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FORM-1

for

PROPOSED BULK DRUGS AND BULK DRUG INTERMEDIATES

MANUFACTURING UNIT

of

M/s. PGC DRUGS PVT. LTD.

Plot No. 6104/6, GIDC Industrial Estate,

Ankleshwar, Tal: Ankleshwar,

Dist: Bharuch-393002, Gujarat

Prepared by:

Aqua-Air Environmental Engineers Pvt. Ltd.

(Pollution Control Consultants & Engineers)

Reg. Office: 403, Centre Point, Nr. Kadiwala School, Ring Road,

Surat – 395 002, Gujarat, India Fax: +91 261 2707273 / 3987273

Tel: + 91 261 3048586 / 2460854 / 2461241

E-mail: [email protected] Visit us at: www.aqua-air.co.in

APPENDIX I

(See paragraph - 6)

FORM 1

Sr.

No.

Item Details

1. Name of the project/s M/s. PGC Drugs Pvt. Ltd. 2. S. No. in the schedule 5 (f)

3. Proposed capacity/area/length/tonnage to

be handled/command area/lease

area/number of wells to be drilled

Proposed Capacity: 75 MT/Month

For detail Please refer Annexure – I

4. New/Expansion/Modernization New

5. Existing Capacity/Area etc. Area: 3,200 m2

6. Category of Project i.e. ‘A’ or ‘B’ A

7. Does it attract the general condition? If yes,

please specify.

Yes. Located in critically polluted area

(Ankleshwar).

8. Does it attract the specific condition? If yes,

please specify.

No

9. Location

Plot/Survey/Khasra No. Plot No. 6104/6

Village GIDC Industrial Estate, Ankleshwar

Tehsil Ankleshwar

District Bharuch

State Gujarat

10. Nearest railway station/airport along with

distance in kms.

Railway Station: Ankleshwar (4 km)

Airport: Surat (65 km)

11. Nearest Town, city, District Headquarters

along with distance in kms.

Ankleshwar (4 Km)

12. Village Panchayats, Zilla Parishad, Municipal

Corporation, local body (complete postal

address with telephone nos. to be given)

Ankleshwar, Tal: Ankleshwar, Dist: Bharuch

(Gujarat)

13. Name of the applicant M/s. PGC Drugs Pvt. Ltd.

14. Registered Address Plot No.6104/6, GIDC Industrial Estate,

Ankleshwar-393002, Dist: Bharuch (Guj.)

15. Address for correspondence: Plot No. 7407, GIDC Industrial Estate,

Ankleshwar-393002, Dist: Bharuch (Guj.)

Name Mr. Ramesh Chodvadiya

Designation (Owner/Partner/CEO) Director

Address Plot No. 7407, GIDC Industrial Estate, Ankleshwar,

Dist: Bharuch (Guj.)

Pin Code 393002

E-mail [email protected]

Telephone No. --

Fax No. --

Mobile No. +919825205460

16. Details of Alternative Sites examined, if any.

Location of these sites should be shown on a

topo sheet.

NA

17. Interlinked Projects NA

18. Whether separate application of interlinked

project has been submitted?

NA

19. If yes, date of submission NA

20. If no, reason NA

21. Whether the proposal involves

approval/clearance under: if yes, details of

the same and their status to be given.

(a) The Forest (Conservation) Act, 1980?

(b) The Wildlife (Protection) Act, 1972?

(c) The C.R.Z. Notification, 1991?

No

22. Whether there is any Government

Order/Policy relevant/relating to the site?

No

23. Forest land involved (hectares) NA

24. Whether there is any litigation pending

against the project and/or land in which the

project is propose to be set up?

(a) Name of the Court

(b) Case No.

(c) Orders/directions of the Court, if any and

its relevance with the proposed project.

NA

• Capacity corresponding to sectoral activity (such as production capacity for manufacturing,

mining lease area and production capacity for mineral production, area for mineral exploration,

length for linear transport infrastructure, generation capacity for power generation etc.,)

(II) Activity

1. Construction, operation or decommissioning of the Project involving actions, which will cause

physical changes in the locality (topography, land use, changes in water bodies, etc.)

Sr.

No.

Information/Checklist confirmation Yes/No Details thereof with approximate

quantities frates, wherever possible)

with source of information data

1.1 Permanent or temporary change in land use,

land cover or topography including increase

intensity of land use (with respect to local

land use plan)

No Proposed project activity is within the

GIDC Industrial Estate- Ankleshwar.

1.2 Clearance of existing land, vegetation and

Buildings?

Yes Minor site clearance activities shall be

carried out to clear shrubs and weed.

1.3 Creation of new land uses?

No The project site is located on level

ground, which does not require any

major land filling for area grading

work.

1.4 Pre-construction investigations e.g. bore

Houses, soil testing?

No

1.5 Construction works?

Yes Please refer Annexure – II.

1.6 Demolition works? No

1.7 Temporary sites used for construction works

or housing of construction workers?

No

1.8 Above ground buildings, structures or

earthworks including linear structures, cut

and fill or excavations

Yes Please refer Annexure – II.

1.9 Underground works mining or tunneling?

No

1.10 Reclamation works?

No

1.11 Dredging?

No

1.12 Off shore structures?

No

1.13 Production and manufacturing processes?

Yes Please refer Annexure –III.

1.14 Facilities for storage of goods or materials?

Yes Proposed project activity is within the

Ankleshwar GIDC Industrial Estate. For

Proposed project, additional raw

material & finished products storage

area will be developed.

1.15 Facilities for treatment or disposal of solid

waste or liquid effluents?

Yes For details of liquid effluent, please

refer Annexure-V.

For Hazardous waste detail please

refer Annexure – VI.

1.16 Facilities for long term housing of operational

workers?

No

1.17 New road, rail or sea traffic during

Construction or operation?

Yes Addition of very few trucks per day.

1.18 New road, rail, air waterborne or other

transport infrastructure including new or

altered routes and stations, ports, airports

etc?

No

1.19 Closure or diversion of existing transport

routes or infrastructure leading to changes in

Traffic movements?

No

1.20 New or diverted transmission lines or

Pipelines?

No

1.21 Impoundment, damming, culverting,

realignment or other changes to the hydrology

of watercourses or aquifers?

No

1.22 Stream crossings? No

1.23 Abstraction or transfers of water form ground

or surface waters?

Yes Water requirement will be met

through Ankleshwar GIDC water

supply.

1.24 Changes in water bodies or the land surface

Affecting drainage or run-off?

No

1.25 Transport of personnel or materials for

construction, operation or

decommissioning?

Yes Transportation of personnel or raw

material and products will be primarily

by road & rail only.

1.26 Long-term dismantling or decommissioning

or restoration works?

No

1.27 Ongoing activity during decommissioning

which could have an impact on the

environment?

No

1.28 Influx of people to an area either

temporarily or permanently?

No

1.29 Introduction of alien species? No

1.30 Loss of native species or genetic diversity? No

1.31 Any other actions? No

2. Use of Natural resources for construction or operation of the Project (such as land, water,

materials or energy, especially any resources which are non-renewable or in short supply):

Sr.

No.

Information/checklist confirmation Yes/No Details thereof (with approximate

quantities /rates, wherever possible) with

source of information data

2.1 Land especially undeveloped or agricultural

land (ha)

No Proposed project activity will be within

GIDC Industrial Area, Ankleshwar, Dist:

Bharuch.

2.2 Water (expected source & competing users)

unit: KLD

Yes Water Source: Ankleshwar GIDC Water

Supply

For details please refer Annexure – IV.

2.3 Minerals (MT) No

2.4 Construction material - stone, aggregates,

and / soil (expected source - MT)

Yes Construction materials, like steel, cement,

crushed stones, sand, rubble, etc. will be

required for the project shall be procured

from the local market of the region.

2.5 Forests and timber (source - MT) No.

2.6 Energy including electricity and fuels (source,

competing users) Unit: fuel (MT), energy (MW)

Yes Please refer Annexure – VII.

