fugitive emission details with its mitigation measures. --

C Hazardous waste (as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. i Sr. Type/Name Source of Category Quantity Disposal Method no. of Hazardous generation as per HW waste Rules. ETP Plant Collection, storage, transportation and @ 300 1 ETP Sludge 35.3 disposal to Kg/Month authorized TSDF site. Plant and Collection, storage, Machinery transportation and 5 2 Used oil 5.1 sold out to the Liter/Month registered Recyclers. Process Collection, storage, transportation and Distillation 0.3 3 36.1 disposal to Residue MT/Month authorized CHWI facility. Raw 15 Collection, storage Discarded Material No’s/month and reused for 4 containers / 33.1 (0.2 disposal of waste / liners MT/Month) sold to recyclers. Process Collection, storage, transportation and Recovered 55.0 5 28.6 sold out to the solvent KL/Month authorized Recyclers. Process Collection, storage, transportation and Process 0.2 6 28.1 disposal to Sludge MT/Month authorized CHWI facility. Process Collection, storage, transportation and Spent 0.5 7 28.3 disposal to Carbon MT/Month authorized TSDF facility. ii Membership details of CETP, TSDF, CHWIF, We will obtain membership

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Common MEE etc. of Common MEE.

ii Details of Non-Hazardous waste & its disposal -- (MSW and others) D i Solvent management (If any) -- Details of Solvent recovery (As per respective ToR) ii VOC emission sources and its mitigation measures --

8. Details of Environmental Consultants: Sr. Particulars Details no. i Name of the Consultant Ramans Enviro Services Pvt. Ltd ii Validity of Certificate of accreditation December,2019 issued by the NABET, QCI iii Accreditation for the categories 5(f) iv Any other details --

Name & designation of the Applicant: Rajesh Gami

Stamp & Signature of Applicant:

Date:21/11/2017

General Instructions  Format shall be in WORD Format (Font type- Arial, Font size- 11)  Provide authenticated (with stamp & Signature) hard copy during presentation.  Kindly mail to: [email protected] and copy to all members.  Above data should be as per application Form-1 & PFR.  Incorporate relevant details in respective column of the Format. Do not attach Annexure in Format.

SEAC, Gujarat [TOR – New Projects]