Enclosure: 1 - Welcome to Environment · 2018-05-09 · Enclosure: 3 Name of Raw Material with Its...

150
Enclosure: 1 Name of Product and Its Quantity Amisulpride 5 Azilsartan Medoxomil 1 Cinitapride Hydrogen Tartrate 1 Indoline 5 Linagliptin 1 Losartan Potassium 5 Luliconazole 1 Moxifloxacin 1 Nebivolol 1 Olmesartan Medoxomil 1 Rosuvastatin Calcium 5 Sertaconazole Nitrate 1 Setraline HCl 1 Sitagliptin 5 Sofosbuvir 1 Tapentadol HCl 1 Telmisartan 5 Teneligliptin Hydrobromide 5 Ursodeoxycholic Acid 5 Velpatasvir 1 Vilazodone 1 Voriconazole 1 Pregabalin 25 R-(-)-3- Carbamoylmethyl-5-Methylhexanoic Acid / R-CMH 25 (+)-3- (Carbamoylmethyl)-5- Methylhexanoic Acid 50 Phenylphrine HCl 5 L-Phenylephrine Base 5 DL-Phenylephrine Base 5 Gliclazide 7 Sucralfate 25 Levosulpiride 10 Total 211

Transcript of Enclosure: 1 - Welcome to Environment · 2018-05-09 · Enclosure: 3 Name of Raw Material with Its...

Page 1: Enclosure: 1 - Welcome to Environment · 2018-05-09 · Enclosure: 3 Name of Raw Material with Its Quantity Raw Material Consumption Detail Product Wise 1. Amisulpride : Sr. No. Name

Enclosure: 1

Name of Product and Its Quantity

Amisulpride 5 Azilsartan Medoxomil 1 Cinitapride Hydrogen Tartrate 1 Indoline 5 Linagliptin 1 Losartan Potassium 5 Luliconazole 1 Moxifloxacin 1 Nebivolol 1 Olmesartan Medoxomil 1 Rosuvastatin Calcium 5 Sertaconazole Nitrate 1 Setraline HCl 1 Sitagliptin 5 Sofosbuvir 1 Tapentadol HCl 1 Telmisartan 5 Teneligliptin Hydrobromide 5 Ursodeoxycholic Acid 5 Velpatasvir 1 Vilazodone 1 Voriconazole 1 Pregabalin 25 R-(-)-3- Carbamoylmethyl-5-Methylhexanoic Acid / R-CMH

25

(+)-3- (Carbamoylmethyl)-5- Methylhexanoic Acid

50

Phenylphrine HCl 5 L-Phenylephrine Base 5 DL-Phenylephrine Base 5 Gliclazide 7 Sucralfate 25 Levosulpiride 10

Total 211

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Enclosure: 2

Packing & Final Use of Products

Sr. No. Product Name CAS No. Type Of Packing Final Use of

Product 1. Amisulpride 53583-79-2

Aluminium Can/ Bag/Foil/HDPE/Fiber Drums/Paper Bags

Used to Produced

Medicines or Formulate

2. Azilsartan Medoxomil 863031-21-4

3. Cinitapride Hydrogen Tartrate 66564-14-5

4. Indoline 496-15-1

5. Linagliptin 668270-12-0

6. Losartan potassium 114798-26-4

7. Luliconazole 187164-19-8

8. Moxifloxacin 354812-41-2

9. Nebivolol 99200-09-6

10. Olmesartan Medoxomil 144689-63-4

11. Rosuvastatin Calcium 147098-20-2.

12. Sertaconazole Nitrate 99592-39-9

13. Setraline HCl 79617-96-2

14. Sitagliptin 654671-78-0

15. Sofosbuvir 1190307-88-0

16. Tapentadol HCl 175591-09-0

17. Telmisartan 144701-48-4

18. Teneligliptin Hydrobromide 906093-29-6

19. Ursodeoxycholic Acid 128-13-2

20. Velpatasvir 1377049-84-7

21. Vilazodone 163521-12-8

22. Voriconazole 137234-62-9

23. Pregabalin 148553-50-8

24. R-(-)-3- Carbamoyl Methyl-5-Methylhexanoic Acid

181289-33-8

25. (+)-3- (carbamoylmethyl)-5- 181289-15-6

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methylhexanoic Acid

26. Phenylphrine HCl 61-76-7

27. L-Phenylephrine Base 59-42-7

28. DL-Phenylephrine Base 89-42-7

29. Gliclazide 21187-98-4

30. Sucralfate 54182-58-0

31. Levosulpiride 23672-07-3

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Enclosure: 3

Name of Raw Material with Its Quantity

Raw Material Consumption Detail Product Wise

1. Amisulpride :

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 4-Amino -2-Methoxy-5-

Ethyl Sulphonyl Benzoic Acid

0.74 3.7

2. N-Ethyl -2-Amino Methyl Pyrolidine

0.39 1.95

3. Ethyl Chloro Formate 0.31 1.55 4. Triethyl Amine 0.42 2.1 5. Acetone 3.32 16.6 6. Sodium Hydroxide 0.76 3.8 7. Iso Propyl Alcohol 0.79 3.95 8. Activated Carbon 0.05 0.25 9. Hyflo Super Cel 0.02 0.1

2. Azilsartan Medoxomil :

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Methyl-1 [(2

Cyanobiphenyl4-Yl ]- 2Ethoxybenzenzimidazole-7-Carboxylate.

1.8 1.8

2. Hydroxyl Amine Hydrochloride

0.304 0.304

3. Sodium Bicarbonate 0.4 0.4 4. DMSO 0.9 0.9 5. Tetrahydrofuran 1.2 1.2 6. Carbonyl Imidazole 0.64 0.64 7. Di Aza Bi Cyclo Undecane 0.3 0.3 8. Sodium Bisulphite 0.5 0.5 9. Sodium Chloride 0.4 0.4 10. Methanol 0.34 0.34 11. Sodium Hydroxide 0.54 0.54

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12. Isopropyl Alcohol 0.36 0.36 13. 4- Methoxymethyl-5-

methyl-1,3-dioxol-2-one 0.4 0.4

14. P-Toluene Sulphonyl Chloride

0.6 0.6

15. 4-chloromethyl-5-methyl-1,3-dioxol-2-one

0.058 0.058

16. Dimethyl Acetamide 0.28 0.28 17. Potassium Carbonate 0.3 0.3 18. HCl 20% 1.24 1.24 19. Ethyl Acetate 0.18 0.18 20. MDC 0.64 0.64 21. Activated Cabon 0.2 0.2 22. Hyflo Super cel 0.06 0.06

3. Cinitapride Hydrogen tartrate:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 4-Amino-2-ethoxy-5-Nitro-

N- (4-piperidyl) benzamide 0.56 0.56

2. 3-Cyclohexene-1-methanol 0.20 0.20 3. Benzene Sulphonyl

chloride 0.32 0.32

4. Sodium carbonate 0.10 0.10 5. TEA 0.70 0.70 6. Tartaric Acid 0.43 0.43 7. Cyclo hexane 2.52 2.52 8. DMF 5.66 5.66 9. Methanol 6.66 6.66 10. Activated Carbon 0.29 0.29 11. Hyflo super cel 0.09 0.09

4. Indoline:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 2,6 Dichloro Phenol 0.86 4.3 2. Sodium Methoxide 2.02 10.1 3. Ethyl Chloro Acetate 0.6 3 4. Aniline 0.48 2.4

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5. Caustic Soda 0.31 1.55 6. Ethoxy Ethanol 2.78 13.9 7. Acetyl chloride 0.61 3.05 8. Methanol 6.11 30.55 9. Aluminum Chloride 0.7 3.5 10. Activated Carbon 0.06 0.3 11. Hyflo Super cel 0.02 0.1

5. Linagliptin:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Bromo Compound 1.64 1.64 2. Chloro Compound 1.28 1.28 3. Potassium Carbonate 4.12 4.12 4. Dimethyl formamide 9.84 9.84 5. 3-Azido piperdene 0.84 0.84 6. 1-Methyl 2- pyrrodinone 12 12 7. Ethyl Acetate 30 30 8. Acetonitrile 7.39 7.39 9. Triphenyl phospine 1.38 1.38 10. THF 15.79 15.79 11. MDC 26.31 26.31 12. Activated Carbon 0.16 0.16 13. Hyflo Super cel 0.05 0.05

6. Losartan Pottasium

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 2-Butyl-4-Chloro-5-

Hydroxy-Methyl Imidazole 0.78

3.9 2. 4-Bromo Methyl-2-Cyano-

Biphenyl 1.08

5.4 3. Tri Butyl Tin Chloride 2.07 10.35 4. Sodium Azide 0.41 2.05 5. Sodium Borohydride 0.11 0.55 6. Toluene 27.71 138.55 7. HCl 0.3 1.5 8. MEK 2.1 10.5 9. Acetone 5.24 26.2

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10. Carbon tetrachloride 8.67 43.35 11. Ortho tolyl benzonitrile 1.08 5.4 12. l,3-Dibromo-5,5- dimethyl

hydantoin 0.8

4 13. Benzoyl peroxide 0.04 0.2 14. TBAB 0.09 0.45 15. O-Xylene 9.64 48.2 16. NaOH 0.3 1.5 17. KOH 0.4 2 18. Activated Carbon 0.06 0.3

7. Luliconazole:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. (Α,S) 2,4 –Dichloro-A-

(Chloromethyl)Benzene- Methanol Methane Sulphonate

1 1

2. 1H-Imidazole-1-Acetonitrile

0.35 0.35

3. Carbon Disulphide 0.23 0.23 4. KOH Powder 0.183 0.183 5. Toluene 1.5 1.5 6. Activated Carbon 0.1 0.1 7. Hyflo Super Cel 0.03 0.03

8. Moxifloxacin:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Moxifloxacin Q-Acid 0.85 0.85 2. 2,8-Diazobicyclo(4.3.0)

nonane 0.22 0.22

3. Sodium hydroxide 0.31 0.31 4. Acetone 3.77 3.77 5. Dimethylformamide 1.89 1.89 6. Activated Carbon 0.19 0.19 7. Hyflo Super Cel 0.056 0.056

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9. Nebivolol:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. R*(S*)]-6-fluoro-3,4-

dihydro-2-oxiranyl-2H-1-benzopyran

0.67 0.67

2. Benzyl amine 1.1 1.1 3. Iso Propyl Alcohol 23.11 23.11 4. Palladium Charcoal 10 % 0.5 0.5 5. Ammonium Formate 0.63 0.63 6. Methanol 12.04 12.04 7. Activated Carbon 0.08 0.08 8. Hyflo Super Cel 0.03 0.03 9. Conc HCl 0.31 0.31 10. Benzyl amine 1.1 1.1

10. Olmesartan Medoxomil:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Ethyl-4-(1-hydroxy-1-

methylethyl) 2-propy H-((2-(2-(triphenyllnethyl)-2H-tetrazol-5 yl biphenyl-4-yl-1-methyl imidazole-5-carboxylic acid

0.655 0.655

2. 4-(chloromethyl)-5-methyl-1,3-dioxol-2-one

0.446 0.446

3. 4-[2-(trityltetrazol-5-yl)phenyl]benzyl bromide

1.491 1.491

4. Potassium Carbonate 0.472 0.472 5. Ethylacetate 18.676 18.676 6. Acetone 32.851 32.851 7. Ativated Carbon 0.111 0.111 8. Hyflo Super Cel 0.02 0.02 9. Nacl 1.756 1.756 10. Di Iso Propyl Ether 8.781 8.781 11. N,N-Dimethylacetamide 7.235 7.235 12. Sodium Iodide 0.052 0.052 13. THF 10.537 10.537

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14. Ethanol 1.756 1.756 15. NaOH 0.103 0.103 16. Sodium Bicarbonate 0.044 0.044 17. methylene chloride 17.831 17.831 18. Acetic acid 10.95 10.95

11. Rosuvastatin Calcium:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 4-Fluoro Benzaldehyde 0.52 2.6 2. 4-Methyl-3-oxo-pentanoic

acid ethyl ester 0.66

3.3 3. KOH 0.3 1.5 4. Methyl Iodide 0.6 3 5. Methanol 5.5 27.5 6. S-Methyl iso thio urea 0.35 1.75 7. 2,3-Dichloro-5,6-dicyano

Benzoquinone 0.85

4.25 8. HMPA

[Hexamethylphosphoramide]

1

5 9. MDC 8 40 10. Meta chloro

peroxybenzoic acid 1.2

6 11. Methyl amine 0.1 0.5 12. Ethanol 2.5 12.5 13. Methane sulfonyl chloride 0.35 1.75 14. Sodium hydride (60%) 0.01 0.05 15. Di methoxy ethane 3 15 16. Hydrogen Gas 0.0104 0.052 17. DIBAL - H

[Diisobutylaluminium hydride]

0.01

0.05 18. Toluene 8 40 19. Methyl(3R)-3-(tert butyl di

methyl silyloxy)-5-oxo-6-triphenyl phosphoranylidene hexanoate

1.45

7.25 20. Triethyl amine 0.15 0.75 21. N,N-Dimethyl formamide 3 15

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22. Hydrogen fluoride 0.05 0.25 23. THF 7.5 37.5 24. Ethyl Acetate 10.5 52.5 25. Diethyl methoxy borane 0.2 1 26. Sodium boro hydride 0.01 0.05 27. Calcium Chloride 0.13 0.65 28. Activated Carbon 0.1 0.5 29. Hyflo Super Cel 0.03 0.15

12. Sertaconazole Nitrate:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 1-2,4-DICHLORO-PHENYL-

2-IMIDAZOLE- -1-YL-ETHANOL.

1.43 1.43

2. Tartaric Acid 0.91 0.91 3. Acetone 10.86 10.86 4. Methanol 6.86 6.86 5. Potassium Butoxide 0.49 0.49 6. Dimethyl Formamide 6.86 6.86 7. Bromo Methyl Thiophene 1.14 1.14 8. Methylene Dichloride 11.43 11.43 9. Nitric Acid 0.4 0.4 10. Ethyl Ether 2.29 2.29 11. Ethanol 5.14 5.14 12. Activated Carbon 0.29 0.29 13. Hyflo Super Cel 0.14 0.14

13. Setraline HCl:

Sr. No.

Name of Raw Material Kg/kg MT/Month

1. Tetralone 2 2 2. Mono Methyl Amine 40 % 6 6 3. Methanol 23.6 23.6 4. Palladium Charcoal 10 % 0.04 0.04 5. Hydrogen Gas 0.56 0.56 6. Methanolic HCl 20 % 1.4 1.4 7. Ethyl Acetate 7.2 7.2 8. NaOH 0.72 0.72

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9. Mandelic Acid 0.48 0.48 10. Acetonitrile 7.2 7.2 11. HCl GAS 0.36 0.36

14. Sitagliptin:

Sr. No.

