SEAC, Gujarat Page 1 of 29 Project details Synthetic Organic Chemicals 5(f) For Terms of Reference [ToR] New Project 1. Basic Information of the Project: i Name & Address of the Project site M/s. Androst Biotech (Complete details with plot no. /Survey no., Landmark etc. ) Plot No.: 23 to 26, G.I.D.C Estate, At. Sojitra Tal: Sojitra, Dist: Anand ii Name of the Applicant Mr. Pradip Darji iii Address for correspondence M/s. Androst Biotech Plot No.: 23 to 26, G.I.D.C Estate, At. Sojitra Tal: Sojitra, Dist: Anand iv Contact no. and e-mail ID of the Applicant Mo. no. :9924658753,9265026574 e-Mail: [email protected] v Aerial distance of nearest Habitat (KM) ~1 KM Name of village vi Longitude & Latitude of the Project Site: (4 22°31’46.27”N and 72°42’56.00”E corners of the site) 22°31’45.38”N and 72°42’59.06”E 22°31’43.83”N and 72°42’58.66”E 22°31’44.61”N and 72°42’55.56”E vii Category as per the Schedule to the EIA 5 (f) Synthetic Organic Chemicals Notification 2006 i.e. 1(d), 2(b), 5(f) etc. Sub-Category: B1 viii Applicability of General Conditions of No EIA Notification 2006: i.e. Ensure that (1) Protected areas notified under the Wildlife (Protection) Act, 1972; (2) CEPI areas (3) Eco-sensitive areas and (4) 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. Note: If located in Vapi-Sarigam region, kindly give exact aerial distance from the interstate boundary i.e. Boundary with Maharashtra state & U.T. of Daman, Diu and Dadra Nagar Haveli. Page 1 of 29 ToR-New [Updated MARCH 2019] SEAC, Gujarat Page 2 of 29 viii In case of unit located outside the Notified No area: Complying the three conditions as per the amendment to EIA Notification, 2006 vide SO 1599 (E) dated 25/06/2014. [i.e. water consumption less than 25 M3/day; Fuel consumption less than 25 TPD; and not covered in the category of MAH units as per the Management, Storage, Import of Hazardous Chemical Rules (MSIHC Rules), 1989] (Storage details of all the hazardous chemicals shall be submitted in tabular form for justification.) 2. Online application & PH reg. : a) Online application proposal no. : SIA/GJ/IND2/39661/2019 b) Date of online acceptance for ToR by SEAC: -- c) Date of presentation for ToR: -- 3. Product profile: Quantity CAS Sr. No. Name of Product (Kg Per End User Number Month) 1 Hydroxyprogesterone caproate(HPC) 630-56-8 2 Nandrolone Decanoate 360-70-3 3 Nandrolone Phenylpropionate 62-90-8 1 500 4 Norethistrone 68-22-4 5 Norethistrone Acetate 51-98-9 6 Norethistrone Enanthate 3836-23-5 1 Estrone 53-16-7 Ethinyl Estradiol Final Products 2 57-63-6 Being Bulk 3 Dydrogesterone 152-62-5 Drugs(API) will be Utilized By 4 Estradiol Valerate 979-32-8 Pharmaceutical 2 5 Estradiol 50-28-2 150 Units For Formulation 6 Levonorgestrel 17489-40-6 7 Lynestrenol 52-76-6 8 Desogestrel 54024-22-5 9 Allylestrenol 432-60-0 1 Testosterone 58-22-0 3 2 Testosterone Decanoate 5721-91-5 200 3 Testosterone Propionate 57-85-2 Page 2 of 29 ToR-New [Updated MARCH 2019] SEAC, Gujarat Page 3 of 29 4 Testosterone Phenylpropionate 1255-49-8 5 Testosterone Enanthate 315-37-7 6 Testosterone