annexure-project feasibility report - welcome to...

1

PRE FEASIBILITY REPORT

for

PROPOSED BULK DRUGS MANUFACTURING

IN EXISTING PREMISES

of

M/s. NIVIKA CHEMO PHARMA P. LTD.

PLOT NO. 1808, 1809/2, 1811, 1812, 1813, 1814 & 1815,

GIDC ESTATE, ANKLESHWAR, DIST: BHARUCH-393002 (GUJ.)

2

CONTENTS

Sr. No. Description Page No.

1. Executive Summary 3

2. Introduction of the Project/Background information 13

3. Project Description 15

4. Site Analysis 16

5. Planning Brief 17

6. Proposed Infrastructure 18

7. Rehabilitation and resettlement (R & R) Plan 19

8. Project Schedule & Cost Estimates 20

9. Analysis of Proposal (Final Recommendations) 20

3

1.0 EXECUTIVE SUMMARY

1.1 Company Profile

M/s. Nivika Chemo Pharma P. Ltd. is an existing unit engaged in production of Ortho Toluene

Nitrite and Optical Brightening Agent at Plot No. 1808, 1809/2, 1811, 1812, 1813, 1814 & 1815,

G.I.D.C. Estate, Ankleshwar-393002, Dist: Bharuch (Guj.). It now also proposes to enter and

produce bulk drugs at this existing premises in GIDC Ankleshwar. At present India is importing

major APIs and hence to cater to the ever expanding market the proposal is to manufacture

various bulk drugs detailed as under.

1.2 Project Details

1.2.1 Products along with Production Capacity

SR.

NO PRODUCTS CAS NO

PRODUCTION CAPACITY (MT/MONTH)

