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1 PRE - FEASIBILITY REPORT for PROPOSED EXPANSION OF BULK DRUG AND BULK DRUG INTERMEDIATES IN EXISTING UNIT of M/s. DARSHAN PHARMACHEM PVT. LTD. PLOT NO. 3609, NEAR FICOM CHOKDI, GIDC ESTATE, ANKLESHWAR-393002, DISTRICT: BHARUCH, GUJARAT NABL Accredited Testing Laboratory ISO 9001:2008 Certified Company Aqua-Air Environmental Engineers P. Ltd. 403, Centre Point, Nr. Kadiwala School, Ring Road, Surat - 395002 Prepared By: NABL Accredited Testing Laboratory ISO 9001:2008 Certified Company Aqua-Air Environmental Engineers P. Ltd. 403, Centre Point, Nr. Kadiwala School, Ring Road, Surat - 395002 NABL Accredited Testing Laboratory ISO 9001:2008 Certified Company Aqua-Air Environmental Engineers P. Ltd. 403, Centre Point, Nr. Kadiwala School, Ring Road, Surat - 395002 Prepared By:

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Page 1: PRE - FEASIBILITY REPORT - Welcome to Environment · PRE - FEASIBILITY REPORT for PROPOSED EXPANSION OF BULK DRUG AND BULK DRUG INTERMEDIATES IN ... Fumarc acd 0.28 Methanol. 2 16

1

PRE - FEASIBILITY REPORT

for

PROPOSED EXPANSION OF BULK DRUG AND

BULK DRUG INTERMEDIATES IN

EXISTING UNIT

of

M/s. DARSHAN PHARMACHEM PVT. LTD.

PLOT NO. 3609, NEAR FICOM CHOKDI, GIDC ESTATE,

ANKLESHWAR-393002, DISTRICT: BHARUCH, GUJARAT

NABL Accredited Testing Laboratory

ISO 9001:2008 Certified Company

Aqua-Air Environmental Engineers P. Ltd.

403, Centre Point, Nr. Kadiwala School, Ring

Road, Surat - 395002

Prepared By:

NABL Accredited Testing Laboratory

ISO 9001:2008 Certified Company

Aqua-Air Environmental Engineers P. Ltd.

403, Centre Point, Nr. Kadiwala School, Ring

Road, Surat - 395002

NABL Accredited Testing Laboratory

ISO 9001:2008 Certified Company

Aqua-Air Environmental Engineers P. Ltd.

403, Centre Point, Nr. Kadiwala School, Ring

Road, Surat - 395002

Prepared By:

Page 2: PRE - FEASIBILITY REPORT - Welcome to Environment · PRE - FEASIBILITY REPORT for PROPOSED EXPANSION OF BULK DRUG AND BULK DRUG INTERMEDIATES IN ... Fumarc acd 0.28 Methanol. 2 16

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CONTENTS

Sr. No. Description Page No.

1. Executive Summary 3

2. Introduction of the Project/Background information 31

3. Project Description 32

4. Site Analysis 40

5. Planning Brief 42

6. Proposed Infrastructure 43

7. Rehabilitation and resettlement (R & R) Plan 44

8. Project Schedule & Cost Estimates 45

9. Analysis of Proposal (Final Recommendations) 45

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1.0 EXECUTIVE SUMMARY

1.1 Company Profile

M/s Darshan Pharmachem Pvt. Ltd. proposes expansion of manufacturing of Bulk Drugs and

Bulk Drug intermediates at Plot No. 3609, Nr. Ficom Chokdi, GIDC Estate, Ankleshwar-393002,

District: Bharuch, Gujarat.

1.2 Project Detail

1.2.1 Products along with Production Capacity

Sr

No Product Cas No.

Existing

Capacity

(MT/Month)

Additional

Capacity

(MT/Month)

Total

Capacity

(MT/Month)

Existing Products

1.

1-(4-Hydroxy Phenyl)

Piperazine

Hydrochloride

0056621-48-8 10 -- 10

2. 2-Chloro Ethyl Amine

Hydrochloride 0000870-24-6 10 -- 10

3.

N,N, Bis (2-Chloro

Ethyl) Amine

Hydrochloride

0000821-48-7 7 -- 7

Total 27 -- 27

Proposed Products

1.

1-(3-Chlorophenyl)-4-

(3-chloropropyl)

piperazine

hydrochloride

52605-52-4

-- 30 30

2.

N-methyl-N-benzyl-3-

hydroxy

acetophenone

suphate ( MAAP

Sulphate)

120410-24-4

3. N-Acetyl-Thiazolid-4-

carboxylic acid

5025-82-1

4.

1-Acetyl-4-(4’-

Hydroxyphenyl)

Piperazine

67914-60-7

5. Dorepenem 148016-81-3

6. Candesartan & 139481-59-7

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intermediates

7. Celecoxib &

intermediates 169590-42-5

8. Clopidogrel Besilate & intermediates

113665-84-2

9. Ketaconazole &

intermediates 65277-42-1

10. Levo cetirizine dihydrochloride

130018-87-0

11. Levetiracetam &

intermediates 102767-28-2

12. Pantoprazole Magnesium & intermediates

102625-70-7

13. Phenylephrin Hydrochloride

61-76-7

14. Prasugrel

Hydrochloride 389574-19-0

15. Quetiapine fumarate 111974-72-2

16. Rabeprazole Sodium 117976-90-6

17. Solifenacin 242478-37-1

18. Tamsulosin Hydrochloride

106463-17-6

19. Telmisartan 144701-48-4

20. Bortezomib 179324-69-7

21. Trimebutine Maleate 34140-59-5

22. Caberogoline 81409-90-7

23. Mycophenolat Mofetil

& intermediates 128794-94-5

24.

