annexure-i list of products &...

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Annexure-I List of Products & By-Products List of Products S.N. Products listed in ToR letter Products proposed for ToR Amendment Name of Product Quantity (MTPM) Name of Product Quantity (MTPM) 1 Cyclohexanyl Acetonitrile 19.5 - - 2 ChloroEthoxy Ethyl Acetate 2.6 - - 3 Sodium Iodide 50.02 - - 4 Potassium Iodide 50.02 - - 5 Calcium Iodide 12.9 - - 6 Metformin Hydrochloride 50.4 Metformin Hydrochloride 50.4 7 Cyanoacetamide 2.03 - - 8 Malonic Acid 3.1 - - 9 Mono Methyl Urea 5.6 - - 10 Lumefantrine 3 Lumefantrine 3 11 Methycyano Acetate 10.4 - - 12 Ethylcyano Acetate 11.7 - - 13 Ethylcyano Acetate 36.15 - - 14 Aluminum Chloride 21 Aluminum Chloride 36.15 15 Cyano Acetic Acid 23.6 - - 16 Ibuprofen 15 Ibuprofen 23.6 17 Orpha-hydrine Citrate 8.5 - - 18 2-Amino-3, 5- DibromoBenzaldehyde (ADBA) 11.2 - - 19 Ambraxol Hydrochloride 10.75 Ambraxol Hydrochloride 10.75 20 Doxofylline 10.5 - - 21 - - Cinnarzine 1 22 - - Amoldipine Baselate 2 23 - - Folic Acid 2 24 - - Oxyclozanide 2 By-Products S.N. Products listed in ToR letter Products proposed for Amendment Name of Product Quantity (MTPM) Name of Product Quantity (MTPM) 1 Sodium Chloride 7.5 MTPM - - 2 Aluminum Hydroxide 96 M3 Aluminum 96 M3

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Page 1: Annexure-I List of Products & By-Productsenvironmentclearance.nic.in/writereaddata/Online/TOR/12_Sep_2017... · List of Products & By-Products List of Products S.N. Products listed

Annexure-I

List of Products & By-Products

List of Products S.N. Products listed in ToR letter Products proposed for ToR

Amendment Name of Product Quantity (MTPM) Name of Product Quantity (MTPM)

1 Cyclohexanyl Acetonitrile

19.5 - -

2 ChloroEthoxy Ethyl Acetate

2.6 - -

3 Sodium Iodide 50.02 - - 4 Potassium Iodide 50.02 - -

5 Calcium Iodide 12.9 - -

6 Metformin Hydrochloride

50.4 Metformin Hydrochloride

50.4

7 Cyanoacetamide 2.03 - -

8 Malonic Acid 3.1 - - 9 Mono Methyl Urea 5.6 - -

10 Lumefantrine 3 Lumefantrine 3

11 Methycyano Acetate 10.4 - -

12 Ethylcyano Acetate 11.7 - -

13 Ethylcyano Acetate 36.15 - -

14 Aluminum Chloride 21 Aluminum Chloride

36.15

15 Cyano Acetic Acid 23.6 - -

16 Ibuprofen 15 Ibuprofen 23.6

17 Orpha-hydrine Citrate 8.5 - - 18 2-Amino-3, 5-

DibromoBenzaldehyde (ADBA)

11.2 - -

19 Ambraxol Hydrochloride

10.75 Ambraxol Hydrochloride

10.75

20 Doxofylline 10.5 - -

21 - - Cinnarzine 1

22 - - Amoldipine Baselate

2

23 - - Folic Acid 2

24 - - Oxyclozanide 2

By-Products

S.N. Products listed in ToR letter Products proposed for Amendment

Name of Product Quantity (MTPM) Name of Product Quantity (MTPM)

1 Sodium Chloride 7.5 MTPM - -

2 Aluminum Hydroxide 96 M3 Aluminum 96 M3

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Hydroxide

3 Potassium Bromide 5 MTPM - -

4 Sodium Sulphate 6.51 MTPM Sodium Sulphate 6.51 MTPM

5 Chromic Sulphate 0.48 MTPM Chromic Sulphate 0.48 MTPM

6 Sulphuric Acid 34.8 M3 - -

7 Hydrochloride Acid 16.5 M3 - -

8 Ammonium Bromide 0.5 MTPM - - 9 Manganese Dioxide 11.4 MTPM - -

10 - - Sodium Chloride 0.80 (Folic Acid)+ 0.38 (Amolodipine

Baselate)

11 - - Sodium Acetate 1.08 (Folic Acid) 12 - - Hydrochloric acid 0.34

(Oxyclozanide)

13 - - Sodium Chloride 0.64 (Cinnarzine)

