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LIST of ANNEXURES SR. NO. NAME of ANNEXURE I List of Products

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LIST of ANNEXURES SR. NO. NAME of ANNEXURE I List of Products LIST OF ANNEXURES SR. NO. NAME OF ANNEXURE I List of Products and Raw materials along with their Production Capacity II Layout Map of the Plant III Brief Manufacturing Process Description IV Details of water consumption & waste water generation V Details of Effluent Treatment Scheme VI Details of Hazardous Waste Generation and Disposal VII Details of Stacks and Vents, Fuel & Energy Requirements VIII Details of Hazardous Chemicals Storage & Handling IX Socio-economic Impacts X Proposed Terms of Reference XI GIDC Plot Allotment Letter XII ETL Membership Letter (M/s. ETL) XIII TSDF & CHWIF Membership Letter (M/s BEIL) XIV Toposheet XV Copy of existing CCA ANNEXURE-I _____________________________________________ _________________________ LIST OF PRODUCTS ALONG WITH THEIR PRODUCTION CAPACITY WITH RAW MATERIALS PRODUCTION CAPACITY (MT/MONTH) SR. PRODUCTS CAS NO NO EXISTING ADDITIONAL TOTAL QUANTITY QUANTITY PROPOSED QUANTITY 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 66108-95- 0/60166-93- 9 Iohexol/Iopamidol/Iodixanol 0/92339-11- 2 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 0 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 37 Cilinidipine 132203-70-4 3.5 3.5 38 Nebivolol 99200-09-6 39 Nebivolol HCL 152520-56-4 0.5 0.5 40 Donepezil Hydrochloride 120011-70-3 41 Brimonidine Tartrate 70359-46-5 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 10 10 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) 0 210.8 210.8 TOTAL (EXISTING+PROPOSED) 5.0 210.8 215.8 RAW MATERIAL CONSUMPTION: EXISITNG PRODUCTS SR. Raw Materials Quantity Name of Products NO. (KG/KG) [1] Ortho toluene nitrile 2.66 Optical Brightening Agent Chlorine gas 4.00 Trimethyl phosphate 1.78 OCBC 1.33 Orthoxylene 1.11 Terpthaldehyde ester 0.45 Sodium methoxide 1.60 Dimethyl formamide 2.22 [2] OTA 2.33 Sulphuric acid 0.83 Ortho toluene Nitrite Urea 1.67 Soda ash 0.50 Caustic lye 1.00 PROPOSED PRODUCTS Sr. Quantity Name of Product Raw Materials No. (KG/KG) [1] Darunavir (3aS,4S,6aR) -4-METHOXY terahydrofuro -[ 0. 628 Hydrochloric Acid 0. 145 Sodium Borohydride 0. 87 0 Hydrogen 0.00 7 Ethyl Acetate 2.300 Tetrahydrofuran 5.020 Sodium Hydroxide 0. 13 0 isobutyl benzenesulfonamide 1.430 Disucinimidyl carbonate 0. 963 Sulphuric acid 0. 10 0 2-Methyl2 -Butanol 0. 60 0 Methylene Chloride 3.000 Cyclohexane 2.400 Sodium bicarbonate 0.0 20 Sodium chloride 0.0 10 Sodium sulphate 0.0 10 Sodium hydroxide 0.00 8 Activated carbon 0.0 20 [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) Cyclopropy1]acetic acid 0.423 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 0.0 86 Catalyst 0.00 3 M bromo Anisole 0.0 69 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 0.0 50 Hydrochloric acid 0.0 23 Sodium hydroxide 0.0 25 Sodium Carbonate 0. 300 Toluene 7.000 Ethanol 8.500 Activated Carbon 0.0 50 [7] Furosemide Lasamide 1.300 Furfuryl amine 2.100 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] L-Acetoxy propionyl chloride 1.200 Iohexol/Iopamidol/Iodixano 5- amino-2, 4, 6- Tri iodoisophthaloyl di 1.500 l chloride 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 [13] Pantaprazole Sodium 2-Chloromethyl-3-4-dimethox pyridine 0.770 hydrochloride 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- 2.990 6-methyltheino[2,3- 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 0.726 Bipsimidine 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 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 1.820 L-Tartaric acid 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 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 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
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