Name of Raw Material Kg/kg MT/Month

1. (2,4,5-Trifluoro-phenyl)aceticacid

0.5 2.5

2. Thionyl chloride 0.32 1.6 3. DMF 0.17 0.85 4. MDC 20 100 5. TEA 2.75 13.75 6. Meldrums acid 0.39 1.95 7. Sodium hydroxide 0.32 1.6 8. 3-(Trifluoro methyl)5,6,7,8-

tetrahydro(4,3-a)pyrazine HCl

0.57

2.85 9. Methane sulphonic acid 0.25 1.25 10. Ammonia 0.04 0.2 11. Sodium bicarbonate 0.22 1.1 12. Ethyl acetate 6.25 31.25 13. Acetonitrile 4.25 21.25 14. Activated Carbon 0.25 1.25 15. Hyflo Super Cel 0.07 0.35

15. Sofosbuvir:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. L-alanine iso propyl ester

HCl 1.72 1.72

2. Phenyl dichloro phosphate 2.15 2.15 3. Triethyl amine 3.22 3.22 4. Methylene chloride 45.46 45.46 5. Pentaflurophenol 3.12 3.12 6. 2'-Deoxy-2'-Fluoro-2'-C-

Methyl Uridine 0.74 0.74

7. THF 19.93 19.93 8. Tert-Butyl magnesium 0.54 0.54

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chloride 9. HCl 32 % 1.37 1.37 10. Ethyl Acetate 13.33 13.33 11. Sodium carbonate 0.3 0.3 12. Sodium Chloride 2.96 2.96 13. MDC 25.42 25.42 14. Di Iso Propyl Ether 22.59 22.59 15. Activated Carbon 0.07 0.07 16. Hyflo Super Cel 0.02 0.02

16. Tapentadol HCl:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 1-(3-

Methoxyphenyl)propan-1-one

0.8 0.8

2. Dimethyl amine 2 2 3. Formaldehyde 0.4 0.4 4. Ethyl Magnesium Bromide 0.58 0.58 5. D(-) Tartaric Acid 0.64 0.64 6. HCl 0.15 0.15 7. Palladium Hydroxide 0.01 0.01 8. Hydrogen Gas 0.008 0.008 9. IPA 4 4 10. Ethyl Acetate 6 6 11. Activated Carbon 0.2 0.2 12. Hyflo Super Cel 0.06 0.06

17. Telmisartan:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 7-methyl-2-propyl-3H-

benzo[d]imidazole COOH 0.47

2.35 2. N-methyl-O-phenylene

diamine 0.28

1.4 3. Toluene 0.07 0.35 4. Poly phosphoric acid 1.18 5.9 5. Bromo Ester compound 0.85 4.25 6. Activated Carbon 0.03 0.15 7. Hyflo Super Cel 0.01 0.05

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18. Teneligliptin Hydrobromide:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Cysteamin HCl 1.5 7.5 2. Formaldehyde 1.05 5.25 3. 2S,4S-4-Hydroxy-L-Prolin 3.1 15.5 4. Fmoc 6.5 32.5 5. HCl SOLN 18 90 6. EDC HCl 3 15 7. Hobt 1 5 8. N=Methyl Morpholine 1.3 6.5 9. Naoh 0.25 1.25 10. Sodium Carbonate 4.25 21.25 11. Sodium Sulphate 1.75 8.75 12. Sodium Bicarbonate 1.55 7.75 13. Sulphur Trioxide Pyridine

Complex 2.85

14.25 14. Phenyl Hydrazine 2.45 12.25 15. 3-Amino Crotononitrile 2 10 16. KOH 1.85 9.25 17. BIS 2-CHLORO ETHYL

AMINE HCl 4

20 18. Sodium Hydride 1 5 19. Toluene 8 40 20. Acetic Acid 3.7 18.5 21. DMF 7.5 37.5 22. Triethyl Amine 3.5 17.5 23. Acetone 1.65 8.25 24. DMSO 7.5 37.5 25. Iso Propyl Alcohol 7.5 37.5 26. Ethyl Acetate 6.5 32.5 27. THF 7.5 37.5 28. Dipe 9 45 29. MDC 40.5 202.5 30. Methanol 5.25 26.25 31. T-BUTYL ALCOHOL 15 75 32. Sodium Triacetoxy

Borohydride 1.12

5.6 33. Piperidine 0.37 1.85 34. Aqueous HBr 1.125 5.625

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35. BRINE SOLUTION [Nacl] 1.5 7.5 36. Activated Carbon 0.097 0.485 37. Hyflo Super Cel 0.02 0.1

19. Ursodeoxycholic Acid:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Starch 80 400 2. Corn Steep Liquor 200 1000 3. Cane Molasses 20 100 4. Polypeptone 20 100 5. Sodium Chloride 20 100 6. Cholic Acid 2 10 7. HCl 7 35 8. Ethyl Acetate 50 250 9. Chloroform 8 40 10. Acetone 8 40 11. Acetic Acid 1 5 12. Ethanol 67 335 13. Silica Gel 53 265 14. Activated Carbon 0.1 0.5 15. Hyflo 0.1 0.5

20. Velpatasvir:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. Acetonitrile 9.7 9.7 2. Diisopropylethylamine 1.5 1.5 3. ((S)-1-(tert-butoxycarbonyl)-

4-(methoxy-methyl) pyrrolidine-2-carboxylic acid

1.0 1.0

4. 9-bromo-3-chloro-10,11-dihydro-5H-naphtho[c,g]chromen-8(9H)-one

0.9 0.9

5. Ethyl acetate 17.7 17.7 6. Toluene 15.2 15.2 7. 2-Methoxyethanol 0.02 0.02 8. Ammonium acetate 0.4 0.4

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9. Manganese(IV) oxide 1.6 1.6 10. residue (2S)-1-tert-butyl-2-

(3-chloro-8-oxo-8,9,10,11-tetrahydro-6H-naphtho[2,3-c]chromen-9-yl)-4(methoxymethyl)pyrrolidine-1,2-dicarboxylate

0.8 0.8

11. MDC 18.5 18.5 12. bis (Pinacolato) diboron 0.7 0.7 13. Potassium Acetate 0.5 0.5 14. tris (dibenzylideneacetone)

Palladium 0.1 0.1

15. 2-DiCyclo HexylPhosphino-2′, 4′, 6′-tri-i-opyl-1,1′-biphenyl

0.1 0.1

16. 1,4 Dioxane 9.7 9.7 17. Tetrakis (triphenyl

phosphine) palladium 0.1 0.1

18. Dichloro[1,1′-bis(diphenyl phosphino) ferrocene]palladium

0.1 0.1

19. 1,2-dimethoxyethane 17.7 17.7 20. Dimethylformamide 5.0 5.0 21. Potassium carbonate 0.4 0.4 22. Methyl(S)-1-((S)-2-(5-

bromo-1H-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-ylcarbamate

0.6 0.6

23. Ethanol 14.5 14.5 24. HCl 0.5 0.5 25. ( R)-2-

(methoxycarbonylamino)-2- phenylacetic acid

0.3 0.3

26. COMU 0.3 0.3 27. Activated Carbon 0.05 0.05 28. Hyflo 0.03 0.03

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21. Vilazodone:

22. Voriconazole:

Sr. No. Name of Raw Material Kg/kg MT/Month 1. THF 26 26 2. 3,5-dibromo-1H-1,2,4-

triazole 1 1

3. 2-chloro-2,4-difluoroacetophenone

1 1

Sr. No. Name of Raw Material Kg/kg MT/Month 1. 5-aminobenzofuran-2-

carboxylic acid 1.88 1.88

2. Methanol 83.59 83.59 3. HCl gas 0.48 0.48 4. Toluene 1.88 1.88 5. Ammonia 30% 0.94 0.94 6. Bis-(2-chloroethyl)amine

hydrochloride 1.47 1.47

7. Sodium acetate 20.3 20.3 8. Methylene chloride 25.06 25.06 9. Ammonia 1.89 1.89 10. N,N-dimethylformamide 3.75 3.75 11. Acetone 16.28 16.28 12. Aluminium trichloride 3.21 3.21 13. 4-chlorobutyryle chloride 3.45 3.45 14. 5-Cyano-indole 1.38 1.38 15. Hydrochloric acid 32% 1.41 1.41 16. Ethyl acetate 26.34 26.34 17. Tetrahydrofuran 4 4 18. Sodium borohydride 0.24 0.24 19. NaOH 0.01 0.01 20. Sodium bicarbonate 1.28 1.28 21. N,N-dimethylacetamide 10.41 10.41 22. Potassium iodide 0.17 0.17 23. Ammonium chloride 0.22 0.22 24. Pd/C 5% 0.18 0.18 25. Activated charcoal 0.07 0.07 26. Hyflo 0.07 0.07

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4. Potassium Carbonate 1 1 5. IPA 7 7 6. MDC 50 50 7. 6-Ethyl-5-Fluoropyrimidin-

4-Ol 1 1

8. Tea 2 2 9. Methane Sulphonyl

Chloride 1 1

10. Acetic Acid 6 6 11. Magnesium Sulphate 27 27 12. N-Bromo Succinimide 0.5 0.5 13. Azo Bis Isobutyronitrile 0.3 0.3 14. Sodium Bisulphite 1 1 15. Sodium Bicarbonate 4 4 16. Zinc 1 1 17. Lead 0.15 0.15 18. Iodine 1 1 19. HCl 4 4 20. NaCl 10 10 21. Ethyl Acetate 33.4 33.4 22. N-HEXANE 32 32 23. Toluene 33 33 24. Pd /Ch 4 4 25. Ammonium Formate 21 21 26. Iso Propyl Ether 52.5 52.5 27. Acetone 21 21 28. R-(-)-10-Camphorsulfonic

Acid 9 9

29. Activated Carbon 0.15 0.15 30. Hyflo Super Cel 0.1 0.1

23. Pregabalin:

Sr. No. Name of Raw Material MT/MT MT/Month 1. R-(-)-3-Carbamoylmethyl-5-

Methylhexanoic Acid (R-CMH) 0.1 2.5

2. Water 0.4 10 3. Chlorine Gas 0.05 1.25 4. Con.HCl 0.15 3.75 5. IPA 0.448 11.2

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6. Activated Carbon 0.002 0.05 7. Hyflow 0.001 0.025 8. Caustic Flakes 0.075 1.875

24. R-(-)-3- (carbamoylmethyl)-5- methylhexanoic Acid

Sr. No. Name of Raw Material MT/MT MT/Month 1. 3-Carbamoylmethyl-5-

methylhexanoic acid ( CMH) 1.19 29.762

2. R(+) Phenyl Ethyl Amine 0.06 1.500 3. Chloroform 0.60 15.000 4. Caustic Flakes 1.01 25.238 5. Sulphuric Acid 0.99 24.762 6. Urea 0.30 7.440 7. Activated Carbon 0.02 0.595 8. Hyflow 0.01 0.298 9. Sodium Sulphate 0.24 5.952

25. (+)-3- (carbamoylmethyl)-5- methylhexanoic Acid

Sr. No. Name of Raw Material MT/MT MT/Month 1. Isovaleraldehyde 0.1 5 2. Cynoacetamide 0.25 12.5 3. Sulfuric Acid 0.2 10 4. Toluene 0.2 10 5. Urea 0.03 1.5 6. Caustic Flakes 0.051 2.55 7. Activated Carbon 0.002 0.1 8. Hyflow 0.001 0.05 9. Con.HCl 0.1 5

26. Phenylphrine HCl

Sr. No. Name of Raw Material MT/MT MT/Month 1. L –Phenylephrine Base 0.1 0.5 2. HCl Gas 0.03 0.15 3. IPA 0.475 2.375 4. Activated Charcoal 0.002 0.01

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5. Hyflow 0.001 0.005

27. L-Phenylephrine Base

Sr. No. Name of Raw Material MT/MT MT/Month 1. D-L-Phenylephrine Base 0.1 0.5 2. L(+) tartaric Acid 0.125 0.625 3. IPA 0.15 0.75 4. Caustic Flakes 0.05 0.25 5. Sulphuric Acid 0.023 0.1155 6. Acetic Anhydride 0.03 0.15

28. DL-Phenylephrine Base

Sr. No. Name of Raw Material MT/MT MT/Month 1. 3- HydroxyAcetophenone (3 –

HAP) 0.1 0.5

2. Bromine (Liq) 0.15 0.75 3. AIBN 0.001 0.005 4. Ethyl Acetate 0.05 0.25 5. Alcl3 0.0026 0.013 6. N-Methyl benzyl Amine 0.07 0.35 7. Toluene 0.635 3.175 8. Caustic Flakes 0.16 0.8 9. Con.HCl 0.28 1.4

29. Gliclazide

Sr. No. Name of Raw Material MT/MT MT/Month 1. Hexahydrocyclopenta[c]pyrrol-

2(1H)-Amine Hydrochloride ( HCl –Compound )

0.100 0.7

2. N-Carbamoyl-4-Methylbenzenesulfonamide (Sulfonamide Compound)

0.150 1.05

3. Sodium Methoxide 0.002 0.014 4. Toluene 0.600 4.200 5. MDC 800 4.400 6. Methanol 426 2.400 7. Activated Carbon 3 0.120 8. Hyflow 1 0.040

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30. Sucralfate

Sr. No. Name of Raw Material MT/MT MT/Month 1. Sucrose 0.1 2.5 2. Pyridine 1.9 47.5 3. Chloro Sulfonic Acid 0.296 7.4 4. Methanol 1.385 34.625 5. Ammonia Solution 0.385 9.625 6. Aluminum Hydroxyl Chloride (50

%) 0.925 23.125

7. Caustic Flakes 0.001 0.025 8. Activated Carbon 0.005 0.125 9. Hyflow 0.001 0.025

31. Levosulpiride

Sr. No. Name of Raw Material MT/MT MT/Month 1. 2-Methoxy-5-Sulfamoyl Benzoic

Acid Methyl Ester 0.1 1

2. S-(-)-1-Ethyl-2-Amino Methyl Pyrrolidine

0.075 0.75

3. Mono Ethylene Glycol 0.3 3

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Overall Raw Material Consumption:

Name of Raw Material MT/Month ( R)-2-(methoxycarbonylamino)-2- phenylacetic acid

0.3

((S)-1-(tert-butoxycarbonyl)-4-(methoxy-methyl) pyrrolidine-2-carboxylic acid

1.0

(2,4,5-Trifluoro-phenyl)aceticacid 2.5 (Α,S) 2,4 –Dichloro-A-(Chloromethyl)Benzene- Methanol Methane Sulphonate

1

1-(3-Methoxyphenyl)propan-1-one 0.8 1,2-dimethoxyethane 17.7 1,4 Dioxane 9.7 1-2,4-DICHLORO-PHENYL-2-IMIDAZOLE- -1-YL-ETHANOL.

1.43

1H-Imidazole-1-Acetonitrile 0.35 1-Methyl 2- pyrrodinone 12 2,3-Dichloro-5,6-dicyano Benzoquinone

4.25

2,6 Dichloro Phenol 4.3 2,8-Diazobicyclo(4.3.0) nonane 0.22 2-Butyl-4-Chloro-5-Hydroxy-Methyl Imidazole

3.9

2-chloro-2,4-difluoroacetophenone

1

2'-Deoxy-2'-Fluoro-2'-C-Methyl Uridine

0.74

2-DiCyclo HexylPhosphino-2′, 4′, 6′-tri-i-opyl-1,1′-biphenyl

0.1

2-Methoxy-5-Sulfamoyl Benzoic Acid Methyl Ester

1

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2-Methoxyethanol 0.02 2S,4S-4-Hydroxy-L-Prolin 15.5 3- HydroxyAcetophenone (3 –HAP) 0.5 3-(Trifluoro methyl)5,6,7,8-tetrahydro(4,3-a)pyrazine HCl

2.85

3,5-dibromo-1H-1,2,4-triazole 1 3-Amino Crotononitrile 10 3-Azido piperdene 0.84 3-Carbamoylmethyl-5-methylhexanoic acid ( CMH)

29.762

3-Cyclohexene-1-methanol 0.20 4- Methoxymethyl-5-methyl-1,3-dioxol-2-one

0.4

4-(chloromethyl)-5-methyl-1,3-dioxol-2-one

0.446

4-[2-(trityltetrazol-5-yl)phenyl]benzyl bromide

1.491

4-Amino -2-Methoxy-5-Ethyl Sulphonyl Benzoic Acid

3.7

4-Amino-2-ethoxy-5-Nitro- N- (4-piperidyl) benzamide

0.56

4-Bromo Methyl-2-Cyano-Biphenyl 5.4 4-chlorobutyryle chloride 3.45 4-chloromethyl-5-methyl-1,3-dioxol-2-one

0.058

4-Fluoro Benzaldehyde 2.6 4-Methyl-3-oxo-pentanoic acid ethyl ester

3.3

5-aminobenzofuran-2-carboxylic acid

1.88

5-Cyano-indole 1.38 6-Ethyl-5-Fluoropyrimidin-4-Ol 1 7-methyl-2-propyl-3H-benzo[d]imidazole COOH

2.35

9-bromo-3-chloro-10,11-dihydro-5H-naphtho[c,g]chromen-8(9H)-one

0.9

Acetic Acid 40.5 Acetic Anhydride 0.15 Acetone 26.2

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Acetonitrile 45.55 Acetyl chloride 3.05 Activated Carbon 6.46 AIBN 0.005 AlCl3 (Aluminium trichloride) 3.22 Aluminum Chloride 3.5 Aluminum Hydroxyl Chloride (50 %) 23.125 Ammonia 12.66 Ammonium acetate 0.4 Ammonium chloride 0.22 Ammonium Formate 21.63 Aniline 2.4 Aqueous HBr 5.625 Azo Bis Isobutyronitrile 0.3 Benzene Sulphonyl chloride 0.32 Benzoyl peroxide 0.2 Benzyl amine 2.2 bis (Pinacolato) diboron 0.7 BIS 2-CHLORO ETHYL AMINE HCl 20.5 BRINE SOLUTION [NaCl] 80 Bromine (Liq) 0.75 Bromo Compound 1.64 Bromo Ester compound 4.25 Bromo Methyl Thiophene 1.14 Calcium Chloride 0.65 Cane Molasses 100 Carbon Disulphide 0.23 Carbon tetrachloride 43.35 Carbonyl Imidazole 0.64 Caustic Flakes 31 Caustic Soda 1.55 Chlorine Gas 1.25 Chloro Compound 1.28 Chloro Sulfonic Acid 7.4 Chloroform 15 Cholic Acid 10 COMU 0.3 Con.HCl 10 Corn Steep Liquor 1000 Cyclo hexane 2.52

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Cynoacetamide 12.5 Cysteamin HCl 7.5 D(-) Tartaric Acid 0.64 Di Aza Bi Cyclo Undecane 0.3 Di Iso Propyl Ether 30 Di methoxy ethane 15 DIBAL - H [Diisobutylaluminium hydride]

0.05

Dichloro[1,1′-bis(diphenyl phosphino) ferrocene]palladium

0.1

Diethyl methoxy borane 1 Diisopropylethylamine 1.5 Dimethyl Acetamide 0.28 Dimethyl amine 2 Dimethyl formamide 22 Dipe 45 D-L-Phenylephrine Base 0.5 DMF 43 DMSO 38 EDC HCl 15 Ethanol 20 Ethoxy Ethanol 13.9 Ethyl Acetate 50 Ethyl Chloro Acetate 3 Ethyl Chloro Formate 1.55 Ethyl Ether 2.29 Ethyl Magnesium Bromide 0.58 Ethyl-4-(1-hydroxy-1-methylethyl) 2-propy H-((2-(2-(triphenyllnethyl)-2H-tetrazol-5 yl biphenyl-4-yl-1-methyl imidazole-5-carboxylic acid

0.655

Ethylacetate 18.676 Fmoc 32.5 Formaldehyde 6 HCl GAS 2 HCl SOLN 90 Hexahydrocyclopenta[c]pyrrol-2(1H)-Amine Hydrochloride ( HCl –Compound )

0.7

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HMPA [Hexamethylphosphoramide]

5

Hobt 5 Hydrogen fluoride 0.25 Hydrogen Gas 1 Hydroxyl Amine Hydrochloride 0.304 Hyflo 2 Hyflo Super Cel 1 Iodine 1 IPA (Isopropyl Alcohol) 10 Isovaleraldehyde 5 KOH 12 L –Phenylephrine Base 0.5 L(+) tartaric Acid 0.625 l,3-Dibromo-5,5- dimethyl hydantoin

4

L-alanine iso propyl ester HCl 1.72 Lead 0.15 Magnesium Sulphate 27 Mandelic Acid 0.48 Manganese(IV) oxide 1.6 MDC 100 MEK 10.5 Meldrums acid 1.95 Meta chloro peroxybenzoic acid 6 Methane sulfonyl chloride 2.75 Methane sulphonic acid 1.25 Methanol 50 Methanolic HCl 20 % 1.4 Methyl amine 0.5 Methyl Iodide 3 Methyl(3R)-3-(tert butyl di methyl silyloxy)-5-oxo-6-triphenyl phosphoranylidene hexanoate

7.25

Methyl(S)-1-((S)-2-(5-bromo-1H-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-ylcarbamate

0.6

Methyl-1 [(2 Cyanobiphenyl4-Yl ]- 2Ethoxybenzenzimidazole-7-Carboxylate.