2.7 Any other natural resources (use appropriate

standard units)

No

3. Use, storage, transport, handling or production of substances or materials, which could be

harmful to human health or the environment or raise concerns about actual or perceived risks

to human health.

Sr.

No.

Information/Checklist confirmation Yes/No Details there of (with approximate

quantities/rates, wherever possible) with


3.1 Use of substances or materials, which are

hazardous (as per MSIHC rules) to human

health or the environment (flora, fauna, and

water supplies)

Yes Please refer Annexure –VIII.

3.2 Changes in occurrence of disease or affect

disease vectors (e.g. insect or water borne

diseases)

No

3.3 Affect the welfare of people e.g. by changing

living conditions?

No

3.4 Vulnerable groups of people who could be

affected by the project e.g. hospital patients,

children, the elderly etc.

No

3.5 Any other causes No

4. Production of solid wastes during construction or operation or decommissioning (MT/month)

Sr.

No.

Information/Checklist confirmation Yes/No Details there of (with approximate

quantities/rates, wherever possible)


4.1 Spoil, overburden or mine wastes No

4.2 Municipal waste (domestic and or commercial

wastes)

No

4.3 Hazardous wastes (as per Hazardous Waste

Management Rules)

Yes Please refer Annexure – VI.

4.4 Other industrial process wastes Yes

4.5 Surplus product No

4.6 Sewage sludge or other sludge from effluent

treatment

No

4.7 Construction or demolition wastes No

4.8 Redundant machinery or equipment No

4.9 Contaminated soils or other materials No

4.10 Agricultural wastes No

4.11 Other solid wastes Yes

Please refer Annexure – VI.

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)

Sr. No. Information/Checklist confirmation Yes/No Details there of (with approximate



5.1 Emissions from combustion of fossil fuels

from stationary or mobile sources

Yes Please refer Annexure – VII.

5.2 Emissions from production processes Yes Please refer Annexure – VII.

5.3 Emissions from materials handling storage or

transport

No

5.4 Emissions from construction activities

including plant and equipment

No

5.5 Dust or odours from handling of materials

including construction materials, sewage and

waste

No

5.6 Emissions from incineration of waste No

5.7 Emissions from burning of waste in open air

e.g. slash materials, construction debris) No

5.8 Emissions from any other sources No

6.Generation of Noise and Vibration, and Emissions of Light and Heat:



source of information data with source of

information data

6.1 From operation of equipment e.g. engines,

ventilation plant, crushers

Yes The Noise level will be within the prescribed

limit. At noisy areas adequate preventive &

control measures will be taken. No

significant noise, vibration or emission of

light & heat from the unit.

6.2 From industrial or similar processes Yes -Do-

6.3 From construction or demolition No

6.4 From blasting or piling No

6.5 From construction or operational traffic No

6.6 From lighting or cooling systems No

6.7 From any other sources No

7. Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea:




7.1 From handling, storage, use or spillage of

hazardous materials

Yes Please refer Annexure – VIII.

7.2 From discharge of sewage or other effluents

to water or the land (expected mode and

place of discharge)

Yes For details please refer Annexure – V.

7.3 By deposition of pollutants emitted to air into

the and or into water

No

7.4 From any other sources No

7.5 Is there a risk of long term build up of

pollutants in the environment from these

sources?

No

8. Risk of accidents during construction or operation of the Project, which could affect human

health or the environment

S .No. Information/Checklist confirmation Yes/No Details there of (with approximate



8.1 From explosions, spillages, fires etc from

storage, handling, use or production of

hazardous substances

Yes Please refer Annexure –VIII.

8.2 From any other causes No

8.3 Could the project be affected by natural

disasters causing environmental damage

(e.g. floods, earthquakes, landslides,

cloudburst etc)?

No

9. Factors which should be considered (such as consequential development) which could lead to

environmental effects or the potential for cumulative impacts with other existing or planned

activities in the locality

Sr. No.

Information/Checklist confirmation

Yes/No

Details there of (with approximate



9.1 Lead to development of supporting. utilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.

• Supporting infrastructure (roads, power

supply, waste or waste water treatment, etc.)

• housing development

• extractive industry

• supply industry

• other

Yes Please refer Annexure – IX.

9.2 Lead to after-use of the site, which could

have an impact on the environment

No

9.3 Set a precedent for later developments No

9.4 Have cumulative effects due to proximity to

other existing or planned projects with

similar effects

No

(II) Environmental Sensitivity

Sr. No. Areas Name/

Identity

Aerial distance (within 15 km.) Proposed

project location boundary

1 Areas protected under international

conventions, national or local legislation for

their ecological, landscape, cultural or other

related value

NA Proposed project site is within the GIDC

Industrial Estate, Ankleshwar.

2 Areas which important for are or sensitive Ecol

logical reasons - Wetlands, watercourses or

other water bodies, coastal zone, biospheres,

mountains, forests

NA

3 Area used by protected, important or sensitive

Species of flora or fauna for breeding, nesting,

foraging, resting, over wintering, migration

NA No protected area or sensitive species within 15

km from the proposed project boundary.

4 Inland, coastal, marine or underground waters Yes Amla Khadi = 6 Km

5 State, National boundaries NA N.A.

6 Routes or facilities used by the public for access

to recreation or other tourist, pilgrim areas

Yes Public transportation

7 Defense installations Yes Ankleshwar

8 Densely populated or built-up area Ankleshwar Ankleshwar City around 4 km from the

proposed project site.

9 Area occupied by sensitive man-made land uses

Hospitals, schools, places of worship,

community facilities)

No

10 Areas containing important, high quality or

scarce resources (ground water resources,

surface resources, forestry, agriculture,

fisheries, tourism, minerals)

No

11 Areas already subjected to pollution

environmental damage. (those where existing

legal environmental standards are exceeded)or

No NA

12 Areas susceptible to natural hazard which could

cause the project to present environmental

problems (earthquake s, subsidence ,landslides,

flooding erosion, or extreme or adverse climatic

conditions)

NO NA

IV). Proposed Terms of Reference for EIA studies: Please refer Annexure – X.

I hereby given undertaking that, the data and information given in the application and

enclosures are true to the best of my knowledge and belief and I am aware that if any

part of the data and information submitted is found to be false or misleading at any

stage the project will be rejected and clearance give, if any to the project will be revoked

at our risk and cost.

Date: January 31, 2017

Place: Ankleshwar

Ramesh Chodvadiya

(Director)

Signature of applicant with full name & Address

(Project Proponent/Authorized Signatory)

NOTE:

1. The projects involving clearance under Coastal Regulation Zone Notification, 1991 shall

submit with the application a C.R.Z. map duly demarcated by one of the authorized agencies,

showing the project activities, w.r.t. C.R.Z. (at the stage of TOR) and the recommendations of

the State Coastal Zone Management Authority (at the stage of EC). Simultaneous action shall

also be taken to obtain the requisite clearance under the provisions of the C.R.Z. Notification,

1991 for the activities to be located in the CRZ.

2. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere

Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map

duly authenticated by Chief Wildlife Warden showing these features vis-à-vis the project

location and the recommendations or comments of the Chief Wildlife Warden thereon (at the

stage of EC).

3. All correspondence with the Ministry of Environment & Forests including submission of

application for TOR/Environmental Clearance, subsequent clarifications, as may be required

from time to time, participation in the EAC Meeting on behalf of the project proponent shall

be made by the authorized signatory only. The authorized signatory should also submit a

document in support of his claim of being an authorized signatory for the specific project.