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Annexure-II

List of Raw Materials

1: Name of the product : Metformin Hydrochloride

Quantity : 50.4 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch

DCDA 1150

DMAHCL 1340

Dimethyl Acetamide 3280

Carbon 5

2: Name of the product : Lumefantrine

Quantity : 3.0 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch DBA 110

Parachloro Benzaldehyde 49 Acetone 500 Methanol 1600 Carbon 5 Hyflow 0.5

3: Name of the product : Aluminum Chloride

Quantity : 36.15 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch Aluminum 500 Chloride 2000

4: Name of the product : Ibuprofen

Quantity : 23.5 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch

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EDC 950 Aluminum Chloride 820

Acetyl Chloride 515 Isobutyl Benzene 775

Ammonia 80 Ice 3000

Stage: II

Name of The Raw Material Input Quantity Kg / Batch

Stage I 1025 MCA 1000

Sulphuric Acid 365 Sodium Bicarbonate 100 Sodium Carbonate 20

Water 500

Stage: III

Name of The Raw Material Input Quantity Kg / Batch Stage II 1330

IPA 3660 Sodium 183

Isobutyl Acetophenone 976 Isophenylchloror 1050

Water 7199

Stage: IV

Name of The Raw Material Input Quantity Kg / Batch Stage III 916

Sulphuric Acid 916 Acetone 3053

Sodium Dichromate 571 N Hexane 1570

Water 3768

5: Name of the product : Ambraxol Hydrochloride

Quantity : 10.75 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch 2 Amino 3, 5 Dibromo Benzaldehyde 350

4 Amino Cyclohexane 150 Toluene 1120

Stage: II

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Name of The Raw Material Input Quantity Kg / Batch Stage I 440

Sodium Borohydride 52 Methanol 1200

Water 2000

Stage: III

Name of The Raw Material Input Quantity Kg / Batch Stage II 420

Isopropyl Alcohol 1016 Activated Charcoal 5 Hydrochloric Acid 135

6: Name of the product : Amlodipine besilate

Quantity : 2 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch PTA 125 MMA 51.4 Water 560 Water 250

Toluene 220 Toluene 25

Stage: II

Name of The Raw Material Input Quantity Kg / Batch Toluene 830

NaH 30 Stagel 61.8 ECAA 59.2

AA 20 HCL 6% 390 Water 440 NaCl 60

Stage: III

Name of The Raw Material Input Quantity Kg / Batch Stage II 600

OCB 44.4 Piperzine 3.14

AA 2.2 Toluene 11.5

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Water 350 Hexane 110

Stage IV: A

Name of The Raw Material Input Quantity Kg / Batch Stage III 142

AA 440 MAC 37 AA 50

Hexane 80

Stage IV: B

Name of The Raw Material Input Quantity Kg / Batch Stage IV A 142

EA 330 EA 45

Stage: V

Name of The Raw Material Input Quantity Kg / Batch MMA 260

Stagel IV B 55 Toluene 320 Water 795

BS 19.5 EA 100

Stage: VI

Name of The Raw Material Input Quantity Kg / Batch Stage V 50 Methanol 330

EA 390 EA 40

7: Name of the product : Oxyclozanide

Quantity : 2 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch DCP 250

HNO3 (70%) 215

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Water 360 NaOH 28

Stage: II A

Name of The Raw Material Input Quantity Kg / Batch Water 725 NaOH 270

SO2 30 Stage I 340 Sulphur 165

MCB 1000

Stage: II B

Name of The Raw Material Input Quantity Kg / Batch

TCSA 250 MCB 625 DMF 2 TC 145

Stage: III

Name of The Raw Material Input Quantity Kg / Batch Stage II A 1050 Stage II B 500 Toluene

Stage: IV

Name of The Raw Material Input Quantity Kg / Batch Technical 360 Acetone 1600 Carbon 2 Hyflow 5

Hydrose 2 Water 1000

8: Name of the product : Cinnazine

Quantity : 1 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch

Piperzine 50

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Hexane 150 Water 5 DPC 60

NaOH 26 HCL 6% 100

Stage: II

Name of The Raw Material Input Quantity Kg / Batch BHP 30

Na2CO3 42 SMPS 0.3

Hexane 150 Cinemic chloride 21

Hexane 75

9: Name of the product : Folic Acid

Quantity : 2 Tones / Month

Stage: I

Name of The Raw Material Input Quantity Kg / Batch PABGA 50 TAPS 60 TCA 100

SMBS 15

NaHCO3 40 Water 4000

Stage: II

Name of The Raw Material Input Quantity Kg / Batch HCl 30% 330 Stage I 245 Water 1200

Water washing 200

Stage: III

Name of The Raw Material Input Quantity Kg / Batch Stage II 150

NaOH 48% 90 Acetic Acid 100

Water 3000

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Annexure-III

Manufacturing Process

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Manufacturing Process & Mass

Balance

For Proposed Project

BULK DRUG & INTERMEDIATES AS WELL AS

CHEMICALS MANUFACTURING UNIT By

M/s. CHALLA CHLORIDE PVT. LTD.