1.8

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methylene chloride 18 Methylene Dichloride 11.43 Mono Ethylene Glycol 3 Mono Methyl Amine 40 % 6 Moxifloxacin Q-Acid 0.85 N,N-Dimethyl formamide 35 N=Methyl Morpholine 6.5 N-Bromo Succinimide 0.5 N-Carbamoyl-4-Methylbenzenesulfonamide (Sulfonamide Compound)

1.05

N-Ethyl -2-Amino Methyl Pyrolidine

1.95

N-HEXANE 32 Nitric Acid 0.4 N-Methyl benzyl Amine 0.35 N-methyl-O-phenylene diamine 1.4 Ortho tolyl benzonitrile 5.4 O-Xylene 48.2 Palladium Charcoal 10 % 0.5 Palladium Hydroxide 0.01 Pd /Ch 4 Pentaflurophenol 3.12 Phenyl dichloro phosphate 2.15 Phenyl Hydrazine 12.25 Piperidine 1.85 Poly phosphoric acid 5.9 Polypeptone 100 Potassium Acetate 0.5 Potassium Butoxide 0.49 Potassium Carbonate 6 Potassium iodide 0.17 P-Toluene Sulphonyl Chloride 0.6 Pyridine 47.5 R-(-)-10-Camphorsulfonic Acid 9 R-(-)-3-Carbamoylmethyl-5-Methylhexanoic Acid (R-CMH)

2.5

R(+) Phenyl Ethyl Amine 1.500 R*(S*)]-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran

0.67

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residue (2S)-1-tert-butyl-2-(3-chloro-8-oxo-8,9,10,11-tetrahydro-6H-naphtho[2,3-c]chromen-9-yl)-4(methoxymethyl)pyrrolidine-1,2-dicarboxylate

0.8

S-(-)-1-Ethyl-2-Amino Methyl Pyrrolidine

0.75

Silica Gel 265 S-Methyl iso thio urea 1.75 Sodium acetate 20.3 Sodium Azide 2.05 Sodium Bicarbonate 14 Sodium Bisulphite 1.5 Sodium boro hydride 1 Sodium carbonate 22 Sodium Hydride 5 Sodium Hydroxide 5 Sodium Iodide 0.052 Sodium Methoxide 10.1 Sodium Sulphate 15 Sodium Triacetoxy Borohydride 5.6 Starch 400 Sucrose 2.5 Sulfuric Acid 10 Sulphur Trioxide Pyridine Complex 14.25 Sulphuric Acid 25 Tartaric Acid 1.5 TBAB 0.45 T-BUTYL ALCOHOL 25 TEA 15 Tert-Butyl magnesium chloride 0.54 Tetrahydrofuran 25 Tetrakis (triphenyl phosphine) palladium

0.1

Tetralone 2 Thionyl chloride 1.6 Toluene 50 Tri Butyl Tin Chloride 10.35 Triethyl Amine 2

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Triphenyl phospine 1.38 tris (dibenzylideneacetone) Palladium

0.1

Urea 10 Zinc 1

* We will maintain as minimum inventory as possible.

Enclosure: 4

Material Safety Data Sheets of Products & Raw Materials

(Attached)

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Page 35: Enclosure: 1 - Welcome to Environment · 2018-05-09 · Enclosure: 3 Name of Raw Material with Its Quantity Raw Material Consumption Detail Product Wise 1. Amisulpride : Sr. No. Name

P.O.Box 92 Maalot, 24952 Israel Tel. 972 4 9978 220, Fax. 972 4 9976 062 www.numinor.com

Page 1 of 5

SAFETY DATA SHEET (SDS)

MANGANESE OXIDE

SECTION 1 – IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY Manufacturer & Supplier: NUMINOR CHEMICAL INDUSTRIES LTD. Address: P. O. BOX 92, MAALOT 24952, ISRAEL. Tel: + 972-4-9978220 Fax: + 972-4-9976062 E-Mail: [email protected] Web Site: www.numinor.comEmergency Contact: Mr. Nir Baram, +972 54 587 3131 Chemical Name: Manganese Oxide: (CAS : 1344-43-0 ) ( EINECS: 215-695-8) Formula: MnO Synonyms: Manganous Oxide % Range: 54 - 62% Primary Use: Mineral nutrient additive for the feed industry.

SECTION 2 - HAZARDS IDENTIFICATION Classification according to Regulation (EC) 1272/2008 (GHS-CLP) Acute toxicity: Dermal (Category 3)

Skin Irritation (Category 2) Eye Irritation (Category 2) Specific target organ toxicity-single exposure (Category 3)

GHS Pictogram: Signal Word: Danger Hazard Statements: H311 Toxic in contact with skin. H315 Causes skin irritation. H319 Causes serious eye irritation. H335: May cause respiratory irritation.

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P.O.Box 92 Maalot, 24952 Israel Tel. 972 4 9978 220, Fax. 972 4 9976 062 www.numinor.com

Precautionary Statements: Page 2 of 5 P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/ protective clothing. P305 +P351 +P338 If in eyes: Rinse cautiously with water for several minutes. Remove

contact lenses, if present and easy to do. Continue rinsing. P312 Call a Poison Center or doctor/physician if you feel unwell. Environmental hazard: None Listed.

SECTION 3 – COMPOSITION / INFORMATION ON INGREDIENTS

Melting Point: Not Listed. Specific Gravity: 5.0 Solubility in water: Insoluble Appearance & Odour: Solid powder(fine),Dark brown-Green in colour, no odour.

SECTION 4 - FIRST AID MEASURES Effects and symptoms: Chills, fever, nausea, vomiting, coughing, weakness and headaches,

skin irritation. First aid - Skin contact: Wash immediately with plenty of water and soap/ - Inhalation: Remove victim to fresh air. Clean nasal cavity with water. Give

oxygen if breathing difficulty. Seek medical attention. If feeling unwell, immediately seek medical attention.

- Eye contact: Rinse immediately with clean water for 15 minutes. If feeling unwell, immediately seek medical attention.

- Ingestion: Immediately rinse mouth with water. Do not induce vomiting. Give large quantities of water or milk to drink. If feeling unwell, immediately seek medical attention.

Protection of rescue personnel: Avoid all unnecessary exposure. Use appropriate protection (see Section 9).

SECTION 5 – FIRE, FIGHTING & EXPLOSION DATA Fire: Non Combustible. Flammability: Non Flammable Flash point: Not Combustible Extinguishing media: In case of fire in immediate vicinity use any extinguishing

agent. Protection of fire-fighters: Use breathing apparatus (self-contained breathing apparatus

with full face shield). Wear suitable protective clothing. Hazardous combustion and: None. Decomposition products

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P.O.Box 92 Maalot, 24952 Israel Tel. 972 4 9978 220, Fax. 972 4 9976 062 www.numinor.com

Page 3 of 5

SECTION 6 - ACCIDENTAL RELEASE MEASURES & SPILL LEAK PROCEDURES Personal precautions: Wear suitable gloves and eye/face protection. Avoid dust creation. Environmental precautions: Avoid allowing product to enter drains, sewage system, ground

water. Methods for cleaning up: Sweep up and shovel into suitable containers for disposal. Re-

use or recycle waste.

SECTION 7 - HANDLING AND STORAGE Handling & storing: Good housekeeping - store in a cool dry place - keep containers shut. Avoid making dust. Packing Materials: All materials suitable.

SECTION 8 - EXPOSURE CONTROL / PERSONAL PROTECTION - Respiratory protection: Respiratory protection equipment necessary. - Hand protection: Gloves.

Material: leather gloves, cotton gloves, rubber gloves. - Skin protection: Work clothes. - Eye protection: Chemical goggles or safety glasses. Occupational Exposure Limits 8 Hour TLV-TWA [mg/m3] : 0.2 (Dust) Engineering measures: Mechanical ventilation is recommended.

SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES Melting Point: Not Listed. Density: 5.4 G/cm³ Solubility in water: Insoluble Appearance & Odour: Solid powder(fine), Dark brown - Green in colour, no odour.

SECTION 10 - STABILITY & REACTIVITY DATA Stability: Stable under ordinary conditions Hazardous Reactions: Soluble in mineral acids. Dust explosion if mixed with fine organic

material and exposed to naked flame. Violent reaction with H2O2,

CaOH, and F2.

Incompatibility (materials to avoid): Not Applicable

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P.O.Box 92 Maalot, 24952 Israel Tel. 972 4 9978 220, Fax. 972 4 9976 062 www.numinor.com

Page 4 of 5

SECTION 11 – TOXILOGICAL INFORMATION Acute toxicity - Inhalation: Can Cause chills, fever, nausea, vomiting, coughing, weakness and

headaches, - Dermal: Exposure can cause skin irritation.. - Ingestion: (Oral rat) LD50 = 9g/kg Dermal irritation: Can cause irritation. Eyes irritation: Not available. Chronic toxicity: Not available. Sensitization: Not available. Carcinogenicity: Not listed by IARC and ACGIH as carcinogen. Mutagenicity: Not available. Reproductive toxicity: An experimental or tumorigen and mutagen.

Other toxicological information: Eye, skin, respiratory kidney or liver diseases or disorders would be aggravated by repeated or prolonged exposure to this chemical. Persons with history of alcoholism, psychiatric, neurological or liver dysfunction would be expected to be at increased risk from exposure.

SECTION 12 - ECOLOGICAL INFORMATION Persistence and degradability: Not applicable. Bioaccumulative potential: Not applicable. WGK (Germany): 1 Ecotoxicity: Not applicable Mobility: Not applicable.

SECTION 13 - DISPOSAL CONSIDERATIONS Disposal: Comply with local regulations for disposal. Waste of residues: This material and its container should be labeled H. Contaminated packaging: Keep waste packaging separate.

Waste should be disposed of in a permitted chemical waste facility.

SECTION 14 - TRANSPORT INFORMATION Hazard Labels: Not restricted. H.S. Code: 2820.9000 UN - No: Not Listed. ADR/RID/ADNR/IMO-IMDG: Not restricted. Shipping Name: Manganese Oxide

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P.O.Box 92 Maalot, 24952 Israel Tel. 972 4 9978 220, Fax. 972 4 9976 062 www.numinor.com

Page 5 of 5 Packaging Group: Not Applicable IMDG-Marine Pollution No EMS No. Not available. MFAG Table Not available.

SECTION 15 – REGULATORY INFORMATION Classification according to Regulation (EC) 1272/2008 (GHS-CLP) Acute toxicity: Dermal (Category 3)

Skin Irritation (Category 2) Eye Irritation (Category 2) Specific target organ toxicity-single exposure (Category 3)

GHS Pictogram: Signal Word: Danger Hazard Statements: H311 Toxic in contact with skin. H315 Causes skin irritation. H319 Causes serious eye irritation. H335: May cause respiratory irritation. Precautionary Statements: P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/ protective clothing. P305 +P351 +P338 If in eyes: Rinse cautiously with water for several minutes. Remove

contact lenses, if present and easy to do. Continue rinsing. P312 Call a Poison Center or doctor/physician if you feel unwell.

SECTION 16 - OTHER INFORMATION Date of Issue: August 2010 Last update: August 2010 MSDS prepared by: AVK Disclaimer: As the conditions or methods of use are beyond our control, we do not assume any responsibility and expressly disclaim any liability for any use of the material. Information contained herein is believed to be true and accurate but all statements or suggestions are made without any warranty, express or implied, regarding accuracy of the information, the hazards connected with the use of the material or the results to be obtained from the use thereof.

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4-(Hydroxymethyl)phenoxyacetic acid 68858-21-9 MSDS 4-(Hydroxymethyl)phenoxyacetic Acid Revision number: 5 SAFETY DATA SHEET

Section 1. IDENTIFICATION Product name: 4-(Hydroxymethyl)phenoxyacetic Acid Revision number: 5

Section 2. HAZARDS IDENTIFICATION GHS classification PHYSICAL HAZARDS Not classified HEALTH HAZARDS Skin corrosion/irritation Category 2 Category 2A Serious eye damage/eye irritation ENVIRONMENTAL HAZARDS Not classified GHS label elements, including precautionary statements Pictograms or hazard symbols Signal word Warning Hazard statements Causes skin irritation Causes serious eye irritation Precautionary statements: Wash hands thoroughly after handling. [Prevention] Wear protective gloves/eye protection/face protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, [Response] if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. IF ON SKIN: Gently wash with plenty of soap and water. If skin irritation occurs: Get medical advice/attention. Take off contaminated clothing and wash before reuse.

Section 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance/mixture: Substance Components: 4-(Hydroxymethyl)phenoxyacetic Acid Percent: >98.0%(T) CAS Number: 68858-21-9 Chemical Formula: C9H10O4

Section 4. FIRST AID MEASURES Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical advice/attention if you feel unwell. 4-(Hydroxymethyl)phenoxyacetic Acid

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Section 4. FIRST AID MEASURES Skin contact: Remove/Take off immediately all contaminated clothing. Gently wash with plenty of soap and water. If skin irritation or rash occurs: Get medical advice/attention. Eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Ingestion: Get medical advice/attention if you feel unwell. Rinse mouth. A rescuer should wear personal protective equipment, such as rubber gloves and air- Protection of first-aiders: tight goggles.

Section 5. FIRE-FIGHTING MEASURES Suitable extinguishing Dry chemical, foam, water spray, carbon dioxide. media: Precautions for firefighters: Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place. In case of fire in the surroundings: Remove movable containers if safe to do so. Special protective When extinguishing fire, be sure to wear personal protective equipment. equipment for firefighters:

Section 6. ACCIDENTAL RELEASE MEASURES Personal precautions, Use personal protective equipment. Keep people away from and upwind of spill/leak. protective equipment and Entry to non-involved personnel should be controlled around the leakage area by emergency procedures: roping off, etc. Environmental precautions: Prevent product from entering drains. Methods and materials for Sweep dust to collect it into an airtight container, taking care not to disperse it. containment and cleaning Adhered or collected material should be promptly disposed of, in accordance with up: appropriate laws and regulations.

Section 7. HANDLING AND STORAGE Precautions for safe handling Technical measures: Handling is performed in a well ventilated place. Wear suitable protective equipment. Prevent dispersion of dust. Wash hands and face thoroughly after handling. Use a local exhaust if dust or aerosol will be generated. Advice on safe handling: Avoid contact with skin, eyes and clothing.

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Conditions for safe storage, including any incompatibilities Storage conditions: Keep container tightly closed. Store in a cool and dark place. Store away from incompatible materials such as oxidizing agents. Packaging material: Comply with laws.

Section 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Engineering controls: Install a closed system or local exhaust as possible so that workers should not be exposed directly. Also install safety shower and eye bath. Personal protective equipment Respiratory protection: Dust respirator. Follow local and national regulations. Hand protection: Protective gloves. Safety glasses. A face-shield, if the situation requires. Eye protection: Skin and body protection: Protective clothing. Protective boots, if the situation requires.