LIST OF ANNEXURES

SR. NO. NAME OF ANNEXURE

I List of Products and Raw materials along with their Production Capacity

II Layout Map of the Plant

III Brief Manufacturing Process Description

IV Details of water consumption & waste water generation

V Details of Effluent Treatment Scheme

VI Details of Hazardous Waste Generation and Disposal

VII Details of Stacks and Vents , Fuel & Energy Requirements

VIII Details of Hazardous Chemicals Storage & Handling

IX Socio-economic Impacts

X Proposed Terms of Reference

ANNEXURE-I

_______________________________________________________________________

LIST OF PRODUCTS ALONG WITH THEIR PRODUCTION CAPACITY WITH RAW MATERIALS

Sr. No. Product Proposed Quantity

(MT/Month)

Group-1

1 4-Sulfonamido Phenyl Hydrazine Hydrochloride

20

2 4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-

1,3-dione

3

4 - [ 5 - ( 4 - M e t h y l p h e n y l ) - 3 - ( t r i f l u o r o

m e t h y l ) p y r a z o l - 1 -

y l ] b e n z e n e s u l f o n a m i d e C e l e c o x i b

4 4 Chloro Phenyl Hydrazine

5 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-

dione Doxofylline

Group-2

6 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one

Bupropion hydrochloride

10

7 6-Methyl pyridine-3 yl-2,4-Methylsulfonyl phenyl

Etanone (Ketosulfone)

8 5 - C h l o r o - 6 ' - m e t h y l - 3 - [ 4 -

( m e t h y l s u l f o n y l ) p h e n y l ] - 2 , 3 ' - b i p y r i d i n e

E t o r i c o x i b and It’s Intermediates

9 2-(2-Fluorobiphenyl-4-yl)propanoic acid Flurbiprofen

and It’s Intermediates

10 Benzamide 5-chloro-N-[2-[4-

[(cyclohexylamino)carbonyl]

amino]sulfonyl]phenyl]ethyl]-2-metoxy

Glibenclamide and It’s Intermediates

11 D i b e n z o [ b , f ] [ 1 , 4 ] T h i a z e p i n - 1 1 ( 1 0 H ) - O n e

12 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-

piperazinyl)ethoxy]-ethanol Quetiapine fumarate and

It’s Intermediates

Group-3

13

N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-

4methyl- 2-oxo-2,5-dihydro-1H-pyrrole-1-

carboxamide [Glimepiride Sulphonamide] 5

14

3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methylcyclohexyl)

carbamoyl]sulfamoyl}phenyl)ethyl]-2-oxo-2,5-

dihydro-1H-pyrrole-1-carboxamide Glimepiride and


15

m-Hydroxy-alpha-(methylaminomethyl) benzyl

alcohol Phenyl ephrine hydrochloride and It’s

Intermediates

16

3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-

chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-

dicarboxylate Amlodipine besylate and It’s

Intermediates

Group-4

17

1 0 , 1 1 - d i h y d r o - 1 0 - o x o - 5 H -

d i b e n z ( b , f ) a z e p i n e - 5 - c a r b o x a m i d e

O x c a r b a z a p i n e

30 18 2, 3-Dibenzoyl-D-tartaric acid (DBDT)

19 p Anisic Alcohol

20 2-Chloro-1,3-bis (dimentylamino)trimethinium

hexafluorophosphate)

Group -5

21 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-

6-amine Brimonidine tartrate and It’s Intermediates

10

22

( S ) - N - { ( 3 , 4 - D i m e t h o x y b e n z o c y c l o b u t - 1 -

y l ) } - N - ( m e t h y l ) ] - N - ( m e t h y l ) a m i n e

I v a b r a d i n e and It’s Intermediates

23 Trifluoro Methyl Cinnamic Acid

24

((R)-N-[1-(1-naphthyl)ethyl]-3-[3-

(trifluoromethyl) phenyl]propan-1-amine

Cinacalcet hydrochloride and It’s Intermediates

25

1 - { 4 - [ 2 - I s o p r o p o x y e t h o x y ) m e t h y l ]

p h e n o x y } - 3 - ( i s o p r o p y l a m i n o ) p r o p a n o l

B i s o p r o l o l f u m a r a t e and It’s Intermediates

26 5-Methyl-1-phenylpyridin-2(1H)-one Pirfenidone and


27 Ursodeoxycholic acid and It’s Intermediates

Total 75

RAW MATERIAL CONSUMPTION

Sr. No. Raw Material Quantity (MT/Month)

1 4-Sulfonamido Phenyl Hydrazine Hydrochloride

Sulfanilamide 16.20

Sodium Nitrite 7.00

Sodium bisulphite 10.60

Conc HCl 34.00

2 4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-

1,3-dione

Sodium Methoxide 5.60

Toluene 30.00

4-Methylacetophenone 12.00

Methyltrifluoroacetate 12.40

Conc HCl 11.60

3 Celecoxib

4-Sulfonamido Phenyl Hydrazine Hydrochloride 14.00

4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-

1,3-dione 13.00

Toluene 56.00

Carbon 0.10

4 4 Chloro Phenyl Hydrazine Hydrochloride

4-Chloro Aniline 15.75

Sodium Nitrite 10.00

Sodium bisulphite 13.75

Conc HCl 41.20

5 Doxofylline

Theofylline 17.40

2-Bromomethyl-1,3-dioxolane 16.20

Sodium Carbonate 5.60

Dimethyl Formamide (DMF) 48.00

Carbon 0.20

6 Bupropion Hydrochloride and It’s Intermediates

Toluene 25.00

3-Chloro-2’-Bromo Propiophenone 10.00

tert butyl amine 3.50

20% Methanolic HCl 8.13

Iso Propyl Alcohol 20.00

Carbon 0.25

7 Ketosulfone

4 Methyl thiophenyl acetonitrile 6.40

Toluene 9.60

Sodium Methoxide 3.20

Methyl 6 Methyl Nicotinate 5.90

Methanol 6.00

Sodium Tangustate 0.10

Hydrogen Peroxide 6.40

Conc Sulfuric Acid 0.20

8 Etoricoxib and It’s Intermediates

Ketosulfone 8.50

DMF 25.00

CDT Salt 9.30

Potassium tert Butoxide 4.30

Toluene 20.00

Acetic Acid 3.00

IPA 15.00

Carbon 0.30

9 Flurbiprofen and It’s Intermediates

2,4-Difluoronitrobenzene 8.75

Diethyl methyl malonate 9.50

Sodium Hydroxide 7.88

DMF [Dimethyl formamide ] 9.75

Toluene 53.75

Palladium Catalyst 0.18

Hydrogen 0.45

Methanol 28.75

Benzene 6.63

Copper Powder 1.45

Sodium Nitrile 4.88

Acetic Acid 4.50

Conc HCl 26.75

Carbon 0.13

10. Glibenclamide and It’s Intermediates

Sulfonamide Deri 8.13

Ammonia 12.50

Cyclo Hexyl Isocyanate 2.75

Acetone 81.25


Conc HCl 4.38

Carbon 0.50

11 Dibenzo[b,f][1,4]Thiazepin-11(10H)-One

2 Amino phenyl phenyl sulfide 9.50

Poly Phosphoric Acid PPA 30.00

Ethyl Chloro formate 6.25

12 Quetiapine and It’s Intermediates

Dibenzo-1,4-thiazepine one 5.75

Thionyl chloride 5.00

Toluene 25.00

Piperazin ethoxy ethanol 4.63

Ethanol 30.00

Fumaric Acid 1.50

Acetic Acid 1.00

13 N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4-

methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide

(Glimepiride Sulfonamide)

3 Ethyl methyl Pyrroline 5.00

2 Phenyl ethyl isocyanate 3.00

Toluene 50.00

Chloro Sulfonic Acid 3.75

Ammonia Solution 20.00

EDC [ethylene di chloride] 8.13

14 Glimepiride and It’s Intermediates

N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4-


(Solfonamide Derivative)

5.00

Trans Iso Cyanate 3.00

Acetone 50.00

Potassium Carbonate 3.75

Methanol 20.00

Conc HCl 8.13

Carbon 0.13

15 Phenyl Ephrine and It’s Intermediates

m Hydroxy Acetophenone 5.63

Ethyl Acetate 8.25

Bromine 7.00

Toluene 28.25

N Methyl benzyl Amine 9.13

IPA.HCl 5.25

Palladium carbon 0.20

Methanol 16.75

Liq Ammonia 11.50

L Tartaric Acid 5.65

IPA 11.63

Acetic Anhydride 5.50

Sulfuric Acid 1.18

Methanolic HCl 5.00

Carbon 0.13

16 Amlodipine Besylate and It’s Intermediates

Phthaloyl Amlodipine 5.44

Mono Methyl Amine 8.38

Methanol 21.88

Ethyl Acetate 15.44

Benzene Sulfonic Acid 1.88

Carbon 0.38

17 Oxcarbazapine

10-Metoxy benz(b,f)azepine 28.20

Sodium cynate 9.00

Toluene 66.00

Acetic acid 3.60

Conc HCl 14.40

Methanol 60.00

Carbon 0.30

18 2,3-Dibenzoyl-D-tartaric acid (DBDT)