Undecanoate 5949-44-0 1 Progesterone 57-83-0 4 2 Medroxyprogesterone Acetate 71-58-9 1000 3 Medroxy Progesterone 520-85-4 1 Mifepristone 84371-65-3 2 Dehydroepiandrosterone 53-43-0 3 Boldenone Undecylenate 13103-34-9 5 200 4 Tibolone 5630-53-5 5 Oxandrolone 53-39-4 6 Danazole 17230-88-5 1 Pregnelonone 145-13-1 2 Dydrogesterone 152-62-5 3 Fluticasone Propionate 80474-14-2 4 Fluticasone Furoate 397864-44-7 5 Ciclesonide 141845-82-1 6 Finasteride 98319-26-7 7 Drospirenone 67392-87-4 6 300 8 Spironolactone 52-01-7 9 Hyrocortisone 50-23-7 10 16-DPA (16-Dehydro Pregnenolone Acetate) 979-02-2 11 16-alpha hydroxy Prednisolone 13951-70-7 12 Ethisterone 434-03-7 13 Stanozolol 10418-03-8 14 Exmestene 107868-30-4 1 Rabeprazole 117976-89-3 2 Rizatriptan Benzoate 145202-66-0 3 Rivoroxaben 366789-02-8 4 Apixaben 503612-47-3 Final Products 5 Dabigatran 211915-06-9 Being Bulk Drugs(API) will 177036-94- 7 Ambrisentan and Darusentan and its 500 be Utilized By 6 1& intermediate Pharmaceutical 171714-84-4 Units For 7 Vilazodone 163521-12-8 Formulation 8 Aripiparazole 129722-12-9 9 Lemotrigine 84057-84-1 10 Irbesartan 138402-11-6 Page 3 of 29 ToR-New [Updated MARCH 2019] SEAC, Gujarat Page 4 of 29 11 Pregabalin 148553-50-8 ‎ 191732- 12 Lenalidomide 72-6 13 Pazopanib 444731-52-6 14 Sorafenib tosylate 284461-73-0 15 Sunitinib Maleate 341031-54-7 16 Abiraterone Acetate 154229-18-2 Ethyl chloro [(4-methoxyphenyl) hydrazono] 1 27143-07-3 acetate 3-Chloro-5,6-dihydro-1-(4-nitrophenyl)-2(1H)- 2 503615-03-0 pyridinone 3 3-Morpholin-4-yl-5,6-dihydro-1Hpyridin-2-one 545445-40-7 3-(4-Morpholinyl)-1-(4-nitrophenyl)-5,6- 4 503615-03-0 dihydro-2(1H)-pyridinone 5 (3β,8ξ,9ξ,14ξ)-17-Iodoandrosta-5,16-dien-3-ol 32138-69-5 6 3-(Diethylboryl)pyridine 89878-14-8 N,N-Dimethyl-3-(2-methylphenoxy)-3-phenyl 7 107688-86-8 propan-1-amine Oxalate 8 4-(methylamino)-3-nitrobenzoic acid 41263-74-5 9 Ethyl 3-(2-pyridylamino) propanoate 103041-38-9 3-[(3-amino-4-methylaminobenzoyl)-pyridin-2- 10 212322-56-0 yl-amino]-propionic acid ethyl ester 11 N-(4-Cyanophenyl)-glycine 42288-26-6 2-(2-Hydroxyphenyl)-4H-Benzo [e][1,3] 12 1218-69-5 oxazin-4-one Final Products Being Bulk (2-Butyl-5-nitrobenzofuran-3-yl)(4-hydroxy Drugs (API) will 8 13 141645-16-1 1500 phenyl) methanone be Utilized By (R)-5-Bromo-3-[(1-methyl-2- Pharmaceutical 14 143322-57-0 pyrrolidinyl)methyl]1H-indole Units. 5-Bromo-1H-indol-3-yl)[(2R)-1-methyl 15 143322-57-0 pyrrolidin-2-yl] methanone (1R)-2-{[2-(4-Nitrophenyl)ethyl]amino}-1- 16 521284-21-9 phenyl ethanol Hydrochloride (R)-2-[2-(4-Aminophenyl)-ethylamino]-1- 17 521284-22-0 phenyl ethanol Hydrochloride (1R)-2-{[2-(4-Nitrophenyl)ethyl]amino}-1- 18 223673-34-5 phenyl ethanol 5,6,7,7a-Tetrahydrothieno[3,2-c] pyridine- 19 115473-15-9 2(4H)-one Hydrochloride 2-Bromo-2-(2-fluorophenyl)-1- 20 204205-33-4 cyclopropylethanone 21 Cyclopropyl-2-fluorobenzyl ketone 150322-73-9 22 3-Isobutyl-pentanedioic acid dimethyl ester 145328-03-6 2-(1-Cyano-3-Methyl-Butyl)-,1,3-Diethyl ester 23 36082-57-2 Propanedioic acid 24 (+/-)-3-(Aminomethyl)-5-methylhexanoic acid 128013-69-4 25 