Plot No. F-2, Maharashtra Industrial Development Corporation

(MIDC) Chincholi, Taluka: Mohol, District: Solapur, Maharashtra, India

Prepared By

GREEN CIRCLE, INC. Integrated HSEQR Consulting Engineers, Scientists & Trainers

(MoEF Recognized Environment Laboratory)

(An ISO: 9001, 14001, NABL/17025:2005, OHSAS: 18001 Certified Organization & GPCB approved Environment

Auditor – Schedule II)

Gujarat High Court Sstay Order for QCI NABET No. C/SCA/10311/2012 dated 24.01.2013

Corp. Office & Environmental Research Laboratory:

Green Empire (Anupushpam), Above Axis Bank, Nr. Yash Complex, Gotri Road, Vadodara-390 021 (Gujarat) India Ph: 0265-2371269

Mumbai: 221, 2nd Floor Hariom Plaza, Beside Omkareshwar mandir, M.G. Road, Borivali(E) Mumbai

– 400066 Ph: 0222-28943060

www.greencircleinc.com E: [email protected]

ALSO AT

BENGALURU RUDRAPUR NEW DELHI HYDERABAD PUNE RAIPUR KOLKATA GOA

OVERSEAS

AUSTRALIA

OMAN

KUWAIT

AFRICA

VIETNAM

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List of Product & By-Product

Sr. No. Name of Product Quantity (MT/M)

1 Metformin Hydrochloride 50.4

2 Lumefatrine 3.0

3 Aluminium Chloride 36.15

4 Ibuprofen 23.6

5 Ambraxol Hydrochloride 10.75

6 Amplodipin Baselate 2

7 Folic Acid 2

8 Oxyclozanide 2

9 Cinnarzine 1

Byproducts

1 Aluminum Hydroxide 96

2 Sodium Sulphate 6.51

3 Chromic Sulphate 0.48

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Product No. 1 – Metformin Hydrochloride

1 Manufacturing Qty. 50.4 MT/Month

3 Batch size 2100 Kg/ Batch

4 No. Of Batches 24/ Month

METFORMIN HCL SYNTHESES:

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Material Balance Table of Metformin Hydrochloride

Stage-I

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions

in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

DCDA 1150 - - - - - - DMAHCL 1340 - - - - - Dimethyl

Acetamide 3280 3280 - - - - -

Carbon 5 - - 5 - - - Product - - - - - - 2100

Residue - - - 390 - - -

Total 5775 3280 - 395 - - 2100

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Product No. 1 – MASS BALANCE & FLOW DIAGRAM OF METFORMIN HYDROCHLORIDE

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Product No. 2 – LUMEFANTRINE

1 Consent Qty. 3.0 MT/Month

2 Batch size 100 Kg/ Batch

3 No. of Batches 30/ Month

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LUMEFANTRINE SYNTHESES:

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Material Balance Table: Stage-I

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions

in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

DBA 119 - - - - - - Parachloro

Benzaldehyde 49 - - - - - -

Acetone 500 500 - - - - - Methanol 1600 1600 - - - - - Carbon 5 - - 5 - - - Carbon Dioxide

- - - - - -

Hyflow 0.5 - - 0.5 - - -

Product - - - - - 100

Residue - - - 59 - -

Total 2264.5 2100 - 64.5 - - 100

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MASS BALANCE & FLOW DIAGRAM OF LUMEFANTRINE :

Water Consomption 0 kg

Waste Water Generation 0 kg

Methanol Recovery 1600 kg

Acetone Recovery 500 kg

Gaseous emission generation during manufacturing process

0 kg

Solid waste generation 0.5 kg + 5.0 kg + 59 kg = 64.5 kg

Finished Products 100 kg

*Note : This product is ZLD product

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Product No. 3 – Aluminium Chloride

1 Consent Qty. 36.15 MT/Month

2 Batch size 2410 Kg/ Batch

3 No. of Batches 15/ Month

Material balance of Aluminium Chloride: Stage-I

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions

in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

Aluminium 500 - - - - - - Chlorine Gas 2000 - - - - - -

Product - - - - - - 2410 Aluminium Hydroxide

- - 90 - - - -

Total 2500 - 90 - - - 2410

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MASS BALANCE & FLOW DIAGRAM OF ALUMINIUM CHLORIDE

Water Consomption 0 kg

Waste water generation 0 kg

Gaseous émission during process 0 kg

Solid waste generation 90 kg (Semi-Solid)

Finished Product 2410 kg (96 drums x 25 kg + 10 kg)

*Note : This Product is ZLD Product

Page 21: Annexure-I List of Products & By-Productsenvironmentclearance.nic.in/writereaddata/Online/TOR/12_Sep_2017... · List of Products & By-Products List of Products S.N. Products listed