Benzoyl Chloride 26.75

D Tartaric Acid 15.75

Toluene 45.00

19 p Anisic Alcohol

4 Methoxy Benzaldehyde 29.94

Nickel Catalyst 0.15

Hydrogen gas 8040 M3

Nitrogen 597 M3

20 2-Chloro-1,3-bis(dimentylamino)trimethinium

hexafluorophosphate (CDT Salt)

Dimethylformamide 10.70

Chloroacetyl chloride 12.00

Phosphorus Oxychloride 16.50

Caustic Flakes 20.00

hexafluorophosphoric acid 27.00

21 Brimonidine Tartrate and It’s Intermediates

Chorobenzene 80.00

5-Bromo-6-thiouredo quinoxaline 8.00

Ethylene diamine 5.00

Isopropyl alcohol 20.00

20% HCl 40.00

20% Caustic Lye dilute 80.00

Methanol 90.00

L Tartaric Acid 5.50

Carbon 1.00

22 Ivabradine and It’s Intermediates


Acetone 20.00

3-(3-Iodopropyl)-7,8-dimethoxy-1,3-dihydro-2H-3-

benzazepin-2-one (IDDB) 9.00

1-[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-

yl]-Nmethylmethanamine hydrochloride (MBC.HCl) 6.00

Toluene 30.00

Palladium on Carbon 0.80

IPA [iso propyl alcohol] 12.00

Conc HCl 15.00

Methanol 60.00

Carbon 1.00

23 Trifluoro methyl Cinnamic Acid

3 Trifluoromethyl Aniline 8.00

Conc HCl 13.30

Sodium Nitrite 4.00

Acrylonitrile 2.90

Caustic Flakes 2.50

Conc Sulfuric Acid 3.50

24 Cinacalcet and It’s Intermediates

Trifluoro methyl Cinnamic acid 7.50

Methanol 30.00

Raney Nickel 1.30

Toluene 15.00

Boric Acid 0.30

Naphthyl ethyl amine 5.80

Sodium Borohydride 1.80

MDC 7.50

Conc HCl 12.50

Carbon 0.80

25 Bisoprolol Fumarate and It’s Intermediates

4-hydroxy benzyl alcohol 3.75

2- Isopropoxy ethanol 3.50

Amberlyst-15 (Resins) 1.25

Sodium Carbonate 3.50


Epichlorohydrin 2.88

Toluene 27.5

Sodium borohydride 0.38

Methanol 31.25

Isopropyl amine 2.75

MDC [Methylene dichloride] 21.25

Acetone 40.00

Fumaric Acid 3.25

Carbon 0.30

26 Pirfenidone and It’s Intermediates

Dimethylformamide 22.50

Bromobenzene 10.80


5-Methyl-1H-pyridin-2-one 1.90

Copper Oxide 7.00

Toluene 16.00


Conc HCl 9.00

27 Ursodeoxycholic acid and It’s Intermediates

3-hydroxy-7-ketocholanic acid 10.80

Butanol 22.50

Sodium metal 1.50

Phosphoric acid 85% 9.30

Imidazole 2.30

Methanol 47.50


Conc HCl 10.50

ANNEXURE-II

_______________________________________________________________________

LAYOUT OF MAP OF THE PLANT

ANNEXURE-III

_______________________________________________________________________

BRIEF MANUFACTURING PROCESS DESCRIPTION

1 . P r o d u c t : 4-Sulfonamido Phenyl Hydrazine Hydrochloride ( 4 S P H )

Ø A ) R e a c t i o n C h e m i s t ry

MW 219.65

Intermediate Step

SO2NH2

NH2

MW 172.20

Sulfanilamide

NaNO2+ + 2 HCl

MW 68.99MW 36.46

2 H2O+ + NaCl

MW 18.02

MW 58.44

SO2NH2

N+

NCl

-

MW 223.68

4 SPH

SO2+

MW 64.06

SO2NH2

NHNH2

ClH

NaHSO3+ + HCl

MW 104.04

MW 36.46

H2O

MW 18.02

+

NaCl

MW 58.44

O2 +

MW 32.00

+

Ø B ) P r o c es s F l o w D i a g r am

Sulfanilamide

Sodium Nitrite

Conc HCl

Sodium Bisulfite

Water

S T A G E Efflulent

Process Emissions

F I N I S H

P R O D U C T

Ø C ) M a n u f a c t u r i n g P r o c e s s

• Charged hydrochloric acid, water and sulphonilamide in Reactor at RT. Cool the RM

• Charged aqueous sodium nitrite in above reaction mixture

• Charged Slowly aqueous sodium bisulphite in above reaction mixture

• The reaction mixture was heated and stirred

• Hydrochloric acid was added to the reaction mixture

• The reaction mixture was cooled.

• The separated solid was filtered and dried.

Ø D ) S u m m a ry o f M a s s

Capacity, Mt/Month : 20.00

Batch Size, Kg : 400

Working Days : 26

Sr.

No Name of Raw Material Kg/batch

Kg/Kg of

Product MT/Month Remarks

Input

1 Sulfanilamide 325 0.81 16.20

2 Sodium Nitrite 140 0.35 7.00

3 Sodium bisulphite 210 0.53 10.60

4 Water 400 1.00 20.00

5 Conc HCl 680 1.70 34.00

Total 1755

Output

1 Final Product* 400 1.00 20.00 Finished product

4 Loss 185 0.46 9.25

5 Effluent 1170 2.93 58.50

Total 1755

2. P r o d u c t : 4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-1,3-dione

[Dione]


CH3

O CF3

O

MW 230.18

Dione deri

COCH3

CH3

MW 134.17

4 Methyl Acetophenone

F3C O

O

CH3

MW 128.05

Methyl Trifluoro Acetate

++ OH

CH3

MW 32.04

Methanol


Methyl trifluoro Acetate

4 Methyl Acetophenone

Toluene

Sodium Methoxide

Conc HCl

Water

S T A G E

Solvent Recovery

Evaroparation Loss

Efflulent

F I N I S H

P R O D U C T


• Charged Sodium methoxide and toluene in Reactor at RT.

• A solution of 4-methylacetophenone in toluene was added in above reaction mixture

• A solution of methyltrifluoroacetate in toluene was added slowly

• The reaction mixture was heated and stirred well

• The reaction mixture was cooled

• Charged aqueous hydrochloric acid toluene in in above reaction mixture

• The layers were separated

• The organic layer were washed with water

• The solvent was removed completely under vacuum to afford the title compound




Working Days : 26

Sr.


Kg/Kg of


Input

1 Sodium Methoxide 110 0.28 5.60

2 Toluene 600 1.50 30.00

3 4-Methylacetophenone 240 0.60 12.00

4 Methyltrifluoroacetate 248 0.62 12.40

5 Water 300 0.75 15.00

6 Conc HCl 230 0.58 11.60

Total 1728

Output

1 Final Product* 400 1.00 20.00 Finished product

2 Toluene (Recd) 580 1.40 28.00 Recycle

3 Distillation Loss 20 0.10 2.00

4 Effluent 718 1.79 35.90

5 Residue 10 0.03 0.50

Total 1728

3 . P r o d u c t : 4 - [ 5 - ( 4 - M e th y l p h e n y l ) - 3 - ( t r i f l u o r o m e t h y l )

p y r a z o l - 1 - y l ] b e n z en e s u l f o n a m i d e: C e l e c o x i b

SO2NH2

N

N

CH3

CF3

MW 381.37

4-[5-(4-Methylphenyl)-3-(trifluoro methyl) pyrazol-1-yl]benzenesulfonamide celecoxib

Water

Toluene

MW 223.68

4 SPH

SO2NH2

NH

NH2

ClH

CH3

O CF3

O

MW 230.18

Dione deri

+

+ ClH + 2 H2O

MW 36.46 MW 18.01


4 SPH

Dione Deri

Toluene

Carbon

Water

S T A G E

Solvent Recovery

Evaroparation Loss

Efflulent

Solid Waste

F I N I S H

P R O D U C T


• Charged water in Reactor at RT.