Section 9. PHYSICAL AND CHEMICAL PROPERTIES Physical state (20°C): Solid Crystal- Powder Form: Colour: Slightly pale yellow - Reddish yellow No data available Odour: pH: No data available Melting point/freezing point:110°C 4-(Hydroxymethyl)phenoxyacetic Acid

Section 9. PHYSICAL AND CHEMICAL PROPERTIES Boiling point/range: No data available Flash point: No data available Flammability or explosive limits: Lower: No data available Upper: No data available Relative density: No data available Solubility(ies): [Water] No data available No data available [Other solvents]

Section 10. STABILITY AND REACTIVITY Chemical stability: Stable under proper conditions. Possibility of hazardous No special reactivity has been reported. reactions: Incompatible materials: Oxidizing agents

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Hazardous decomposition Carbon monoxide, Carbon dioxide products:

Section 11. TOXICOLOGICAL INFORMATION No data available Acute Toxicity: Skin corrosion/irritation: No data available Serious eye No data available damage/irritation: Germ cell mutagenicity: No data available Carcinogenicity: No data available IARC = NTP = No data available No data available Reproductive toxicity:

Section 12. ECOLOGICAL INFORMATION Ecotoxicity: Fish: No data available Crustacea: No data available Algae: No data available Persistence / degradability: No data available Bioaccumulative No data available potential(BCF): Mobility in soil Log Pow: No data available Soil adsorption (Koc): No data available Henry's Law No data available constant(PaM3/mol):

Section 13. DISPOSAL CONSIDERATIONS Recycle to process, if possible. Consult your local regional authorities. You may be able to dissolve or mix material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber system. Observe all federal, state and local regulations when disposing of the substance.

Section 14. TRANSPORT INFORMATION Hazards Class: Does not correspond to the classification standard of the United Nations UN-No: Not listed 4-(Hydroxymethyl)phenoxyacetic Acid

Section 15. REGULATORY INFORMATION Safe management ordinance of dangerous chemical product (State Council announces on January 26, 2002

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and revised on February 16,2011): Safe use and production, the storage of a dangerous chemical, transport, loading and unloading were prescribed.

SECTION 16 - ADDITIONAL INFORMATION N/A

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www.Lagunaclay.com 800-452-4862 [email protected]

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www.Lagunaclay.com 800-452-4862 [email protected]

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www.Lagunaclay.com 800-452-4862 [email protected]

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www.Lagunaclay.com 800-452-4862 [email protected]

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www.Lagunaclay.com 800-452-4862 [email protected]

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www.Lagunaclay.com 800-452-4862 [email protected]

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MSDS-HCL PAGE 9A-1 Issued 8/5/1999 Revised 10/27/06

Material Safety Data Sheet(MSDS-HCL)

PRODUCT IDENTIFICATION Product Name Hydrochloric Acid Solution 20 Deg. Be – 31.5%

22 Deg. Be – 35.2% Trade Names and Synonyms Hydrogen Chloride (Aqueous)

Muriatic Acid Manufacturer/Distributor Trans Chem, Inc.

1259 Safe Energy Dr. Port Allen, Louisiana 70767 (225) 389-9133 Various others

Transportation Emergency 800-255-3924 (24 hrs -- CHEM • TEL)

HAZARDOUS COMPONENTS Material or Component CAS No. TLV PEL Hydrochloric Acid 7647-01-0 7mg/m3 5PPM N/A = Not assigned NE = Not established

PHYSICAL DATA Boiling Point 127° F Vapor Pressure 24mm Hg – 20 Deg. Be

100mm Hg – 22 Deg. Be Solubility in Water Complete Specific Gravity 1.16 @ 15.5° C 20 Deg. Be

1.1789 @ 15.5° C 22 Deg. Be Melting Point N/A Vapor Density Similar to Water Evaporation Rate Not Applicable Appearance and Odor Clear Colorless to Yellowish Fuming Liquid, Pungent and Irritating

HAZARDOUS REACTIVITY Stable under ordinary conditions of use and storage. Does not polymerize. Incompatible with aluminum and aluminum alloys, carbon steel, copper and copper alloys, and nylon. Hydrogen gas will be formed if acid contacts metal.

FIRE AND EXPLOSION DATA Flashpoint Not Flammable Extinguishing Media Use any means suitable for extinguishing surrounding fire. Decomposition Products Contact with most metals may produce Hydrogen gas to potentially explosive limits. Unusnal Explosion Containers may explode when heated. Consult the 2000 Emergency Response

Guidebook, Guide 157 for further details.

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MSDS-HCL PAGE 9A-2 Issued 8/5/1999 Revised 10/27/06

HEALTH HAZARDS / FIRST AID Inhalation Inhalation causes severe irritation of upper respiratory tract. FA: Remove person to to

fresh air. If not breathing, give artificial respiration. Call physician. Ingestion CORROSIVE ! Ingestion of Hydrochloric Acid can cause burns of the mouth, throat,

esophagus and gastrointestinal tract. FA: DO NOT INDUCE VOMITING. Give large quantities of water or milk of magnesia. Never give anything by mouth to an unconscious person. Get immediate medical attention.

Skin Contact CORROSIVE ! Can cause redness, pain and skin burns. Can cause some tissue destruction. FA: Immediately flush with water.

Eye Contact CORROSIVE ! FA: Continuously flush eyes with large amounts of water for at least 20 minutes. If irritation continues, seek medical attention.

SPILL OR LEAK PROCEDURES Spill/leak In the event of a spill or leak, keep upwind. Ventilate enclosed areas until spill or leak is

contained, neutralized and prepared for removal. Waste disposal Disposal of waste material or residue may be subject to federal, state, or local

regulation. Before transporting waste material see 49 CFR 172.

SPECIAL PROTECTION INFORMATION Ventilation Use only in areas with adequate ventilation. Eye Protection Use chemical safety goggles, plus a safety shield is recommended. Contact lenses

should not be worn when working with this material. Skin Protection Wear impervious protective clothing; i.e., Boots, Gloves, Lab Coat, Apron or Coveralls to

prevent skin contact. Other If working in an area of potential exposure, use an NIOSH approved respirator when

material is fuming and exceeds the TLV.

STORAGE CONDITIONS Store and handle only in containers suitably lined with or constructed of materials specified, by the manufacturer, for the product. Protect against physical damage. Keep separated from incompatible materials.

REGULATORY INFORMATION Proper shipping name Hydrochloric acid Hazard class 8 UN Number UN1789 DOT Label & Placard Corrosive NFPA / HMIS Ratings Health – 3; Flammability – 0; Reactivity – 0 SARA Title III Reporting Sections 302, 311 & 313

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MSDS-HCL PAGE 9A-3 Issued 8/5/1999 Revised 10/27/06

The information contained in this Material Safety Data Sheet is based upon available data and believed to be correct; however, as such has been obtained from various sources, including the manufacturer and independent laboratories, it is given without warranty or representation that it is complete, accurate, and can be relied upon. OWEN COMPLIANCE SERVICES, INC. has not attempted to conceal in any manner the deleterious aspects of the product listed herein, but makes no warranty as to such. Further, OWEN COMPLIANCE SERVICES, INC. cannot anticipate nor control the many situations in which the product or this information may be used; there is no guarantee that the health and safety precautions suggested will be proper under all conditions. It is the sole responsibility of each user of the product to determine and comply with the requirements of all applicable laws and regulations regarding its use. This information is given solely for the purposes of safety to persons and property. Any other use of this information is expressly prohibited.

For further information contact: David W. Boston, President OWEN COMPLIANCE SERVICES, INC. 12001 County Road 1000 P.O. Box 765 Godley, TX 76044

Telephone number: 817-551-0660 FAX number: 817-396-4584

MSDS prepared by: Allen M. Sweeney Original publication date: 8/5/1999 Revision date 10/27/06

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Specification – MPDSA

Product Name : Meta Phenylene Diamine 4 Sulfonic Acid Free Acid

Synonym : 1,3 Diamino Benzene 4 Sulfonic Acid Free Acid

Trade Name : MPDSA

CAS No. : 88-63-1

Molecular Weight : 188 grams/Mole

Empirical Formula : C6 H8 O3 N2 S

Structural Formula : NH2

NH2 SO3H

Purity : Min. 98.00%

Insoluble Content : Max. 00.20%

Moisture : Max. 0.30%

Other impurities : Max. 0.10%

Physical appearance : Light gray White powder

Basis of Sale : On As Is basis

Packing : 25/50kgs HDPE bags with double liners inside

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Specification – MPDSA (Sodium Salt)

Product Name : Meta Phenylene Diamine 4 Sulfonic Acid

(Na Salt)

Synonym : 1,3 Diamino Benzene 4 Sulfonic Acid

Trade Name : MPDSA (Na Salt)

Molecular Weight : 210 grams/Mole

Empirical Formula : C6 H8 O3 N2 S

Structural Formula :

NH2

NH2 SO3Na

Purity : Min. 72.00% on MW 188

Insoluble Content : Max. 00.20%

Moisture : Max. 2.00%

Physical appearance : Light Cream powder

Basis of Sale : On 100% basis

Packing : 25/50kgs HDPE bags with double liners inside

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Enclosure: 5

Chemical Name and Physical Form of Raw Materials with Its Storage Facility

Raw Material CAS No. Physical form

Container Type Pack Size Maximum Storage

capacity (MT) ( R)-2-(Methoxycarbonylamino)-2- Phenyl acetic Acid

50890-96-5 Solid Fiber Drum 25 0.75

((S)-1-(Tert-Butoxycarbonyl)-4-(Methoxy-Methyl) Pyrrolidine-2-Carboxylic Acid

1378388-16-9 Solid Fiber Drum 25 1.5

(2,4,5-Trifluoro-Phenyl)Aceticacid

209995-38-0 Solid Fiber Drum 25 0.75

(Α,S) 2,4 –Dichloro-A-(Chloromethyl)Benzene- Methanol Methane Sulphonate

53984-39-7 Solid Fiber Drum 25 1.5

1-(3-Methoxyphenyl)Propan-1-One

37951-49-8 Solid Fiber Drum 25 1.5

1,2-Dimethoxyethane 110-71-4 Liquid HDPE Drum 5.5 20

1,4 Dioxane 123-91-1 Liquid HDPE Drum 200 15 1-2,4-Dichloro-Phenyl-2-Imidazole- -1-Yl-Ethanol.

24155-42-8 Solid Fiber Drum 25 3

1h-Imidazole-1-Acetonitrile 18502-05-1 Liquid HDPE Drum 200 0.5 1-Methyl 2-Pyrrodinone 872-50-4 Liquid HDPE Drum 200 20 2,3-Dichloro-5,6-Dicyano Benzoquinone

84-58-2 Solid Fiber Drum 25 1.5

2,6 Dichlorophenol 87-65-0 Solid Fiber Drum 25 1.25 2,8-Diazobicyclo(4.3.0) Nonane 151213-40-0 Liquid HDPE Drum 200 0.5 2-Butyl-4-Chloro-5-Hydroxy-Methyl Imidazole

79047-41-9 Solid Fiber Drum 25 1.25

2-Chloro-2,4-Difluoroacetophenone

51336-94-8 Solid Fiber Drum 25 4.5

2'-Deoxy-2'-Fluoro-2'-C-Methyl Uridine

883329-66-2 Solid Fiber Drum 25 1.25

2-Dicyclo Hexylphosphino-2′, 4′, 6′-Tri-I-Opyl-1,1′-Biphenyl

564483-18-7 Solid Fiber Drum 25 0.25

2-Methoxyethanol 109-86-4 Liquid HDPE Drum 200 0.25

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2s,4s-4-Hydroxy-L-Prolin 618-27-9 Solid Fiber Drum 25 4.5 3-(Trifluoro Methyl)5,6,7,8-Tetrahydro(4,3-A)Pyrazine HCl

762240-92-6 Solid Fiber Drum 25 1

3,5-Dibromo-1h-1,2,4-Triazole 510758-28-8 Solid HDPE Drums 200 1.5 3-Amino Crotononitrile 1118-61-2 Liquid HDPE Drums 200 3 3-Azido Piperdene Solid Fiber Drum 25 1.5 3-Cyclohexene-1-Methanol 1679-51-2 Liquid HDPE Drum 200 0.5 4-(Chloromethyl)-5-Methyl-1,3-Dioxol-2-One

80841-78-7 Liquid HDPE Drum 200 0.75

4-[2-(Trityltetrazol-5-Yl)Phenyl]Benzyl Bromide

----- Solid PP Bag 50 2.5

4-Amino-2-Ethoxy-5-Nitro-N-(4-Piperidyl) Benzamide

121873-04-9 Solid Fiber Drum 25 0.75

4-Amino-2-Methoxy-5-Ethyl Sulphonyl Benzoic Acid

71675-87-1 Solid Fiber Drum 25 1

4-Bromo Methyl-2-Cyano-Biphenyl

114772-55-3 Solid Fiber Drum 25 1.5

4-Chlorobutyryle Chloride 4635-59-0 Liquid HDPE Drum 200 5 4-Chloromethyl-5-Methyl-1,3-Dioxol-2-One

80841-78-7 Solid Fiber Drum 25 0.25

4-Fluoro Benzaldehyde 459-57-4 Liquid HDPE Drum 200 0.75 4-Hydroxymethyl -5-Methyl-1,3-Dioxol-2-One

931-40-8 Solid Fiber Drum 25 0.75

4-Methyl-3-Oxo-Pentanoic Acid Ethyl Ester

7152-15-0 Solid Fiber Drum 25 1

5-Aminobenzofuran-2-Carboxylic Acid

42933-44-8 Solid Fiber Drum 25 3

5-Cyano-Indole 15861-24-2 Solid Fiber Drum 25 2.5 6-Ethyl-5-Fluoropyrimidin-4-Ol 137234-87-8 Solid HDPE Drums 200 2 7-Methyl-2-Propyl-3h-Benzo[D]Imidazole Cooh

152628-03-0 Solid Fiber Drum 25 0.75

9-Bromo-3-Chloro-10,11-Dihydro-5h-Naphtho[C,G]Chromen-8(9h)-One

Not Available Solid Fiber Drum 25 1.5

Acetic Acid 64-19-7 Liquid HDPE Drum 200 15

Acetone 67-64-1 Liquid Tanker 10000 10 Aceto nitrile 75-05-8 Liquid HDPE Drum 200 12

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Acetyl Chloride 75-36-5 Liquid HDPE Drum 200 1 Activated Carbon 7440-44-0 Solid Fiber Drum 25 2 Aluminium Chloride 7446-70-0 Solid Fiber Drum 25 1.25 Aluminium Trichloride 7446-70-0 Solid Fiber Drum 25 5 Ammonia 1336-21-6 Gas Cylinder 30 20 Ammonia 30% 1336-21-6 Liquid HDPE Drum 200 1.5 Ammonium Acetate 631-61-8 Solid Fiber Drum 25 0.75 Ammonium Chloride 12125-02-9 Solid Fiber Drum 25 0.5 Ammonium Formate 540-69-2 Solid HDPE Drums 200 12.5 Aniline 62-53-3 Liquid HDPE Drum 25 0.2 Anhydrous Lithium Chloride 7447-41-8 Solid HDPE Drums 200 1.5 Aquous Hbr 10035-10-6 Liquid Glass Bottles 2.5 2 Azo Bis Isobutyronitrile 78-67-1 Liquid Fiber Drum 25 4 Benzene Sulphonyl Chloride 98-09-9 Liquid HDPE Drum 200 0.5 Benzoyl Peroxide 94-36-0 Liquid HDPE Drum 200 0.1 Benzyl Amine 100-46-9 Liquid HDPE Drum 200 2 Bis (Pinacolato) Diboron 73183-34-3 Liquid HDPE Drum 200 1 Bis-(2-Chloroethyl)Amine Hydrochloride

821-48-7 Solid Fiber Drum 25 2.5

Brine Solution [NaCl] 7647-14-5 Solid PP Bag 50 2.5 Bromo Ester Compound ---- Solid Fiber Drum 25 1.5 Bromo Methyl Thiophene 30318-99-1 Solid Fiber Drum 25 2 Butanol 71-36-3 Liquid Tanker 10000 20 Calcium Chloride 10043-52-4 Solid Fiber Drum 50 0.25 Cane Molasses 68990-09-0 Liquid HDPE Drums 200 40 Carbon Disulphide 75-15-0 Liquid HDPE Drum 200 0.5 Carbon Tetrachloride 56-23-5 Liquid HDPE Drum 200 10.25 Carbonyl Imidazole 530-62-1 Solid Fiber Drum 25 1 Caustic Soda 1310-73-2 Solid PP Bag 50 0.75 Chloro Compound --- Solid Fiber Drum 25 2 Chloroform 67-66-3 Liquid HDPE Drums 200 5 Cholic Acid 81-25-4 Solid Fiber Drum 25 5 Comu 1075198-30-9 Solid Fiber Drum 25 0.5 Conc HCl 7647-01-0 Liquid HDPE Drum 200 0.5 Corn Steep Liquor 66071-94-1 Liquid Tanker 10000 60 Cyclohexane 110-82-7 Liquid HDPE Drum 200 3 Cysteamin HCl 156-57-0 Solid Fiber Drum 25 2.5