Product No. 4 – Ibuprofen

Sr. No. 17 of Consentent

1 Consent Qty. 24.5 MT/Month

2 Batch size 1025 Kg/ Batch

3 No. of Batches 25 / Month

1. Brief description of process

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2. Chemical reaction

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3. Material Balance-Ibuprofen Stage-I

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions

in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

EDC 950 950 - - - - - Aluminium Chloride

820 - - - - - -

Acetyl Chloride

515 - - - - - -

Isobutyl Benzene

775 - - - - - -

Ammonia 80 - - - - - - ICE 3000 - - - - - -

Aluminium Hydroxide

- - 3783 - - - -

Product - - - - - - 1025

HCL - - - - 382 - -

Total 6140 950 3783 - 382 - 1025 Spent Aluminum Hydroxide generated will be sold to Paper Industries

Stage-II

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions

in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

Stage-I 1025 - - - - - - MCA 1000 - - - - - -

Sulphuric Acid

365 - - - - - -

Sodium Bicarbonate

100 - - - - - -

Water 20 - - - - - - Product 500 - - - - - 1330 Spent

Sulphuric Acid

- - 1229 - - - -

Carbon Dioxide

- - - - 251 - -

Sodium Sulphate

- - - 200 - - -

Total 3010 - 1229 200 251 - 1330

Stage-III

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

Stage-2 1330 - - - - - - IPA 3660 3660 - - - - -

Sodium 183 - - - - - - Isobutyl

Acetophenone 976 - - - - - -

Isophenylchloror Acetyl

1050 - - - - - -

Water 7199 - 9822 - - - - Product - - - - - - 916

Total 14398 3660 9822 - - - 916

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Stage-IV

Name of the Raw Material

Input qty. in Kg/ Batch

Recycle qty. in

Kg/Batch

Liquid Effluent in Kg/Batch

Solid Waste in Kg/Batch

Process Emissions in Kg/Batch

Evaporation Losses in Kg/Batch

Output in

Kg/Batch

Stage-3 916 - - - - - - Sulphuric Acid 916 - - - - - -

Acetone 3053 2898 - - - 155 - Sodium

Dichromate 571 - - - - - -

N Hexane 1570 1490 - - - 80 - Product - - - - - - 942 Chromic Sulphate

- - - 570 - - -

Water 3768 - 4343 - - - - Sodium Sulphate

- - - 316 - - -

Total 10794 4388 4343 886 - 235 942

4. Process flow chart

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Product No. 5 – Ambraxol Hydrochloride

1 Product Qty. 10.75 MT/Month

2 Batch size 440 Kg/ Batch

3 No. of Batches 25 / Month

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Synthesis of Ambraxol Hydrochloride

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Material balance Table of Ambraxol Hydrochloride

Stage: I

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

ADBA 350 - - - - - -

4ACH 150 - - - - - -

Toluene 1120 1064 - - - 56 -

Water - - 60 - - - -

Others - - - - - - -

Product - - - - - - 440

Total 1620 1064 60 - 0 56 440

ADBA- 2-Amino 3,5 Dibromo Benzaldehyde.

4ACH - 4-Amino Cyclohexanol

1. Water is produced in the reaction - about 23 kg.

2. Amino Cyclo Hexanol excess about 6 kg.

Stage: II

NaBH4 – Sodium Boro Hydride.

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batch

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Output

in

kg/batc

h

Stage-I 440 - - - - - -

NaBH4 52 - - - - - -

Methanol 1200 1140 - - - 60 -

Water 2000 - 2072 - - - -

Product - - - - - 420

Total 3692 1140 2072 - - 60 420

Sodium Boro Hydride reacts with Methanol and releases hydrogen (4 x H 2) and forms Sodium Tetra Methoxy Boron. Hydrogen (1 x H 2) is used to reduce –N=C-. Hydrogen (3 x H 2) is lost in the process.

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2. Sodium Tetra Methoxy Boron formation consumes 152 kg Methanol, contains about 35 kg of Sodium and Boron put together.

Stage: III

Name of

Raw

material

Input

qty. in

kg/batch

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

Stage-II 420

IPA 1016 965 51

Activated

charcoal.

5 5

HCl 135 125

Product 430

Total 1576 965 125 5 51 430

IPA – Isopropyl alcohol

HCl – Hydrochloric acid.