EXISTING ADDITIONAL TOTAL

EXISITING PRODUCTS

1 OPTICAL BRIGHTENING AGENT 13001-39-3 1.0 0 1.0

2 ORTHO TOLUENE NITRITE 88-72-2 4.0 0 4.0

TOTAL (EXISITING PRODUCTS) 5.0 0 5.0

PROPOSED PRODUCTS

1 Darunavir

206361-99-1

5 5

2 Levosulpiride 23672-07-3 10 10

3 Montelukast Sodium 151767-02-1 5.5 5.5

4 Tramadol hydrochloride

36282-47-0

7 7

5 Nifedipine 21829-25-4 4.5 4.5

6 Quetiapinehemifumarate

111974-72-2

3 3

7 Furosemide 54-31-9 3.5 3.5

8 Risedronate Sodium 105462-24-6 4.5 4.5

4

9 Iohexol/Iopamidol/Iodixanol

66108-95-

0/60166-93-

0/92339-11-

0.0

6 6

10 Lauryl Pyridinium chloride 104-74-5 10 10

11 Vildagliptin 274901-16-5 4 4

12 Ambroxol Hydrochloride 23828-92-4 4 4

13 Pantaprazole Sodium 138786-67-1 7.5 7.5

14 Miconazole Nitrate 22916-47-8 4.5 4.5

15 Dorzolamide Hcl 130693-82-2 4 4

16 Bosentan 147536-97-8 5.5 5.5

17 Febuxostat 144060-53-7 10 10

18 Fesoterodine NDMF 286930-02-7 6 6

19 Rizatriptan 145202-66-0 2.5 2.5

20 Olanzapine 132539-06-1 4.5 4.5

21 Levocetirizine 130016-77-8 5 5

22 Revaroxaban 366789-02-8 7 7

23 Ciprofloxacin 85721-33-1 10 10

24 Agomelatine 138112-76-2 10 10

25 Brinzolamide 138890-62-7 2.5 2.5

26 Atorvastatin Calcium 134523-00-5 8.3 8.3

27 Capecitabine 154361-50-9 3.5 3.5

28 Diacerein 13739-02-1 3.5 3.5

29 Dabitgatran 211915-06-9 3 3

30 Vilazodone Hydrochloride 163521-08-2 2 2

31 Posaconazole 171228-49-2 5.5 5.5

32 Dapoxetine Hydrochloride 129938-20-1 3.5 3.5

33 Canagliflozin 842133-18-0 2.5 2.5

34 Bronopol(BP) 52-51-7 7 7

35 Carbamazepine 298-46-4 5.5 5.5

36 Cefsulodine Sodium 52152-93-9 6.5 6.5

5

37 Cilinidipine 132203-70-4

3.5 3.5

38 Nebivolol 99200-09-6

0.5

0.5

39 Nebivolol HCL 152520-56-4

40 Donepezil Hydrochloride 120011-70-3

41 Brimonidine Tartrate 70359-46-5

10

10

42 Captopril 62571-86-2

43 Cilostazol 73963-72-1

44 Clopidogrel bisulphate 120202-66-6

45 Entacapone 130929-57-6

46 Graniserton HCL 107007-99-8

47 Meloxicam 71125-38-7

48 Modafinil 68693-11-8

49 Piogltazone HCL 112529-15-4

50 Zaltoprofen 74711-43-6

51 Zonisamide 68291-97-4

52 Pregabalin 148553-50-8

53 Rampril 87333-19-5

54 Sodium Valroate 1069-66-5

TOTAL(Proposed) 0.0 210.8 210.8

TOTAL (EXISTING+PROPOSED) 5.0 210.8 215.8

1.3 Raw Material Requirement

List of Raw Materials and Their Capacity

EXISTING:

SR.

NO. Name of Products

Raw Materials

Quantity

(KG/KG)

[1] OPTICAL BRIGHTENING AGENT

Ortho toluene nitrile 2.66

Chlorine gas 4.00

Trimethyl phosphate 1.78

6

OCBC 1.33

Orthoxylene 1.11

Terpthaldehyde ester 0.45

Sodium methoxide 1.60

Dimethyl formamide 2.22

[2]

Ortho toluene Nitrite

OTA 2.33

Sulphuric acid 0.83

Urea 1.67

Soda ash 0.50

Caustic lye 1.00

PROPOSED:

Sr.

No. Name of Product Raw Materials

Quantity

(KG/KG)

[1]

Darunavir

(3aS,4S,6aR)-4-METHOXY terahydrofuro-[ 0.628 Hydrochloric Acid 0.145 Sodium Borohydride 0.870 Hydrogen 0.007 Ethyl Acetate 2.300 Tetrahydrofuran 5.020 Sodium Hydroxide 0.130 isobutyl benzenesulfonamide 1.430 Disucinimidyl carbonate 0.963 Sulphuric acid 0.100 2-Methyl2-Butanol 0.600 Methylene Chloride 3.000 Cyclohexane 2.400 Sodium bicarbonate 0.020 Sodium chloride 0.010 Sodium sulphate 0.010 Sodium hydroxide 0.008 Activated carbon 0.020

[2] Levosulpiride

Monoethylene Glyco 1.000

2-Methoxy-5-Sulphomyl Benzoate 0.750

S-1-Ethyl 5- Amino methyl Pyrolidine 0.390 [3]

Motelukast Sodium 2-[2-[3(s)-[3-[2-(7-chloro-2-quinoliny1) -Ethanl

]pheny1]-3-hydroxypropy1]pheny1-2

propanol 1.326

2-[1-(Sunfonyl methy1) 0.423

7

Cyclopropy1]acetic acid

Methane sulfonyl chloride 0.332

Sodium hydroxide 0.182

N,N-Diisopropylethylamine 0.007

Hydrochloric acid 0.046

Sodium chloride 0.007

Acetic acid 0.013

Toluene 1.000

Acetonitrile 0.867

Methanol 1.333

n Hexane 1.733

Activated Carbon 0.013

[4] Tramadol Hydrochloride Isopropyl Alcohol 2.069

Cyclohexanone 0.345 Para Formaldehyde 0.103 Dimethyl amine Hcl 0.281 Caustic Lye 0.414 Tetrahydrofuran 1.034 Manganese Turning 0.086 Catalyst 0.003 M bromo Anisole 0.069 Hcl 0.345 Toluene 2.758 Methanol 1.724 Nitric Acid 0.217 IPA Hcl 0.638

[5] Nifedipine Methyl Aceto Acetate 2.250 Methanol 13.700 ONBA 1.500 Acetic Acid 3.200 Liquid Ammonia 1.100

