M/s. Maitri Pharma, GIDC Jhagadia- Bharuch LIST OF ANNEXURES

Transcription

1 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch LIST OF ANNEXURES Sr. No. Title Page No. Annexure 1 Terms of References 12 Annexure 2 List of Products 13 Annexure 3 List of Partners 14 Annexure 4 Plant Layout 15 Annexure 5 Products With Raw Material 16 Annexure 6 Details of Manufacturing Process 19 Annexure 7 Details of Effluent Treatment Scheme and List of Plant Machinery 41 Annexure 8 Details of Water Consumption & Waste Water Generation 48 Annexure 9 Details of Energy and Fuel Consumption 51 Annexure 10 Details of Hazardous Waste 52 Annexure 11 Details of Flue Gas & Process Gas Emission 54 Annexure 12 Details of Solvent Recovery 55 Annexure 13 List of Hazardous Chemicals as per MSIHC Rules 58 Annexure 14 Land Possession Document 59 Annexure 15 NCT Membership Certificate 61

2 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch TERMS OF REFERENCES ANNEXURE-1 TOR prescribed by MoEF & CC for this sector will be taken into account.

3 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch LIST OF PRODUCTS ANNEXURE-2 SR. CAS No End use of product Quantity No. Name of Product MT / Month 1 Pharma Intermediates 5 Flavouring agent agent inchewing gum, Cinnamyl aldehyde & OR beverages m-phenoxy benzyl alcohol & OR used as active in pharmaceutical products P-anisaldehyde/ 4-methoxy benzaldehyde & OR fragrance and flavor industry. UV curing type coating, printing ink, Chlorobenzophenone & OR medical 2-[4-(4-cyclopropyl carbonyl phenyl]-2-methyl propionic Fexofenadine Intermediate API acid cyclohexyl amine salt & OR (anti allergic ) N-(2-chloro-4-methyl-3-pyridinyl)2-(cyclopropyl amine)-3- pyridinecarboxamide & OR Nevirapine API ( anti HIV drug) Trans-4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Ambroxole Hydrochloride API ( for hydrochloride respiratory disease) 2 Fine Chemical 20 Used as bacteriostatic in medications, Benzyl alcohol cosmetics and topical drugs 3 Anti allergic 1 2-[4-[4-chlorophenyl)phenyl methyl [1-piperazinyl] ethoxy] Cetrizine API acetic (anti allergic ) 4 Dye Intermediates 5 4-chlorophthalic acid mono sodium salt Dyes intermediate Phenyl peri acid magnasium salt Dyes intermediate Total 31

4 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch ANNEXURE-3 LIST OF NAME AND ADDRESS OF PARTNERS Sr.No. Name of Director Address Contact No. 1 Mr. Divyeshkumar Ravinbhai Nargoriya Add : 9, Nilkanth Society, Near Gandhikutir society, Bhatar Road, Surat , Gujarat, India Ms. Maitreyee Divyeshkumar Nagoriya 3 Mrs. Tarulataben Chandravadan Palsanawala Add : 9, Nilkanth Society, Near Gandhikutir society, Bhatar Road, Surat , Gujarat, India Add :B-2 Muktanand Nagar Adajan Road, Opp New Sardar Bridge, Surat Gujarat, India

5

6 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch LIST OF PRODUCTS WITH RAW MATERIAL ANNEXURE-5 Sr. No. Name of products Pharma Intermediates 1 Cinnamyl aldehyde & OR 2 3 m-phenoxy benzyl alcohol & OR P-anisaldehyde/ 4-methoxy benzaldehyde & OR Quantit y of (MT/mo nth) 5 Name of Raw materials CAS NO. Quantity (MT/MT) Quantity (MT/mont h) Benzaldehyde Acetaldehyde Sodium hydroxide m-phenoxy benzaldehyde Ni catalyst H2 gas p-cresol Dimethyl sulfate sodium hydroxide Sulfuric acid Magnesium oxide Toluene (Fresh) Chlorobanzoic acid Thionyl chloride Chlorobenzophenone & OR 2-[4-(4-cyclopropyl carbonyl phenyl]-2-methyl propionic acid cyclohexyl amine salt & OR Dimethyl formamide Benzene Aluminium chloride Caustic Solution methyl-2-phenyl propanoic acid Thionyl chloride Sodium hydroxide Dimethyl amine

7 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch 40% Alluminium chloride Chloro butyryl chloride Dichloromethane (Fresh) Hydrochloric acid 30% (Recovered) Toluene (Fresh) Brine solution Methanol (Fresh ) N-(2-chloro-4-methyl-3- pyridinyl)2-(cyclopropyl amine)-3- pyridinecarboxamide & OR Trans-4-(2-amino-3,5- dibromobenzylamino)cyclo hexanol hydrochloride & OR Fine Chemical 8 Benzyl alcohol 20 cyclohexyl amine Amino-2-chloro methyl pyridine Chloronicotinoyl chloride Cyclopropyl amine Methanol (Fresh ) Toluene (Fresh) Aminobenzaldehyde Fresh Methanol Bromine Potassium bromide Trans-4-amino cyclohexanol Toluene (Fresh ) Isopropyl alcohol (Fresh ) HCl gas Sodium borohydrate Benzyl chloride sodium carbonate