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MASS BALANCE & FLOW DIAGRAM OF AMBRAXOL HYDROCHLORIDE

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Water Consumption 2000 kg

Waste water generation 123 kg

Evaporation Loss 356 Kg

Toluene Recovery 1064 Kg

Water Recovery 1800 Kg

Methanol Recovery 1000 Kg

IPA Recovery 966 Kg

Gaseous emission during process 0 kg

Solid waste generation 268 kg

Finished Product 443 kg

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Product No. 6 – Amlodipin Baselate

1 Product Qty. 2.0 MT/Month

Brief description of Amlodipin Baselate

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Synthesis process:

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Product No. 6 – Amlodipin Baselate

1 Product Qty. 2.0 MT/Month

Material Balance Table of Amlodipin Baselate

Stage I:

PTA: Phthalic anhydride, MMA: Mono methyl amine, DCP: Dichloro phenol

Stage I is divided in to two parts.

Stage II:

NaH; Sodium hydride, ECAA: Ethyl 4-chloro aceto acetate. AA: Acetic acid

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

Toluene 830 342 - - - 38 -

NaH 30 - - 22 0.6 - -

Stage I 61.8 - - - - - -

ECAA 59.20 - - - - - -

AA 20 - 15 7 - 2 -

HCl 6% 390 - 325 18.72 - 20 -

Water 440 400 - - - 40 -

NaCl 60 - - 60 - - -

Product - - - - - - 601

Total 1891 742 340 108 0.6 148 601

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

PTA 125 - - - - - -

MMA 51.4 - - - - - -

Water 560 500 - - - 60 -

Water 250 225 - - - 25 -

Toluene 220 210 - - - 10 -

Toluene 25 23 - - - 2 -

Product - - - - - - 124

Total 1231 958 15 37 0.00 97 124

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Stage III :

OCB: Ortho chloro benzaldehyde.

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

Stage-II 601

OCB 32

Piperzine 3.14 3.14

AA 2.20 2.20

Toluene 10 440 20

Water 350 320 30

Hexane 110 104 6

Product 142

Total 1108.34 864 2.20 3.14 56 142

AA: Acetic acid

Stage IV A:

AA: acetic acid

MAC: Mono methyl amine crotonate.

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

Stage-III 142 37

AA 440 420 20

MAC 37

AA 50 47 3

Hexane 80 75 5

Product 142

Total 749 542 37 28 142

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Stage IV B:

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

Stage IVA 142 - - 32 - - -

EA 330 315 - - - 15 -

EA 45 40 - - - 5 -

Product - - - - - - 110

Total 517 355 0.00 32 0.00 20 110

Product Name: Amlodipine besilate

Output is divided in two equal parts.

Stage V :

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

MMA 260 (40%)

235 - - - 10 -

StageIVB 55 - - - - - -

Toluene 320 305 - - - 15 -

Water 795 715 - - - 80 -

BS 19.5 - - - - -

EA 100 95 - - - 5 -

Product - - - - - - 50

Total 1549.5 1350 0.00 34.5 0.00 110 50

BS: Benzene sulphonic acid

MMA: Mono methyl amine.

Stage VI :

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batc

h

Stage V 50 - - 2 - - -

Methanol 330 315 - - - 15 -

EA 390 370 - - - 20 -

EA 40 38 - - - 2 -

Product - - - - - - 48

Total 810 723 0.00 2 0.00 37 48

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S.S Reactor, 2 KL 1231 kg

ANF

124 kg

MASS BALANCE & FLOW DIAGRAM OF AMIODIPINE BASELATE Stage – I

1. PTA -- 125 kg 2. MMA – 51.4 kg 3. Toluene – 245 kg

4. Water – 810 kg

Note : Stage-1 divided in two part

Stage – II 1. Stage-1 – 61.8 kg 2. Toluene – 830 kg 3. NaH – 30 kg 4. ECAA – 59.20 kg 5. AA – 20 kg 6. Water – 440 kg 7. NaCl – 60 kg 8. 6% HCl – 390 kg

Note : NaH – Sodium Hydride,

ECAA- Ethyl 4-Chloro AcetoAcetate AA- Acetic Acid

Stage – III 1. Stage-II – 551 kg 2. Toluene – 20 kg 3. Hexane – 110 kg 4. AA – 2.20 kg 5. Water – 350 kg 6. Piperzine – 3.14 kg 7. OBC – 44.4 kg