• Charged 4 SPH and Dione Deri in Reactor

• The reaction mixture was heated and stirred well.

• Cool the RM and Filter the Product.

• Charged Toluene and wet cake in above reactor again.

• Heat the RM and stir well for several time

• The organic layer were washed with water add Activated carbon at stirred under

heating.

• Filter the RM with Sparkler

• The filtrate was cooled.

• The separated solid was filtered and dried




Working Days : 26

Sr.


Kg/Kg of


Input

1 4 SPH 350 0.70 14.00

2 Dione Deri 325 0.65 13.00

3 Toluene 1400 2.80 56.00

4 Carbon 5 0.01 0.10

5 Water 800 1.60 32.00

Total 2875

Output

1 Final Product 500 1.00 20.00 Finished product


3 Distillation + Drying Loss 50 0.19 3.80

4 Residue 15 0.03 0.60

5 Carbon Waste 10 0.02 0.20

6 Effluent 940 1.88 37.60

Total 2875

4 . P r o d u c t : 4 - C h l o r o P h e n y l H y d r a z i n e H y d r o c h l o r i d e


MW 175.03

Intermediate Step

Cl

NH2

MW 127.57

4-Chloro Aniline

NaNO2+ + 2 HCl

MW 68.99MW 36.46

2 H2O+ + NaCl

MW 18.02

MW 58.44

Cl

N+

NCl

-

MW 179.05

4-Chloro Phenyl Hydrazine Hydrochloride

SO2+

MW 64.06

Cl

NHNH2

ClH

NaHSO3+ + HCl

MW 104.04

MW 36.46

H2O

MW 18.02

+

NaCl

MW 58.44

O2 +

MW 32.00

+


4-Chloro Aniline

Sodium Nitrite

Conc HCl

Sodium Bisulfite

Water

Efflulent

Process Emissions

F I N I S H

P R O D U C T

S T A G E

1


• Charged hydrochloric acid, water and 4 Chloro Aniline in Reactor at RT. Cool the RM

• Charged aqueous sodium nitrite in above reaction mixture

• Charged Slowly aqueous sodium bisulphite in above reaction mixture


• Hydrochloric acid was added to the reaction mixture






Working Days : 26

Sr.


Kg/Kg of


Input

1 4-Chloro Aniline 315 0.79 15.75


3 Sodium bisulphite 275 0.69 13.75

4 Water 400 1.00 20.00

5 Conc HCl 825 2.06 41.20

Total 2015

Output


4 Drying loss 320 0.80 16.00

5 Effluent 1295 3.24 64.80

Total 2140

5 . P r o d u c t : 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-dione :

Doxofylline


STAGE 1 : 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-dione doxofylline

2-Bromomethyl-1,3-dioxolane

MW 180.16

N

N

CH3

N

H

NO

CH3

O

Theofylline

MW 266.25

7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-dione doxofylline

MW 167.00

+

Br

OO

N

N

CH3

N

NO

CH3

O

O

O

Na2CO

3

NaBr+

MW 102.89

Sodium

Bromide

CO2+

MW 44.01

H2O

MW 18.01

+


Theofyline

2-Bromomethyl-1,3-dioxolane

Dimethyl formamide

Sodium Carbonate

Water

Carbon

S T A G E

Solvent Recovery

Evaroparation Loss

Process Emissions

Effluent

Carbon waste

F I N I S H

P R O D U C T


• Charged DMF and Theofylline in Reactor at RT

• Charged 2-Bromomethyl-1,3-dioxolane in above reaction mixture



• Remove excess of solvent under vacuum.

• Now warm the reaction mass and add water in mass.

• Add carbon in above reaction mass and stir well under heating

• Filter the above mass in hot condition

• Cool and then Chilled the reaction mixture

• Maintain same temp for 4 hrs.

• Filter the solid mass and dry it.




Working Days : 26

Sr.


Kg/Kg of


Input

1 Theofylline 650 0.87 17.40

2 2-Bromomethyl-1,3-

dioxolane 610 0.81 16.20

3 Sodium Carbonate 210 0.28 5.60

4 Dimethyl Formamide (DMF) 1800 2.40 48.00

5 Water 1100 1.47 29.40

6 Carbon 10 0.01 0.20

Total 4380

Output


2 Dimethyl Formamide (DMF) 1740 2.32 46.40 Recycle

3 Distillation + Drying loss 135 0.18 3.60

4 Effluent 1740 2.32 46.40


Total 4380

6 . P r o d u c t : 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one:

Bupropion hydrochloride


STAGE 1 : 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one bupropion hydrochloride

3 Chloro 2 Bromo Propiophenone Bupropion.HCl

MW 247.52 MW 276.20

Cl

OCH3

Br

(CH3)

3CNH

2

Cl

OCH3

NHCH3

CH3CH3

. HCl


3-Chloro-2'-Bromo Propiophenone

tert Butyl Amine

Tlouene

Water

Methanolic HCl

Iso Propyl Alcohol

Carbon

S T A G E 1

Solvent Recovery

Evaporation Loss

Process Emissions

Carbon Waste

F I N I S H

P R O D U C T


STAGE 1 : 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one bupropion hydrochloride

• Charged Toluene in Reactor at RT.

• Charge 3-Chloro-2’-Bromo Propiophenone in Toluene

• Slowly charged tert butyl amine in about mass at RT

• Heat Reaction Mass to 55-60oC. Maintain this temp for 3-4 hrs

• Add water in above reaction mass and stir for 1 hrs.

• Now cool the reaction mass and separate the organic layer.

• Charged Carbon in above layer and heat it.

• Filter the above Reaction Mass by Sparkler filter.

• Chilled the filtrate and then Charged Methanolic HCl in Reactor at 5-10oC.

• Maintain RM for 3 hrs at same temp.

• Filter the solid mass.

• Charged Iso Propyl Alcohol in Reactor at RT.

• Add solid mass and stir for 2 hrs.

• Filter the solid mass and dry it




Working Days : 26

Sr.


Kg/Kg of

Product

MT/Mon

th Remarks

Input

1 Toluene 1000 2.50 25.00

2 3-Chloro-2’-Bromo

Propiophenone 400 1.00 10.00

3 tert butyl amine 140 0.35 3.50

4 Water 600 1.50 15.00

5 20% Methanolic HCl 325 0.81 8.13

6 Iso Propyl Alcohol 800 2.00 20.00

7 Carbon 10 0.03 0.25

Total 3275

Output



3 Isopropyl alcohol (Recd) 770 1.81 18.13 Recycle


4 Residue 20 0.06 0.50

5 Effluent 910 2.28 22.80


Total 3275

7 . P r o d u c t : 6-Methyl pyridine-3 yl-2,4-Methylsulfonyl phenyl Etanone

(Ketosulfone)


Intermediate Step

MW 282.37

CH3

S

CN

O

N

CH3

Ketosulfone

MW 289.35

H3CO2S

O

N

CH3

4 Methyl Thiophenyl Acetonitrile

MW 163.24

Methyl 6 Methyl Nicotinate

MW 151.16

CH3

S

CN

COOCH3

N

CH3

+

+CH3 OH

Methanol

MW 32.04

MW 18.02

2 H2O

+ + CO2

NH3

O2


4 Methyl Thiophenyl Acetonitrile

Methyl 6 Methyl Nicotinate

Sodium Methoxide

Sodium Tungstate

Toluene

Hydrogen Peroxide 48%

Conc Sulfuric Acid

Methanol

Water

S T A G E

Effluent

Process Emissions

Solvent Recovery

Evaporation Loss

F I N I S H

P R O D U C T


• Charged 4 Methyl thiophenyl acetonitrile in toluene in Reactor at RT.