Raloxifene

Hydrochloride

& intermediates

82640-04-8

25. Febuxostat &

intermediates 144060-53-7

26. Pregabline &

intermediates 148553-50-8

27. Rosuvastatin Calcium

& intermediates 147098-20-2

28. Biperidine

Hydrochloride 514-65-8

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29. Donepizil

Hydrochloride 120011-70-3

30. Domperidone &

intermediates 57808-66-9

31. Carisoprodole 78-44-4

32. Topiramate 97240-79-4

33. Valsartan 137862-53-4

34.

Moxifloxacin

Hydrochloride &

intermediates

354812-41-2

35. Cinnarizine 298-57-7

36. Cyano diol base 103146-25-4

37. Dextromethorphan

Hydrobromide 125-69-9

38. 2-Amino-5- Methyl

Thiazol 7305-71-7

Total

(Proposed Products) -- 30 30

Total

( Existing+ Proposed) 27 30 57

By-Products

1. 4-Nitro Toluene 99-99-0

--

13.8 13.8

2. 4-Nitrobenzyl Alcohol 619-73-8 3.8 3.8

3. Ammonium Sulphate 7783-20-2 7.17 7.17

4. Butane-1-thiol 4779-86-6 2.52 2.52

5.

2,3-Dichloro-5,6-

Dicyano

benzoquinone

84-58-2

8.6 8.6

6. Triphenyl phosphine

oxide 791-28-6

7.5 7.5

7. Tert-butyl fluoro

dimethyl silane --

3.4 3.4

8. Methoxy Ethanol 109-86-4 6.5 6.5

9. Dimethyl Sulfide 75-18-3 2.1 2.1

Total (By-Products) -- 55.4 55.4

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Raw Material Requirement

List of Raw Materials And Their Capacity:

EXISTING PRODUCTS:

Sr.No. Raw Material Quantity (KG/KG)

1. 1-(4-Hydroxy Phenyl) Piperazine Hydrochloride

Bis HCL 1.88

PAP 1.18

NaOH 0.29

EDC 3.53

Acetic anhydride 1.13

Methanol 1.82

Toluene 0.59

2. 2-Chloro Ethyl Amine Hydrochloride

Monoethanolamine 0.63

Thionyl chloride 1.38

NaOH 0.16

EDC 1.88

3. N,N, Bis (2-Chloro Ethyl) Amine Hydrochloride

DiEthanolamine 0.63

Thionyl chloride 1.38

NaOH 0.16

EDC 1.88

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PROPOSED PRODUCTS:

Sr. No. Raw Materials Quantity

(KG/KG)

1. 1-(3-Chlorophenyl)-4-(3-chloropropyl) piperazine hydrochloride

MCA 2

Bis HCL 1.2

Toluene 20

Triethylamine 0.67

MDC 20

NaOH 0.27

Hydrochloric Acid (36%) 0.67

1-Bromo 3-chloro propane 1.17

Ethyl Acetate 33.33

Isopropyl Alcohol 23.33

Hexane 11.67

2. N-methyl-N-benzyl-3-hydroxy acetophenone suphate ( MAAP Sulphate)

M-Hydroxy Acetophenone 2.03

N-Methyle amine 0.47

Di isopropyl ethylamine 0.43

Toluene 10

Bromine 30

Palladium Carbon 2

n-Heptane 8

Hydrogen gas 0.03

Hydrochloric Acid 1.2

NaOH 1.33

Ethyl Acetate 110

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3. N-Acetyl-Thiazolid-4-carboxylic acid

Bi cyclic ketone (BCK) Acetophenone 1.2

Amino Ethane thiol 0.28

Di-Isopropyl Amine

0.4

Hydrochloric Acid (36%) 0.36

Acetonitrile 19

MDC 6

Formamidine 0.18

Para toluene sulfonyl chloride 0.36

Sodium Hydroxide 0.23

Hydrochloric Acid 0.22

Ethyl Acetate 18.74

Activated Carbon 0.1

Acetic anhydride 3.46

Hydrogen 0.06

Methanol 17.34

Hexane

8.6

4. 1-Acetyl-4-(4’- Hydroxyphenyl) Piperazine

Bis-(2-Chloro ethyl)amine HCl 2.5

P-Amino phenol 1.55

Methanol 10

Sodium acetate trihydrate 3

Acetic anhydride 2.5

Sodium hydroxide(47%)

7.13

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5. Dorepenem

Methyl Vinyl Phosphate 1.5

Mercapto Pyrrolidine Chain 0.9

Acetonitrile

30

N-Ethyl Diispropyl Amine

0.5

DMF 15

NaOH 0.4

HCl (36%) 1

Palladium Carbon (10%)

1.65

Tetrahydrofuran 15

6. Candesartan & intermediates

Trityl Candisartan 1.9

Dimethyl form amide 10.35

Potassium Carbonate 1.05

Cyclohexyl,1-Chloro ethyl carbonate

0.58

Ethyl Acetate 65.4

Sodium Chloride 1.05

Sodium Sulphate 1.08

Cyclo hexane 25

MDC 6.5

Methanol 10.4

Formic Acid 0.09

Sodium Bicarbonate 1.25

Isopropyl alcohol

4.3

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7. Celecoxib & intermediates