Note : OCB- Orthochlo Benzaldehyde

Stage – IV A

1. Stage-III – 142 kg 2. MAC – 37 kg 3. Hexane – 80 kg

4. AA – 490 kg

Note : MAC – Monomethyl

GLR, 3 KL

1891 kg

ANF

551 Kg

GLR, 2 KL 1891 kg

ANF

551 Kg

S.S Reactor, 2 KL 749 kg

ANF

142 Kg

Amine crotonate

1. Hexane Recovery- 75 kg 2. AA Recovery – 467 kg

3. Solid waste Generation – 37 kg

4. Evporation Loss -28 kg

1. Toluene Recovery- 233 kg

2. Water Recovery – 725 kg 3. Effluent Generation – 15 kg

4. Solid waste Generation – 15 kg

5. Evaporation Loss -97 kg

1. Toluene Recovery- 342 kg

2. Water Recovery – 400 kg

3. Effluent Generation – 387 kg

4. Solid waste Generation – 108 kg

5. Evaporation Loss -103 kg

1. Toluene Recovery- 342 kg

2. Water Recovery – 400 kg 3. Effluent Generation – 387 kg

4. Solid waste Generation – 108 kg

5. Evporation Loss -103 kg

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ANF

110 Kg

GLR, 2 KL 1549.5 kg

ANF

50 Kg

Stage – IV B

1. Stage-IV A– 142 kg 2. EA – 375 kg

Note : Out put is divide in two equal parts

Stage – V

1. Stage-IVB – 55 kg 2. MMA – 260 kg (40%) 3. Toluene – 320 kg

4. Water – 795 kg 5. BS – 19.5 kg

6. EA – 100 kg

Note : BS – Benzene Sulphonic Acid MMA – Mono Methyl Amine

Stage – VI

1. Stage-V – 50 kg 2. Methanol – 330 kg 3. EA – 430 kg

S.S Reactor 517 kg

Sr. No.

Particulars Quantity in Kg

Sr. No.

Particulars Quantity in Kg

1 Water consumption 2395 7 MMA Recovery 235

2 Water Recovery 2160 8 Ethyl Acetate Recovery 355

3 Waste water Generation 407.06 9 Methanol Recovery 315

4 Evporation Loss 439 10 Toluene Recovery 899

5 Solid waste Generation 236.4 11 Acetic Acid 467

6 Process emission 0 12 Hexane Recovery 75

Filteration

48 Kg

S.S Reactor, 2 KL 810 kg

1. Methanol Recovery- 315 kg

2. EA Recovery – 405 kg

3. Solid waste Generation – 2 kg

4. Evporation Loss -40 kg

1.Ethyl Acetate Recovery- 355 kg

3. Solid waste Generation – 32 kg

4. Evporation Loss -20 kg

1. MMA Recovery- 235 kg 2. Toluene Recovery – 305 kg

3. Water Recovery -715 kg

4. EA Recovery – 90 kg

3. Solid waste Generation – 39.5 kg

4. Evporation Loss -115 kg

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Product No. 7 – Folic Acid

1 Product Qty. 2.0 MT/Month

Brief Manufacturing Details:

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Chemical Synthesis:

Material Balance Table of Folic Acid:

Stage: I

Name

of Raw

materia

l

Input

qty. in

kg/batch

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Output

in

kg/batc

h

PABGA 50 - - - - - -

TAPS 60 - - - - - -

TCA 100 - - - - - -

SMBS 15 - - - - - -

NaHCO3 40 - - - 20 - -

water 4000 3600 400 - - - -

Total 4265 3600 400 - 20 - 245

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1. Side products- sodium chloride (about 33 kg), sodium Sulphate (about 27 kg), and

water (about 18.60 kg) are formed in the process.

2. Process emissions- carbon dioxide (about 33 kg), sulphur dioxide (about 12) evolved

during the process are trapped in scrubber using lye solution.

Stage II First purification:

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Output

in

kg/batc

h

HCl

30%

330 - - - - - -

Stage -I 245 - - - - - -

Water 1200 - - - - - -

Water

washing

200 - 1730 95 - - 150

Total 1975 - 1730 95 - - 150

1. The effluent is sent to MEE.

Stage III: Second Purification

Name of

Raw

material

Input

qty. in

kg/batch

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batch

Solid

waste in

kg/batch

Process

emissions

in

kg/batch

Evaporation

losses in

kg/batch

Out put

in

kg/batch

Stage-II 150 - - - - - -

NaOH (as 100%)

90 - - - - - -

Acetic

acid

100 - - - - - -

water 3000 2700 190 100 - 300 -

Total 3340 2700 190 100 - 300 50

1) Side products- CH3COONa salt (about 26 kg),

MASS BALANCE & FLO

W DIAGRAM OF FOLIC ACID Stage – I

5. PABGA -- 50 kg 6. TAPS – 45kg 7. TCA – 32 kg

8. Water – 4000 kg 9. SMBS- 18 Kg

10. NaHCO3 - 63

Note: 1.By-Products – Sodium Chloride (about 33 kg), Sodium Sulphate (about 27 kg),

and Water (about 18.60 Kg) are formed in the process. 2. Process Emission: Carbon Dioxide (about 33 kg), Sulphur Dioxide (about 12 Kg) Evolved during the process are trapped in scrubber using Caustic soda lye solution

S.S Reactor, 10KL 84.40 kg

1. Water Recovery – 3600 kg 2. Effluent Generation – 418.60 kg

3. Solid waste Generation – 60 kg

4. Process Emission - 45 kg

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PP FRP Reactor, 10 KL 1891 kg

Filter Press

SS Reactor, 6 KL

S.S Reactor, 6 KL 3083 kg

Centrifuge

142 Kg

Stage – II First Purification

9. Stage-1 – 84.40 kg 10. HCl (30%) – 300 kg 11. Water – 1300 Kg

Dissolution

Stage – III 5. Stage-II – 56 kg 6. NaOH (100%) – 11 kg 7. Acetic acid– 16 kg 8. Water – 3000 kg

Leaf Filter

300 liter

1 Water Recycled – 2700 kg

2. Solid waste Generation – 33 kg

3. Evporation Loss – 300 kg

Drying & Packing

50 Kg

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Sr. No.