8 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Anti allergic 4 Chlorobenzophenone sodium borohydrate [4-[4- chlorophenyl)phenyl methyl [1-piperazinyl] ethoxy] acetic Dye Intermediates 10 4-Chloropthalic acid mono sodium salt & OR 11 Phenyl peri acid magnesium salt & OR 1 5 Fresh Methanol Piprizine Fresh Toluene Hydrochloricacid chloroethanol sodium monochloroacetate Potasium hydroxide dimethyl formamide Dichloromethane (Fresh) Pathallic anhydride Sodium hypochlorite Aniline (Fresh) Peri acid Magnesium sulfate Sulphuric Asid 30% Total

9 1. Cinnamylaldehyde M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Process: Benzaldehyde and acetaldehyde charged in sodium hydroxide solution. Reflux reaction mixture for several hours. After completion of reaction layer separated and pure product will be collected by distillation from crude Cinnamyl aldehyde under vacuum Chemical Reaction: CHO O + H 3 C CHO NaOH H + NaOH + H 2 O benzaldehyde acetaldehyde Cinnamayl aldehyde sodium hydroxide water M.Wt M.wt M.Wt- 132 M.Wt M.Wt Material Balance: Input Kg Out put Kg Benzaldehyde Reaction Mass 1,886.0 Acetaldehyde Sodium hydroxide 56.0 STAGE 1 Water 1,123.0 TOTAL 1,886.0 TOTAL 1,886.0 Reaction Mass 1,886.0 Crude Cinnamylaldehyde Layer Effluent 1,286.0 Separation TOTAL 1886 TOTAL 1,886.0 Crude Cinnamylalde Product Cinnamylaldehyde Dehydration Evaporation Loss 40.0 TOTAL 600 TOTAL 600

10 2. m-phenoxy benzyl alcohol M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Process: M-Phenoxy Benzaldehyde and Nickel catalyst charged to autoclave. Apply Hydrogen gas slowly and heat reaction mixture to ºC for several hours. After completion of reaction cool reaction mass to room temperature. Catalyst separated by filtration and m-phenoxy benzyl alcohol isolated by distillation. Chemical Reaction: O CHO Ni cat H 2 O OH + Ni cat m-phenoxy Benzaldehyde M.Wt Catalist m-phenoxy Benzyl alcohol Recovered cat. M.wt M.Wt M.wt Molecular Formula = C 13 H 10 O 2 Molecular Formula = C 13 H 12 O 2 Material Balance: Input Qty., Kg Output Qty. Kg m-phenoxy benzaldehyde Reaction Mass Ni catalyst 10.0 Autoclave Catalyst recover 10.0 H2 gass 2.0 Total Total Reaction Mass m-phenoxy benzyl alcohol Distillation Distilation Residue 10.0 Distilation loss 17.0 Total Total 202.0

11 M/s. Maitri Pharma, Jhagadia- Bharuch 3. P-anisaldehyde/ 4-methoxy benzaldehyde ANNEXURE 6 Process : P-Cresol acid charged to SS Reactor with sodium hydroxide and water under heating dimethyl sulfate added to it slowly at elevated temperature. After completion of reaction sulfuric acid added and p- methyl anisole separated by filtration. Chemical Reaction Material Balance: Input Kg Output Kg p-cresol P-Methyl anisole Dimethyl sulfate Effluent 1,699.0 sodium hydroxide 80.0 Stage 1 (Heating at Sulphuric Acid ºC and filtration) water Total 1,844.0 Total 1,844.0

12 Process: M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 P-methyl anisole, magnesium oxide, sulfuric acid Charged in toluene. Heat reaction mass for several hours. After completion of reaction water added and layer separated. Organic acid on distillation gives 4-methyl Benzaldehyde Chemical Reaction: Material Balance: P-Methyl anisol P-anisaldehyde Magnase oxide Effluent Sulfuric acid Stage 2 (Layer Recovered Toluene Toluene (F) 10.0 separation and Vapour loss 10.0 Toluene (R ) Distillation) Methanol (Recover) 41 Water Spent Sulfuric acid 500 Total 1,683.0 Total 1, Chlorobenzophenone Process:

13 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 4-Chlorobenzoic acid charged to GLR with thionyl chloride and DMF as a catalyst. This mass heated for several hours and cooled. Benzene added to reaction mass followed by aluminum chloride. Reaction mass heated and quench to ice water. Solid filtered and dried to give 4-chlorobenzophenone as off white powder Chemical Reaction: COOH COCl + SOCl 2 DMF + SO 2 + HCl Cl Cl 4-chlorobenzoic acid 4-chlorobenzoyl chloride Sulfer dioxide Hydrochloric acid M.wt M.wt M.wt M.wt 64.6 M.wt Molecular Formula = C 7 H 5 ClO 2 Molecular Formula = C 7 H 4 Cl 2 O M. F. -SO 2 M F. -HCl COCl + Cl M.F.= C 7 H 4 Cl 2 O M.F = C 6 H 6 4-chlorobenzoyl chloride benzene M.wt M.wt O AlCl 3 M.wt H 2 O M.wt Cl Molecular Formula = C 13 H 9 ClO (4-chlorobenzophenone M.wt M.wt M.wt HCl Al(OH) 3 Alluminium hydroxide Hydrochloric acid

14 Material Balance: M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Input Output Qty. Kg Qty., Kg 4-Chloro banzoic acid Chlorobenzoyl Chloride Thionyl chloride SO2 Gas 89 Dimethyl formamide 3.0 HCl 55 GLR Total Total Input Qty., Kg Output Qty. Kg 4-Chlorobenzoyl Chloride Product (Reaction Mass) Chlorobenzophenone Benzene Reaction Effluent 1,100.0 Aluminium chloride HCl 240 Water 1,000.0 Total 1,630.0 Total 1,630.0 Input Qty., Kg Output Qty. Kg HCl Scrub Solution To ETP 1,651.0 SO Caustic Solution Scrubbing Water 1,000.0 Total 1,651.0 Total 1,651.0