[6] Quetiapine hemifumarate Dibenzo - (1,4)- thiazepine - 11 (10H) one 3- 2.780 Fumaric acid 0.402 Thionyl chloride 0.050 Hydrochloric acid 0.023 Sodium hydroxide 0.025 Sodium Carbonate 0.300 Toluene 7.000 Ethanol 8.500 Activated Carbon 0.050

[7] Furosemide Lasamide 1.300

Furfuryl amine 2.100

8

Iso propyl Alcohol 4.850

Caustic soda 0.600

Citric acid 0.100

EDTA 0.010

Hydrose 0.010

Hyflow 0.150

Acetic Acid 0.500

[8] Risedronate Sodium 3-Pyridyl Acetic Acid 2.446

Diethyl carbonate 0.750

Caustic soda lye 0.050

Phosphorous trichloride 0.025

Methane sulphonic Acid 0.500

Isopropyl alcohol 5.800

Sodium hydroxide flakes 0.309

Hyflow 0.050

Activated carbon 0.050


[9]

Iohexol/Iopamidol/

Iodixanol

L-Acetoxy propionyl chloride 1.200

5- amino-2, 4, 6- Tri iodoisophthaloyl di

chloride

1.500

2-Amino-1, 3-propanediol 1.200

Sodium Hydroxide 0.350

Isopropyl Alcohol 4.000

[10]

Lauryl Pyridinium Chloride

Lauryl chloride 0.722

Pyridine 0.560

Methyl Ethyl ketone 4.000

Acetone 2.000

[11] Vildagliptin KSM I 0.770

KSM II 0.720

DMF 5.400

Methylene dichloride 15.000

Potassium Carbonate 2.600

Isopropyl Acetate 5.040

Sulphate 3.750

Sodium chloride 0. 630

Acetone 12.500

Charcoal 0.050

[12] Ambroxol Hydrochloride Ambroxol Base 0.912



9

[13] Pantaprazole Sodium 2-Chloromethyl-3-4-dimethox pyridine

hydrochloride

0.770

5-difluoromethoxy-2-mercapto benzimidazole 0.740



Sodium Hypochlorite (10%aqueous) 2.790

Acetone 6.230

[14] Miconazole Nitrate TCAP 1.059

Imidazol 0.424

Sodium Carbonate 0.848

Toluene 9.481

Sodium borohydride 0.069

TBAB 0.375

Caustic Soda flake 3.750

DCBC 0.917

Hydrose 0.010

Carbon 0.350

Nitric acid 0.300

Methanol 2.300

[15]

Dorzolamide Hcl

(+-)- Trans -5,6 - DIHYDRO-4H-4-Ethyl amino-

6-methyltheino[2,3-

2.990

N butanol 23.200

Methanol 30.200

Ethyl Acetate 14.500

Acetone 0.800


Sodium Bicarbonate 1.500

Sodium Chloride 1.500



[16] Bosentan 4,6 Dichloro 5 (2-Methoxyphenoxy)2,2

Bipsimidine

0.726

4 Tert Butylbenzene Sulfonamide 0.443

Hydrochloric Acid 0.179


Sodium Tert Butoxide 0.998

Ethylene Glycol 12.339

[17] Febuxostat KSM 1.547

Isobutyl Bromide 1.162

10


Ammonium Hydroxide Hcl 0.323




Acetone 0.750

[18] Fesoterodine NDMF Benzyl Amine DPTT 5.454


Ceric Ammonium nitrate 12.544

Barium Borohydrate (BaBH4) 0.774

Fumaric Acid 1.477

Hydrogen gas 0.013

Isobutyl Chloride 0.340

Triethylamine 0.301

[19] Rizatriptan Triazole Compound 1.250

Dimethyl amine Indole 2.000

Catalyst 1.120

Acetonitrile 5.000

Methanol 6.250

[20]

Olanzapine

Methyl Piperazinyl 1.060

Chloro-thiano benzodiazepine 0.933

N N DMA 5.330

Catalyst 0.130

Acetonitrile 4.000 [21]