Particulars Quantity in Kg

1 Water consumption 8300

2 Water Recovery 6300

3 Waste water Generation 418.6

4 Evporation Loss 300

5 Solid waste Generation 93

6 Process emission 45

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Product No. 8 – Oxyclozanide

1 Product Qty. 2.0 MT/Month

Brief description of Oxyclozanide

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Synthesis of Oxyclozanide:

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Material balance Table of Oxyclozanide:

Stage I:

Name

of Raw

materia

l

Input

qty. in

kg/batch

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Output

in

kg/batch

DCP 250 - - - - - - HNO3

(70%)

215 - - - - - -

Water 360 300 - - - 60 -

NaOH 28 - - - - - -

Total 853 300 153 - - 60 340

DCP: Dichloro phenol

1. Water from main reaction and water from acid neutralization .about 31 kg and water

from Nitric acid about 44 kg.

2. Sodium Hydroxide about 4 kg (excess for neutralization)

3. Solid waste formed or un-reacted about 16 kg.

Stage II A :

MCB: Mono chloro benzene.

1) Sulphur dioxide, sulphur and sodium hydroxide in presence of water will form

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Out put

in

kg/batc

h

Water 725 600 - - - 125 -

NaOH 270 - - 270 - - -

SO2 30 - - - - - - Stage-I 340 - - - - - - Sulphur 165 - - 165 - - -

MCB 1000 - - - - - 1050

Total 2530 600 320 435 - 125 1050

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Na2S2O4 ( about 269 kg Hydrose ) and releases hydrogen acting as a reducing

agent and finally gets converted to Na2S2O6 ( about 298 kg ) in the process.

2) Slightly excess Na2S2O4 formed will be about 17 kg.

Stage II B:

TCSA: Trichloro salysilic acid.

TC: Thionyl chloride.

1. Release of Sulphur dioxide is about 93 kg, and release of Hydrogen chloride

is about 53 kg. Excess thinly chloride is about 18 kg

Name

of Raw

materia

l

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Out put

in

kg/batc

h

TCSA 250 - - - - - -

MCB 625 562 - - - 63 -

DMF 2 - - - - - -

TC 145 - - - 78 - -

Total 1022 562 2 - 78 63 317

Stage III:

1. Hydrogen chloride about 50 kg is released in the process.

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Output

in

kg/batc

h

Stage-IIA 1050 - - - - - -

Stage-IIB 317 - - - - - -

Toluene 856 - - - 95 -

Total 1367 856 - 56 - 95 360

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Stage IV:

Name of

Raw

material

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batch

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emission

s in

kg/batch

Evaporation

losses in

kg/batch

Output

in

kg/batc

h

Technical 360 - - 35 - - -

Acetone 1600 1440 - - - - -

Carbon 2 - - - - - -

Hyflow 5 - - 2 - - -

Hydrose 2 - - 5 - - -

water 1000 900 - 2 - 100 -

Total 2969 2340 - 44 - 260 325

Product No. 8 – Oxyclozanide

1 Product Qty. 2.0 MT/Month

Mass Balance & Flow Diagram of Oxyclozanide

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GLR, 2 KL 765 kg

Filteration

302 kg

SS Reactor, 2 KL 2299.8 kg

Filteration

245 Kg IIA + 1000 kg MCB

Stage – I

1. DCP -- 250 kg

MASS BALANCE & FLOW DIAGRAM OF OXYCLOZANIDE

2. HNO3 (70%) – 147 kg 3. NaOH – 8 kg

4. Water – 360 kg

Stage – IIA 1. Stage-1 – 302 kg 2. MCB – 1000 kg 3. NaOH – 124 kg 4. SO2 – 99.20 kg 5. Sulphur- 49.6 kg