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D(-) Tartaric Acid 87-69-4 Solid Fiber Drum 25 0.75 Di Azo Bi Cyclo Undecane 6674-22-2 Liquid HDPE Drum 200 0.5 Di Iso Propyl Ether 108-20-3 Liquid Tanker 10000 20 Di Methoxy Ethane 110-71-4 Liquid HDPE Drum 200 5 Dibal - H [Diisobutylaluminium Hydride]

1191-15-7 Liquid PP Carboy 2.5 0.015

Dichloro[1,1′-Bis(Diphenyl Phosphino) Ferrocene]Palladium

72287-26-4 Solid Fiber Drum 25 0.25

Diethyl Methoxy Borane 7397-46-8 Liquid HDPE Drum 200 0.5 Di Isopropylethylamine 7087-68-5 Liquid HDPE Drum 200 2.5 Di Methyl Acetamide 127-19-5 Liquid HDPE Drum 200 10 Di Methyl Amine 124-40-3 Liquid HDPE Drum 200 3 Di Methyl Formamide 68-12-2 Liquid HDPE Drum 200 20 DIPE 108-20-3 Liquid HDPE Drums 200 15 DMF 68-12-2 Liquid HDPE Drums 200 12.5 DMSO 67-68-5 Liquid HDPE Drum 200 14 EDC HCl 25952-53-8 Solid Fiber Drum 25 4.5 Ethanol 64-17-5 Liquid HDPE Drum 200 2.5 Ethoxy Ethanol 110-80-5 Liquid HDPE Drum 200 4 Ethyl Acetate 141-78-6 Liquid Tanker 10000 20 Ethyl Chloro Acetate 105-39-5 Liquid HDPE Drum 200 1 Ethyl Chloro Formate 541-41-3 Liquid HDPE Drum 200 0.75 Ethyl Ether 60-29-7 Liquid HDPE Drum 200 3 Ethyl Magnesium Bromide 925-90-6 Liquid HDPE Drum 200 0.75 Ethyl-4-(1-Hydroxy-1-Methylethyl) 2-Propy H-((2-(2-(Triphenyllnethyl)-2h-Tetrazol-5 Yl Biphenyl-4-Yl-1-Methyl Imidazole-5-Carboxylic Acid

144689-24-7 Solid Fiber Drum 25 1

FMOC 28920-43-6 Solid Fiber Drum 25 10 Formaldehyde 50-00-0 Liquid HDPE Drum 200 0.75 HCl Gas 7647-01-0 Gas Cylinder 32 15 HCl Soln 7647-01-0 Liquid Tanker 10000 20 HMPA / [Hexamethylphosphoramide]

680-31-9 Liquid HDPE Drum 200 1.5

HOBT 2592-95-2 Solid Fiber Drum 25 1.5 Hydrazine Hydrate 10217-52-4 Solid Fiber Drum 25 1 Hydrochloric Acid 32% 7647-01-0 Liquid HDPE Drum 200 2.5

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Hydrogen Fluoride 7664-39-3 Gas Cylinder 21 0.1 Hydrogen Gas 1333-74-0 Gas Cylinder 7 5 NOS Hydroxyl Amine Hydrochloride 11-1-5470 Solid Fiber Drum 25 0.5 Hyflo 68855-54-9 Solid Paper Bag 10 0.1 Hyflo Super Cel 14464-46-1 Solid Paper Bags 10 0.25 Iodine 7553-56-2 Solid Tanker 10000 12.5 IPA 67-63-0 Liquid Tanker 10000 10 Iso Propyl Alcohol 67-63-0 Liquid Tanker 10000 20 Iso Propyl Ether 108-20-3 Liquid HDPE Drums 200 15 KOH Powder 1310-58-3 Solid PP Bag 50 0.5 L, 2- Cyclo Pentane O Ni Anhydride (Compound-Iii)

474919-59-0 Solid Fiber Drum 25 2

L,3-Dibromo-5,5- Dimethyl Hydantoin

77-48-5 Solid Fiber Drum 25 1.25

L-Alanine Iso Propyl Ester HCl 62062-65-1 Solid Fiber Drum 25 2.5 Lead 7439-92-1 Solid Metal Drums 10 1.5 Magnesium Sulphate 7487-88-9 Solid PP Bag 50 2.5 Mandelic Acid Manganese(Iv) Oxide 1313-13-9. Solid Fiber Drum 25 2.5 MDC 75-09-2 Liquid Tanker 10000 20 MEK 78-93-3 Liquid HDPE Drum 200 5 Meldrums Acid 2033-24-1 Solid Fiber Drum 25 0.75 Meta Chloro Peroxybenzoic Acid 937-14-4 Solid Fiber Drum 25 2 Methane Sulfonyl Chloride 124-63-0 Liquid PP Carboy 30 0.5 Methane Sulphonic Acid 75-75-2 Liquid HDPE Drum 200 0.6 Methane Sulphonyl Chloride 124-63-0 Liquid PP Bag 50 6.5 Methanol 67-56-1 Liquid Tanker 10000 20 Methanolic HCl 20 % 67-56-1 Liquid HDPE Drum 200 1.5 Methyl Amine 74-89-5 Liquid HDPE Drum 200 0.5 Methyl Iodide 74-88-4 Solid Fiber Drum 25 1 Methyl(3r)-3-(Tert Butyl Di Methyl Silyloxy)-5-Oxo-6-Triphenyl Phosphoranylidene Hexanoate

147118-35-2 Solid Fiber Drum 25 2

Methyl(S)-1-((S)-2-(5-Bromo-1h-Imidazol-2-Yl)Pyrrolidin-1-Yl)-3-Methyl-1-Oxobutan-2-Ylcarbamate

1292836-05-5 Solid Fiber Drum 25 1

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Methyl-1[(2’cyanobiphenyl4-Yl) Methyl]-2ethoxybenzimidazole -7-Carboxylate

632322-61-3 Solid Fiber Drum 25 2.5

Methylene Chloride 75-09-2 Liquid Tanker 10000 20 Methylene Dichloride 75-09-2 Liquid Tanker 10 20 Mono Methyl Amine 40 % 74-89-5 Liquid HDPE Drum 200 5 Moxifloxacin Q-Acid 86393-33-1 Solid Fiber Drum 25 1.25 N,N-Dimethyl Formamide 68-12-2 Liquid M S Drum 200 5 N,N-Dimethyl Acetamide 127-19-5 Liquid HDPE Drum 200 12.5 N=Methyl Morpholine 109-02-4 Liquid HDPE Drums 200 2 NaCl 7647-14-5 Solid HDPE Drums 200 12.5 NaOH 1310-73-2 Solid PP Bag 50 0.1 N-Bromo Succinimide 128-08-5 Solid Fiber Drum 25 4 N-Ethyl-2-Amino Methyl Pyrrolidine

26116-12-1 Liquid HDPE Drum 200 0.75

N-Hexane 110-54-3 Liquid HDPE Drums 200 12.5 Nitric Acid 7697-36-2 Liquid HDPE Drum 200 1 N-Methyl-O-Phenylene Diamine 4760-34-3 Liquid HDPE Drum 25 0.5 Ortho Tolyl Benzonitrile 100-47-0 Liquid HDPE Drum 200 1.5 O-Xylene 95-47-6 Liquid HDPE Drum 200 15 Palladium Charcoal 10 % 7440-05-3 Solid Metal Drums 10 0.25 Palladium Hydroxide 12135-22-7 Solid M S Drum 20 0.02 Para Toluene Sulphonic Acid 6192-52-5 Solid Fiber Drum 25 0.5 Pd /Ch 7440-05-3 Solid HDPE Drums 200 12.5 Pd/C 5% 5/3/7440 Solid HDPE Drum 10 0.5 Pentaflurophenol 771-61-9 Liquid HDPE Drum 200 4.5 Phenyl Dichloro Phosphate 770-12-7 Liquid HDPE Drum 200 3 Phenyl Hydrazine 59-88-1 Solid Fiber Drum 25 4 Piperidine 110-89-4 Solid Fiber Drum 25 0.75 Poly Phosphoric Acid 8017-16-1 Liquid HDPE Drum 200 1.5 Polypeptone 73049-73-7 Solid Fiber Drum 25 40 Potassium Acetate 127-08-2 Solid Fiber Drum 25 0.75 Potassium Butoxide 865-47-4 Solid Fiber Drum 25 1 Potassium Carbonate 584-08-7 Solid PP Bag 50 0.5 Potassium Iodide 7681-11-0 Solid HDPE Drum 10 0.5 P-Toluene Sulphonyl Chloride 98-59-9 Solid Fiber Drum 25 0.75 R-(-)-10-Camphorsulfonic Acid 35963-20-3 Solid HDPE Drums 200 10

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R*(S*)]-6-Fluoro-3,4-Dihydro-2-Oxiranyl-2h-1-Benzopyran

99199-90-3 Solid Fiber Drum 25 1

Residue (2s)-1-Tert-Butyl-2-(3-Chloro-8-Oxo-8,9,10,11-Tetrahydro-6h-Naphtho[2,3-C]Chromen-9-Yl)-4(Methoxymethyl)Pyrrolidine-1,2-Dicarboxylate

Not Available Solid Fiber Drum 25 1.5

Silica Gel 112926-00-8 Solid Fiber Drum 25 25 S-Methyl Iso Thio Urea 867-44-7 Solid Fiber Drum 25 0.5 Sodium Acetate 127-09-3 Solid Fiber Drum 25 15 Sodium Azide 26628-22-8 Solid Fiber Drum 25 0.75 Sodium Bicarbonate 144-55-8 Solid PP Bag 50 3 Sodium Bisulphite 7631-90-5 Solid HDPE Drums 200 3 Sodium Boro Hydride 16940-66-2 Solid HDPE Drum 200 0.5 Sodium Carbonate 497-19-8 Solid PP Bag 50 6.5 Sodium Chloride 7647-14-5 Solid PP Bag 50 10 Sodium Hydride 7646-69-7 Solid Metal Drums 10 1.5 Sodium Iodide 7681-82-5 Solid Fiber Drum 25 0.1 Sodium Methoxide 124-41-4 Solid Fiber Drum 25 3 Sodium Sulphate 7757-82-6 Solid PP Bag 50 3 Sodium Triacetoxy Borohydride 56553-60-7 Solid Fiber Drum 25 2 Starch 9005-25-8 Solid Fiber Drum 25 40 Sulphur Trioxide Pyridine Complex

26412-87-3 Solid Fiber Drum 25 4

Tartaric Acid 87-69-4 Solid Fiber Drum 25 0.75 Tartaric Acid 67-69-4 Solid Fiber Drum 25 1.5 TBAB 1643-19-2 Solid Fiber Drum 25 0.25 T-Butyl Alcohol 75-65-0 Liquid Tanker 10000 20 TEA 121-44-8 Liquid HDPE Drum 200 5 Tert-Butyl Magnesium Chloride 677-22-5 Liquid HDPE Drum 200 1 Tetrahydrofuran 109-99-9 Liquid HDPE Drum 200 10 Tetrakis (Triphenyl Phosphine) Palladium

14221-01-3 Solid Fiber Drum 25 0.25

THF 109-99-9 Liquid HDPE Drums 200 20 Thionyl Chloride 7719-07-9 Liquid PP Carboys 30 0.5 Toluene 108-88-3 Liquid Tanker 10000 20 Toluene Sulfonyl Urea 1694-06-0 Solid Fiber Drum 25 3

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Tri Butyl Tin Chloride 1461-22-9 Liquid HDPE Drum 200 3 Triethyl Amine 121-44-8 Liquid HDPE Drums 200 6 Tri phenyl Phospine 603-55-0 Solid Fiber Drum 25 2 Tris (Dibenzylidene acetone) Palladium

32005-36-0 Solid Fiber Drum 25 0.25

Zinc 7440-66-6 Solid Fiber Drum 25 6.5

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Enclosure: 7

Details of Hazardous Chemicals

The Raw Materials, which are termed as Hazardous Chemicals as per the "Manufacturing, Storage and Import of Hazardous Chemicals Rules, 1989", are as listed in below:

Name of Hazardous Chemical

Reference The Manufacturer, storage

& Import of Hazardous chemical Rules 1989

Maximum quantity that

can be stored at a time (MT)

Threshold Quantity in

Dioxane Sr. .No. 224 (Part II, Schedule 1 of MSIHCR, 1989 15 No listed

2-Methoxy Ethanol

Sr. .No. 373 (Part II, Schedule 1 of MSIHCR, 1989 0.25 No listed

Acetic Acid Sr. No. 2(Part II, Sch. 1 of MSIHCR, 1989) 15 No listed

Acetone Sr. No. 4 (Part II, Sch. 1 of MSIHCR, 1989) 10 25

Aceto nitrile Sr. No. 7 (Part II, Sch. 1 of MSIHCR, 1989) 12 No listed

Ammonia Sr. No. 31 (Part II, Sch. 1 of MSIHCR, 1989) 20 Not Listed

Aniline Sr. No. 37 (Part II, Sch. 1 of MSIHCR, 1989) 0.2 Not Listed

Hydrogen Bromide

Sr. No. 315 (Part II, Sch. 1 of MSIHCR, 1989) 2 No listed

Azo bis Iso Butyronitrile

Sr. No. 329 (Part II, Sch. 1 of MSIHCR, 1989) 4 No listed

Benzene Sulphonyl Chloride

Sr. No. 57 (Part II, Sch. 1 of MSIHCR, 1989) 0.5

No listed

Benzoyl Peroxide

Sr. No. 66 (Part II, Sch. 1 of MSIHCR, 1989) 0.1 No listed

Carbon Disulphide

Sr. No. 110 (Part II, Sch. 1 of MSIHCR, 1989) 0.5 20

Carbon Tetrachloride

Sr. No. 109 (Part II, Sch. 1 of MSIHCR, 1989) 10.25 No listed

Chloroform Sr. No. 130 (Part II, Sch. 1 of MSIHCR, 1989) 5 No listed

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Hydrochloric Acid

Sr. No. 313 (Part II, Sch. 1 of MSIHCR, 1989) 15 No listed

Cyclohexane Sr. No. 161 (Part II, Sch. 1 of MSIHCR, 1989) 3 No listed

Dimethyl Amine Sr. No. 215 (Part II, Sch. 1 of MSIHCR, 1989) 3 No listed

Ethanol Sr. No. 248 (Part II, Sch. 1 of MSIHCR, 1989) 2.5 No listed

Ethyl Acetate Sr. No. 247 (Part II, Sch. 1 of MSIHCR, 1989) 20 No listed

Ethyl Ether Sr. No. 253 (Part II, Sch. 1 of MSIHCR, 1989) 3 No listed

Formaldehyde Sr. No. 37 (Part II, Sch. 1 of MSIHCR, 1989) 0.75 5,50

Hexamethyl Phosphoramide

Sr. No. 304 (Part II, Sch. 1 of MSIHCR, 1989) 1.5 1kg

Hydrogen Fluoride

Sr. No. 317 (Part II, Sch. 1 of MSIHCR, 1989) 0.1 5,50

Hydrogen Gas Sr. No. 314 (Part II, Sch. 1 of MSIHCR, 1989) 5 2,20

Iodine Sr. No. 323 (Part II, Sch. 1 of MSIHCR, 1989) 12.5 No listed

Iso Propyl Alcohol

Sr. No. 334 (Part II, Sch. 1 of MSIHCR, 1989) 20 No listed

Methanol Sr. No. 377 (Part II, Sch. 1 of MSIHCR, 1989) 20 No listed

Methyl Amine Sr. No. 378 (Part II, Sch. 1 of MSIHCR, 1989) 0.5 No listed

Methylene Chloride

Sr. No. 400 (Part II, Sch. 1 of MSIHCR, 1989) 20 No listed

Sodium Hydroxide

Sr. No. 571 (Part II, Sch. 1 of MSIHCR, 1989) 0.1 No listed

N-Hexane Sr. No. 413 (Part II, Sch. 1 of MSIHCR, 1989) 12.5 No listed

Nitric Acid Sr. No. 423 (Part II, Sch. 1 of MSIHCR, 1989) 1 No listed

O-Xylene Sr. No. 442 (Part II, Sch. 1 of MSIHCR, 1989) 15 No listed

Sodium Azide Sr. No. 566 (Part II, Sch. 1 of MSIHCR, 1989) 0.75 No listed

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Tert- Butyl Alcohol

Sr. No. 596 (Part II, Sch. 1 of MSIHCR, 1989) 20

No listed

Tetrahydrofuran Sr. No. 602 (Part II, Sch. 1 of MSIHCR, 1989) 10 No listed

Thionyl Chloride Sr. No. 620 (Part II, Sch. 1 of MSIHCR, 1989) 0.5 No listed

Toluene Sr. No. 628 (Part II, Sch. 1 of MSIHCR, 1989) 20 No listed

Triethyl Amine Sr. No. 652 (Part II, Sch. 1 of MSIHCR, 1989)