Trifluro Acetic Acid 0.56

Methanol 3.5

Sulfuric Acid 0.02

4-Methyl Acetophenone 0.58

Sodium Methoxide 0.3

Hydrochloric Acid (35%) 0.65

Toluene 15.95

4-Amino benzene Sulfonamide 1

Hydrochloric Acid (32%) 3

Sodium Nitrite 0.4

Sodium Hydroxide 0.52

Sodium metabisulfite 1.2

Isopropyl Alcohol 2

Ethyl Acetate 1.5

Activated Carbon 0.23

8. Clopidogrel Besilate & intermediates

2-Thophene Ethyl Amne 0.5

Formaldehyde 0.2

Sodum Sulphate 0.38

DMF 2

Hydrochlorc Acd (25%) 0.52

Toluene 9

Acetone 12.26

PA 3.2

Bromo Ester 0.9

Sulphurc Acd 0.28

Potassum carbonate

0.4

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Methanol 7.05

L(-)Camphor sulphonc acd 0.66

Soda Ash 0.5

MDC 28.65

MBK 3.3

Ethyl Acetate 1.36

Sodum bcarbonate 0.25

Sodum bsulphate 0.18

Benzene sulfonc acd 0.38

MTB Ether 5.55

Hexane 2.27

Activated Carbon 0.1

9. Ketaconazole & intermediates

Cs-2-(2,4-dchlorophenyl)2-(1H-mdazol-1-yl-methyl)-1,3-

doxolane-4-methanol 1.0

Para Toluene Sulfonyl Chlorde 0.58

Sodum Carbonate 0.2

Methanol 9.4

Methylene Dchlorde 7

Trethyl Amne 0.35

Hydrochlorc Acd (30%) 0.5

Ethyl Acetate 8.3

n-Hexane 5

Actvated Carbon 0.2

AHPP 0.55

Dmethyl Sulfoxde 2.96

SMO Powder

0.14

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CS Flakes 0.15

Acetone 5

10. Levo cetirizine dihydrochloride

p-chloro benzo phenone 1.2

Ammonum formate 0.35

Hydrochlorc acd 0.25

Toluene 16

Actvated carbon 0.1

Sodum hydroxde 0.25

Tartarc acd 0.32

MDC 16.5

para toluene sulphonyl chlorde 0.52

n,n-bs( 2-chloro ethyl)amne 0.5

HCl 0

Sodum Hydroxde 0.25

Ethyl d sopropyl amne

0.28

Methanol 4

Hydro bromc acd 0.23

Acetc acd 0.15

Chloro ethanol 0.2

Trethyl amne 0.247

Sodum mono chloro acetate 0.27

Hydrochlorc acd 0.17

D methyl formamde 1

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Actvated Carbon 0.1

Acetone 1.0

11. Levetiracetam & intermediates

(S)-2-Amnobutanamde hydrochlorde 1.25

4-Chlorobutyryl chlorde 1.4

Sodum Sulphate 1.5

Potassum Hydroxde Powder 2.57

Tetrabutyl ammonum bromde 0.09

Ethyl acetate 6.07

Methylene Dchlorde 9.7

12. Pantoprazole Magnesium & intermediates

Maltol 0.85

Dmethyl sulphate 0.45

Potassum carbonate 0.47

Acetone 10

Ammonum Carbonate 0.65

Toluene 3

Phosphorous oxy chlorde 0.35

Sodum Hydroxde 0.92

Methylenedchlorde 3

Hydrogen peroxde (30%) 0.5

Acetc acd 0.45

Methanol 8.75

MDC 7

Acetc Anhydrde 0.45

Chloroform 2

Thonyl chlorde 0.39

Methylenedchlorde 8.5

5-dFluoromethoxy-2-mercapto-benzmdazole 0.7

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Sodum Hydroxde flakes 0.37

Toluene 5

Sodum hypochlorte (4%) 5.1

Methylenedchlorde 10

Actvated Carbon 0.1

Magnesum chlorde (5%) 3

13. Phenylephrin Hydrochloride

3-Hydroxy Acetophenone 1

Ethyl Acetate 6

Bromne 0.6

Aluminum Chlorde 0.02

Toluene 11

10% Sodum bcarbonate 1

Sodum Sulphate 0.1

N-Methyl Benzyl Amne 0.75

IPA-HCl 2

IPA 1

Methanol 10

10% Palladum Carbon 0.15

Hydrogen gas 0.03

Actvated Carbon 0.12

Lq.Ammona 3.7

L(+) Tartarc acd 2.44

PA 8

PA HCl 4

Acetone 3

14. Prasugrel Hydrochloride

2-Bromo-1-Cyclopropyl-2-(2-Fluorophenyl) Ethanone 0.88

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5,6,7,7a-Tetrahydrotheno [3,2-c] Purdne-2(4H)-one 0.54