15 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE [4-(4-cyclopropyl carbonyl phenyl]-2-methyl propaonic acid cyclohexylamine salt Process: 2-Methyl-2-phenyl propionic acid and thionyl chloride charged to G L Reactor than heated for several hours. After completion of reaction mass cool to room temperature and charged dimethyl amine, sodium hydroxide slowly, followed by water under cooling and thus product obtained by filtration gives N, N, 2-trimethyl-2-phenyl propanamide a solid. Chemical Reaction: STAGE- 1 H 3 C CH 3 H 3 C CH 3 OH O SOCl 2 CH 3 H 3 C N NaOH NH O CH H 3 2 O H 3 C HCl + SO HCl + H 2 O + NaOH sulfur dioxide Water Sodium hydroxide Hydrochloric acid 2-methyl-2-phenylpropanoic acid N,N,2-trimethyl-2-phenylpropanamide M. wt M.wt = M.Wt Molecular Formula = C 10 H 12 O 2 Molecular Formula = C 12 H 17 NO Material Balance: Input Qty., Kg Output Qty. Kg 2-methyl-2-propionic acid N,N-2-trimethyl-2-phenyl proanamide Thionyl chloride HCl gass Sodium hydroxide 60.0 Effluent Stage 1 Dimethyl amine 40% Water Total 1,101.0 Total 1,101.0

16 Process: M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Dichloromethane and aluminum chloride was charged to GL reactor, cool the reaction mass and 4- chlorobutyryl chloride added slowly drop wise under cooling then N, N, 2-trimethyl-2-phenyl propanamide in dichloromethane was added Slowly. Reaction mixture was refluxed for several hours. After completion of reaction water added and separated and organic layer distilled out gives oily product 2-[4-(4-chlorobutanoyl) phenyl]-n, N, 2-trimethylpropanamide. Chemical Reaction: Material Balance: Input Qty., Kg Output Qty. Kg N,N-2-trimethyl-2-phenyl [4-(4-chlorobutanoyl)phenyl] propanamide N,N-2-trimethyl propanamide Alluminium chloride HCl gass Chloro butyryl chloride Dichloromethane (Recovered ) Stage 2 Dichloromethane (Fresh ) 15.0 Vapour loss 15.0 Dichloromethane Effluent 1, (Recovered) water 1,490.0 Total 3,049.0 Total 3,049.0

17 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Process: Dichloromethane and aluminum chloride was charged to GL reactor, cool the reaction mass and 4- chlorobutyryl chloride added slowly drop wise under cooling then N, N, 2-trimethyl-2-phenyl propanamide in dichloromethane was added Slowly. Reaction mixture was refluxed for several hours. After completion of reaction water added and separated and organic layer distilled out gives oily product 2-[4-(4-chlorobutanoyl) phenyl]-n, N, 2-trimethylpropanamide. Chemical Reaction: STAGE - 3 Cl O H 3 C O CH 3 N CH 3 CH 3 HCl H 2 O Cl O H 3 C O CH 3 OH + HN CH 3.HCl CH 3 Dimethylamine hydrochloride Molecular Formula = C 16 H 22 ClNO 2 Molecular Formula = C 14 H 17 ClO 3 Molecular Formula = C 2 H 8 ClN H 3 C O OH H 3 C O OH O CH 3 NaOH H 2 O O CH 3 + NaCl + 2 H 2 O Cl 2-[4-(4-chlorobutanoyl) 2-[4-(4-chlorobutanoyl)phenyl] phenyl]-n,n-2-trimethyl propanamide N,N-2-trimethyl propanonic acid Hydrochloric acid 30% 1,311.0 Stage 3 Recovered Toluene Water Vapour loss 10.0 Sodium hydroxide Effluent 2,379.0 Fresh Toluene 10.0 Recovered Toluene Brine solution Total 3,526.0 Total 3, [4 (4 chlorobutanoyl)phenyl] N,N,2 2 [4 (4 chlorobutanoyl)phenyl] 2 trimethylpropanamide methylpropanoic acid [4 (4 chlorobutanoyl)phenyl] 2 methylpropanoic acid [4 (cyclopropylcarbonyl)phenyl] 2 methylpropanoic acid Sodium Chloride Water Molecular Formula = C 14 H 17 ClO 3 Molecular Formula = C14 H 16 O 3 Material Balance: Input Qty., Kg Output Qty. Kg

18 Process: M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 2-[4-(cyclopropylcarbonyl) phenyl]-2-methyl propionic acid in Toluene and methanol was charged to reactor. Cyclohexyl amide was added drop wise slowly under cooling. The reaction mixture was refluxed for several hours then cooled and filter to give 2-[4-(cyclopropylcarbonyl) phenyl] -2-methyl propionic acid Cyclohexyl amine sate Chemical Reaction: Material Balance: Input Qty., Kg Output Qty. Kg 2-[4-(4-chlorobutanoyl) phenyl]-n,n-2-trimethyl [4-(4-cyclopropyl carbonyl phenyl]-2-methyl propaonic acid cyclohexylamine salt prpanoic acid Stage 4 Recovered methanol Fresh Toluene Recovered Toluene Fresh Methanol Vapour loss cyclohexyl amine Drying loss Recovered Toluene Recovered Methanol Total 1,665.0 Total 1,665.0 Scrubbing of HCl Gas: Input Qty., Kg Output Qty. Kg HCl HCl 30% reused in at stage 3 1,311.0 Scrubbing Water Total 1,311.0 Total 1,311.0