• Charged Sodium Methoxide powder in above reaction mixture slowly at RT

• Charged Methyl 6 methyl nicotinate in RM and was heated and stirred

• Add water in above reaction mass.

• The reaction mixture was heated and stirred. Now cool the reaction mass.

• The separated solid was filtered.

• Charged methanol and above solid in Reactor at RT

• Cool the reaction mass and add Sulfuric Acid and Sodium Tangustate

• Slowly add hydrogen peroxide under stirring with cooling

• Cool the reaction mass and separate the wet cake by filtration. Dry the Product




Working Days : 26

Sr.


Kg/Kg of


Input

1 4 Methyl thiophenyl

acetonitrile 160 0.64 6.40

2 Toluene 240 0.96 9.60

3 Sodium Methoxide 80 0.32 3.20

4 Methyl 6 Methyl Nicotinate 148 0.59 5.90

5 Water 500 2.00 20.00

6 Methanol 150 0.60 6.00

7 Sodium Tangustate 3 0.01 0.10

8 Hydrogen Peroxide 160 0.64 6.40

9 Conc Sulfuric Acid 5 0.02 0.20

Total 1446

Output

1 Finish Product 250 1.00 10.00 Finished product



4 Residue 3 0.01 0.10

5 Effluent 873 3.49 34.90

Total 1446

8 . P r o d u c t : 5 - C h l o r o - 6 ' - m e t h y l - 3 - [ 4 - ( m e t h y l s u l f o n y l ) p h e n y l ] -

2 , 3 ' - b i p y r i d i n e : E t o r i c o x i b


MW 289.35

Ketosulfone

MW 358.84

5-Chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-2,3'-bipyridine etoricoxib

O

CH3

S

O

O

N CH3

O

CH3

S

O

N

N CH3

Cl

CH3

N+

N

CH3

CH3

Cl CH3

PF6

-

MW 306.62

CDT Salt

+


Ketosulfone

CDT Salt

Potassium tert Butoxide

Acetic Acid

Toluene

DMF

Iso Propyl Alcohol

Carbon

Water

S T A G E

Solvent Recovery

Evaporation Loss

Effluent

Carbon waste

F I N I S H

P R O D U C T


• Charged DMF in Reactor at RT.

• Charged Stage 1 and 2-chloro-1,3-bis(dimethylamino) trimethinium hexaflouro

phosphate salt CDT Salt in above reaction mixture.

• Charged Potassium tert Butoxide in Reactor at RT

• The reaction mixture was heated and stirred.

• Remove excess of solvent by distillation.

• Charge toluene and acetic acid in above reaction mixture


• Charge water in above reaction mixture

• Separate organic layer and aqueous layer

• Add carbon in Organic layer and stir and filter under heating

• Cool the organic layer and separate the wet cake by filtration

• The separated solid was charged in IPA. Heat and then coolthe RM.

• Separate the wet cake by filtration. Dry the Product.




Working Days : 26

Sr.


Kg/Kg of


Input

1 Ketosulfone 170 0.85 8.50

2 DMF 500 2.50 25.00

3 CDT Salt 185 0.93 9.30

4 Potassium tert Butoxide 85 0.43 4.30

5 Toluene 400 2.00 20.00

6 Acetic Acid 60 0.30 3.00

7 Water 450 2.25 22.50

8 IPA 300 1.50 15.00

9 Carbon 5 0.03 0.30

Total 2155

Output


2 DMF (Recd) 465 2.33 23.30 Recycle


4 IPA (Recd) 285 1.33 13.30 Recycle


6 Residue 17 0.09 0.90

7 Effluent 768 3.84 38.40

8 Waste Carbon 10 0.05 0.50

Total 2155

9. Product : 2-(2-Fluorobiphenyl-4-yl)propanoic acid : Flurbiprofen


Stage 1

+

Diethyl Methyl

Malonate

MW 174.19

NO2

F

F

2,4 Difluoro

Nitrobenzene

MW 159.09

O

O

O

O

CH3

CH3CH3

NH2

F

O

O

O OCH3

CH3

CH3

Stage 1

MW 283.29

NaOH

DMF

Pd/C

Methanol + HF + H2O

MW 20.01

MW 18.01

Stage 2

F

O

O

O OCH3

CH3

CH3

Stage 2

NaNO2

Water

+

Stage 1

MW 283.29

NH2

F

O

O

O OCH3

CH3

CH3

Benzene

MW 78.11 MW 344.37

2,4 Difluoro Nitro Benzene

Diethyl Methyl Malonate

Sodium Hydroxide

Dimethyl Formamide

Methanol

Toluene

Palladium Carbon

Hydrogen

Water

S T A G E 1

Solvent Recovery

Evaporation Loss

Organic Residue

Process Emissions

Effluent

Stage 1

Benzene

Copper Powder

Sodium Nitrile

Conc HCl

Toluene

Water

S T A G E 2

Stage 2

Sodium Hydroxide

Acetic Acid

Conc HCl

Toluene

Carbon

S T A G E 3

Solvent Recovery

Evaporation Loss

Organic Residue

Carbon Waste

Process Emissions

Effluent

F I N I S H

P R O D U C T

Solvent Recovery

Evaporation Loss

Organic Residue

Process Emissions

Effluent

Stage 3

Finish Product

MW 244.26

NaOH

Conc HCl

Acetic Acid

F

O

O

O OCH3

CH3

CH3

Stage 2

MW 344.37

F

O

OHCH3

+ 2 H2O

+ 2 C2H

5OH + CO

2



Stage 1

• Charge 2,4-Difluoronitrobenzene in Reactor at RT.

• Charge Diethyl methyl malonate, Sodium Hydroxide and Dimethylformamide in RM at

RT.

• Heat Reaction Mass. Maintain this temp for 3 to 4 hrs.

• Charge Toluene in Reactor. Heat to reflux for 30 min.

• Wash the Toluene layer with water.

• Toluene layer was concentrated under pressure to give Diethyl-3-fluoro-(4-

nitrophenyl) methyl propanedioate.

• Resulting intermediate reduction in presence of Palladium Catalyst and Hydrogen gas,

Methanol as solvent.

• After completion of the reaction catalyst was filtered under nitrogen and Methanol

layer was concentrated under reduced pressure to get Stage-1 Compound.

Stage 2

• Charge Stage 1 in Reactor at RT.

• Charge Sodium Nitrile solution, Conc HCl and copper powder in above reaction mass.

• Chilled the Reaction Mass. Maintain this temp for 1-2 hrs.

• Charge slowly Benzene in above reaction mass under chilling condition.

• Now Charged Toluene in above RM under stirring.

• After completion of the reaction Toluene layer was washed with water and

concentrated under reduced pressure to form Stage-2 Intermediate.

Stage 3

• Charge Stage 2 and Sodium Hydroxide solution in Reactor at RT.

• Heat the Reaction Mass. Maintain this temp for 1-2 hrs.

• After completion of the reaction crude solid was isolated by adding Acetic Acid and

Conc HCl to the reaction mass.

• The crude solid was recrystalized in Toluene and Carbon to obtain Finish Product




Working Days : 26

Sr.