Potassum Hydroxde 0.22

Methanol 8.76

Acetc Anhydrde 0.32

Methyl Ethyl Ketone 2.94

Hydrogen Chlorde 0.12

Acetone 3.12

15. Quetiapine fumarate

2-Amnbphenylsulphate 0.63

Phenylchlorofumarate 0.54

Toluene 5.75

phosphorc acd 0.23

Acetone 2

Pperazne 0.205

Chloro ethoxy ethanol 0.30

Fumarc acd 0.28

Methanol. 2

16. Rabeprazole Sodium

2,3-Lutdne 0.46

Hydrogen Peroxde (50%) 0.33

Ntrc acd 0.3

Sulphurc acd 1.08

Acetc acd 0.46

3-Methoxy-1-Propanol 0.4

Sodum Hydroxde 0.67

Toluene 13.5

DMSO 2

Acetc anhydrde 1.5

Hydrochlorc acd 0.2

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Thonyl Chlorde 0.53

MDC

13.5

Sodum Sulphate 0.1

2-Mercaptobenzmdazole 0.53

Sodum Hypochlorte (8%) 3.27

Acetone 1.5

Sodum hydro sulphate 0.12

MMA n Methanol 0.1

Isopropyl Alcohol 3

Actvated Carbon 0.1

17. Solifenacin

2-Phenyl ethyl amne 0.6

Benzoyl chlorde 0.7

Tr ethyl amne 0.75

Chloroform 6

N-Hexane 2.75

Phosphorus pentoxde 0.76

Phosphorus oxy chlorde 0.82

Toluene 5

MDC 17

NaOH flakes 1.26

Sodum boro hydrde 0.278

Methanol 6

D(-)-Tartarc acd 0.72

PA 8.4

Sodum Hydroxde 0.38

18. Tamsulosin Hydrochloride

(S)-5-(2-amnopropyl)-2- methoxybenzene sulfonamde 0.62

2-(O-Ethoxy phenoxy)ethyl bromde 0.91

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Methanol 16.02

n-Hexane 3.73

50% lye soluton

0.4

Ethyl acetate 14.28

Ethanol 99% 7.45

Ethanol HCl 1.24

Absolute ethanol

5.58

19. Telmisartan

OTBN 0.45

Ethylene glycol 0.15

Potassum Hydroxde 0.37

Hydrochlorc acd 0.09

D methyl sulphate 0.30

Potassum Carbonate 0.32

D bromo d methyl hydanton 0.67

Acetone 12.52

Cyclohexane 1.8

Actvated Carbon 0.35

MDC 10

2-n-Propyl-4-methyl-6-(1- methylbenzmdazole-2-

yl)benzmdazole 0.71

DMF 0.7

Methanol 6.8

20. Bortezomib

so Butyl Boronc Acd 0.8

N-Heptane 43.6

Pnanedol 1.8

Sodum Chlorde 0.12

Znc Chlorde 0.72

THF 26

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N-Hexyl Lthum 9.5

D so Propyl Amne 0.54

MDC 73

Sulphurc acd

0.52

HMDS 0.8

DPE 2.7

Tr Fluoro Acetc Acd 0.46

Dsopropyl Ether 45

L-Phenyl Alanne 0.9

Thonyl Chlorde 0.7

Methanol 41.5

PA 4.5

Pyrazne Carboxylc acd 0.5

DMF 10

N-Hydroxy Succnamde 3

D Cyclohexyl Carbodmde 1

N-Methyl Morpholne 0.7

Ethyl Acetate 18

Acetone 4

Sodum Hydroxde 0.2

Hydrochlorc Acd 0.82

N-Hydroxysuccnamde 0.5

Dcyclohexyl dcarbodmde 0.8

D sopropyl ethylamne 0.9

Sodum bcarbonate 0.78

Bortezomb base 1.5

sobutyl boronc Acd 0.3

21. Trimebutne Maleate

Methyl-2-(d methyl amno)-2-phenylbutyrate 0.55

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70%Vtrde Toluene soluton 1.02