19 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 6. N-(2-chloro-4-methyl-3-pyridinyl)2-(cyclopropyl amine)-3- pyridinecarboxamide Process: 3-Amino-2-Chloro-4-methyl pyridine and 2-Chloronicotinyl chloride charged in Toluene to Reactor and stir at ambient temperature for several hours. After completion of reaction water added, layer separated and thus product obtained is as 2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3- pyridinecarboxamide Chemical Reaction: STAGE - 1 CH 3 N NH 2 Cl + N COCl Cl Toluene CH 3 N NH Cl O Cl N + HCl 3 Amino 2 chloro 4 methyl pyridine 2 Chloronicotinoyl chloride 2 Chloro N (2 chloro 4 methyl 3 p yridyl) 3 pyridinecarboxiamide M.Wt M.Wt 176 M.Wt M.Wt Molecular Formula = C 6 H 7 ClN 2 Molecular Formula = C 6 H 3 Cl 2 NO Molecular Formula = C 12 H 9 Cl 2 N 3 O Hydrochloric acid Material Balance: 3-Amino-2-chloro-4-methyl 2-Chloro-n-(2-chloro methyl-3-pyridinyl)-3- pyridine pyridinecarboxamide 2-Chloronicotinoyl chloride Recovered Toluene Stage 1 Fresh Toluene 20.0 Vapour loss 20.0 Recovered Toluene Effluent Water Total 1,067.0 Total 1,067.0 Process: 2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3-pyridinecarboxamide, cyclo propyl amine charged in methanol. Reflux reaction mixture for several hours. After completion of reaction distilled out methanol and water added to reaction mass. Obtained precipitate filtered to get N-(2-Chloro-4-methyl- 3-pyridinyl)-2-cyclopropylamino)-3-pyridinecarboxamide.

20 Chemical Reaction: STAGE - 2 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 CH 3 N NH Cl O Cl N + NH 2 Methanol CH 3 N NH Cl O NH N + HCl 2 Chloro N (2 chloro 4 methyl 3 p yridyl) 3 pyridinecarboxiamide Cyclopropyl amine N (2 chloro 4 methyl) 3 pyridinyl) 2 (cy clopropylamino) 3 pyridinecaraxamide Hydrochloric acid M.Wt M.Wt M.Wt M.Wt Molecular Formula = C 12 H 9 Cl 2 N 3 O Molecular Formula = C 3 H 7 N Molecular Formula = C 15 H 15 ClN 4 O Material Balance: 2-Chloro-n-(2-chloro-4-methyl N-(2-chloro-4-methyl pyridinyl)-3-pyridinecarboxamide pyridinyl)2-(cyclopropyl amine)-3- pyridinecarboxamide Cyclopropyl amine 65.5 Stage 2 Recovered Methanol Fresh Methanol 10.0 Vapour loss 10.0 Recovered Methanol Efflluent water Total Total 883.5

21 M/s. Maitri Pharma, Jhagadia- Bharuch 7. Trans-4-(2-amino-3,5-dibromo benzyl amino)cyclohexanol hydrochloride (Ambroxol hydrochloride) Process: ANNEXURE 6 2-Amino Benzaldehyde charged to GL Reactor. Bromine added to it by dissolving it in water with potassium bromide. After completion of addition, mass stirred for several hours and filtered to give 2-amino-3, 5-dibromo Benzaldehyde as a solid. Chemical Reaction: Material Balance: 2-Aminobenzaldehyde Amino-3,5- dibromobenzaldehyde 320 Recovered Methanol 480 KBr 204 Fresh Methanol 20 Effluent 980 Bromin 402 Stage 1 Recovered Methanol 480 water 800 Evaporation Loss 20 Potassium bromide 150 Total 2,004 Total 2,004

22 Process: M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 2-Amino-3,5-dibromo Benzaldehyde charged to toluene with trance-4-amino cyclohexanol in GL reactor. This mass heated for several hours and then toluene distilled under vacuum to give 4-[[(E)-2- amino-3,5-dobromophenyl) methylidiene] amino] cyclohexanol Chemical Reaction : STAGE - 2 CHO NH 2 OH Br NH 2 Br + OH Heating Br Br NH 2 N + H 2 O 2-amino-3,5-dibromo benzaldeyde Trans-4-aminocycloheanol 4[[(E)-(2-amino-3,5-dibromophenyl) methylidene]aminocyclohexanol Water M.Wt M.Wt M.Wt Molecular Formula = C 7 H 5 Br 2 NO Molecular Formula = C 13 H 16 Br 2 N 2 O Molecular Formula = C 6 H 13 NO M.Wt Material Balance: 2-Amino-3,5-4-[[(E)-(2-amino-3,5- dibromophenyl)methyledine]amino 370 dibromobenzaldehyde 320 ]cyclohexanol ] Trans-4-amino cyclohexanol 132 Stage 2 Vapor loss 82 Fresh Toluene 72 Recovered Toluene 1,728 Recovered Toluene 1,728 Effluent 72 Total 2,252 Total 2,252