Levocetirizine

1-[4Chlorophenyl) Phenyl methyl] piperizine

L-Tartaric acid

1.820

2-Chloroethoxy 0.620

Acetonitrile 1.450


Potassium Iodide 0.150

N-Butanol 2.250


Ethyl Acetate 2.950

[22] Rivaroxaban (4-4-Aminophenyl)-morpholin-3-one 1.410

Glycidyl Phthalimide 1.640

4-Dimethylaminoopyridine (DMAP) 0.010

Carbonyldiimidazole 4.030

5-Chlorothiophene-2-cacoxylic acid 1.230

11

Sodium Acetate 1.480

Oxalyl Chloride 1.500

Methyl Amine(Aqueous) 1.630


Acetic Acid 0.040

[23] Ciprofloxacin Flouro Quinolic acid 1.000

Piperazine 0.400

Dimethyl Sulphoxide 0.050

Causitc lye 0.950


Methanol 1.400

[24] Agomelatine 2-(7-methoxy-1-napthyl-napthyl) Acetonitrile 1.000

Hydrogen Gas 0.020


Sodium Acetate (Anhydrous) 0.420

Acetic Acid (Anhydrous) 0.510

[25]

Brinzolamide

4(S)-4-hydroxy-6- sulfonamide dioxide 2.610

Methanol sulfonic anhydride 0.600

Ethyl amine 0.330

Ammonia liquor 0.200



Pyridine 0.200

Tetrahydrofuran 10.050




Hyflow 0.101

[26]

Atorvastatin calcium

1, 1--dimethyl ethyl-6-(2- aminoethyl) 0.770

4- Fluoro-2-methyl-1-oxopropyl 1.176

Cyclohexane 3.000



Acetonitrile 3.500


Calcium Acetate 0.179

Hyflow 0.012

[27] Capectabine 2,3 di-o-actyl-5-dexy-5-fluorocytidine 1.247

12

n-Pentyl Chloroformate 0.570




Methylene Chloride(MDC) 4.000

Methanol 2.500

Ethyl Acetate 5.500


[28] Diacerein Aloe emodine 1.966

Sodium dichromate dihydro 2.168

Sulphuric Acid 0.814



Acetone 6.200

Acetic Anhydride 1.018

N Methyl pyrolidone 3.498

Methanol 2.200


Celite 0.200

[29]

Dabigatran

3-[(1-Methyl-2-{[4-(5-oxo-4,5-dihydro-[1,2,4]

oxadiazol-3-yl)-phenylamino]-methyl)-1H-

benzoimidazole-5-carbonyl)-pyridin-2-yl

amino]-propionic acidethyl ester

0.970

Para toluene sulphonic acid 0.250

Acetic acid 0.200

Ethanol 25.000

Hexa Chlorofomate 0.280

Acetone 12.000

Potassium Hydroxide 0.096


[30]

Vilazodone Hydrochloride

5-{4-(5-Cyano-1H-indol-3-yl)-butyl]-piperazin-

1-yl}-benzofuran-2carboxylicacid methyl ester 1.510

Ammonia 0.951

Methanol 16.100


Sodium Hydroxide 30% 0.122



13

[31]

Posaconazole

2-[2-[3(S)-[3-[2-(7-Chloro-2- Quinolinyl)

ethenyl ]pheny]-3 hydroxy propyl] phenyl-2-

Propanol

1.326

2-[1-(sulfonyl methyl) cyclopropyl} acetic acid 0.423

Methane sulfonyl chloride 0.332

sodium hydroxide 0.182

N,N-Disopropyletylamine 0.007



Acetic acid 0.013

Toluene 1.000

Acetonitrile 0.867

Methanol 1.333

n-Hexane 1.733


[32] Dapoxetine Hydrochloride ᵦ- (dimethylamino) benzenepropanol 1.062

1-fluoronaphthalene 0.865

sodium hydroxide 0.357

Hydrochloric acid

0.325 Di methyl Sulphoxide (DMSO) 12.500

n-Propanol 10.000


[33] Canagliflozin 2-(5-bromo-2-methylbenzil)-5-(4-

flurophenyl)thiophene 2.123

silyl D-gloconolactone 2.770

Methanol 16.667

Acetone 25.000


[34] Bronopol(BP) Nitro Methane 0.333

Methanol 1.667

caustic 0.233

Formaldehyde 0.733

Carbon 0.017

Bromine 0.883

[35]