Kg/Kg of


Input

1 2,4-Difluoronitrobenzene 350 0.88 8.75

2 Diethyl methyl malonate 380 0.95 9.50

3 Sodium Hydroxide 315 0.79 7.88

4 Dimethylformamide 390 0.98 9.75

5 Toluene 2150 5.38 53.75

6 Palladium Catalyst 7 0.02 0.18

7 Hydrogen 18 0.05 0.45

8 Methanol 1150 2.88 28.75

9 Water 1850 4.63 46.25

10 Benzene 265 0.66 6.63

11 Copper Powder 58 0.15 1.45


13 Acetic Acid 180 0.45 4.50

14 Conc HCl 1070 2.68 26.75

15 Carbon 5 0.01 0.13

Total 8383

Output


2 Toluene 2025 5.06 50.63 Recycle

3 Methanol 1080 2.70 27.00 Recycle

4 Palladium Catalyst 10 0.03 0.25 Recycle


6 Residue 40 0.10 1.00

7 Carbon waste 10 0.03 0.25

8 Effluent 4423 11.06 110.60

Total 8383

10. Product : Benzamide 5-chloro-N-[2-[4-[(cyclohexylamino)carbonyl]

amino]sulfonyl]phenyl]ethyl]-2-metoxy : Glibenclamide


Ammonia, Acetone

MW 368.83

CHIC Salt

MW 516.99

NO

Cl

OCH3

O NHSO2NH2

5-Chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)

ethyl]benzamide

+

MW 113.16

Cyclo Hexyl Isocyanate

Cl

OCH3

O NHS

NH

O

OO

NH

. Na

Sodium Hydroxide

Methanol

Benzamide 5-chloro-N-[2-[4-[(cyclohexylamino)

carbonyl]amino]sulfonyl]phenyl]ethyl]-2-metoxy glibenclamide

MW 494.00

Cl

OCH3

O NHS

NH

O

OO

NH

Conc HCl

CHIC Salt

MW 516.99

Cl

OCH3

O NHS

NH

O

OO

NH

. Na


Sulfonamide Deri

Ammonia

Cyclo Hexyl Isocyanate

Sodium Hydroxide

Acetone

S T A G E 1

Evaporation Loss

Solvent Recovery

Effluent

Residue

Step 1

Conc HCl

Methanol

Water

S T A G E 2

Evaporation Loss

Solvent Recovery

Residue

Effluent

F I N I S H

P R O D U C T


STAGE 1

• Charge Ammonia, Sodium Hydroxide, Sulfonamide deri and Acetone in Reactor.

• Slowly Charged Cyclohexyl isocyante in Acetone in above solution.

• Heat the reaction mass under stirring for several times.

• After completion of the reaction, Solvent was removed under vacuum to get crude

material

• The solid was treated with water under stirring and heating. Cool the rm and filter the

solid

• The crude solids are washed with chilled methanol.

• Dry the product to give White to off white solid

STAGE 2

• Charge Methanol and step 1 and in Reactor.

• Conc HCl and water solution is slowly charged in above RM. Heat the mass.

• Heat the reaction mass under stirring for several time.

• Cool the reaction mass and filter the solid

• The crude solids are washed with water.





Working Days : 26

Sr.


Kg/Kg of


Input

1 Sulfonamide Deri 325 0.81 8.13

2 Ammonia 500 1.25 12.50

3 Cyclo Hexyl Isocyanate 110 0.28 2.75

4 Acetone 3250 8.13 81.25


6 Conc HCl 175 0.44 4.38

7 Carbon 20 0.05 0.50

8 Water 2400 6.00 60.00

Total 6820

Output


2 Acetone 3090 7.43 74.25 Recycle

3 Residue 50 0.13 1.25

4 Drying + Distillation loss 190 0.73 7.25

5 Effluent 3060 7.70 77.00


Total 6820

1 1 . D i b en z o [ b , f ] [ 1 , 4 ] Th i a z ep i n - 1 1 ( 10 H ) - O n e


MW 227.28

Ethyl Chloro Formate

MW 108.52

PPA

+ HCl

MW 36.46

MW 201.28

2 Amino Phenyl Phenyl Sulfide

NH2

S

N

H

S

O

Dibenzo[b,f][1,4]Thiazepin-11(10H)-One

+

MW 46.09

C2H5OH


2 Amino Phenyl Phenyl Sulfide

Ethyl Chloro formate

Poly Phosphoric Acid

Water

S T A G E

Process Emissions

Evaroparation Loss

Effulent

Phosphoric Acid Solution

F I N I S H

P R O D U C T


• Charged 2 Amino phenyl phenyl sulfide and Ethyl chloro formate in Reactor at RT


• Charged PPA and water in above reaction mass.

• Heat the RM and stir well for several time.

• Separate Organic layer and aqueous layer.

• Charged water in above organic layer and heat under stirring.


• The separated solid was filtered wash with water and dried.




Working Days : 26

Sr.


Kg/Kg of


Input

1 2 Amino phenyl phenyl

sulfide 380 0.95 9.50

2 Poly Phosphoric Acid PPA 1200 3.00 30.00

3 Ethyl Chloro formate 250 0.63 6.25

4 Water 1400 3.50 35.00

Total 3230

Output


2 Drying Loss 130 0.33 3.25

3 Effluent 2700 6.75 67.50

Total 3230

1 2 . 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol :

Quetiapine fumarate


Thionyl Chloride

Ethanol

Fumaric Acid

+ H2O

MW 18.02

2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol quetiapine fumarate

MW 227.28

N

H

S

O

Dibenzo[b,f][1,4]Thiazepin-11(10H)-One

N

NH

O

OH+

MW 174.24

2-((2-Piperazin-1-yl)ethoxy)ethanol

NN

O

OH

N

S

H

O

OH

O

OH

H

MW 883.02


Dibenzo-1,4-thiazepine-11-one

Thionyl Chloride

Toluene

2-(2-(Piperazin-1-yl)ethoxy)ethanol

Ethanol

Fumaric Acid

Acetic Acid

Water

S T A G E

Process Emissions

Evaroparation Loss

Effulent

Solvent Recovery

Organic Residue

F I N I S H

P R O D U C T


• Charged Dibenzo-1,4-thiazepine-11-one and Thionyl chloride in Reactor at RT


• Charged Toluene and water in above reaction mass.

• Cool the RM and stir well for several time.

• Separate Organic layer and aqueous layer.

• Charged Piperazin ethoxy ethanol in above reaction mass and heat for some time.

• Remove excess of Toluene for Organic layer.

• Charged ethanol Acetic Acid and Fumaric Acid in above reaction mass.

• The reaction mixture was heated and stirred well

• Cool the RM and stir well for several time

• The separated solid was filtered wash with water and dried.




Working Days : 26

Sr.


Kg/Kg of


Input

1 Dibenzo-1,4-thiazepine

one 230 0.58 5.75

2 Thionyl chloride 200 0.50 5.00

3 Toluene 1000 2.50 25.00

4 Piperazin ethoxy ethanol 185 0.46 4.63

5 Ethanol 1200 3.00 30.00

6 Fumaric Acid 60 0.15 1.50

7 Acetic Acid 40 0.10 1.00

8 Water 1000 2.50 25.00

Total 3915

Output



Ethanol 1130 2.83 28.25 Recycle


6 Effluent 1260 3.15 31.50

Total 3915

1 3 . P r o d u c t : N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4methyl-

2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide [Glimepiride Sulphonamide]


3-Ethyl-4-methyl-3-pyrrolin-2-one

MW 125.17

N

CH3CH3

NHO

O

3-Ethyl-4-methyl-2-oxo-N-(2-phenylethyl)

-2,5-dihydro-1H-pyrrole-1-carboxamide

MW 272.34



MW 147.17

N

H

CH3CH3

OOCN

+

Toluene

N

CH3CH3

NHO

O



MW 272.34

N

CH3CH3

NHO

O SO2NH2

N-{2-[4-(Aminosulfonyl)phenyl]ethyl}-3-ethyl-4-


MW 351.42

Chloro Sulfonic Acid

+ +ClSO3H 2 NH3

Liq Ammonia

MW 116.52 MW 17.03

+NH4Cl H2O

MW 53.49 MW 18.02

+


3 Ethyl 4 Methyl Pyrrolin

2 Phenyl Ethyl Isocyanate

Toluene

S T A G E 1Solvent Recovery

Evaporation Loss

Organic Residue

Amide deri

Chlorosulfonic acid

Liq Ammonia

Water

EDC

Solvent Recovery

Evaporation Loss

Organic Residue

Effluent

Process Emissions

F I N I S H

P R O D U C T

S T A G E 2


• Charged 3 Ethyl 4 methyl Pyrroline and toluene is SSR.

