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• Synthetic Organic Chemicals 5(F) • for Amendment SEAC, Gujarat Page 1 of 27 • Synthetic Organic Chemicals 5(f) • For Amendment - Environmental Clearance [EC] 1. Earlier EC letter no. and Date: 2. Basic Information of the Project: i Name & Address of the Project site M/s. Unique Chemicals (Complete details with plot no./Survey (A div of J B Chemicals & no., Landmark etc. ) Pharmaceuticals Ltd. Plot no 5, Phase IV, GIDC, Panoli- 394116, and Dist.: Bharuch, Gujarat. ii Name of the Applicant Mehta Chidambar Bipinchandra iii Address for correspondence M/s. Unique Chemicals (A Div. of J B Chemicals & Pharmaceuticals Ltd) Neelam Centre, B Wing, 4th Floor, Hind Cycle Road, Worli, Mumbai-400030 iv Contact no. and e-mail ID of the Mo. no. : 9998014353 Applicant e-Mail: [email protected] v Aerial distance of nearest Habitat Panoli-5.5 Km (KM) vi Longitude & Latitude of the Project Latitude 21°33’15.62”N, Site: (4 corners of the site) Longitude 73°00’04.81” E. 1st 21°33’20.04”N, 72°59’58.52” E 2nd 21°33’19.79”N, 73°00’05.15” E 3rd 21°33’10.24”N, 73°59’56.27” E 4th 21°33’9.31”N, 73°00’3.55” E vii Category as per the Schedule to the 5 (f) Synthetic Organic Chemicals EIA Notification 2006 i.e. 1(d), 2(b), 5(f) etc. Sub-Category: Pharmaceuticals Ingredients & its Intermediates. viii Applicability of General Conditions NA of 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. Page 1 of 27 Amendment- EC--SEAC, Gujarat SEAC, Gujarat Page 2 of 27 3. Online application & PH reg. : a) Date of SEAC meeting for 8th -9th December, 2016 (Expert recommendation to grant TOR: Appraisal Committee) (Industry 2) (MoEF& CC, New Delhi) b) Online application proposal no. : SIA/GJ/IND2/20647/2016 c) Date online acceptance of EC 14/11/2017 amendment application by SEAC: d) EC issued by SEIAA: Letter no & date. SEIAA/GUJ/EC/5(f)/660/2018 dated 30 th June, 2018 e) Date of presentation for Appraisal: 28/02/2018 4. Product profile: (As per EC) Sr. Name of the CAS no. /CI no. Quantity End-use of products No. Products MT/Month 1). Synthetic Active --- 290 Pharmaceuticals Pharmaceutical Ingredients & its Ingredients & Intermediates Intermediates (All sellable) The project falls under Category B of project activity 5(f) as per the schedule of EIA Notification 2006. CAS No. & End Uses of Representative Products Sr. Name of Representative CAS No. End Uses No. Products 1 Diclofenac sodium 15307-79-6 Anti-inflammatory &derivatives & intermediate 2 Nifedipine& intermediate 21829-25-4 Antiianginal 3 Diclofenac Potassium 15307-81-0 Anti inflammatory 4 Fluconazole 86366-73-4 Antifungal 5 Ciprofloxacin 86393-32-0 Antibacterial 6 Ofloxacin 82419-36-1 Antibacterial 7 Levetericitam 102767-28-2 Antibacterial 8 Losartan Potassium 124750 -99 -8 Antihypertensive 9 Lisinoprill 83915-83-7 Antihypertensive 10 Leveocetrizine/CetrizineHCl 130018-87-0/ Antiallergic 83881-52-1 11 Ropinirole 91374 -20 -8 Antiparkinsonian 12 Atorvastatin Calcium 134523-03-8 Antihyperliproteinemic 13 Clopidogril Bisulphate 135046-48-9 Antithrombotic 14 Sertraline HCl 79559-97-0 Antidearesant 