23 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Process: 4 [[(E) 2 amino 3, 5 dobromophenyl) methylidiene] amino] cyclohexanol charged to methanol followed by addition of sodium borohydride in water. This mass stirred for several hours and water added to it. This mass stirred, filtered and wet cake charged to IPA. HCl gas passed to it to form solid which filtered and dried to give Trans 4 (2 amino 3,5 dibromo benzyl amino) cyclohexanol hydrochloride ( Ambroxol hydrochloride) as a solid. Chemical Reaction: STAGE - 3 OH OH Br Br N NH 2 4[[(E)-(2-amino-3,5-dibromophenyl) methylidene]aminocyclohexanol Chemical Formula: C 13 H 16 Br 2 N 2 O Molecular Weight: Cl Chemical Formula: Cl Molecular Weight: NaBH 4 Sodium borohydrate Chemical Formula: BH 4 Na Molecular Weight: CH 3 OH Chemical Formula: CH 4 O Molecular Weight: BH 3 Trihybridoboron Chemical Formula: BH 3 Molecular Weight: Br N H.HCl NH 2 Br Trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride Chemical Formula: C 13 H 19 Br 2 ClN 2 O Molecular Weight: CH 3 ONa Sodium Methoxide Chemical Formula: CH 3 NaO Molecular Weight: Material Balance: 4-[[(E)-(2-amino-3,5- dibromophenyl)methyledine]ami no]cyclohexanol ] 370 Trans-4-(2-amino-3,5- dibromobenzylamino)cyclohexanol hydrochloride Fresh Methanol 38 Recovered Isopropyl alcohol 1,536 Fresh Isopropyl alcohol 64 Effluent 2,191 Recovered Isopropyl alcohol 1536 Stage 3 vapour loss 64 HCl gas 50 Sodium borohydrate 38 water 2,075 Total 4,171 Total 4,

24 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 8. Benzyl alcohol Process: Benzyl chloride is hydrolyzed with dilute soda ash for 12 hours at an elevated temperature. The mass is washed and the layer is separated to get crude Benzyl Alcohol. The crude is distilled under high vacuum at normal temperature to get pure Benzyl Alcohol. Chemical Reaction: Material Balance: Benzyl chloride Benzyl alcohol sodium carbonate Stage 1 Waste water Water CO TOTAL TOTAL Distillation: Waste Water Distilled Water Distillation NaCl Salt 115 Total Total [4-[4-chlorophenyl)phenyl methyl [1-piperazinyl] ethoxy] acetic Process:

25 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 4- Chloro benzophenone in methanol charged under stirring and Sodium borohydrate added lot wise at room temperature. Stir reaction mass for 4-5 hours at room temperature and after completion of reaction distilled out methanol and water added to residue on filtration gave a 4-chlorobenzhydrol as solid. Chemical Reaction: Material Balance: 4-Chlorobenzophenone Chlorobenzhydrol sodium borohydrate 80.0 Recovered Methanol 1,180.0 Fresh Methanol 20.0 Vapour loss 20.0 Stage 1 Recovered Methanol 1,180.0 Water 1,200.0 Effluent 1,280.0 Total 2,880.0 Total 2,880.0 Process:

26 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 Chemical Reaction: Material Balance: 4-chlorobenzhydrol chlorobenzhydril piperazine Piprizine Recovered Toluene Fresh Toluene 35.0 Vapour loss 35.0 Stage 2 Recover Toluene Efflluent 2,775.0 Hydrochloricacid water 1,812.0 Total 3,993.0 Total 3,993.0 Process: 4-Chloro Benzhydril Piperazine and toluene was charged to reactor. 2-chloro ethanol added slowly dropwise to reaction mixture. Stir reaction mass till completion of reaction. After completion of

27 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 reaction water added, layer separated. Organic layer distilled to give 2-{4-[4-chlorophenyl) phenyl methyl] piperazine-1-yl) ethanol. Chemical Reaction: Material Balance: 4-chlorobenzhyril 2-{4-[ chlorophenyl)phenyl methyl] piperazine-1- piperazine yl}-ethanol 2-chloroethanol Stage 3 Recovered Toluene Fresh Toluene 30.1 vapour loss 30.1 Recovered Toluene Effluent 2,424.8 Water 2,004.0 Total 3,529.0 Total 3,529.1 Process:

28 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE 6 2-{4-[4-chlorophenyl) phenyl methyl] piperazine-1-yl) ethanol, Dimethyl formamide, sodium monochloro acetate, potassium hydroxide was charred to Reactor. Heat reaction mass till completion of reaction. After completion of reaction dichloromethane and water added and layer separated. Dichloromethane distilled to give 2-[2-[(4 chlorophenyl) methyl [1-ppiperazinyl] ethoxy] acetic. Chemical Reaction: Material Balance: 2-{4-[4- chlorophenyl)phenyl methyl] piperazine-1-yl}- ethanol sodium monochloroacetate 2-[4-[4- chlorophenyl)phenyl methyl [1-piperazinyl] ethoxy] acetic Recovered dichloromethane ,565.1 Potasium hydroxide Stage 4 Vapour loss 42.1 dimethyl formamide 1, Effluent 4,008.0 Dichloromethane (Fresh) Dichloromethane (Recoverd ) 2, Water 2, Total 7,116.2 Total 7,116.15