6 10 Kg

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Enclosure: 8

Manufacturing Process and Mass Balance

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AMISULPRIDE :

STAGE - I :

INPUT (KG) OUTPUT(KG)

4-amino-2-methoxy-5-ethyl sulphonyl benzoic acid 141

REACTION STEP - I

PRODUCT (Stage - I) 200

N-ethyl-2-amino methyl pyrrolidine 75 Acetone Recover 620

Ethyl chloro format 59 Triethyl amine 80

Waste Water To ETP 946 Acetone 630 Residue 64 Sodium hydroxide soln 20 % 145 Water 700 TOTAL 1830

TOTAL 1830

STAGE - II

STAGE - I 200

REACTION STEP - II

PRODUCT (STAGE - II) 190

Iso Propyl Alcohol 150 Iso Propyl Alcohol Recover 143 Activated Carbon 10

Residue 30 Hyflo Super Cel 3 TOTAL 363 TOTAL 363

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STAGE - I

INPUT (Kg)

OUTPUT (Kg)

Methyl-1[(2’Cyanobiphenyl4-yl) methyl]-2Ethoxybenzimidazole -7-carboxylate

90

REACTION STEP - I

Product (Stage I) 85

Hydroxyl amine hydrochloride 15 DMSO Recover 883 Sodium bicarbonate 20

DMSO 900 Residue 32

WATER 900

Waste Water To ETP 925

TOTAL 1925 TOTAL 1925

STAGE - II

STAGE - I

85

REACTION STEP - II

PRODUCT (STAGE - II) 75

TETRAHYDROFURAN 1200 THF Recover 1160 Carbonyl imidazole 32 Di aza bicycle undecane 15 MDC Recover 380

Sodium bisulphite 25

Sodium chloride 20 Methanol Recover 335 Methanol 350 MDC 400 Waste Water To ETP 660 WATER 600

Residue 117

TOTAL 2727

TOTAL 2727

AZILSARTAN MEDOXOMIL:

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STAGE - III

STAGE - II

74

REACTION STEP - III

PRODUCT (Stage - III) 50

Sodium hydroxide 7 IPA Recover 352 Hydrochloric acid 12

Isopropyl alcohol 370 Waste Water 920 WATER 900

Residue 41

TOTAL 1363 TOTAL 1363

STAGE - IV :

STAGE - III

50

REACTION STEP - IV

STAGE - IV 57

4-Hydroxymethyl -5-methyl-1,3-dioxol-2-one 20 DMA Rec 266 P-TOLUENE SULPHONYL CHLORIDE 30

Dimethyl Amino Pyridine 3 Water Reuse 840

Dimethyl Acetamide 280

Residue 85 Potassium Carbonate 15

HCl 20% 50 Water 800

TOTAL 1248

TOTAL 1248

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STAGE - V

STAGE - IV

57

REACTION STEP - V

Product 50

Ethyl Acetate 180 Ethyl Acetate Recover 171 MDC 200

Activated Carbon 10

MDC Recover 188 Hyflo Super Cel 3

Residue 41

TOTAL 450 TOTAL 450

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CINITAPRIDE HYDROGEN TARTRATE

STAGE - I

INPUT (kg)

OUTPUT (kg)

4-Amino-2-ethoxy-5-nitro-N-(4-piperidyl) benzamide

20

REACTION STEP - I

PRODUCT

35

3-Cyclohexene-1-methanol 7 DMF Recover 189 Benzene sulphonyl chloride 11

Sodium Carbonate 3 WASTE WATER 730

TEA 25 Residue 49

Tartaric acid 15

Cyclohexane 88 Cyclohexane Recover 85

DMF 198

Methanol 233 Methanol Recover 225

Activated Carbon 10

Hyflo Super Cel 3

Water 700

TOTAL 1313

TOTAL 1313

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GLICLAZIDE

STAGE - I Butanol 200

REACTION STEP-I

PRODUCT (Stage I) 30

Toluene Sulfonylurea 30

Butanol Recover 190 Sodium Carbonate 20

Hydrazine Hydrate 11

Residue 22

Water 300

Waste Water 325 HCl 6

TOTAL 567

TOTAL 567

STAGE - II

Toluene 308

REACTION STEP - II

PRODUCT (STAGE - II) 27.7

p-toluenesulfonic acid 5

Toluene Recover 298 Stage - 1[N _ [(4_ methylphenyl) sulfonyl] - hydrazide carboxamide ] (Compound-IV)

30

l, 2- cyclopentane o ni anhydride (Compound-III)

23

Residue 62.3

Water 400

Water to ETP 440

TOTAL 828

TOTAL 828

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STAGE - III

THF

610

REACTION STEP - III

PRODUCT (Stage - III) 18.8

Stage - 2 27.7

THF Recover 595.0 anhydrous lithium chloride 13.85

Vapor Loss 30.0

sodium borohydride 4.43

Water Reuse 433 Water 415.5

Residue 26.68 Activated Charcoal 1.5

Hyflo 0.5

TOTAL 1073.48

TOTAL 1073.48

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STAGE - I [DCDPA]

INPUT (Kg)

OUTPUT (Kg)

2,6 Dichlorophenol 0.772

REACTION STEP - I

Product (Stage I) DCDPA 1

Sodium Methoxide 1.82

Ethyl Chloro Acetate Recover 0.513

Ethyl Chloro Acetate 0.54

Residue 1.923 Aniline 0.429

Waste Water To ETP 2.8

Caustic Soda 0.275

Water 2.4

TOTAL 6.236

TOTAL 6.236

STAGE - II [CPDCA]

Stage - I (DCDPA) 1

REACTION STEP - II

Product (Stage - Ii) CPDCA 1 Ethoxy Ethanol 2.5

Ethoxy Ethanol Recover 2.25 Acetyl Chloride 0.55

Residue 0.8

TOTAL 4.05

TOTAL 4.05

INDOLINE :

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STAGE -III

Stage - Ii CPDCA 1

REACTION STEP - III

PRODUCT (Stage - III) 0.9

Methanol 5.5

Methanol Recover 5.3 Aluminium Chloride 0.7

Vapor Loss 0.2 Water 3.7

Water reuse 4.5

Activated Carbon 0.05

Hyflo Super Cel 0.02

TOTAL 10.9

TOTAL 10.9

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LINAGLIPTIN :

STAGE - I INPUT [kg]

OUTPUT [kg]

Bromo Compound

100

REACTION STEP - I

PRODUCT (Stage I) 122

Chloro Compound 77.8 DMF Recover 588 Potassium carbonate 139.5 Dimethyl formamide 600 Residue 55.3 WATER 800

Waste Water To ETP 952 TOTAL 1717.3 TOTAL 1717.3

STAGE - II

STAGE - I

122

PRODUCT (STAGE - II) 107

3-Azido Piperdene 51 Acetonitrile Recover 176 Potasium Carbonate 112 1-Methyl 2-Pyrrodinone 732 1-Methyl 2-Pyrrodinone 713

Ethyl Acetate 1830

Acetonitrile 183 Ethyl Acetate Recover 1780 Water 1270 Waste Water To ETP 1298 Residue 226 TOTAL 4300 TOTAL 4300

REACTION STEP - II

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STAGE - III

Stage - Ii (Azido Compound)

107

REACTION STEP - III

Product (Stage - Iii) 61 Triphenyl Phospine 84.4 Acetonitrile Recover 261 THF 963

MDC 1605 Triphenyl Phospine 27

Acetonitrile 267.5 Triphenyl Phospine OXIDE 57

Water 2107 THF Recover 946 Activated Carbon 10 Waste Water 700 Hyflo Super Cel 3 Water Reuse 1500 Residue 36 MDC Recover 1553

Process Emission N2 6

TOTAL 5147 TOTAL 5147

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LOSARTAN : STAGE - I

INPUT (Kg)

OUTPUT (Kg)

2-Butyl-4-Chloro-5-hydroxy-methyl Imidazole

65

REACTION STEP - I

PRODUCT (STAGE - I) 83

Tri Butyl Tin Chloride 172

Toluene Recover 2225 Sodium Azide 34

Sodium Borohydride 9

Methanol Recover 420 Toluene 2300

HCl 25

Waste Water 2400

MEK 174

Residue 418.1 Acetone 435

Spent Carbon [Dry] 7 TBAB 7.2 MEK Recover 165 O-Xylene 800

NaOH 25 Acetone Recover 418 KOH 33.3

Carbon Tetrachloride 720 O-Xylene Recover 775 Ortho Tolyl Benzonitrile 90 L,3-Dibromo-5,5- Dimethyl Hydantoin 66 Carbon Tetrachloride 700 Benzoyl Peroxide 3.6 Water 2210 Activated Carbon 5 Hyflo Super Cel 2 Methanol 435

TOTAL 7611.1

TOTAL 7611.1

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LULICONAZOLE :

STAGE - I

INPUT (Kg)

OUTPUT (Kg)

(α,s) 2,4 –dichloro-a-(chloromethyl)benzene- methanol methane sulphonate 100

REACTION STEP - I

Product 100

1H-imidazole-1-acetonitrile 35

Toluene Recover 142 Carbon disulphide 23

KOH powder 18

Waste Water 221 Toluene 150

Residue 31

Water 200 Activated Carbon 10

Water Vapor Loss 45 Hyflo Super Cel 3

TOTAL 539

TOTAL 539

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MOXIFLOXACIN :

STAGE - I INPUT (Kg)

OUTPUT (Kg)

Moxifloxacin Q-Acid 100

REACTION STEP - I

PRODUCT 78

2,8-Diazobicyclo(4.3.0) nonane 29

Acetonitrile Recover 480

Acetonitrile 500

Residue 164

Triethyl amine 5

Waste Water 600

Methanol 650

Methanol Recover 625

HCl 90

Liquor Ammonia 60

Activated Carbon 10

Hyflo Super Cel 3

Water 500

TOTAL 1947

TOTAL 1947

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NEBIVOLOL :

STAGE - I :

INPUT (KG) OUTPUT(KG)

REACTION STEP - I

PRODUCT (Stage - I) 17

R*(S*)]-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran

15 Iso Propyl Alcohol Recover 250

Benzyl amine 24.8 Iso Propyl Alcohol 265

Waste Water To ETP 0 Benzyl Amine Rec 18 Residue 19.8 TOTAL 304.8

TOTAL 304.8

STAGE - II

STAGE - I 17

REACTION STEP - II

PRODUCT (STAGE - II) 22.5 R*R*)-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran 13.6

Palladium Charcoal 10 % 11.3 Methanol Recover 260 Ammonium Formate 14.2 Residue 73 Methanol 271

Pd / Ch Recover 10.9 Iso Propyl Alcohol 255 Iso Propyl Alcohol Recover 245 Activated Carbon 1.7 Hyflo Super Cel 0.6

Conc HCl 7 TOTAL 591.4 TOTAL 591.4

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OLMESARTAN MEDOXOMIL:

STAGE - I A + I B

INPUT (Kg)

OUTPUT (Kg)

Ethyl-4-(1-hydroxy-1-methylethyl) 2-propy H-((2-(2-(triphenyllnethyl)-2H-tetrazol-5 yl biphenyl-4-yl-1-methyl imidazole-5-carboxylic acid (Imidazole Ethyl Ester Derivative)

100

REACTION STEP - I

PRODUCT (Stage I) 272

4-[2-(trityltetrazol-5-yl)phenyl]benzyl bromide

227.5

Ethyl Acetate Recover 2600

Potassium Carbonate 72

N,N-Dimethylacetamide 1104 Residue 374.7

Acetone 700

Waste Water To ETP 4050.7

Water 3387

DIPE Recover 1273 THF 1608 Ethanol 268

THF Recover 1561.8

NaOH 15.72

4-(chloro methyl ) -5-methyl-1,3-dioxol-2-one 68

Acetone Recover 665

Sodium Iodide 8

Ethyl Acetate 2680

DMA Recover 1049 Nacl 268

Di Iso Propyl Ether 1340

TOTAL 11846.22 TOTAL 11846.2

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STAGE - II A + II B

STAGE - I

272

REACTION STEP - II

PRODUCT (STAGE - II) 152.6 Acetone 4313

Acetone Recover 4200

Sodium Bicarbonate 6.7 Activated Carbon 17 MDC Recover 2600

Hyflo Super Cel 3

Waste Water 1720 Ethyl Acetate 170

Water reuse 2000 Water 3707

Methylene Chloride 2721

Acetic Acid Recover 1590 Acetic acid 1671

Residue 618.1

TOTAL 12880.7

TOTAL 13380.7

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ROSUVASTATIN CALCIUM:

STAGE - I

4-Fluoro Benzaldehyde 52

REACTION STEP - I

PRODUCT (Stage I) 100

4-Methyl-3-oxo-pentanoic acid ethyl ester 66.3

Methanol Recover 237 KOH 30

Methyl Iodide 60

Waste Water To ETP 590.5 Methanol 250

Organic Residue 31.3

Water 500

TOTAL 958.3

TOTAL 958.8

STAGE - II

STAGE - I 100

REACTION STEP - II

PRODUCT (STAGE - II) 115

S-Methyl iso thio urea 35

MDC Recover 474 2,3-Dichloro-5,6-dicyano Benzoquinone 85

HMPA 100

HMPA Recover 94 MDC 500

WATER 300

Waste Water To ETP 310

Residue 45

2,3-Dichloro-5,6-dicyano Benzoquinone 82

TOTAL 1120

TOTAL 1120

STAGE – III

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STAGE - II 115

REACTION STEP - III

PRODUCT (Stage - III) 120

Meta chloro peroxybenzoic acid 118.68

Waste Water 500.5 MDC 300

MDC Recover 285 Water 500

Meta Chloro Benzoic Acid 108

Organic Residue 20.2

TOTAL 1033.7

TOTAL 1033.7

STAGE - IV :

STAGE - III 120

RECTION STEP - IV

PRODUCT (STAGE - IV) 96

Methyl amine 10.2

Methanol Recover 285 Ethanol 250

Residue 4.2 Methanol 300

Waste Water To ETP 327

Water 300

Ethanol Recover 238

TOTAL 980.2

TOTAL 980.2

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STAGE - V :

STAGE - IV 96

REACTION STEP - V

PRODUCT (STAGE - V) 112

Methane sulfonyl chloride 35

Di methoxy ethane Recover

285

Sodium hydride (60%) 1

Di methoxy ethane 300

HCl Gas Emission 11

Organic Residue 24

TOTAL 432

TOTAL 432

STAGE - VI :

STAGE - V 112

REACTION STEP - VI

PRODUCT (STAGE - VI) 95

Hydrogen Gas 0.56

Toluene Recover 284

Dibal - H 1

Toluene 300

Organic Residue 34.56

TOTAL 413.56

TOTAL 413.56

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STAGE - VII :

STAGE - VI 95

REACTION STEP - VII

PRODUCT (STAGE - VII) 155

Methyl(3R)-3-(tert butyl di methyl silyloxy)-5-oxo-6-triphenyl phosphoranylidene hexanoate

144.5

By Product - Triphenyl Phosphine (Reuse In Process) 75.2

Triethyl amine 15

DMF Recover 280 N,N-Dimethyl formamide 300

WATER 200

Organic Residue 24.3

Waste Water 220

TOTAL 754.5

TOTAL 754.5

STAGE - VIII :

STAGE - VII 155

REACTION STEP - VIII

PRODUCT (STAGE - VIII) 120

Hydrogen fluoride 5.1

THF Recover 237 THF 250

Ethyl Acetate 300

Ethyl Acetate Recover 285

Organic Residue 33.86

By Product - Tert-Butyl-Fluoro-Dimethyl Silane (Reuse In Process)

34.24

TOTAL 710.1

TOTAL 710.1

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STAGE - IX :

STAGE - VIII 120

REACTION STEP - IX

PRODUCT (STAGE - IX) 115

HYDROGEN GAS 0.48

THF Recover 480 Diethyl methoxy borane 20

Sodium boro hydride 1

Ethyl Acetate Recover 240 Ethyl acetate 250

THF 500

Residue 56.48

TOTAL 891.48

TOTAL 891.48

STAGE - X : (ROSUVASTATIN CALCIUM)

STAGE - IX

115

REACTION STEP - X

PRODUCT (STAGE - IX) 100

Calcium Chloride 13

Toluene Recover 478 Toluene 500

Ethyl Acetate 500

Ethyl Acetate Recover 483 Water 250

Activated Carbon 10

Residue 67 Hyflo Super Cel 3

Water reuse 263

TOTAL 1391

TOTAL 1391

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SERTACONAZOLE NITRATE : STAGE - I 1-2,4-Dichloro-Phenyl-2-Imidazole -1-Yl-Ethanol.