15 Oxacarbazepine 28721-07-5 Anticonvulsant 16 Midazolam & Derivative 59467 -96 -8 Anesthetic 17 Nebivolol 152520-56-4 Antihypertensive 18 Bicalutamide 90357 -06 -5 Antineoplastic Page 2 of 27 Amendment- EC--SEAC, Gujarat SEAC, Gujarat Page 3 of 27 19 Gadopententic acid 80529-93-7 Diagnostic acid 20 Gandodiamide 131410-48-5 Diagnostic acid 21 Pioglitazone 112529-15-4 Antidiabetic 22 Fexofenidine 153439-40-8 Antihystaminic 23 Citalopram HBr 59729-32-7 Antidepressant 24 Iohexol / Iopamidol / Iodixanol 66108-95-0 Diagnostic aid /60208-45-9 / 92339-11-2 25 Pantoprazole & derivative 138786-67-1 Antialcerative 26 Montelucast& derivative 138786-67-1 Antiasthamatic 27 Ioxatalamic acid/Ioxaglic acid 59017-64-0 Diagnostic acid 28 Cilnidipine 132203-70-4 Antihypertensive 29 Amlodipine 111470-99-6 Antihypertensive 30 Cetrizine Cetirizine 83881-52-1 Antihistaminic 31 Carvediol 72956-09-3 Antihypertensive 32 Zolpidom 99294-93-6 Sedative Hypnotic 33 Promedol HCl 125-80-4 Reduce pain & irritation in teeth 34 Indolinone 15307-86-5 -- 35 2-Methyl Imidazole 693-98-1 Antihyperthyroid 36 Indinevir 150378-17-9 Antiviral 37 Nevirapine 129618-40-2 Antiviral 38 Rizatripram 145202-66-0 Antimigrone 39 Xabapentin 60142-96-3 Prevent & control seizure 40 Telmisartan 144701-48-4 Antihypertensive 41 Ondansctron 99614-02-5 Antiemetic 42 Candesartam 145040-37-5 Antihypertensive 43 Glipizide 29094-61-9 Antidiabetic 44 Glimepiride 93479-97-1 Antidiabetic 45 Moxifioxine 151096-09-2 Antibiotic 46 Meloxicam 71125-38-7 Antiinflamitory 47 Lercandipine HCl 132866-11-6 Antihypertentive 48 Anastrazole 120511-73-1 Antineoplastic 49 Clomipramine HCl 17321-77-6 Antidopressout 50 Letrozole 112809-51-5 Anti neoplastic 51 Isradipine 75695-93-1 Antihypertensive 52 BisoprololFumarate 104344-23-2 Antihypertensive 53 Olanzapine 132539-06-1 Antipsychotic 54 Rosigilitazone 122320-73-4 Anti diabetic 55 Fentanyl Citrate 990-73-8 Analgesic 56 Lacidipine 103890-78-4 Antihypertensive 57 Lucanthone HCl 479-50-5 Antihypertensive 58 Venlafaxine 99300-78-4 Anthelmintic 59 Calcium Fructoboroate 250141-42-5 Dietary supplement 60 Atenolol 29122-82-7 Anti hypertensive 61 Oxybutanin/ Oxybutanin 5633-20-5/1508-65-2 Hyperrhidrosis chloride 62 Magulamine 6284-40-8 Diagnostic & imaging 63 Metronidazole & 443-48-1 Anti ameboic dystentry Metronidazole benzoate 13182-89-3 64 Econazole 27220-47-9 Antifungal Page 3 of 27 Amendment- EC--SEAC, Gujarat SEAC, Gujarat Page 4 of 27 65 Diatrizoic acid 50978-11-5 Diagnostic & imaging 66 Meclizine 31884-77-2 To treat nausea & vomit 67 Chlorohexadine gluconate 55-56-1 Germicidal 68 Itopride 122898-67-3 treatment of functional dyspepsia and other gastrointestinal conditions 69 Oxybutanin HCl 5633-20-5 Anticholinergic medication used to relieve urinary and bladder difficulties, Details of Haz. Waste : II By Products Existing As per Proposed Total (Existing + CCA No. 57529 Expansion Proposed) 2. Methanol 120 301 421 3. Iso Propyl Alcohol 10 20 30 4. Acetic acid 10 10 20 5. Di methyl Formamide 0 7 7 6. Acetone 10 10 20 7. Mix Phenol 10 20 30 8. Aluminum Chloride/ 140 380 520 Aluminum hydroxide 9. Toluene 