Toluene 9

Sodum hydroxde flake

0.1

Sodum sulphate 0.05

3,4,5-Trmethoxy benzoc acd 0.47

Trphosgene 0.67

DMF

0.01

Methanol 5

Trethyl Amne 0.23

Sodum sulphate 0.07

Malec acd 0.23

22. Cabergolne

Lysergol 1.4

Trethyl amne 0.56

Tert-butyldmethyl slyl chlorde 0.84

4-Dmethyl amno pyrdne 0.2

DMF 8

Palladum carbon 0.04

MDC 22

N-Heptane 4

Hydrogen gas 0.01

Ntrogen Gas 0.04

Chloro ethyl formate 0.4

Methanol 13

Sodum bcarbonate 0.6

Sodum chlorde 0.2

Toluene 8

4-Dmethylamno pyrdne 0.4

D-tert-butyl dcarbonate 0.8

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TBAF 0.2

Acetc acd 0.4

Acetontrle 8

THF 6

TEMPO 0.2

odobenzene dacetate 0.1

Sodum thosulphate 0.24

Thonyl chlorde 0.4

MDC 8

Allyl bromde 0.4

Sodum hydroxde 0.14

TEA 0.34

Hydrochlorc Acd 0.12

EDC Free base 0.42

Alumna 0.1

MTBE 6

Acetone 4

n-Heptane 2

Actvated carbon 0.2

23. Mycophenolate Mofetl

Mycophenolc acid 1

Methanol 6.4

Sulphuric acid 0.335

Morpholne ethanol 0.4

Znc oxde 0.048

Ethyl acetate 12

Sodum hydroxde 0.26

Sodum bcarbonate 0.1

Phosphorc acd 0.012

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Actvated carbon

0.2

24. Raloxfene Hydrochlorde

4[2-(1-pperdnoethoxy)]benzoc acd hydrochlorde

1

Thonyl chlorde 0.416

Toluene 8

Heptane 6

6-Methoxy-2-(4-methoxyphenyl)benzo(b)thophene 0.9

MDC 12

Ntrogen Gas 0.1

Alumnum chlorde 0.6

Ethane thol 0.2

Methanol 18

Hydrochlorc acd (10%) 1.4

DMF 2

Actvated carbon

0.2

25. Febuxostat

2-(4- hydroxyphenyl)-4-methyl-5- thazole carboxylc Acid

ethyl ester 1.4

Polyphosphouric acid 1.8

Hexamethyl tetramanine 0.2

Acetic Acid 0.32

DMF 11

Potassum carbonate 0.57

sobutyl bromde 0.57

Hydorxyl amne Hydrochlorde 0.28

Formc acd 0.19

Sodum Formate 0.27

THF 25

Sodum hydroxde 0.16

Ethanol 15

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Hydrochlorc Acd 0.14

Actvated carbon 0.1

26. Pregabalin

Isoveraldehyde 0.89

Diethyl malonate 1.68

Acetic acid 1.21

Di isopropyl amine 0.09

n-Hexane 1.64

Sodium cyanide 0.43

Ethanol 8.64

Toluene 4.55

Methanol 2

Potassium hydroxide 0.45

Raney nickel 0.27

IPA 3.18

Hydrogen gas 0.05

(S)-Mandelic acid 1.07

Isopropyl alcohol 8.73

27. Rosuvastatin Calcium

4-Fluoro benzaldehyde 0.52

4-Methyl-3-oxo-pentanoic acid 0.663

Potassium hydroxide 0.24

Methyl Iodide 0.6

Methanol 5.5

S-Methyl iso thio urea 0.35

2,3-Dichloro-5,6-dicyano 0.85

HMPA 1

MDC 8

Meta chloro peroxy benzoic acid 1.19

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Methyl amine 0.10

Ethanol 2.5

Methane sulfonyl chloride 0.35

Sodium hydride (60%) 0.01

Di methoxy ethane 3

Hydrogen 0.01

DIBAL-H 0.01

Toluene 8

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

triphenyl phosphoranylidene hexanoate 1.45

Triethyl amine 0.15

N,N-Dimethyl formamide 3

Hydrogen fluoride 0.05

Ethyl acetate 10.5

Diethyl methoxy borane 0.2

Sodium boro hydride 0.01

THF 5

Calcium chloride 0.13

28. Biperiden Hydrochloride

Cyclo pentadiene 0.3

Methyl vinyl ketone 0.32

Sodium hydroxide 0.35

Methanol 5

Piperdine Hydrochloride 0.5

Para formaldehyde 0.15

Isopropyl alcohol 10

Phenyl magnesium chloride 0.5

Hydrochloric acid 0.2

THF 5

1,4-Dioxane 4

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Hydrochloric acid 0.15

29. Donepezil Hydrochloride

Ethyl isonipecotate 0.75

Benzyl chloride 0.62

Toluene 14

Potassium carbonate 0.35

Vitride 0.86

Dimethyl sulfoxide 0.3

Hydrobromic Acid (48%) 0.3

5,6-Dimethoxy indanone 0.57

Methanol 8

Raney Nickel (catalyst) 0.1

Hydrogen 0.02

Isopropyl alcohol 3

Hydrogen chloride 0.2

30. Domperidone

N-Carbethoxy-4-piperidone 1.6

Ammonia gas 0.56

Methanol 16

Raney Nickel 0.6

Hydrogen 0.1

2,5-Dichloro Nitrobenzene 1.56

Sodium Carbonate 0.6

Hydrogen 0.1

Toluene 7

Urea 0.4

Sodium Hydroxide (48%) 1.5

1-(3-Chloropropyl)-1,3-dihydro- 0.8

2H-benzimedazole-2-one 0

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Sodium Carbonate 0.4

Methyl Isobutyl Ketone 24

31. Carisoprodol

2-Methyl-2-propyl-1,3-propane diol 0.78

Dimethyl carbonate 1.1

Toluene 8.1

Sodium methoxide 0.06

Isopropylamine 1.64

Sodium cyanate 0.315

Chloroform 6.3

Hydrochloric acid (35%) 1

Sulphuric acid 0.5

Carisoprodol (Tech) 1.12

Methanol 3.35

Activated carbon

0.15

32. Topiramate

Fructose 1.15

Sulfuric Acid 0.31

Acetone 4.2

Sodium Hydroxide 0.26

n-Hexane 0.1

Toluene 3.2

Pyridine 0.24

Ammonia gas 0.05

Sulfonyl Chloride 0.42

Sodium bicarbonate 0.01

n-Hexane 2.64

Sodium Chloride 0.01

Ethyl Acetate 3.22

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Isopropyl Alcohol 2.83

33. Valsartan

L-Valine 0.45

Thionyl Chloride 0.457

Methanol 8

Toluene 25

4-Bromomethyl-biphenyl-2- carbonitrile 0.82

Potassium carbonate 0.45

Valeryl Chloride 0.34

TEA 0.2

Sodium bicarbonate 0.25

Sodium Sulphate 0.1

Sodium Azide 0.16

Tri butyl tin chloride 0.8

Hydrogen 0.005

Sodium hydroxide 0.2

Xylene 2.4

MDC 5

Acetic Acid 0.4

N-Hexane 2

Activated Carbon 0.1

34. Moxifloxacin Hydrochloride

Moxifloxacin Q-Acid 0.9

2,8-Diazobicyclo(4.3.0)nonane 0.4

Triethylamine 0.32

Acetone 4

Dimethylformamide 2

Moxifloxacin Base 1.06

Hydrochloric acid 0.2

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Methanol 10

EDTA 0.02

Activated Carbon 0.1

35. Cinnarizine

1-Benzhydryl piperazine 1.06

Cinnamyl chloride 0.93

Potassium carbonate 0.64

Ethyl acetate 9.15

Methanol 1.9

Activated carbon 0.08

Hyflow 0.05

36. Cyano Diol Base

Para Bromo fluoro benzene 0.27

Magnesium turnings 0.10

Ethylene dibromide 0.04

THF 5.73

Dimethl amino propyl chloride 12.14

Potassium hydroxide 1.4

Sodium hydroxide 2.34

hydrochloric acid 1.4

Magnesium turnings 0.55

Iodine 0.17

5-Cyano phthalide 0.67

THF + Toluene 14.6

Uene 29.75

Acetic acid 3.4

37. Dextromethorphan Hydrobromide

PMPPA 4.94

CHEA 3.72

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Phosphorous oxy chloride 4.57