5

REACTION STEP-I

PRODUCT (Stage I) 3.85

Tartaric Acid 3.2 Methanol/ Acetone Recover 59 Acetone 38

Vapor Loss 3 Methanol 24 Organic Residue 4.35 TOTAL 70.2 TOTAL 70.2 STAGE – II STAGE – I 3.85

REACTION STEP – II

PRODUCT (STAGE – II) 3.5 Potassium Butoxide 1.72 DMF Recover 22 DMF 24 Bromo Methyl Thiophene 4 MDC Recover 36 MDC 40

Water 50 Ethyl Ether 7.2 Ethyl Ether 8 Waste Water To ETP 53 Residue 9.9 TOTAL 131.6 TOTAL 131.6

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STAGE – III

STAGE – II 3.5

REACTION STEP – III

PRODUCT (Stage – III) 3.5

Ethanol 18

Ethanol Recover 17 Water 16

Nitric Acid 1.4

Waste Water to ETP 17.4 Activated Carbon 1

Spent Carbon 2.5

Hyflo Super Cel 0.5

TOTAL 40.4

TOTAL 40.4

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SERTACONAZOLE NITRATE :

STAGE - I

1-2,4-DICHLORO-PHENYL-2-IMIDAZOLE -1-YL-ETHANOL.

5

REACTION STEP-I

PRODUCT (Stage I) 3.85

TARTARIC ACID 3.2

METHANOL/ ACETONE REC 59

ACETONE 38

VAPOR LOSS 3

METHANOL 24

ORGANIC RESIDUE 4.35

TOTAL 70.2

TOTAL 70.2

STAGE - II

STAGE - I

3.85

REACTION STEP -

II

PRODUCT (STAGE - II) 3.5

POTASSIUM BUTOXIDE

1.72

DMF REC 22

DMF 24

VAPOR LOSS 2

BROMO METHYL THIOPHENE 4

MDC REC 36

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MDC

40

VAPOR LOSS 4

WATER

60

ETHYL ETHER 7.2 ETHYL ETHER 8

VAPOR LOSS 0.8

WASTE WATER TO ETP 63

ORGANIC RESIDUE 3.1

TOTAL 141.6

TOTAL 141.6

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SERTRALINE HCl

STAGE - I :

INPUT (KG) OUTPUT(KG)

Water 250

REACTION STEP - I

PRODUCT (Stage - I) 52

Tetralone 50 Methanol Recover 95

Mono Methyl Amine 40 % 150

Methanol 100 Waste Water To ETP 298 Residue 105 TOTAL 550

TOTAL 550

STAGE - IIA

STAGE - I 52

REACTION STEP - II

PRODUCT (STAGE - II) 40

Methanol 390 Methanol Recover 387 Palladium Charcoal 10 % 1.04

Hydrogen Gas 14

Pd / Ch Recover 1.04 Methanolic HCl 20 % 35

Gas Emission 12 Activated Carbon 5.2 Hyflo Super Cel 1.6

Residue 58.8

TOTAL 498.84 TOTAL 498.84

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STAGE - IIB

STAGE -2A 40

REACTION STEP - III

PRODUCT (STAGE - III) 19

Ethyl Acetate 180 Ethyl Acetate Recover 171 NaOH 18

Mandelic Acid 12

Methanol Recover 95 Methanol 100

Organic Residue 47 Waste Water 18 TOTAL 350 TOTAL 350

STAGE - III

STAGE -2B 19

REACTION STEP - III

PRODUCT (STAGE - III) 25

Aceto nitrile 180 Aceto nitrile Rec. 172 HCl Gas 9

Residue 11 TOTAL 208 TOTAL 208

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SITAGLIPTIN :

STAGE – I

INPUT [kg]

OUTPUT [kg]

(2,4,5-Trifluoro-phenyl)aceticacid 20

REACTION STEP - I

PRODUCT (Stage I) 34 Thionyl chloride 12.5 MDC Recover 775 DMF 7

MDC 800

TEA Recover 105 TEA 110

Meldrums acid 15.5 Residue 32.3 Sodium hydroxide 13 Waste Water To ETP 265 WATER 240 SO2 Gas Emission 6.7 TOTAL 1218 TOTAL 1218

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STAGE - II

STAGE - I

34

REACTION STEP - II

PRODUCT (STAGE - II) 40

3-(Trifluoro methyl)5,6,7,8-tetrahydro(4,3-a)pyrazine HCl

23 Acetonitrile Recover 162

Methane sulphonic acid 10

Ammonia 1.7

Sodium bicarbonate 8.5

Ethyl Acetate Recover 238

Ethyl acetate 250

Acetonitrile 170 Waste Water To ETP 367.5

Water 340

Activated Carbon 10 Residue 33.6

Hyflo Super Cel 3 Process Emission 8.9

TOTAL 850

TOTAL 850

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SOFOSBUVIR :

STAGE - IA

INPUT [kg]

OUTPUT [kg]

L-alanine iso propyl ester HCl

232

REACTION STEP - I

PRODUCT (Stage I) 558

Phenyl dichloro phosphate 290 MDC Recover 5904 Triethyl amine 435 Methylene chloride 6137

TEA HCl Recover 406 Pentaflurophenol 421 Water 4080 Organic Residue 142 Waste Water To ETP 4200

Pentaflurophenol Recover 385

TOTAL 11595 TOTAL 11595

STAGE - IB Stage - IA 558

REACTION STEP - II

PRODUCT (STAGE IB) 174

Di isopropyl ether 2760 Di isopropyl ether

Recover 2650

Residue 494 TOTAL 3318 TOTAL 3318

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STAGE - II

STAGE - I

174

REACTION STEP - III

PRODUCT (STAGE - II) 135

2'-Deoxy-2'-Fluoro-2'-C-Methyl Uridine 100 THF Recover 2588 THF 2690

Tert-Butyl magnesium chloride 72.7 Ethyl Acetate Recover 1728 HCl 32 % 184.4

WATER 5644 Waste Water 3000 ETHYL ACETATE 1800 Water Reuse 3000 Sodium carbonate 40

Sodium Chloride 400 Process Emission Butane 36 MDC 3432 MDC Recover 3295 Activated Carbon 10

Hyflo Super Cel 3 Di Isopropyl Ether Recover 278 Diisopropylether 290 Residue 711 Penta Fluorophenol Recover 69

TOTAL 14840

TOTAL 14840

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TAPENTADOL HCl

STAGE - I

1-(3-Methoxyphenyl)propan-1-one

40

REACTION STEP - 1

PRODUCT 50

Dimethyl Amine 100

Ethyl Acetate Recover 285 Formaldehyde 20

Ethyl Magnesium Bromide 29

Waste Water 150 D(-) Tartaric Acid 32

Residue 151.9

HCl 7.5 Palladium Hydroxide 0.5

IPA Recover 185 Hydrogen Gas 0.4

IPA 200

PROCESS EMISSION [HBr] 20 Ethyl Acetate 300

Water 100

Palladium Hydroxide 0.5 Activated Carbon 10

Hyflo Super Cel 3

TOTAL 842.4

TOTAL 842.4

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TELMISARTAN :

STAGE - I

INPUT (Kg)

OUTPUT (Kg)

7-methyl-2-propyl-3H-benzo[d]imidazole COOH

1.43

REACTION STEP - I

PRODUCT

3.03

N-methyl-O-phenylene diamine 0.84 Toluene 4.29 Toluene Recover 4.07

Poly phosphoric acid 3.57

Residue 3.22

Bromo Ester compound 2.58 Waste Water With H3PO4 6

Water 4.29 Distillation Residue 0.81

Activated Carbon 0.1

Hyflo Super Cel 0.03

TOTAL 17.13

TOTAL 17.13

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TENELIGLIPTIN HYDROBROMIDE STAGE - I

CYSTEAMIN HCl 1.5

REACTION STEP-I

Product (Stage I) 1.15

Formaldehyde 1.05

MDC Recover 7.3 MDC 7.5

Sodium Carbonate 2.5

Residue 2.6

Sodium Sulphate 1.5

Waste Water 12.5 Water 9.5

Total 23.55

Total 23.55

STAGE – II 2S,4S-4-hydroxy-L-prolin 3.1

REACTION STEP – II

Product (Stage – Ii) 4.6

THF 7.5

THF Recover 7.2

Sodium Bicarbonate 1.5

FMOC 6.5

DIPE Recover 1.4 Water 8.5

DIPE 1.5

Waste Water To ETP 11.5 1 N HCl SOLN 3.5

Residue 7.4

TOTAL 32.1

Total 32.1

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STAGE - III

STAGE - II

4.6

REACTION STEP - III

PRODUCT (Stage - III) 2.53 MDC 8.5

MDC Recover 8.1

HOBT 1 N=Methyl Morpholine 1.3

DIPE Recover 7.2 Stage - I 1.15

EDC HCl 3

Ethyl Acetate Recover 6.3 NaOH 0.25

DIPE 7.5

IPA Recover 7.2 Ethyl Acetate 6.5

HCl Solution 50% 2

Waste Water 8.85 Water 5.6

Residue 8.72

Iso Propyl Alcohol 7.5

TOTAL 48.9

TOTAL 48.9

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STAGE - IV

STAGE - III 2.53

REACTION STEP – IV

PRODUCT (STAGE – IV) 1.5

Triethyl Amine 3.5

TEA Recover 3.3 MDC 10

DMSO 7.5

MDC Recover 9.6 Sulphur Trioxide Pyridine Complex 2.85

HCl 7

DMSO Recover 7.1 Na2CO3 0.5

Na2SO4 0.25 Acetone 1.65

Residue 12.85

Acetone Recover 1.45

TOTAL 35.8

TOTAL 35.8

STAGE -V

3-Amino Crotononitrile

2

REACTION STEP - V

PRODUCT (Stage - V) 3.7

HCl 2

Waste Water 5.8 Phenyl Hydrazine 2.45

NaHCO3 0.05

Water 3

TOTAL 9.5

TOTAL 9.5

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STAGE -VI

BIS 2-CHLORO ETHYL AMINE HCl

4

REACTION STEP - VI

PRODUCT (Stage - VI) 1.23

DMF 7.5

DMF Recover 7.1 Sodium Hydride 1

Stage - V 3.7

MDC Recovery 2.3 KOH 1.85

MDC 2.5

Toluene Recover 7.50 Toluene 8

Acetic Acid 3.7

Residue 10.47 Activated Carbon 0.04

Waste Water reuse 7.2

Hyflo 0.01 Water 3.5

TOTAL 35.80

TOTAL 35.80

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URSODEOXYCHOLIC ACID

STAGE - I Methanol 1200

REACTION STEP-I

Product (Stage I) 837

Cholic Acid 750

Ethyl Acetate Recover 1305 HCl 7.5

Sodium Acetate 10

Methanol Recover 1140 Toulene 1250

Dimethyl Amino Pyridine 22.5

Residue 320 Ethyl Acetate 1375

Toluene Recover 1185

Water 450 Acetic Anhydride 190

Waste Water 468

TOTAL 5255

TOTAL 5255

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.

STAGE - II

Ethyl Acetate 1125

REACTION STEP-II

Product (Stage Ii) 792

Stage - I 837

Ethyl Acetate Recover 1070 Acetic Acid 75

Sodium Hypochlorite 750

Methanol Recover 1140 Methanol 1200

Organic Residue 760

Waste Water 225

TOTAL 3987

Total 3987

STAGE - III

Triethylene Glycol 1320

REACTION STEP-III

PRODUCT (Stage Iii) 585

Stage - Ii 792

Waste Water 3000 KOH 354

Triethylene Glycol Recover 1255

Hydrazine Hydrate 67 Sulphuric Acid 310

Residue 519 Water 2510

Chenodeoxycholate 6

TOTAL 5359

TOTAL 5359

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STAGE - IV

Butanol 864

REACTION STEP-IV

Product (Stage Iv) 526 Methylene Chloride 672

Waste Water 585

Stage - Iii 585

Butanol Recover 820 Sulphuric Acid 37

Sodium Bromide 92

Residue 619 Water 300

TOTAL 2550

TOTAL 2550

STAGE - V Butanol 1570

REACTION STEP-V

Product (Stage - V) 589

Stage - Iv 26

Butanol Recover 1500 Sodium Metal 46

Phosphoric Acid 156

Ethyl Acetate Recover 2020 Imidazole 97

Residue 180

Ethyl Acetate 2130

Waste Water 986 Water 750

Total 5275

Total 5275 Stage - Vi

Butanol 450

REACTION STEP-VI

Product (Stage - Vi) 520 Stage - V 589

Butanol Recover 420

D M Stage – 5 Phosphoric Acid

450

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Phosphoric Acid 90

Ethyl Acetate Recover 850 Methanol 810

HCl 9

Waste Water 200 Ethyl Acetate 900

Methanol Recover 770

Residue 538

Total 3298

Total 3298

Stage – Vii

D M Water 1200

REACTION STEP-VII

Product (Stage – Vii) 465 Stage – Vi 520

Ethyl Acetate Recover 855

NaOH 193.8 Ethyl Acetate 900

Water reuse 1618 Acetic Acid 97.2

Residue 100

Phosphoric Acid 97

Activated Carbon 24

Hyflo 6

Total 3038

TOTAL 3038

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VORICONAZOLE STAGE - I THF 300

REACTION STEP-I

PRODUCT (Stage I) 64

3,5-dibromo-1H-1,2,4-triazole

43.7

THF REC 285

2-chloro-2,4-difluoroacetophenone 40.4

VAPOR LOSS 15

POTASSIUM CARBONATE 36.3

IPA REC 211

IPA

219

VAPOR LOSS 8

WATER 44

ORGANIC RESIDUE 20.4

WASTE WATER 80

TOTAL 683.4

TOTAL 683.4 STAGE - II

MDC

300

REACTION STEP - II

PRODUCT (STAGE - II) 46

6-ethyl-5-fluoropyrimidin-4-ol

30

MDC REC 285 TEA 59

VAPOR LOSS 15

METHANE SULPHONYL CHLORIDE 18

WASTE WATER TO ETP 174.8

ACETIC ACID

37.8

ORGANIC RESIDUE 2

MAGNESIUM SULPHATE

18

WATER 60

TOTAL 522.8

TOTAL 522.8

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STAGE - III

STAGE - II

46

REACTION STEP - III

PRODUCT (Stage - III) 65

MDC 30

MDC REC 27 N-BROMO SUCCINIMIDE 55.8

VAPOR LOSS 3

Azo bis IsoButyronitrile 1.71

WASTE WATER 152

SODIUM BISULPHITE 19.86

ORGANIC RESIDUE 38.37 SODIUM BICARBONATE 15

MAGNESIUM SULPHATE 27

WATER 90

TOTAL 285.37

TOTAL 285.37

STAGE - IV

STAGE - III

65

REACTION STEP - IV

PRODUCT (STAGE - IV) 75.5

THF 640

THF REC 608 MDC 1200

VAPOR LOSS 32

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STAGE - I 64

MDC REC 1140

ZINC 44

VAPOR LOSS 60

LEAD 3.5

ETHYL ACETATE REC 190 IODINE 21.3

VAPOR LOSS 10

HCL 23.5

WASTE WATER TO ETP 444

NaCl 57.7

ORGANIC RESIDUE 53.5 MgSO4 70

n-HEXANE REC 182

ETHYL ACETATE 200

VAPOR LOSS 10 n-HEXANE 192

WATER 224

TOTAL 2805

TOTAL 2805

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STAGE -V

STAGE - 4

75.5

REACTION STEP - III

PRODUCT (Stage - V) 40.5

TOLUENE

200

WASTE WATER 220 Pd /Ch 22.6

TOLUENE REC 190

AMMONIUM FORMATE 124.6

VAPOR LOSS 10

ISO PROPYL ETHER 180

ISO PROPYL ETHER 171

MAGNESIUM SULPHATE 21

VAPOR LOSS 9 WATER 75

REC Pd /Ch 22.6

ORGANIC RESIDUE 35.6 TOTAL 698.7

TOTAL 698.7

STAGE -VI

ACETONE

125

REACTION STEP - III

PRODUCT (Stage - VI) 27

STAGE - 5 40.5

ACETONE REC 119 R-(-)-10-camphorsulfonic acid 54

VAPOR LOSS 6

ORGANIC RESIDUE 67.5

TOTAL 219.5

TOTAL 219.5

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STAGE -VII

MDC

270

REACTION STEP - III

PRODUCT (Stage - VII) 6

SODIUM BICARBONATE 108

MDC RECOVERY 257

STAGE - VI 27

VAPOR LOSS 13 MAGNESIUM SULPHATE 24

IPA REC 25.4

CARBON 1.35

VAPOR LOSS 1.4 HYFLO 0.54

ORGANIC RESIDUE 21

IPA 27

WASTE WATER 213

ISO PROPYL ETHER 135

DIPE REC 128

WATER 80

VAPOR LOSS 7

SPENT CARBON 1.09

TOTAL 672.89

TOTAL 672.89

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3-[1-Hydroxy-2-(Methylamino)ethyl]phenol

(D,L- Phenylephrine Base)

PROCESS FLOW DIAGRAM

Stage-1:- Bromo compound

3-Hydroxy Acetophenone + Ethyl acetate

AIBN +Alcl3 + Bromine (Liq)

GLR Reactor

Water addition & layer separation

Ethyl Acetate layer Charging GLR Reactor

N-methyl benzyl amine addition GLR Reactor

Water addition and workup GLR Reactor

Toluene and HCl addition then Layer separation GLR Reactor

Product Isolation + temp 40 to 45° Maintaining GLR Reactor

Washing Centrifuge& Drying

Bromo- Compound

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Stage-2 :-D-L Phenylephrine Base

Bromo compound

S.S Reactor

Methanol solvent + Acetic Acid + 10 % PDC

Nitrogen gas + Hydrogen gas

Temp 50 to 55 ° + 24hrs. Maintain

S.S Reactor

Filter 10 % PDC

Water addition and Charcoal treatment S.S Reactor

Methanol reuse & Recycle

PH adjustment S.S Reactor

Filtration and washing Centrifuge, Drying

D-L

Phenylephrine Base

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N-(Hexahydrocyclopenta[c]pyrrol-2(1H)-ylcarbamoyl)-4-Methylbenzenesulfonamide

(Gliclazide)

Stage – 1 :Gliclazide –crude

Hexahydrocyclopenta[c]pyrrol-2(1H)-Amine Hydrochloride

N-Carbamoyl-4-Methylbenzenesulfonamide

S.S. Reactor

Toluene + SodiumMethoxide

Reflux Temp S.S. Reactor

Centrifuging

Drying

Gliclazide Crude

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PROCESS FLOW DIAGRAM

Stage -2 : Gliclazide

Gliclazide Crude

G.L. Reactor

MDC solvent

Activated Charcoal Sparkler Filter

MDC Recovery

Methanol Centrifuging ML for Reuse

Drying

Milling, Shifting & Packing

Gliclazide

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N-[[(2S)-(-)-1-Ethylpyrrolidin-2-yl]-2-Methoxy-5-Sulfamoylbenzamide

(Levosulpiride)

PROCESS FLOW DIAGRAM

Stage -1 : Levosulpiride -Crude

2-Methoxy-5-Sulfamoyl Benzoic Acid Methyl Ester.