20 20 40 10. Sodium Chloride 15 40 55 11. Butanol 5 5 10 12. Hexane 10 15 25 13. Ethyl acetate 0 15 15 14. Di methyl acetamide 0 10 10 15. Piperizine 0 15 15 16. Tetra Hydro Furan 0 5 5 17. Pyridine 0 10 10 18. Ethyl Cello-sol 0 30 30 19. Aceto nitrile 0 2 2 20. Ethylene 0 2 2 dichloride/Methylene dichloride 21. Chloroform 0 5 5 22. Sodium Acetate 0 55 55 23. Dimethyl Sulphoxide 0 1 1 24. Methyl Iso butyl Ketone 0 2 2 25. Sodium Glyconate 0 15 15 26. *Other byproducts based -- -- Qty. depends on on product manufactured products 5. Representative Products Raw material consumption: Sr. Name of the Products Name of the Raw CAS / CI no. of Quantity no. Materials raw materials. MT/Month Details as under Note: As we have applied for generalize form to produce Synthetic Active Pharmaceutical Ingredients & Intermediates (All sellable). Page 4 of 27 Amendment- EC--SEAC, Gujarat SEAC, Gujarat Page 5 of 27 Representative Products Raw material consumption: Sr. Name of Representative Name of Representative Raw Consumption In No. Products Materials Kg/ kg of Product 1. Diclofenac Sodium Aluminium Chloride 0.656 Aniline 0.424 Concentrated HCl 0.5 Charcoal 0.08 Ethyl Chloro acetate 0.544 Mo. Methyl Chl. Acetate 2,6-dichloro phenol 0.722 Toluene/Ethoxy ethanol 2.2 Chloro acetyl chloride 0.58 Sodium Methoxide Sol 1.82 Caustic Flakes/K 2CO 3 0.302 Caustic lye 0.275 IPA 0.14 2. Diclofenac Potassium Aluminium Chloride 0.656 Aniline 0.424 Concentrated HCl 0.5 Charcoal 0.08 Ethyl Chloro Acetate 0.544 2,6-dichloro phenol 0.722 Toluene 2.2 Chloro acetyl chloride 0.58 Sodium Methoxide Sol 1.82 Caustic Potash Flakes 0.302 Caustic lye 0.275 IPA 0.14 3. Indolinone Aluminium Chloride 0.656 Aniline 0.424 Concentrated HCl 0.5 Charcoal 0.08 Ethyl Chloro Acetate 0.544 2,6-dichloro phenol 0.722 Toluene 2.2 Chloro acetyl chloride 0.58 Sodium Methoxide Sol 1.82 Caustic lye 0.275 4. Nifedipine& Intermediates Ortho nitro benzaldehyde 1.5 Methyl Aceto Acetate 2.25 Methanol 13.7 Liq. Ammonia 1.1 Acetic acid 3.2 5. Fluconazole Epoxide intermediates 1.2 1.2,4 Triazole 1.43 Pottasium Carbonate 0.175 Page 5 of 27 Amendment- EC--SEAC, Gujarat SEAC, Gujarat Page 6 of 27 Sr. Name of Representative Name of Representative Raw Consumption In No. Products Materials Kg/ kg of Product Dimethyl formide 0.2 Water 2 Ethyl Acetate 2.4 IPA 1.5 6. Ofloxacin Quinolic Acid 1.25 N-Methyl Piperazine 0.9 Butanol 1 Acetic Acid 0.3 Liquor Ammonia 0.45 7. Ciprofloxacin HCl Fluro-Quinolic Acid 1 Piperazine 0.68 Butanol 0.81 Hydrochloric Acid 1.26 Methanol 6.8 Acetic acid 0.86 Caustic lye 1.16 8. Levitiracitem L-2amino butyric acid 1.45 Thionyl Chloride 0.85 Ammonia 1.12 4 – Chloro butyl Chloride 0.35 9. Losartan Potassium 2-Buty-4 Chloro-5 hydroxy methyl 1.95 imidazole 4-bromomethyl-2-cyanobiphenyl 1.01 Na Methoxide 3.1 Sodiumazide 0.35 NH 4Cl 0.21 DMF 2.32 Methanol + Water 2.79 10. Lisinopril N-[N2-Benzyloxycarbonyl-N6-tertiary 1.36 butoxycarbonylLysyl]-L-Praline benyl ester Catalyst Hydrogenated 0.12 2-Oxo-4 Phenyl Butyric acid 0.8 Sodium Hydroxide 1.1 Methanol 2.33 11.
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