5-Methylisoxazole-4-carboxylic acid 42831-50-5 Page 4 of 29 ToR-New [Updated MARCH 2019] SEAC, Gujarat Page 5 of 29 26 3-(4-Chlorobutyl)-1H-indole-5-carbonitrile 143612-79-7 Ethyl-5-amino-1-benzofuran-2-carboxylate 27 183288-42-8 Hydrochloride 28 5-(Piperazin-1-yl) benzofuran-2-carboxamide 183288-46-2 5-(1-Piperazinyl)-2-Benzofuran carboxylic acid 29 765935-67-9 ethyl ester Hydrochloride 4,5,6,7-Tetrahydrothieno [3,2-c] pyridine 30 28783-41-7 hydrochloride 1 Trimethyl ortho propionate (TMOP) 24823-81-2 9 2 Trimethyl ortho Valerate (TMOV) 13820-09-2 1500 3 Trimethyl ortho butyrate (TMOB) 43083-12-1 TOTAL 5850 - The project falls under Category B of project activity 5(f) as per the schedule of EIA Notification 2006. 4. Product wise Raw materials consumption: Quantity Sr. Produc Product Name Raw Material Name in No. t Group Kg/Month 17-Alphahydroxy Progesterone 500.00 Toluene 4000.00 Para toluene sulfonic acid 20.00 HYDROXYPROGESTERONE N-Caproic anhydride 500.00 1 CAPROATE (HPC) Methanol 4100.00 Hydrochloric Acid 375.00 Dichloromethane 4000.00 DIPE 1500.00 Deconyl chloride 550.00 Pyridine 50.00 MDC 2500.00 2 Nandrolone Decanoate HCl 250.00 Nandrolone 400.00 Group Activated carbon 20.00 No: -1 Methanol 1000.00 Nandrolone 500.00 Phenylpropanoyl Chloride 650.00 Pyridine 50.00 NANDROLONE 3 Dichloromethane 2500.00 PHENYLPROPANOATE HCl 250.00 Methanol 1000.00 Activated Carbon 20.00 19-norandrostenedione 450.00 Acetyline gas 100.00 4 NORETHISTERONE Potassium Hydroxide 100.00 THF 2500.00 Methanol 1000.00 Page 5 of 29 ToR-New [Updated MARCH 2019] SEAC, Gujarat Page 6 of 29 Norethisterone 500.00 Acetyl Chloride 600.00 TEA 50.00 5 NORETHISTERONE ACETATE Dichloromethane 2500.00 HCL 250.00 Methanol 1000.00 Activated carbon 20.00 Norethisterone 500.00 Enanthyl Chloride 500.00 TEA 50.00 NORETHISTERONE 6 Dichloromethane 2500.00 ENANTHATE HCL 250.00 Methanol 1000.00 Activated carbon 20.00 ADD (Androstadienedione) 149.88 PTSA Catalyst 4.50 MDC 749.40 Triethylamine/Triethyl Orthoformate 83.93 Ethylene Glycol 74.94 THF 749.40 1 ESTRONE Biphenyl Methane 83.93 Sodium metal 53.96 Methanol 407.67 Hydrochloric Acid 194.84 Activated carbon 8.99 Acetone 1049.16 Estrone 150.00 Acetyline Gas 30.00 2 ETHINYL ESTADIOL Potassium Hydroxide 15.00 THF 450.00 Acetone 300.00 Progesterone 150.03 Group Ethylene Glycol 75.02 No: -2 MDC 750.15 PTSA 0.03 Activated carbon 9.00 3 DYDROGESTERONE DBH 66.25 Cyclohexene 2325.47 Na2CO3 30.01 Collidine 126.03 Ethyl acetate 1050.21 Estrone 150.00 Valeric anhydride 151.50 Pyridine 15.00 4 ESTRADIOL VALERATE Dichloromethane 750.00 HCl 75.00 Activated Carbon 6.00 Methanol 300.00 Estrone 150.06 5 ESTRADIOL NaBH4 15.01 NaOH 27.01 Page 6 of 29 ToR-New [Updated MARCH 2019] SEAC, Gujarat Page 7 of 29 Methanol 150.06 Acetic acid 52.61 Acetone 1200.48 Methoxy dienone 150.00 Tetra hydrofuran 600.00 Acetyline gas 33.00 Potassium tert-butoxide 22.80 6 LEVONORGESTREL Sulfuric acid 21.00 Methanol 750.00 Hydrochloric acid 17.10 Sodium carbonate 18.60 Nandrolone 150.00 Ethane-1,2-dithiol 300.00 Boron trifluoride etherate 75.00 Na metal 18.00 7 Lynestrenol Liq.