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Project Feasibility Report PRE FEASIBILITY REPORT For PROPOSED BULK DRUGS AND BULK DRUG INTERMEDIATES IN EXISTING THINERS FORMULATION UNIT of M/s. ANJU LIFE SCIENCE Plot No. 6007/1, GIDC, Ankleshwar – 393 002, Dist. Bharuch, Gujarat 0 CONTENTS Sr. No. Description Page No. 1. Executive Summary 2 2. Introduction of the Project/Background information 21 3. Project Description 22 4. Site Analysis 28 5. Planning Brief 29 6. Proposed Infrastructure 30 7. Rehabilitation and resettlement (R & R) Plan 31 8. Project Schedule & Cost Estimates 31 9. Analysis of Proposal (Final Recommendations) 32 1 1.0 EXECUTIVE SUMMARY 1.1 Company Profile M/s. Anju Life Science engages in manufacturing of formulation of thinners unit at Plot No. 6007/1, GIDC, Ankleshwar - 393 002, Dist: Bharuch, Gujarat, INDIA. Now, company is going for new bulk drugs, bulk drug intermediates & solvent distillation (in-house common group facility) within existing premises. 1.2 Project Details 1.2.1 Products along with Production Capacity Sr. Products Capacity CAS No. No. (MT/Month) Existing Additional Total Existing 1. Formulation of Thinners/Reducers 500 -- 500 Proposed 1 Furosemide -- 5 5 54-31-9 2 Diaminomethyleneamino (1-amino-1- -- 100 100 -- iminomethylene) thiomethyl thiozole dihydrochloride [ITU] 3 N-Sulfomyl-3-chloropropionamide -- 100 100 123-92-2 hydrochloride[IF] 4 Famotidine -- 5 5 105-68-0 5 Fomepizole -- 14205-39-1 6 Colsevelam hydrochloride -- 88150-62-3 7 Glimepiride -- 93479-97-1 8 Betahistine Dihydrochloride -- 106649-95-0 9 Adapalene -- 76824-35-6 10 Telmisartan -- 152751-57-0 11 Tapentadol Hydrochloride -- 845273-93-0 12 Colistimethate Sodium -- 71550-12-4 13 Rusvastatin Calcium -- 7554-65-6 14 1-3 dichloro Acetone -- 182815-44-7 15 Gunylthiourea -- 10 10 93479-97-1 16 Rabeprazole Sodium -- 5579-84-0 17 Carvediol -- 106685-40-9 18 Celecoxib -- 144701-48-4 2 19 Clopidogrel Bisulfate -- 175591-09-0 20 Atoravastatin Calcium -- 8068-28-8 21 Etoricoxib -- 147098-20-2 22 Valsartan -- 534-07-6 23 Tranexamic Acid -- 2114-02-5 24 Folic Acid -- 117976-90-6 25 Zolpidic Acid --- 72956-09-3 26 Pregabaline --- 169590-42-5 27 Chlorohexidine Base --- 120202-66-6 28 Benzarone --- 134523-03-8 29 Benzbromarone -- 202409-33-4 30 Zaltoprofen -- 137862-53-4 31 Ondansetron Hydrochloride -- 1197-18-8 32 Miconazole Nitrate -- 59-30-3 33 Ecanazole Nitrate -- 189005-44-5 34 Desloratadine -- 148553-50-8 35 Loratidine -- 79794-75-5 36 Gabapentine -- 60142-96-3 37 Albendazole -- 54965-21-8 38 Citrezine Hydrochloride -- 83881-52-1 39 Lasamide -- 2736-23-4 40 Pioglitazone Hydrochloride -- 112529-15-4 41 Mesalamine -- 89-57-6 42 Febuxostat -- 144060-53-7 43 Itopride Hydrochloride -- 122892-31-3 44 Amodafinil -- 68693-11-8 45 Quetipine Fumrate -- 111974-72-2 46 Aripiprazole -- 200 200 129722-12-9 47 Amlodipine Besylate -- 111470-99-6 48 Nebivilol Hydrochloride -- 152520-56-4 49 Sevelamer Hydrochloride -- 106-27-4 50 Sevelamer Carbonate -- 103-45-7 