29 M/s. Maitri Pharma, Jhagadia- Bharuch chlorophthalic acid mono sodium salt ANNEXURE 6 Process: Phallic anhydride is charged in water under stirring sodium hypochlorite solution were added under stirring at moderate temperature after completion of reaction chlorinated product is isolated by diluted with water. The product is filtered; wash with brine solution and centrifuge, dried to give 4-chloropthalic acid mono so Chemical Reaction: Material Balance: Input Qty., Kg Output Qty. Kg Pthalic anhydride Reaction Mass 3,500.0 Sodium Hypochlorite 3,000.0 Stage 1 Total 3,500.0 Total 3,500.0 Reaction Mass 3,500.0 Water 4,000.0 Stage 2 Precipitated 4 chloropthalic acid mono sodium salt 7,500.0 Total 7,500.0 Total 7,500.0 Precipitated 4 chloropthalic 7, chloropthalic Cetrifuge & Effluent 6,950 Drying Total 7,500.0 Total 7,500.0

30 M/s. Maitri Pharma, Jhagadia- Bharuch ANNEXURE Phenyl peri acid magnesium salt Process: Aniline is charged to reactor under stirring peri acid dry powder is charged slowly and heat reaction mixture to C till reaction completed the excess aniline was recovered by vacuum destination reaction mass is dumped in water and the product is isolated by magnesium sulfate product filtered and washed with water and dry. Chemical Reaction: Material Balance: Input Qty., Kg Process Output Qty. Kg Aniline (Fresh) Phenyl peri acid Aniline (Recovered) Effluent 2,470.0 Peri acid Stage 1 Distilled aniline Magnasium Sulfate Ammonia 220 Water 2,000.0 Total 3,820.0 Total 3,820.0 Water 1000 Scrub solution 1220 Ammonia 220 Scrubbing Total 1,220.0 Total 1,220.0

31 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch DETAILS OF EFFLUENT TREATMENT SCHEME ANNEXURE-7 WASTE WATER TREATMENT SCHEME Waste water generation, Segregation & Treatment Facility The effluent generated from the various area will be: Process Waste water Washing from plant area. Domestic use Utility Blow downs- Boiler, Cooling Tower, DM Plant The Effluent will be generated from various activities, utility, Operations & domestic activities will be channeled toward common ETP. Where it will be treated in various stages. Effluent generated from plant will be divided into two categories. High Concentrated Stream, Low Concentrated Stream. Highly concentrated stream will be allowed through pass from volatile organic removal reactor where spent solvents will be remove then it will be pass through single stage evaporation process where condense generated, Condensate of evaporation process and Low concentrated effluent from utility will collected in equalization cum neutralization tank and then treat in ETP followed by Sand filter and activated carbon filter and will be send to NCT Domestic Effluent will be disposed through Soak pit.

32 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Quality of Process Effluent Sr. No. Name of Products Quantity of effluent in KL/Day ph COD in mg/l COD in KG/Day BOD in mg/l BOD in KG/Day TSS in mg/l TSS in KG/Day TDS in mg/l TDS in KG/Day Cinnamyl aldehyde & OR m-phenoxy benzyl alcohol & OR P-anisaldehyde/ 4- methoxy benzaldehyde & OR 4- Chlorobenzophenone & OR 2-[4-(4-cyclopropyl carbonyl phenyl]-2- methyl propionic acid cyclohexyl amine salt & OR N-(2-chloro-4- methyl-3-pyridinyl)2- (cyclopropyl amine)- 3- pyridinecarboxamide & OR Trans-4-(2-amino- 3,5- dibromobenzylamino) cyclohexanol hydrochloride & OR

33 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Sr. No. Name of Products Quantity of effluent in KL/Day ph COD in mg/l COD in KG/Day BOD in mg/l BOD in KG/Day TSS in mg/l TSS in KG/Day TDS in mg/l TDS in KG/Day 8 Benzyl alcohol [4-[4- chlorophenyl)phenyl methyl [1-piperazinyl] ethoxy] acetic 4-chloropthalic acid mono sodium salt Phenyl peri acid magnasium salt

34 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Note: 1) COD < 5000 mg/ lit is consider as Low COD and shall be send to ETP 2) COD > mg/ lit is consider as high COD and shall be send to first VOC removal reactor followed by single stage evaporator then its outlet will be sent to ETP. List of ETP units Sr. No. Name of Unit No. of Unit Capacity (m 3 ) 1 Collection tank Flash Mixture Flocculator Lamella type settler Aeration Tank Secondary hopper bottom settling tank Aeration Tank Secondary clarifier II Treated Water sump Sludge Drying Bed-1 Nos Sludge Drying Bed-2 Nos Pressure Send Filter Activated Carbon Filter Volatile organic compound removal 1 10 reactor 15 Single stage Evaporator 1 10 EFFLUENT QUALITY Quality of High COD stream going to Volatile organic compound removal reactor Sr.No. Parameter Unit Inlet to VOC removal reactor Outlet of Single stage evaporator 1 ph TDS mg/lit SS mg/lit <2 4 COD mg/lit BOD mg/lit Ammonical Nitrogen (ppm) mg/lit

35 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Stage wise Quality of low COD Wastewater Sr. No. Paramet er Unit Inlet low COD Outlet of Single stage evaporato r Final ETP Inlet Primary Treatme nt Outlet of Seconda ry settling tank-01 Outlet of secondary settling tank-02 After Sand Carbon filter 1 ph TDS mg/li t SS mg/li t < COD mg/li t BOD mg/li t Process Description of Effluent Treatment Plant VOC removal reactor & Single Stage Evaporator High Concentrated Process Effluent from plant will be collected in Equalization Tank-1 and then it will be treated in to Volatile organic compound removal reactor. Volatile organic compound removal reactor will reduce remaining solvent from waste water and by then single stage evaporation process will reduce maximum high COD/TDS. Condensate of single stage Evaporator will be transfer to ETP for further treatment & Evaporation salt will be send to TSDF for landfilling. ETP Primary Treatment: The effluent from plant, utility and filtrate from filter press will taken to equalization tank-2, the effluent is neutralized between ph 8.5 to 9.0 and transferred to flash mixture. Flash Mixer Alum solution will be prepared in dosing tank I. The solution will be dosed to flash mixer tank through dosing tank.