6. Water – 725 kg

Stage – IIB 1. TCSA – 350 kg 2. MCB– 750 kg 3. DMF – 3 kg 4. TC – 190

Stage – III

1. Stage-IIA – 245 + 1000 kg MCB

2. Stage IIB – 358 kg

1. Water Recovery – 340 kg

2. Effluent Generation – 87 kg

3. Solid waste Generation – 16 kg

4. Evporation Loss -20 kg

1. Water Recovery – 655 kg

2. Effluent generation – 316.15 kg 3. Solid waste Generation – 13 kg

4. Evporation Loss -70 kg

GLR, 2 KL 1293 kg

Filteration

362 Kg

1. MCB Recovery- 715 kg 2. Process Emission – 164 kg

3 Solid waste Generation – 17 kg

4. Evporation Loss -35 kg

S.S Reactor, 3 KL 1603 kg

Filteration

525 Kg

1. MCB Recovery- 950 kg 2. Process Emission – 50 kg

3. Solid waste Generation – 28 kg

4. Evporation Loss -50 kg

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Stage – IV

1. Stage-III – 525 kg 2. Water – 1000 kg 3. Acetone – 1600 kg 4. Carbon – 2 kg 5. Hyflow – 5 kg 6. Hydrose – 2 kg

Sr. No.

Particulars Quantity in Kg

Sr. No.

Particulars Quantity in Kg

1 Water consumption 2085 7 MCB Recovery 2320

2 Water Recovery 1303.15 8 Acetone Recovery 1520

3 Waste water Generation 407.06 9 4 Evporation Loss 355 10 5 Solid waste Generation 109 11 6 Process emission 214 12

S.S Reactor, 4 KL 3134 kg

Filteration, Drying

,Blending & packing

499 Kg

1. Acetone Recovery- 1520 kg 2. Water Recovery – 900 kg

3. Solid waste Generation – 35 kg

4. Evporation Loss -180 kg

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Product No. 9 – Cinnarzine

1 Product Qty. 1.0 MT/Month

Brief description of process

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Chemical synthesis of Cinnarzine

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Material balance Table of Cinnarzine

Stage I:

Name

of Raw

materia

l

Input

qty. in

kg/batch

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Output

in

kg/batc

h

Piperzine 50 27 23 - - - - Hexane 150 143 - - - 7 -

Water 5 - 5 - - - -

DPC 60 - - - - - - NaOH 12.5 - 100 18.13 - - -

HCl 6% 120 - 128 5.85 - - -

Total 397.5 170 256 23.51 - - 68

DPB: Diphenyl Chloride

1) Liquid effluent contains Sodium chloride,excess Piperzine and product residue.

Stage II:

Name

of Raw

materia

l

Input

qty. in

kg/batc

h

Recycle

qty. in

kg/batc

h

Liquid

effluent

in

kg/batc

h

Solid

waste in

kg/batc

h

Process

emissions

in

kg/batch

Evaporatio

n losses in

kg/batch

Out put

in

kg/batc

h

BHP 68 - - - - - - Na2CO3 95 - - - - - -

SMPS 0.3 - - - - - - Hexane 350 315 - - - 35 - Cinemicc

hloride

47.6 - - - -

Hexane 150 140 - - - 10 -

Product - - - - - - 97

Total 710.9 455 0.00 102.9 11 45 97

1) Solid waste contains excess sodium carbonate, sodium chloride and also product

residue.

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PP FRP Reactor, 10 KL 710.9 kg

Filter Press

Drying

MASS BALANCE & FLOW DIAGRAM OF CINNARZINE Stage – I

1. Piperzine -- 50 kg 2. Hexane – 150kg 3. DPC – 60 kg

4. Water – 5 kg

5. NaOH- 26 Kg 6. HCl (6%) - 100

Note : DPB : Diphenyl Chloride Liquid effluent contains Sodium Chloride, Excess Piperzine & product residue.

Stage – II

1. Stage-1 – 68 kg

2. Na2CO3 – 95 kg 3. SMBS – 0.3 Kg 4. Hexane – 500 kg 5. Cinemic Chloride – 47.6 kg

Note ; Solid waste contains excess Sodium Carbonate, Sodium Chloride and also product residue.

Sr. No.

Particulars Quantity in Kg

1 Water consumption 5

2 Water Recovery 0

3 Waste water Generation 173

4 Evporation Loss 75

5 Solid waste Generation 113.9

6 Process emission 0

7 Hexane Recovery 455

1. Hexane Recovery- 455 kg

2. Solid Waste :113.9 kg

1. Evporation Loss- 45 kg

Blending & Packing

97 kg

GLR Reactor, 2KL 391 kg

Filtration & Drying

1.. Hexane Recovery – 120kg 2. Effluent Generation – 173 kg

3. Evporation Loss – 30 kg

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Annexure-IV

Public Hearing Exemption

The proposed project “Bulk Drugs and intermediates as well as Chemicals Manufacturing Project”

located at Plot F-2, MIDC Chincholi, Taluka Mohol, District Solapur, Maharashtra. As per Office

Memorandum dated 4th April, 2016 viz. Exemption from public Consultation for the projects/ activities

located within the Industrial Estates/ Parks, the proposed project is exempted from public hearing since

the proposed project is located in notified industrial area. Hence, no public hearing was conducted for

the proposed project.

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