51 Poly Allaylamine Hydrochloride -- 122-70-3 Total (A) 500 420 920 Distillation of Solvent (B) -- 200 200 Total (A+B) 500 620 1120 3 1.3 Raw Material Requirement Sr. No. Raw Material Qu antity (MT/MT) 1. Furosemide Furfuryl Amine 0.450 Lasamide 0.850 Caustic Flake 0.234 IPA 0.240 Carbon 0.080 Acetic Acid 0.220 2. Diaminomethyleneamino (1 -amino -1- iminomethylene) thiomethyl thiozole dihydrochloride [ITU] 1,3 DCA 0.435 Gu anyl Thiourea 0.413 Acetone 3.100 Catalyst 0.004 Thiourea 0.261 Acetic Acid 0.261 3. N-Sulfomyl -3-chloropropionamide hydrochloride [IF] Acrylonitrile 1.303 Hydrogen Peroxide 0.008 HCl (Gas) 1.495 Sulfamide 0.500 Acetone 0.400 4. Famoti dine ITU 1.150 IF 0.965 Methanol 5.710 NaOH 0.690 Water 20.50 Acetic Acid 0.200 5. Colsevelam hydrochloride Monoallylamine 0.60 2,2 -dimethyl -2,2 -azopropane dihydrochloride 0.01 Concentrated Hydrochloric acid 1.15 Methanol 0.31 Pol yallylamine 0.90 Epichlorohydrin 0.01 n-Decylchloride 0.02 Trimethylammoniumhexylchloride 0.02 Sodium hydroxide 0.45 6. Glimepiride 3 Ethyl methyl Pyrroline 0.40 4 2 Phenyl ethyl isocyanate 0.40 Toluene 0.15 Chloro Sulfonic Acid 1.00 Amm onia Solution 3.10 EDC 0.30 7. Fomepizole Propanaldehyde 1.31 Ethanol 0.015 Hexane 0.015 Phosphorus oxychloride 3.45 Hydrazine Hydrate 1.10 Potassium Carbonate 0.75 Carbon 0.15 Di isopropyl Ether 0.02 N,N -Dimethyl Formamide 0.01 Dic hloro Methane 0.03 8. Betahistine Dihydrochloride 2- vinyl pyridine 0.63 Methylamine hydrochloride 0.80 Chloroform 0.23 Sodium hydroxide 0.45 Acetic Acid 0.06 IPA 0.01 IPA HCl(20%) 1.38 9. Adapalene Adamentanol 0.48 Para Bromo Phenol 0.30 THF 0.025 Mg Turning 0.06 MDC 0.04 6-Bromo -2-methyl naphthoate 0.72 HCl 1.32 10. Telmisartan 4-Amino 3 - Methylbenzoic acid 1.484 Conc. Sulphuric Acid 1.423 Liq. Ammonia 2.968 Methanol 0.06 MDC 0.03 TEA 0.01 Butryl Chloride 1. 287 Sodium Bicarbonate 0.153 Sodium Sulphate 0.387 Hexane 0.02 Fuming Nitric Acid 4.050 11. Tapentadol Hydrochloride 3-methoxy propiophenone 1.412 5 IPA 0.350 Dimethyl Amine HCL 1.059 Paraformadehyde 0.588 Sodium Hydroxide 0.376 MDC 0.3 50 L ( -) Dibenzoyl tartaric acid 1.412 THF 0.080 Mg Turning 0.171 Ethyl Bromide 0.588 Acetic Acid 0.118 Ammonium Solution 0.506 Ethyl Acetate 0.230 Trifluroacetic anhydride 0.882 Palladium 0.070 Acetone 0.260 HBr 1.765 IPA HCl 0.882 12. Colistimethate Sodium Colistin Sulphate 1.33 Sodium Bicarbonate 0.67 Sodium Carbonate 0.33 Formaldehyde 1.33 Sodium Bisulfite 3.06 Acetic Acid 0.16 Solvent 0.80 Acetone 2.00 Methanol 3.00 13. Rusvastatin Calcium 4-Fluoro Benza ldehyde 0.52 4-Methyl -3-oxo -Pentatonic Acid Ethyl Ester 0.66 Potassium Hydroxide 0.24 Methyl Iodide 0.60 Methanol 5.50 5-Methyl Iso Thio Urea 0.35 2,3 -Dichloro -5,6 -Dicyano Benzoquinone 0.85 HMPA 1.00 MDC 8.00 Meta Chloro Peroxy Benzoic Ac id 0.11 Methyl Amine 0.10 Ethanol 2.50 Methane Sulfonyl Chloride 0.35 Sodium Hydride (60%) 0.01 Di Methoxy Ethane 3.00 Hydrogen 0.01 6 DIBAL -H 0.01 Toluene 8.00 Methyl(3R) -3-(tert butyl dimethyl silyloxy) -5-oxo -6- 1.45 triphenyl phosphoranylidene hexanoate Triethyl Amine 0.15 N,N -Dimethyl Formamide 3.00 Hydrogen Fluoride 0.05 THF 7.50 Ethyl Acetate 10.50 Diethyl Methoxy Borane 0.20 Sodium Borohydride 0.01 Calcium Chloride 0.13 14. 