Carbamazepine

Methanol 1.014

Imino stilbene carbonyl Chloride 1.282

Ammonia Liquor 2.802

Acetone 6.504

Toluene 0.040

14

Caustic lye 0.406

Hyflow 0.013


[36]

Cefsulodine Sodium

RS-a-Sulfophenyl acetic acid 0.515

(S)-a-Methyl benzyl amine 0.288

Acetonitrile 6.150

1-Hydroxy benzotriazole 0.309

Methane sulphonyl chloride 0.261

Sodium bicarbonate 0.100

Methylene dichloride 5.125

Hexane 3.000

Sodium hydroxide 0,086

7-Amino cephalosporic acid 0.598

Boron triflouride etherate 1.875

Tert-butyl acetate 0.255

Hyflow 0.050

Zinc chloride 0.025

Triethyl amine 0.025

Ethyl acetate 1.025

Di isopropyl ether 0.500

Pyridine -4-carboxamide 0.242

Sodium Iodide 0.200

Dimethyl formamine 0.276


Ethanol 1.750


DMF 1.500

Diethyl ether 2.250

[37]

Cilinidipine

Methanol 7.500

2 Methoxy Ethyl Acetoacetate 3.250

Cinramyl Aceto Acetate 1.000

3 Nitro Benzaldehyde 0.750

Ammonium Carbonate 1.000

[38] NEBIVOLOL Benzopyran-2- Carboxaldehyde Deri 1.4

Trimethyl sulfoxonium Iodide 1.15

Potassium hydroxide 0.56

Benzylamine 0.4

Toluene 3.0

15

Ammonium formate 0.6

(Hydrogen source) Pd/C 0.01

Methanol 5.2

[39] NEBIVOLOL HCL NSR-19C 1.0

Methanol 7.6

Acetonitrile 3.0

Diisopropyl ether 6.0

HCl (CP) 0.6

Methanol 144.1

NSR-19D 0.3

IPA HCl (20%) 3.4

Hyflow 1.7

[40] DONEPEZIL

HYDROCHLORIDE

NSR-10A

1.61

NSR-10B 1.39

Sodium methoxide solution (30%) 1.57

Methanol 42.33


NSR-10C 0.78

Recycled NSR-10C from Donepezil

Hydrochloride crude (cycle-1) 0.06

Recycled NSR-10C from Donepezil

Hydrochloride crude (cycle-2) 0.12


Ammonia solution 16.39

Ethyl acetate 60.00

Hydrogen gas 1.11

Hyflo super cel 1.11

Methanol 147.22

Methanol 16.39

Methyl tertiary butyl ether 23.99

Activated charcoal 0.11


Donepezil Hydrochloride seed 0.02

[41] BRIMONIDINE TARTRATE NSR-2A 5

Benzoyl chloride 3.8

NSR-2B 2.1

Acetone 15

Sodium Hydroxide Flakes 4.5

Hydrochloric acid 10

16

Hyflo supercel 5.1

Ethylenediamine 2.05

Chlorobenzene 55.5

Isopropyl alcohol 15

Hydrochloric acid 2

Sodium Hydroxide flakes 7.1

Ethylacetate 72

Hyflo supercel 138.6

[42] CAPTOPRIL NSR-5A 3.55

NSR-5B 4.36

Thionyl chloride 5.91

Methanol 1.82

Sodium hydroxide lye 22.73

NSR-5C 1.82

Methylene chloride 9.09

N,N-Dimethyl aniline 1.91


Ammonia solution 1.18


NSR-5D 0.28




Ethyl acetate 14.77

[43] CILOSTAZOL NSR-7A 0.92

NSR-7B 0.70

Sodiumhydroxide 0.44

Sodiumsulphate 0.71

NSR-7C 0.03


Toluene 0.64

Methanol 3.21

Methanol 26.38


hyflow 0.09

[44] CLOPIDOGREL BISULPHATE NSR-8A 5.43


Sulphuric acid 0.83

Methanol 18.26

17

Chloroform 13.04

Mehtyl-Alpha-bromo-2-hlorophenyl acetate 5.00


NSR-8B 3.22

Acetone 29.57

Chloroform 17.39

Methanol 28.26