Caustic lye 3.17

Toluene 25.89

Mandelic acid 0.61

Formic acid 0.15

Sodium methoxide powder 0.04

Phosphoric acid 16.28

Phosphorous pentoxide 0.59

Methanol 2.70

CS Lye 1.74

Formaldehyde 0.5

Acetone 1.79

Activated carbon 0.05

Hyflow 0.05

38. 2-Amino-5-Methyl Thiazol

Propionaldehyde 0.77

Sulphuryl Chloride 0.19

NaOH 0.02

Thiourea 0.42

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1.4 Water Requirement, Waste Water Generation and Treatment

Source of water will be met through Anklehwar GIDC Water Supply. Total water requirement

will be 42.5 m3/day. Total 25 m3/day (24 m

3/day Industrial + 1 m

3/day domestic) of effluent

shall be generated. 4 m3/day = High COD & high TDS stream-I will be neutralized & then sent to

Common MEE, Ankleshwar for further treatment & disposal and 20 m3/day = low COD and low

TDS stream-II will be treated in ETP then sent it to ETL, Ankleshwar for further treatment and

disposal.

Domestic Waste water will be disposed by septic tank & soak pit.

1.5 Air Pollution Source and Control Management

There will be flue gas emission from Boiler, Thermic Fluid Heater and D.G. Sets and process gas

emission from process vent only. Company will install Multi cyclone separator, Bag Filter and

Two stage Scrubber to reduce air pollution.

1.6 Hazardous Waste

Sr.

No

Category

No.

Type of

waste Existing Proposed Total Disposal Method

1 33.1

Discarded

Containers

6

MT/ year

4

MT/ year

10

MT/ year

Collection, Storage,

Transportation & Disposal by

selling to registered recycler

2 5.1

Used/

Spent Oil

0.01

MT/ year

0.01

MT/ year

0.02

MT/ year

Collection, Storage,

Transportation & Disposal by

selling to registered recycler

3 35.3 ETP sludge -- 10

MT/ year

10

MT/year

Collection, Storage,

Transportation and dispose

common TSDF site.

4 B36 Salts of

Per-Acids

420

MT/year --

420

MT/year

(Collection, Storage,

Transportation and disposal)

Sodium Sulphide (30% Sol):

Disposal by sell out to

authorized users who is having

valid CCA and Rule 9

permission to receive this

waste.

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1.7 Green Belt

Total 10,360 sq. meter land area is available at site; out of this area about 4,662 sq. meter area

(45% of total land area) will be developed as greenbelt and other forms of greenery.

1.8 Power & Fuel Requirements

FUEL:

Existing:

Natural gas = 500 sm3/Day,

Diesel = 27 Lit/ Hr.

Proposed:

Agrowaste = 15 MT/Day

Diesel = 10 Lit./ Hr (Only for emergency).

ENERGY:

Existing:

Power required from DGVCL is 150 KVA .

1 DG Set = 250 KVA (for Emergency case only)

Proposed:

Power required from DGVCL will be 500 KVA.

1 DG Set = 125 KVA (for Emergency case only)

5 28.1 Organic

Residue --

20

MT/year 20 MT/year

Collection, Storage,

Transportation & sent to

cement industries for co-

processing or incineration in

CHWIF.

6 28.3 Spent

Carbon --

5

MT/year

5

MT/year

Collection, Storage,

Transportation and sent for co-

processing in cement industries

or Disposal at common

incineration site.

7 --

Inorganic

Solid

Waste

-- 13

MT/year 13 MT/year

Collection, Storage,

Transportation and dispose

common TSDF site.

8 26.3 Spent Acid -- 84.7

MT/year

84.7

MT/year

Collection, Storage,

Transportation &

sale to authorize vendor.

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2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION

2.1 Identification of the project and project proponent. In case of mining project, a copy of

mining lease/letter of intent should be given.

Identification of the project and project proponent

M/s. Darshan Pharmachem Pvt. Ltd. proposes expansion of manufacturing of Bulk Drugs and

Bulk Drug intermediates at Plot No. 3609, Nr. Ficom Chokdi, GIDC Estate, Ankleshwar-393002,

District: Bharuch, Gujarat.

List of Directors:

Sr. No. List of Directors

1. Ms. Lilaben Rameshbhai Dobariya

2. Mr. Jitendra Gordhanbhai Dobaria

3. Mr. Rasikkumar Jadavbhai Dobaria

4. Mr. Rasilaben Rasikbhai Dobariya

2.2 Brief description of nature of the Project

Proposed expansion of Bulk Drugs and bulk drug intermediates manufacturing unit in existing

premises.

2.3 Need for the project and its importance to the country and or region

The demand for products intended to be manufacture is increasing in the country by setting up

this unit, Company will be able to meet the demand of various products locally. The project will

save forex as certain products import will be reduced. This will also generate direct and indirect

employment opportunity for various levels of people.

2.4 Demands-Supply Gap

Based on our informal survey of the market with our current customers and various traders, we

have found that there is a big potential for the range of the products we are planning.