S-(-)-1-Ethyl-2-Amino Methyl Pyrrolidine

S.S. Reactor

Mono Ethylene Glycol

Temp 50 to 55° S.S. Reactor

Cool 30 to 35° S.S. Reactor

Centrifuge

Drying

Levosulpiride

Crude

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Stage-2 :Levosulpiride

Levosulpiride -crude

Methanol

GLR Reactor

Temp 60 To 65 °c

Activated carbon Sparkler Filter

GLR Reactor

Methanol Washing Centrifuge ML for reuse and recycle

Drying

Milling, Shifting & packing

Levosulpiride

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3-[(1S)-1-Hydroxy-2-(Methylamino)Ethyl]Phenol

(L- Phenylephrine Base)

PROCESS FLOW DIAGRAM

Stage-1 :- L- Phenylephrine Base

IPA +Water + L(+) tartaric Acid

D-L Phenylephrine Base

S.S. Reactor

Temp 40 to 45 °

Filtration

Centrifuge ML for L-base Isolation

Wet cake Charging + Caustic Flakes addition and Solid isolation

S.S Reactor

Centrifuge MLRecycle and Reuse.

Drying

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Acetic anhydride + Sulfuric acid and Heating 80 to 85° temp

GLR Reactor Acetic Acid Distilled out

CF ML from D,L –Base Resolution Stage.

Water + PH adjustment with Caustic Flakes

S.S. Reactor

Filtration

Centrifuge ML for Recycle and Reuse.

Drying

L-

Phenylephrine Base

PH adjust with Caustic Solution

GLR Reactor

Centrifuge &Drying

L-

Phenylephrine Base

L- Phenylephrine Base (Resolution )

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3-[(1S)-1-Hydroxy-2-(Methylamino)ethyl]phenol Hydrochloride(Phenylephrine HCL)

PROCESS FLOW DIAGRAM

Stage-1 : Phenylephrine HCl

L-Phenylephrine Base

IPA and HCL Gas

GLR Reactor

Temp 60 To 65 °c

Activated carbon Sparkler Filter

GLR Reactor

IPA Washing Centrifuge ML for reuse and recycle

Drying

Milling, Shifting & packing

Phenylephrine HCl

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(3S)-3-(Aminomethyl)-5-Methylhexanoic Acid

(PREGABALIN)

PROCESS FLOW DIAGRAM

STAGE :(3S)-3-(Aminomethyl)-5-Methylhexanoic Acid (PREGABALIN)

R-CMH + Water

Caustic Flakes

S.S Reactor

Chlorine Gas

Temp 60° to 65° and Adjust PH S.S Reactor

Centrifuge

IPA+Water

Charcoal Treatment GLR Reactor

Isolation GLR Reactor

Centrifuge

CF ML for Reuse and Recycle

Drying , Milling & Shifting

Packing

( PREGABALIN )

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(+/-)-3-( Carbamoylmethyl )-5-Methylhexanoic Acid (CMH)

PROCESS FLOW DIAGRAM

STAGE-1 :(+/-) 3-(Carbamoylmethyl)-5-Methylhexanoic Acid ( CMH)

Isovaleraldehyde

Cynoacetamide + Water

GLR Reactor

Sulfuric Acid

Heat Temp 70 to 80° GLR Reactor

Toluene Charging GLR Reactor

Urea Charging and temp 130 to 140° GLR Reactor Toluene for Distillation

PH adjustment, Maintaining& Charcoal treatment GLR Reactor

PH adjustment and Isolation GLR Reactor

Centrifuge

Drying & Packing

CMH

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(Sucralfate)

PROCESS FLOW DIAGRAM

Stage -1 : Sucralfate

Pyridine GLR Reactor

Chlorosulfonic Acid

Sucrose

GLR Reactor

Ammonia Solution + Methanol

Methanol washing Centrifuge

Wet Cake Charging + Water S.S Reactor

Activated Carbon + Hyflow Filter

Charging Filtrate

S.S Reactor

Aluminum Hydroxy Chloride

Centrifuge

Water Washing

Drying

Milling & Shifting

Sucralfate

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Enclosure: 9 Details of Water Consumption and Waste Water Generation

Application Water Consumption

(KL/Day) Waste Water Generation

(KL/Day) Domestic (A) 6.0 6.0 Gardening (B) 2.0 0.0 Industrial (C) Process 60 49 Washing 4.0 4.0 Boiler 1.0 0.1 Cooling 2.0 0.2 Scrubber 1.0 1 Total ( Industrial)

68.0 54.3

Total (A+B+C) 76.0 60.3

Domestic water Consumption will be around 6 KLPD and sewage generated will be disposed to soak pit via septic tank @6 KLPD.

Gardening water consumption will be 2.0 KLPD Industrial effluent generation will be 54.3 KLPD which will send to Chhatral Enviro Management

System Pvt. Ltd for spray drying to achieve zero Discharge.

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Product Batch Size(In

kg)

Production in

MT/Month

No. of Batches/Month

Water Consumption in KL/Batch

Effluent Generation in KL/Batch

Water Consumption

in KL/Day

Effluent generation in

KL/Day

Amisulpride 190 5 26 0.7 0.946 0.74 1.00

Azilsartan Medoxomil

50 1 20 3.2 2.505 2.56 2.00

Cinitapride Hydrogen Tartrate

35 1 29 0.7 0.73 0.80 0.83

Indoline 0.9 5 5556 0.0061 0.0028 1.36 0.62 Linagliptin 61 1 16 4.177 2.25 2.74 1.48 Losartan Potassium 83 5 60 2.21 2.4 5.33 5.78 Luliconazole 100 1 10 0.2 0.221 0.08 0.09 Moxifloxacin 78 1 13 0.5 0.6 0.26 0.31 Nebivolol 22.5 1 44 0 0 0.00 0.00 Olmesartan Medoxomil

152.6 1 7 7.094 6.0507 1.86 1.59

Rosuvastatin Calcium 100 5 50 2.05 1.621 4.10 3.24

Sertaconazole Nitrate

3.5 1 286 0.066 0.0704 0.75 0.80

Setraline HCl 25 1 40 0.25 0.316 0.40 0.51 Sitagliptin 40 5 125 0.58 0.6325 2.90 3.16 Sofosbuvir 135 1 7 9.724 7.2 2.88 2.13 Tapentadol HCl 50 1 20 0.1 0.15 0.08 0.12 Telmisartan 3.03 5 1650 0.00429 0.006 0.28 0.40 Teneligliptin Hydrobromide

1.23 5 4065 0.0271 0.03285 4.41 5.34

Ursodeoxycholic Acid

465 5 11 5.21 5.464 2.24 2.35

Velpatasvir 200 1 5 3.6 4.28 0.72 0.86 Vilazodone 200 1 5 3.42 4.1 0.68 0.82 Voriconazole 200 1 5 1.91 1.484 0.38 0.30 Pregabalin 700 25 36 2.8 1.981 4.00 2.83 R-CMH 504 25 50 4.8 2.532 9.52 0.00 (+)-3- (carbamoylmethyl)-5- methylhexanoic Acid

1260 50 40 3.5 4.543 5.56 7.21

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Phenylphrine HCl 550 5 9 0 0 0.00 0.00 L-Phenylephrine Base

460 5 11 2.5 1.205 1.09 0.52

DL-Phenylephrine Base

238 5 21 1.25 3.254 1.05 2.73

Gliclazide 875 7 8 0 0 0.00 0.00 Sucralfate 1160 25 22 4 2.056 3.45 1.77 Levosulpiride 1250 10 8 0 0 0.00 0.00

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Water Balance Diagram

Note: Industrial Effluent will be primary treated at In-house ETP and finally discharge to Chhatral Enviro Management System Pvt. Ltd for spray drying to achieve zero discharge.

Water Consumption 76

Domestic 6

Sewage

2

Gardening 2

Industrial 68

Process 60

Boiler 1.0

W/W 49

Cooling 2.0

W/W 4

Scrubber 1.0

Blow down 0.1

To Soak Pit/ Septic Tank

Washing 4.0

All unit in KL/Day

To ETP 54.3

Blow down 0.2

W/W 1

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Enclosure: 10

Details of Effluent Treatment Plant

Sr. No. Name of Unit No. of Unit Size (Feet)

1. Collection Tank 2 12×12×7 (Each)

2. Neutralization Tank 2 12×12×7 (Each)

3. Primary Settling Tank 1 16×16×7

4. Final Collection Tank 1 60 KL

5. Sludge Drying Bed 4 ---

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Enclosure: 11

Details of Flue Gas Emission And Process Gas emission system with APC System

Details of Flue Gas Emission:

Sr. No.

Stack Attached To

No. of Unit

Stack Height (m)

Air Pollution Control Measure

Pollutants SPM

mg/NM3 Sox

PPm NOx

PPm

1 IBR Boiler (3 MT/Hr) 1 16

Multi Cyclone Dust collector and Bag Filter

<150 <100 <50

2 Hot Air Generator 1 16

Multi Cyclone Dust collector and Bag Filter

<150 <100 <50

3 D.G. Set 1 9 --- <150 <100 <50

Details of Process Emission:

Sr. No.

Stack Attached To

No. of Unit

Stack Height (m)

Air Pollution Control Measure Pollutants

1. Reaction Vessel 1 16

Two Stage Scrubber System

Scrubber NH3

2. Reaction Vessel 1 16

Water Scrubber Followed By

Alkali Scrubber

SO2<100 ppm

3. Reaction Vessel 1 16 Water Scrubber HCl

4. Reaction Vessel 1 16 - N2

5. Reaction Vessel 1 16 --- HBr

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Fuel Requirement:

Sr. No Name of Fuel Quantity

1 Briquette/Agro Waste/Bio Coal 9 Ton/Day

2 Diesel 10 Lit. /Hr

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Enclosure: 12

Details of Hazardous Waste Generation with its Management

Sr. No.

Type of Hazardous Waste Cat. No.

Quantity Management

01 ETP Waste 26.2 250 MT/Annum.

We will pack all our generated ETP waste into HDPE bags. Then after we will store it into proposed Solid Waste Storage Area. Then after it will be disposed to TSDF as we will become the member of it after obtaining Environment Clearance.

02 Discarded Containers 33.3 500 Nos./M We will store all our discarded containers into provided solid waste storage area. Then after it will be return back to raw material supplier or use for packing of ETP waste.

03 Spent Oil 5.1 10 Lit/Yr. We will store into carboys and then after it will be reuse as a lubricant in our plant machineries.

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Enclosure: 13

Name and Address of Director

Sr. No. Name Address

1. Jagdish Kantilal Sheth 23, Ashwavilla Bunglows off. S. G. Road sindhu Bhavan, Thaltej,

Ahmedabad-380059

2. Keyur Jagdishchandra sheth 23, Ashwavilla Bunglows off. S. G. Road sindhu Bhavan, Thaltej,

Ahmedabad-380059

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Enclosure: 14

Land SuPPorting Document

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Enclosure: 15

Site Plan and Layout Plan

(Attached)

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904

905/P

904

905/P

903/1

903/2

906

907

913

908

909

910

911

912

VILLAGE BOUNDARY OF DHANOT

902

V

I

L

L

A

G

E

B

O

U

N

D

A

R

Y

O

F

A

N

K

H

O

L

905/P

R

A

I

L

W

A

Y

L

I

N

E

914

QA-QC-MICROBIOLOGYLAB (R&D AND PROCESSDEVELOPMENT LAB G+1)

200 SQ MT

RO

AD

RO

AD

9.1

44 R

OA

D

RO

AD

R

O

A

D

9.144 M

T R

OA

D

RO

AD

APi S

TORA

GE A

NDDI

PATC

H AR

EA (

G+1)

250

SQ M

T

RM STORAGE GODOWN1200 SQ MT.

STOR

AGE

AREA

-IN

TERM

EDIA

TES

100

SQ M

T.

INTERMEDIATEPRODUCTION AREA

(G+2)700 SQ MT.(PRESENT)

ADMIN BUILDING(G+1)

200 SQ MT.

ETP500 SQ MT.

FINI

SHED

GOO

DS -

INTE

RMED

IATE

S80

SQ M

T.

PHARMA PRODUCTION AREAINCLUDING DRYING &

PACKAGING AREA (G+1)500 SQ MT.(PRESENT)

TANK FARM550 SQ MT.

UTILITY AREA415 SQ MT.

CANTEENFOR

STAFF/WORKER(G+1)

150 SQ MT.

SECU

RITY

CAB

IN50

SQ M

T.4.5 MT WIDE ROAD

4.5 MT WIDE ROAD

4.5

MT

WID

E RO

AD

4.5 MT WIDE ROAD

EXIT

ENTRY GATE

GATE

PILO

T PL

ANT

175

SQ M

T.

WAITING /FIRST AID /

CRECHE / CHANGE RMFOR STAFF & WORKERS

200 SQ MT.

UG TANK, PUMP HOUSE& RO WATER PLANT

140 SQ MT.

TWO AND FOUR WHEELER PARKING455 SQ MT.

18.0

MT

WID

E RO

AD

BORE WELL

PHARMA PRODUCTION AREAINCLUDING DRYING &

PACKAGING AREA (G+1)335 SQ MT.(FUTURE)

INTERMEDIATEPRODUCTION AREA

(G+2)465 SQ MT.(FUTURE)

STP

TWOPOLE

STRUCTURE

MECH. UTILITIES HVAC

ELECTRICAL---

FIRE SAFETY

01. ARCHITECTURAL :02. STRUCTURAL :03. HVAC :04. ELECTRICAL :05. UTILITIES :

REF. DRGS. :

ASSOCIATES :

---

--- ---

-------------------------

DESCRIPTION CHECKEDDATEREV NO. DRAWN

GENERAL NOTES :

KEY PLAN

N

---- ---- ---- ---- ----

SCALE

CHECKED

DRAWN

DESIGNED

DRAWING NUMBER :

DATE :

REVISION

APPROVED

PROJECT NO:

S3M DESIGN CONSULTANTS LLP

ENGINEERING + PLANNINGPHONE: +91 (079) 66118122/66118123W: www.s3mconsultants.com E: [email protected]

B-801, WESTGATE, NEAR YMCA CLUB, S G HIGHWAY, AHMEDABAD-15.

THIS DRAWING IS EXCLUSIVE PROPERTY OF "S3M DESIGN CONSULTANTS LLP"AND SHOULD NOT BE USED,COPIED,REPRODUCED AND EXHIBITED IN ANY WAYDETRIMENTAL TO OUR INTEREST WITHOUT OUR WRITTEN CONSENT.

MASTER LAYOUT---

ALT-03 R0APPROVAL

A1:300

13-03-2018

KETAN

J.M

J.M

J.M

ATLAS LIFE SCIENCESAT CHHATRAL

----

A1

AutoCAD SHX Text
B
AutoCAD SHX Text
B
AutoCAD SHX Text
B
AutoCAD SHX Text
B
AutoCAD SHX Text
1. ALL DIMENSIONS ARE IN mm. & LEVELS ARE IN METER. ALL DIMENSIONS ARE IN mm. & LEVELS ARE IN METER.
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Enclosure: 16

Valuation Certificate

(Attached)

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