NSR-8C 2.43

Clopidogrel seed-1 0.06


Chloroform 22.17

Ethyl acetate 19.13



Sulphuric acid 0.52



Chloroform 22.17

Ethyl acetate 23.48



Sulphuric acid 0.30


[45] ENTACAPONE NSR-11A 1.79

Nitric acid 1.60

Sulphuric acid 2.07

Methylenedichloride 12.50

5-Nitro Vanillin 1.19

NSR-11B 1.10

Pyridine 2.14



DHNB 0.54

NSR-11C 0.60

NSR-11D 0.65


Acetic acid 2.48

Methanol 1.07

Cyanoacetic acid 0.86

18

Diethylamine 0.81

NSR-11E 2.02



Acetic acid 0.29

[46] GRANISERTON HCL NSR-13A 1.13

Thionyl chloride 1.47

NSR-13B 0.03

n-Hexane 16.67

Stage-I 1.00

NSR-13C 0.92

Triethylamine 0.92



Sodiumbicarbonate 1.33



Solvent E 13.00

[47] MELOXICAM NSR-16A 1.08

NSR-16B 0.47

Meloxicam Crude 1.13


Acetic acid 0.76

Methanol 1.95


Hyflow 0.25

Meloxicam Purified 1.07

Acetic acid 2.96

Meloxicam Purified 1.03

Toluene 4.90

Dimethylformamide 0.49

[48] MODAFINIL NSR-17A 1.21

Ethylene Dichloride 12.12

Triethyl Amine 0.73

Ethyl Chloroformate 0.80

NSR-17B 0.12

Methanolic Ammonia (20%) 16.36

Methanol 6.36

Modafinil Crude 1.03

19

Methanol 13.33


Hyflow 0.03

[49] PIOGLTAZONE HCL NSR-22A 1.23

Methane sulphonylchloride 1.07

Toluene 13.09

NSR-22B 1.06



Methanol 18.52

NSR-22C 0.31

2,4-Thiazolidinone 0.87

Triethylamine 1.01


NSR-22D 0.12

NSR-22E 0.10

Dimethylformamide 17.78

Sodiumborohydride 0.31


Methanol 8.32



Hyflow 0.12

[50] ZALTOPROFEN NSR-27A 1.43

NSR-27B 5.71


Acetone 4.29


Hyflow 0.04

NSR-27C 5.36

Sodium carbonate 0.23

Denatured Spirit 2.79

NSR-27D 0.01

Acetic acid 0.82

[51] ZONISAMIDE NSR-28A 2.5

NSR-28B 3.8

NSR-28C 4.4

Methanol 25.0

Ammonia Solution 6.3

20


Ethyl Acetate 6.3


NSR-28D 2.2

1,4 Dioxane 1.6

Phosphorus Oxy chloride 8.2

Toluene 61.3

Ethyl Acetate 102.1


Hyflow Super cell 0.8

Sodium Chloride 4.4

Anhydrous ammonia 0.8

Acetone 8.3


Hyflow supercel 0.4

[52] PREGABALIN 3-isobutylglutaric acid 2.2

acetic anhydride 1.2

Toluene 6.6

4-Dimethyl aminopyridine 0.01

(S)-(-)-phenyl ethylamine 2.84

caustic lye 2


Acetone 12.5

Triethylamine 1.09

Ethylchloroformate 1.03

Sodium Azide 1.4

Toluene 13

Methanol 0.5

70% sulphuric acid 24.8

Sodium Hydroxide lye 13

Iso Butanol 8.68

A. carbon 0.02

Hyflow 0.06

[53] RAMIPRIL ECPPA 0.88

Azabicyclo Benzylester 8.33

TEA 0.6

HOBT 0.5

DCC 0.67

MDC 16.67

21


Benzyl Ramipril 1.56

Ab. Alcohol 12.5

pd/C 0.16

Hyflow 0.1

Acetonitrile 7.8

[54] SODIUM VALROATE valporic acid 0.91

Acetonitrile 3.5

sodium Hydroxide 0.29


hyflow 0.02

1.4 Water Requirement, Waste Water Generation and Treatment

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

will be 126 m3/day (Fresh Water: 60 KL/Day + Reuse water: 66 KL/Day). Total 93.1 m3/day (91.1