36 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Flocculator Poly solution of 1 % will be prepared in Dosing tank II. The solution will be dosed to flocculator dosing tank. Lamella Type Tube Settler The effluent will be settled in lamella type Tube settler. The clarified water will be discharged to sump and sludge will be discharges to sludge bed or dewatered through filter press. Aeration Tank- I The treated effluent from tube settler by gravity line after ensuring ph between 7.5 to 8.5. The COD inlet to aeration Tank-I is always maintained below mg/lit. MLSS=4000 mg/lit OR F/M= 0.10 to 0.12 Secondary Settling Tank I (SST- I) The effluent from Aeration Tank I is discharged to SST I, through gravity line. The ph at this stage have to be between 7.5 to 8.5. The settled sludge is recycled to Aeration tank I. The over flow is discharged to aeration Tank II. Aeration Tank II The treated supernatant from SST I is discharged to aeration tank II by gravity line after ensure ph between 7.5 and 8.5 The COD inlet to Aeration Tank I is always maintained below mg/lit. MLSS=3500 mg/lit OR F/M= 0.10 to 0.12 Secondary Settling Tank II (SST II) The effluent from Aeration tank - I is discharged to SST II Through gravity line. The ph at this stage shall have to be between 7.5 and 8.0. The settled sludge is recycled to aeration Tank II. Pressure Sand Filter The neutral effluent will be pass through pressure sand filter for further reduction in suspended solids. Activated Carbon Filter From pressure sand filter, effluent will be allows through activated carbon filter for to remove color of effluent & to remove partial.

37 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch ETP Diagram:

38 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch ANNEXURE 8 Category DETAILS OF WATER CONSUMPTION Quantity KLD Remarks (A) Domestic 5 (B) Gardening 3 (C) Industrial Process Washing KLD will be recycle in process Boiler 1 Cooling 2.5 Others Water use for Scrubbing Industrial Total Total (A + B + C) Total Fresh Water KLD & Internal Recycled Water 1.77 KLD 1) Total water requirement for the project: KLD 2) Quantity to be recycled: 1.77 KLD (Internal Recycled) 3) Total fresh water requirement: KLD

39 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch DETAILS OF WASTE WATER GENERATION Category Waste water Remarks KLD (A) Domestic 4 Disposed through Soak pit (B) Industrial Process Treated in to VOC removal reactor & Single stage evaporator then send to ETP Washing 2.5 Boiler Cooling 0.11 Others Scrub Solution HCl, Na2SO4 & Ammonium Sulphate will be generated and treated in to in house ETP Total Industrial waste water Total [A + B]

40 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Water Balance Diagram

41 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch DETAILS OF ENERGY & FUEL CONSUMPTION ANNEXURE 9 Sr. No. Particulars Requirement Remark 1. Electricity 140 KVA Will be met through Electricity company 2 Bio Coal 1 MT/day Local Supplier 3. Natural Gas 45 Nm 3 /Hr Local Supplier 4. Diesel (in case of power failure, DG set will be operated) 130 Liter/ Hr. Local suppliers

42 Sr. No. Name of Hazardous Waste M/s. Maitri Pharma, GIDC Jhagadia- Bharuch ANNEXURE-10 DETAILS OF HAZARDOUS WASTE Categ ory Total Quanti ty MT/Ye ar Source of Generation Mode of Disposal 1 Effluent Treatment From ETP Collection, Storage & Send Plant Sludge to TSDF for landfilling 2 Evaporator salt From Single stage Collection, Storage & Send Evaporator to TSDF for landfilling 3 Used Oil From Lubrication Collection, Storage, Sold to MoEF Approved Vendors. 4 Empty Barrels/ From Collection, Storage, Containers/ Liners Packing decontami Contaminated with Material nation, Sold to GPCB, hazardous chemicals/ approved Vendors wastes 5 Process Residue and Production process of Collection, Storage, Send wastes m-phenoxy benzyl for Incineration/co- / Distillation alcohol & processing Residue NaCl salt will be & NaCl Salt generated from benzyl 6 Spent Carbon (From ETP ) 7 Spent Carbon Solvent Recovery System 8 Spent Solvent From Production process & VOC 9 Date-expired products 10 Off specification products alcohol Activated Carbon filter Collection, Storage, Send for Incineration/coprocessing Carbon tower of Collection, Storage, Send Solvent recovery for Incineration/co- System processing Collection, Storage, Send for Incineration/coremoval reactor processing From premises Collection, Storage, Send for Incineration/coprocessing Production process Collection, Storage, Send for Incineration/coprocessing Collection, Storage, Send for authorised regenerator 11 Spent catalyst Production process of Benzyl alcohol and or 4-Chlorobenzophenone 12 Scrubbed Solution Na2SO4 10% to 20 % C2 200 Scrub solution will be generates from 4- Chlorobenzophenone Send to ETP for treatment.