1-3 dichloro Acetone Epichlorohydrin 1.302 HCl (30%) 3.125 Sulfuric Acid (98%) 1.862 Sodium Dichromate 1.562 15. Gunylthiourea Phosphorus Penta Sulphide 0.827 KOH 1.000 Dicyanadiamide 0.909 Sodium Hydro Sulphite 0.181 16. Rabeprazole Sodium 2,3 -Lutidine 0.460 H2O2 (50%) 0.330 Nitric Acid 0.380 Acetic Acid 0.060 3-Methoxy 1 -Propanol 0.430 NaOH 0.155 Toluene 0.012 DMSO 0.010 Acetic Anhydride 0.390 HCl 0.200 Thionyl Chloride 0.530 MDC 0.370 Sodium Sulphate 0.100 2-Mercaptobenzimidazole 0.530 Ammonium Hyd roxide 0.125 Sodium Hypochlorite (8%) 3.270 Acetone 0.100 Sodium Hydro Sulphate 0.120 MMA 0.100 IPA 0.150 7 Activated Carbon 0.100 17. Carvediol 4-Hydroxy Carbazole 0.447 Epichlorohydrin 0.790 Hydrose 0.116 Methanol 0.067 Ethyl Acetat e 0.029 Carbon 0.022 Hyflo 0.005 Monoethylene Glycol Dimethyl Ether 2.330 2-(2 -Methoxy Phenoxy) Ethyl Amine 0.956 Acetone 0.101 Potassium Carbonate 0.372 Oxalic Acid 0.532 IPA 0.052 Sodium Sulphate 0.207 Ortho Phosphoric Acid 0.442 18. Celecoxib 4 SPH 0.70 Dione Deri 0.65 Toluene 2.80 Carbon 0.01 19. Clopidogrel Bisulfate amino(2 -chlorophenyl)acetic acid 1.25 methanol 0.20 Potassium salt 0.7 MDC 0.50 Liq. ammonia 0.62 Thiophene -2-Ethanol 0.5 p-toluene sulphonyl chloride 1.05 Toluene 0.16 Sodium hydroxide 1.25 Acetonitrile 0.32 Dipotassium phosphate 0.87 Ethyl acetate 0.28 HCL 0.85 P-Formaldehyde 0.53 MDC 1.02 Liq. Ammonia 0.60 Acetone 1.10 Tartaric acid 0.82 MDC 0.67 Sodium carbonate 0.70 8 Acetone 0.24 Activated carbon 0.15 Sulfuric acid 0.31 20. Atoravastatin Calcium Ethyl -4-Cyano -3-hydroxy butanaote 1.00 THF 0.85 Diisopropyl amine 1.22 N-Butyl Lithium 0.6 Tert -Butyl acetate 1.68 HCl 0.76 Ethyl Acetate 1.5 NaC l 1.20 Methanol 1.02 DEMB (50 % Soln) 0.70 Sodium Borohydride 0.44 Acetic Acid 0.98 Dimethoxy Propane 1.81 Methane Sulphonic Acid 0.03 Sodium Bicarbonate 2.00 n-Hexane 0.023 Raney Nickel 1.00 Pivalic Acid 0.240 Toluene 0.45 Activate d Carbon 0.100 Methyl Tert Butyl 0.410 21. Etoricoxib Acetic Acid 1.520 Acetone 2.80 Ammonia Solution 5.80 CPT -Phosphate 1.520 D M Water 26.00 Hydroxylamine Hydrochloride 0.115 Hyflow 0.177 Isopropyl Alcohol 10.00 Ketosulfon e 0.574 Methanol 10.00 Potassium Tertrabutoxide (KTB) 0.664 Sodium Acetate 0.297 Sodium Hydroxide 2.153 Toluene 55.000 THF 23.00 Trifluro Acetic Acid 0.465 Activated Carbon 0.022 9 Hexane 0.250 22. Valsartan L-Valine 1.44 Metha nol 0.23 Thionyl Chloride 6.90 Toluene 0.38 DCM 2.41 NaOH 0.65 NaCL 0.29 4-Bromo Methyl 2 -Cyano biphenyl 2.17 Acetonitrile 1.00 Potassium Carbonate 1.49 Oxalic Acid 1.00 o-Xylene 1.16 Valeoryl Chloride 1.24 Sodium Bicarbonate 0.28 HCl 0.65 Tributyl Tin Chloride 5.55 Calcium Hydroxide 0.42 Ethyl Acetate 0.35 Diisopropyl ether 7.17 TBAB 0.14 23.
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