m3/day Industrial + 2.0 m3/day domestic) of effluent shall be generated. 2.5 m3/day Industrial

effluent generated from existing products will be treated in existing ETP to give primary

treatment and sent to ETL, Ankleshwar. 88.6 m3/day of Industrial effluent will be given primary

treatment in ETP & then sent to Solvent Stripper and in-house MEE for further treatment. ETP

sludge and MEE salt will be sent to common TSDF site of BEIL, Ankleshwar and MEE condensate

(66 KL/day) will be reused in industrial processes. Domestic Waste water will be disposed by

septic tank & soak pit.

1.5 Air Pollution Source and Control Management

There will be flue gas emissions from Boiler, Thermic Fluid Heater and D.G. Sets however as

natural gas will be used as fuel in the boilers the emissions will be well within permissible norms

as natural gas is a clean fuel. Process gas emissions will be in the form of Chlorine, HCL, SO2 and

NH3 which will be controlled by Wet scrubber, alkali scrubber & Water + HCl Scrubber. Fugitive

emissions will be well within permissible norms as all precautionary measures for fugitive

emission will be taken.

1.6 Hazardous Waste

Type of waste Category Existing Additional

Total

(Existing+

Proposed)

Disposal Method

22

Used oil 5.1

120

liters/

annum

350

liters/

annum

470

liters/

annum

Collection, storage,

Transportation and sale to

registered refiners

Distillation and

process residue

20.3 and

28.1

1.2 MT/

Year

78 MT/

Year

79.2 MT/

Year


Transportation and

disposal at BEIL common

incinerator/

Co processing in cement

plant

Spent catalyst 28.2 0 MT/

year

5.0 MT/

year

5.0 MT/

year


Transportation and return

back to regenerator

Spent carbon 28.3 0 MT/

year

15.0 MT/

year

15.0 MT/

year


Transportation and


incinerator/


plant

Date expired

discarded and

off specification

drugs/medicines

28.4 and

28.5

0 MT/

year

1.0 MT/

year

1.0 MT/

year


Transportation and


incinerator/


plant

HCl (35%) -- 6.0 MT/

year --

6.0 MT/

year

Collection, Storage,

Transportation, Purification

& Sale to GPCB approved

vendors.

Discarded

Drums/

Bags/ Liners

33.1

3060

Nos/

year

3000

Nos/year

6060

Nos/year


Transportation,

Decontamination & Sale to

GPCB approved vendors.

Spent solvents 28.6

0

MT/

year

650

MT/year

650

MT/year


Transportation & Sale to

GPCB registered re-

processor.

ETP Sludge 35.3

2.4

MT/

year

84

MT/year

86.4

MT/year


Transportation and

disposal at BEIL TSDF

Ankleshwar

23

1.7 Green Belt

Total 5,835 sq. meter land area is available at site; out of this area about 1,750 sq. meter (30%

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

1.8 Power & Fuel Requirements

FUEL:

Existing:

Natural gas= 140 SCM/day

Proposed:


HSD= 20 lit/hr for DG Sets.

ENERGY:

Existing:

Power supply is from DGVCL and its about 125 KVA.

Proposed:

After Proposed expansion, 600 KVA will be required from DGVCL.

Standby power supply will be from D.G. sets (250 KVA) in emergency.

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. Nivika Chemo Pharma P. Ltd. proposes to manufacture bulk drugs in existing premises at

Plot No. 1808, 1809/2, 1811, 1812, 1813, 1814 & 1815, G.I.D.C. Estate, Ankleshwar-393002,

Dist: Bharuch (Guj.).

List of Directors

Sr.

No.

Name of Directors

1. Mr. Satyan M. Patel

2. Mrs. Ramaben M. Patel

MEE Salt 35.3 --

600

MT/

year

600

MT/

year


transportation and dispose

common TSDF site of BEIL,

Ankleshwar.