43 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch 13 Scrubbed Solution HCl 10% to 20 % 14 Scrubbed Solution HCl 30% 15 Scrubbed Solution Ammonium sulphate 10% to 20 % C2 160 Scrub solution will be generates from 4- Chlorobenzophenone C2 252 Scrub solution generates from 2-[4-(4- cyclopropyl carbonyl phenyl]-2-methyl propaonic acid cyclohexylamine salt C2 160 Scrub solution generates from Phenyl peri acid magnasium salt 16 Spent Sulphuric acid C2 250 Scrub solution generates from P- anisaldehyde/ 4- methoxy benzaldehyde Send to ETP for treatment. Recycle in process Send to ETP for treatment Send to ETP for treatment. OTHER NON HAZARDOUS WASTE Sr. No. Waste Quantity Mode Of Disposal 1. Glass Waste ( Z 13) 0.1 MT/month To TSDF. 2. Paper waste (Z44) 0.5 MT/month At notified area facility. 3. Bio-Medical Waste 0.05 MT/month Will be disposed off as per Bio Medical Waste Rules. 4. Wooden Waste 2 MT/month Authorized Scrap Vendors. 5. Used Batteries 0.1 MT / month Authorized Scrap Vendors. 6 Fly Ash 3 MT / Month Send to authorize Brick manufactures

44 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch DETAILS OF FLUE GAS EMISSION ANNEXURE- 11 Sr. No. Stack Attached to Fuel Consumption Stack Height in meter APCM Probable Pollutants Permissible Limit 01 Steam Boiler 1 TPH 02 Thermic Fluid Heater 2 Nos. (0.5 lac Kg Cal/hr.) 03 DG Set 125 KVA Bio Coal 1 MT /day Natural Gas 45 Nm 3 /Hr Diesel 130 Lit/ Hr. 12 Bag Filter Adequate PM SO2 NOX Stack Height 09 Adequate Stack Height 150 mg/nm ppm 50 ppm DETAILS OF PROCESS GAS EMISSION Sr. No. Stack Attached To Stack Height(m) Air Pollution Control System Parameter Permissible Limit 1 Reactor Vent 17 SO2 40 mg/nm Water Scrubber Followed by HCl 30 mg/nm 3 Alkali Scrubber 2 Reactor Vent 17 HCl 30 mg/nm 3 3 Reactor Vent 17 Acid Scrubber Ammonia 175 mg/nm 3

45 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch ANNEXURE-12 DETAILS OF SOLVENT RECOVERY A solvent recovery system comprises of two stage heat exchangers. Cooling tower water will be circulated in primary heat exchanger and in secondary heat exchanger chilled water circulation is done. The uncondensed solvent after the secondary heat exchanger will be diverted to water scrubber the traces of solvent will get dissolved in water. On getting saturation, the solvent mix water will be subjected for recovery of solvent (if feasible) and/or water will be diverted to ETP plant for further treatment the process will ensure no VOC emission from solvent recovery system. The scrubbing system consists of a scrubber (packed column absorber), an exhaust blower and scrubbing media circulation via pumps followed by carbon adsorption tower. The vapors coming from the process vents and raw material storage area enters the primary scrubber where they are absorbed in water. Thus, the air leaving from the scrubber is clean, which is again feed into the secondary tower consists of carbon to trap any remaining VOC. The figure of scrubber system is given below as figure.

46 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch FLOW DIAGRAM OF SOLVENT RECOVERY SYSTEM Cooling Tower i Chilled Water i l i VOC Spray Vent Primary Condenser Secondary Condenser Reactor Receiver Un scrubbed VOCs Water Tank Carbon Adsorption

47 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch Details of Solvent Recovery Sr. No. Name of Representative Product 31 P-anisaldehyde/ 4-methoxy benzaldehyde 52 2-[4-(4-cyclopropyl carbonyl phenyl]-2-methyl propionic acid cyclohexyl amine salt 63 N-(2-chloro-4-methyl-3- pyridinyl)2-(cyclopropyl amine)-3-pyridinecarboxamide 74 Trans-4-(2-amino-3,5-dibromo benzyl amino)cyclohexanol hydrochloride (Ambroxol hydrochloride) 95 2-[4-[4-chlorophenyl)phenyl methyl [1-piperazinyl] ethoxy] acetic Product Quantity in MT/Month 5 1 Name of Solvent used Solvent Recovered Quantity in MT/Month Toluene Methanol Toluene Di chloromethane Toluene Methanol Toluene Methanol Isopropylalcohol Methanol Toluene Di chloromethane % Recovery

48 M/s. Maitri Pharma, GIDC Jhagadia- Bharuch ANNEXURE-13 LIST OF HAZARDOUS CHEMICALS AS PER MSIHC RULES Sr. No. Name of Chemicals 1 Acetaldehyde 2 Sodium hydroxide 3 Hydrogen 4 p-cresol 5 Dimethyl sulfate 6 Sulphuric Acid 7 Magnesium oxide 8 Toluene 9 Thionyl chloride 10 Dimethyl formamide 11 Benzene 12 Aluminium chloride 13 Dimethyl amine 14 4-Chloro butyryl chloride 15 Dichloromethane 16 Hydrochloric acid 30% 17 cyclohexyl amine 18 3-Amino-2-chloro-4-methyl pyridine 19 Methanol 20 Bromine 21 Potassium bromide 22 Isopropyl alcohol 23 Sodium borohydrate 24 Benzyl chloride 25 sodium carbonate 26 Piperazine 27 sodium monochloroacetate 28 Potassium hydroxide 29 Pathallic anhydride 30 Sodium hypochlorite 31 Aniline 42

49

50

51