2.5 Imports vs. Indigenous production

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Based on the current cost of indigenous raw materials and the non availability of some

materials, we will have to import some of the key raw materials as they are not available

indigenously. This will make us very competitive against imported finished products and we will

export of our finished products in the international market.

2.6 Export possibility

We shall explore the possibility of export the products.

2.7 Domestic/Export Markets

Our products have good demand in domestic & international markets. We shall explore the

possibility of export the products.

2.8 Employment Generation (Direct and Indirect) due to project.

M/s. Darshan Pharmachem Pvt. Ltd. will give direct employment to local people based on

qualification and requirement. In addition to direct employment, indirect employment shall

generate ancillary business to some extent for the local population.

3.0 Project Description

3.1 Type of Project including interlinked and interdependent projects, if any.

No interlinked project has been submitted.

• Location (map showing general location, specific location and project boundary & project

site layout) with coordinates.

• Map showing general location.

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PROJECT

SITE

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Specific location and project boundary

• Project Site (Google Map)

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• Plant Layout

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3.3 Details of alternate sites considered and the basis of selecting the proposed site,

particularly the environmental considerations gone into should be highlighted.

Looking to the international market demand of the products it was decided by M/s. Darshan

Pharmachem Pvt. Ltd. to expand existing facility.

Major factors involved in the selection of site are listed below:

• Minor site clearance activities shall be carried out to clear shrubs and weed.

• The project site is located on level ground, which does not require any major land filling

for area grading work.

• Proximity to Raw Material suppliers.

• Site is very well connected by road and railway.

• Availability of Fuel, Power, CETP, TSDF, etc. within the estate.

Modern infrastructure support and amenities at par in other global markets, including:

� Efficient transport facilities.

� Environment-friendly zone.

� Uninterrupted power supply.

3.4 Size or Magnitude of Operation

Please refer Section-1.2.1, Page No. 3.

3.5 Project Description with process details (a schematic diagram/flow chart showing the

project layout, components of the project, etc. should be given)

Please refer Please refer Form-I, Annexure-III.

3.6 Raw Material required along with estimated quantity, likely source, marketing area of

final product/s, mode of transport of raw material and Finished product.

For raw material required along with quantity; Please refer Section-1.3, Page No. 3. We shall

procure the raw material as much as possible from domestic market and if there is no

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availability of any raw material we will import. We shall explore the possibility of export the

finished products.

3.7 Resource optimization/recycling and reuse envisaged in the project, if any, should be

briefly outlined.

Company will explore the possibility of reuse & recycle.

3.8 Availability of water its source, energy/power requirement and source should be

given.

Water Source

Total water requirement shall be met through Ankleshwar G.I.D.C Water Supply.

FUEL:

EXISTING:

Existing:

Natural gas = 500 sm3/Day,

Diesel = 27 Lit/HR

PROPOSED:

Agrowaste = 15 MT/Day

Diesel = 10 Lit./HR (Only for emergency).

ENERGY:

EXISTING:

Power required from DGVCL is 150 KVA

1 DG Set = 250 KVA (for Emergency case only)

PROPOSED:

Power required from DGVCL will be 500 KVA.

1 DG Set = 125 KVA (for Emergency case only)

3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their

management/disposal.

Please refer Please refer Form-I, Annexure-IV & VI.

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3.10 Schematic representations of the feasibility drawing which give information of EIA

purpose.

4.0 Site Analysis

4.1 Connectivity

• Site is very well connected by road

• Availability of fuel, power, CETP, TSDF, etc. within the estate.

4.2 Land Form, Land Use and Land Ownership

Land Use will be incorporated in the EIA Study.

4.4 Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including

area under CRZ)), shortest distances from the periphery of the project to periphery of the

RECONNAISSANCE SURVEY OF EXISTING PLANT ANNUAL REPORT

MARKET ASSESSMENT

FINANCIAL REPORT

PROJECT REPORT

INTRODUCTION

MONITORING OF AIR, WATER & SOIL QUALITY & NOISE

LEVELS. DATA ON METEOROLOGY SOCIO-ECONOMIC

STATUS & BASIC AMENITIES. SITE VISITS BY AND

INTERVIEWS WITH LOCALS

BASELINE

ENVIRONMENTAL

STATUS

ENVIRONMENTAL INFORMATION CENTRE

CENTRAL GROUND WATER BOARD

GUJARAT POLLUTION CONTROL BOARD (GPCB)

PUBLIC HEALTH ENGINEERING DEPT.

AGRICULTURE DEPARTMENT

FOREST DEPARTMENT

IRRIGATION DEPARTMENT

EMPLOYMENT EXCHANGE

HEALTH CENTER

CENSUS DEPT.

INDIAN METEOROLOGICAL DEPT.

SOCIOECONOMIC

STATUS &

INFRASTRUCTURE

PROPOSED

PLANT

FACILITY DESCRIPTION

IMPACTS

METHODOLOGY OF

IMPACT

ASSESSMENT

IDENTIFICATION & ASSESSMENT OF IMPACTS

EVALUATION OF IMPACTS BY MATRIX METHOD

SOURCE OF INFORMATION OVERVIEW OF

E. I. A. STUDIES

ACTIVITIES

ENVIRONMENTAL

MANAGEMENT

PLAN

DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR

POLLUTION CONTROL, HAZARDOUS WASTE

MANAGEMENT, GREEN BELT DEVELOPMENT

MONITORING PROGRAM

RISK ANALYSIS

STUDIES &

DISASTER

MANAGEMENT PLAN

SAFETY, HEALTH & ENVIRONMENTAL POLICY, GUIDELINES BY

DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR. CONSEQUENCE ANALYSIS

PREPARATION OF DISASTER MANAGEMENT PLAN

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forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from

HFL of the river), CRZ. In case of the notified industrial area, a copy of the Gazette

notification should be given.