24

2.2 Brief description of nature of the Project

Proposed to manufacture bulk drugs in existing premises at Plot No. 1808, 1809/2, 1811, 1812,

1813, 1814 & 1815, G.I.D.C. Estate, Ankleshwar-393002, Dist: Bharuch (Guj.).

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

The demand for products intended to be manufactured is increasing in the country. APIs are

imported in the country and by manufacturing bulk drugs at this unit, company will be able to

meet the demand of various products locally. The project will save forex as imports 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, we have found that there is a big potential for the

range of the products we are planning. These products will be an addition to the current

products as they are directly related to health of the people and their well being.

2.5 Imports vs. Indigenous production

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

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

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

also export our finished products in the international market.

2.6 Export possibility

All possibilities of exports will be explored.

2.7 Domestic/Export Markets

Our products have good demand in international market. We shall explore the possibility of

exporting the products.

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

M/s. Nivika Chemo Pharma P. Ltd. will give direct employment to local people based on their

qualification and requirement. In addition to direct employment, indirect employment will also

be generated. Ancilliary businesses will be developed to some extent for the local population.

25

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.

PROJECT

SITE

26

Specific location and project boundary

• Project Site (Google Map)

10

• Plant layout:

14

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 local and international market demand of the proposed bulk drug products,

Nivika Chemo Pharma P. Ltd. decided to set up its manufacturing facility at existing optical

brightening making unit in GIDC Ankleswar.

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

• No site clearance activities are required to be carried out.

• 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 water, Fuel, Power, CETP, TSDF and other infrastructures in the estate.

Modern infrastructure support and amenities at par with 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

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.

All possibilities of water reuse / recycle, energy conservation and environment friendly

operations will be explored and implemented.

15

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.

Power Requirements:

FUEL:

EXISTING:


PROPOSED:


HSD= 20 lit/hr for DG Sets.

ENERGY:

Existing:

Power supply is from DGVCL and its about 125 KVA.

PROPOSED:

After Proposed expansion, 600 KVA will be required from DGVCL.

Standby power supply will be from D.G. sets (250 KVA) in emergency.

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.

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

purpose.

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

16

4.0 Site Analysis

4.1 Connectivity

• Site is very well connected by road and rail

• Availability of water, fuel, power, CETP, TSDF and other infrastructure facilities in the

estate.

4.2 Land Form, Land Use and Land Ownership

Land Use will be incorporated in the EIA Study.

4.3 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

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.

4.4 Existing Infrastructure

Existing operating industry having Manufacturing plant, Adm. Bldg., Godown, etc.

4.5 Soil Classification

Soil Classification will be incorporated in the EIA Study.

4.6 Climatic data from secondary sources.

Climatic data will be incorporated in the EIA Study.

4.7 Social infrastructure available.

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

has been planned, which are as follows.

17

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 -

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 bulk drugs Manufacturing Unit in existing dyes unit.

5.2 Population Projection

Population Projection will be incorporated in the EIA Study.

18

5.3 Land use planning (breakup along with green belt etc.)

Total Area= 5,835 m2

Industrial Area (Processing Area)

Processing Area (Plant facilities, ETP Area and Utility Services) = 2,335 m2

Residential Area (Non Processing Area)

Non Processing Area (Raw material storage area, finished storage area, green belt and open

area) = 3,500 m2

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 expansion 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) = 2,335 m2

6.2 Residential Area (Non Processing Area)

Non Processing Area (Raw material storage area, finished storage area, green belt and open

area) = 3,500 m2

6.3 Green Belt

Total 5,835 sq. meter land area is available at site; out of this area about 1,750 sq. meter

(30% of the total land area) area will be developed as greenbelt and other forms of

greenery.

19

6.4 Social Infrastructure

• Water requirement will be met through Ankleshwar 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

• 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 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 expansion 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.

20

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 expansion project after getting EC & CTE 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. 25 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 expansion project.

• Social Welfare will be done with allocation of designated funds for this purpose as

percentage.

• 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.

annexure-project feasibility report - welcome to...

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