Existing land use pattern will be incorporated in the EIA Study. CRZ Clearance is not

applicable.

4.5 Existing Infrastructure

Processing Area (Plant facilities, ETP Area and Utility Services) = 2,500 m2

Non Processing Area (Raw material storage area, finished storage area, Workshop and Engg.

Store, Canteen, security cabin, green belt and open area) =7,860 m2

4.6 Soil Classification

Soil Classification will be incorporated in the EIA Study.

4.7 Climatic data from secondary sources.

Climatic data will be incorporated in the EIA Study.

4.8 Social infrastructure available.

Various Programs/ Projects related to Social & Economic development of surrounded area

has been planned, which are as follows.

A) Natural Resource Management – The main focus of this program will be to maximize the

yield returns of the farmers through efficient management of existing resources &

extension of new agricultural practices.

1) Integrated Agricultural Growth Project – For improvement and use of the modern

techniques and thereby would certainly contribute to prosperity in the agriculture

sector and reduce the rural poverty by programs like Farmers Training, Nursery

Growing Trainings, Modern agriculture equipment distribution programs etc.

2) Animal Husbandry Projects – Various programs like health checkups & treatment,

vaccination program, Anti sterility camps, breed improvement etc. will be carried

out.

B) Income Generation Program -

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1) Establishment of Self help groups.

2) Rural Entrepreneurship Development Program

3) Handcrafts Development Program

4) Vocational Training

5) Business process outsourcing

C) Health, Education & Infrastructure

1) Aids Awareness Program

2) General Health Camps

3) Innovative Teaching Methods

4) Adult Education

5) Sanitation

6) Infrastructure Development Projects

5.0 Planning Brief

5.1 Planning Concept (type of industries, facilities, transportation etc) Town and Country

planning/Development authority classification.

Type of Industry: Proposed expansion of Bulk Drugs and bulk drug intermediates in existing

unit.

5.2 Population Projection

Population Projection will be incorporated in the EIA Study.

5.3 Land use planning (breakup)

Total Plot Area = 10,360 sq mt.

Processing Area = 2,500 sq mt

Non-Processing area = 7,860 sq mt

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5.4 Assessment of Infrastructure Demand (Physical & Social)

• Employment would be as per prevailing norms of state government for skilled and

unskilled people for the proposed activity.

• Social Welfare

• Cordial relation with the villages shall be established and representation shall be made

to villagers for help for creation of facilities related to health, education, etc.

5.5 Amenities/Facilities

Details of amenities available in study area

Population Projection will be incorporated in the EIA Study.

6.0 Proposed Infrastructure

6.1 Industrial Area (Processing Area)

Processing Area (Plant facilities, ETP Area and Utility Services) = 2,500 m2

6.2 Residential Area (Non Processing Area)

Non Processing Area (Raw material storage area, finished storage area, Workshop and Engg.

Store, Canteen, security cabin, green belt and open area) =7860 m2

6.3 Green Belt

Total 10,360 sq. meter land area is available at site; out of this area about 4,662 (45% of

total land area) sq. meter area will be developed as greenbelt and other forms of greenery.

Green Belt: 4,662 m2

6.4 Social Infrastructure

• Water requirement will be met through G.I.D.C Water Supply.

• Power supply by DGVCL.

6.5 Connectivity (Traffic and Transportation Road/ Rail/Metro/ Water ways, etc.)

Major factors involved in the selection of site are listed below:

• Site is very well connected by road

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• Proximity to Raw Material suppliers

• Availability of sufficient land free from cultivation

• Availability of power facilities

• Availability of fuel

6.6 Drinking water Management (Source & Supply of water)

Total water requirement shall be met through Ankleshwar, G.I.D.C. Water Supply.

6.7 Sewerage System

Sewage pipes are laid in entire company for the removal and disposal of mainly non-

harmful liquid wastes from the offices, canteen and domestic waste coming from different

section of industry. These liquid wastes are sent to septic tank & soak pit.

6.8 Solid Waste Management

Please refer Form-I, Annexure-VI.

6.9 Power Requirement & Supply/Source

Please refer Section 1.8, Page No. 5 of this report.

7.0 Rehabilitation and Resettlement (R & R) Plan

7.1 Policy to be adopted (central/state) in respect of the project affected including home

oustees, land oustees and landless laborers (a brief outline to be given)

There is no habitation on the proposed project activity area and it is open industrial land, so

R & R policy is not applicable to this project.

There shall not be displacement of any population in project area. Any major activity that

may lead to resettlement of the people is considered as permanent impact. Hence, there is

no permanent impact on this account. The increasing industrial activity will boost the

commercial and economical status of the locality up to some extent.

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8. Project Schedule & Cost Estimates

8.1 Likely date of start of construction and likely date of completion (Time schedule for

the project to be given).

We shall start construction of proposed expansion project after getting EC and we shall start

production after applying for CCA.

8.2 Estimated Project cost along with analysis in terms of economic viability of the

project.

Total Project Cost for proposed project activity is Rs. 2.0 Crores.

9. Analysis of Proposal (Final Recommendations)

9.1 Financial and social benefits with special emphasis on the benefit to be local people

including tribal population, if any, in the area.

• Employment would be as per prevailing norms of state government for skilled and

unskilled people for the proposed project.

• Social Welfare shall be done.

• Cordial relation with the industry shall be established and representation shall be made

to villagers for help for creation of facilities related to health, education, etc.