• Charged slowly 2 Phenyl Isocyante in it.

• Heat the RM to reflux for 2 hrs.

• Cool and then chilled the rm.

• Filter the mass and dry it.

• Charged Chloro Sulfonic Acid in Reactor at RT and chilled it.

• Charged Amide derivative in above reaction mixture in chilling condition.


• The reaction mixture was very slowly quenched in chilled ammonia solution.

• Filter the solid mass, wash with water and dry it.

• Charged EDC and above crude product in Reactor at RT.

• The reaction mixture was heated and stirred. the chilled to 0-5oC

• Filter the solid mass under chilling condition and dry it.




Working Days : 26

Sr.


Kg/Kg of


Input

1 3 Ethyl methyl Pyrroline 80 0.40 2.00

2 2 Phenyl ethyl isocyanate 80 0.40 2.00

3 Toluene 700 3.50 17.50

4 Chloro Sulfonic Acid 200 1.00 5.00

5 Ammonia Solution 620 3.10 15.50

6 EDC 400 2.00 10.00

7 Water 200 1.00 5.00

Total 2280

Output



3 EDC 385 1.70 8.50 Recycle


5 Residue 5 0.03 0.13

6 Effluent 875 4.38 21.88

Total 2280

14. P r o d u c t : 3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methylcyclohexyl)

carbamoyl]sulfamoyl}phenyl)ethyl]-2-oxo-2,5-dihydro-1H-pyrrole-1-

carboxamide : Glimepiride


K2CO3

N

CH3

CH3

NH

O O

S

O

NH

O

O

NH

CH3

3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methylcyclohexyl)carbamoyl]sulfamoyl}

phenyl)ethyl]-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide glimepiride

MW 490.62

N

CH3CH3

NHO

O SO2NH2+

CH3

OCN

N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4-

methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamideTrans 4 methyl cyclohexyl isocyanate

MW 351.42 MW 139.19


Sulfonamide deri

Trans Isocyanate

Potassium Hydroxide

Acetone

Methanol

Conc HCl

Water

Carbon

Solvent Recovery

Evaporation Loss

Organic Residue

Effluent

Waste Carbon

F I N I S H

P R O D U C T

S T A G E


• Charged Acetone, Potassium Carbonate and Sulfonamide derivative in Reactor at RT.

• Charged Trans 4 methyl cyclo hexyl isocyanate in Reaction Mixture.


• Cool the reaction mixture and separate the solid mass by filtration.

• Charged methanol, carbon and above wet cake in Reactor.

• The reaction mixture was heated and stirred then filter by sparkler filter

• Charged Conc HCl in Reaction Mixture.

• Filter the solid mass, wash with water and dry it




Working Days : 26

Sr.


Kg/Kg of


Input

1 Sulfonamide Derivative 200 1.00 5.00

2 Trans Iso Cyanate 120 0.60 3.00

3 Acetone 2000 10.00 50.00

4 Potassium Carbonate 150 0.75 3.75

5 Methanol 800 4.00 20.00

6 Conc HCl 325 1.63 8.13

7 Water 200 1.00 5.00

8 Carbon 5 0.25 0.13

Total 3800

Output


2 Acetone 1900 9.50 47.50 Recycle

3 Methanol 775 3.50 17.50


5 Residue 15 0.08 0.40

6 Effluent 825 4.12 20.60

7 Carbon 10 0.05 0.25

Total 3800

15. Product : m-Hydroxy-alpha-(methylaminomethyl) benzyl alcohol : Phenyl

ephrine hydrochloride


Stage 1

OH

O CH2Br

OH

O CH3

MW 136.15 MW 215.04

3'-Hydroxy Acetophenone 2-Bromo-3'-Hydroxy Acetophenone

Br2

+ HBr

Stage 2

OH

O

N

CH3

OH

O CH2Br

NHCH3

MW 255.31

MW 121.17

2-Bromo-3'-Hydroxy Acetophenone1-(3-Hydroxyphenyl)-2-[Methyl

(Phenylmethyl)amino]ethanone

MW 215.04

+ HBr

Stage 3

OH

ON

CH3

OH

OHNH

CH3

MW 167.21MW 255.31

1-(3-Hydroxyphenyl)-2-[Methyl

(Phenylmethyl)amino]ethanoneDL Phenyl Ephrine

Hydrogen

CH3

+

MW 92.14

Toluene

Stage 4

OH

OHNH

CH3

OH

NH

CH3

OH

H

MW 167.21

DL Compound

Methanolic HCl

L Tartaric Acid

MW 203.66

Finish Product

. HCl


m Hydroxy Acetophenone

Ethyl Acetate

Water

Bromine

Toluene

S T A G E 1Process Emissions

Effluent

Stage 1

Toluene

n Methyl Benzyl Amine

IPA.HCl

S T A G E 2

Stage 3

L Tartaric Acid

Iso Propyl Alcohol

Liq Ammonia

Acetic Anhydride

Sulfuric Acid

Water

Methanol

Carbon

Methanolic HCl

S T A G E 4

Solvent Recovery

Evaporation Loss

Process Emissions

Effluent

Carbon waste

F I N I S H

P R O D U C T

Solvent Recovery

Evaporation Loss

Organic Residue

Process Emissions

Effluent

Stage 2

Methanol

Pd/C

Liq Ammonia

Water

S T A G E 3

Solvent Recovery

Evaporation Loss

Pd/C

Effluent


Stage 1

• Charge Ethyl Acetate and m Hydoxy Acetophenone in Reactor at RT. Cool the RM

• Slowly charge Liq Bromine in RM under starring and cooling.

• Maintain this temp for 3 to 4 hrs.

• Charge Toluene in Reactor.

• Wash the Toluene layer with water.

• Toluene layer was concentrated under pressure to Crude stage 1.

Stage 2

• Charge Stage 1 and Toluene in Reactor at RT. Now cool the RM.

• Charge n methyl benzyl amine in above reaction mass.

• Chilled the Reaction Mass. Maintain this temp for 1-2 hrs.

• Filter the RM. Separate the wet cake for N methyl benzyl amine recovery.

• Charge slowly IPA.HCl above filtration mass under chilling condition.

• After completion of the reaction separate Stage-2 Intermediate by filtration.

• Wash the product with chilled Toluene.

• Dry the product for next stage reaction.

Stage 3

• Charge Stage 2, Methanol and Palladium carbon in Pressure Reactor at RT.

• Heat the Reaction Mass. Maintain this temp for 4-5 hrs under pressure.

• Cool the RM and filter the mass to separate used Pd/C.

• Remove excess of Methanol under reduced pressure. Add water in RM.

• Crude solid was isolated by adding liq Ammonia in the reaction mass.

• Dry the product for next stage reaction

Stage 4

• Charge Stage 3, IPA and L Tartaric Acid Reactor at RT.

• Charge water in above RM and heat the Reaction Mass. Maintain this temp for 6-8 hrs.

• Cool the RM and filter the Mass - D Salt.

• Take filtrate and adjusted pH to with Liq Ammonia.

• Crude solid A was wash with water and dry it.

• Take D Salt in water and heat it to get clear solution.

• Crude solid was isolated by adding liq Ammonia in the reaction mass

• Dry the product for next stage reaction

• Take Acetic Anhydride and above dry product in reactor and slowly add sulfuric acid.

• Heat the Reaction Mass. Maintain this temp for 8-10 hrs

• Cool the reaction mass and add Liq Ammonia slowly at RT.

• Filter the Solid mass B and dry it.

• Charged Methanol in reactor and add Solid mass A and B. Heat the mass to get clear

solution.

• Give carbon treatment the above solution.

• Charges slowly Methanolic HCl in above filtrate and cool the reaction mass.

• Filter the solid product, wash with chilled Methanol and dry it.




Working Days : 26

Sr.


Kg/Kg of


Input

1 m Hydroxy Acetophenone 225 1.13 5.63

2 Ethyl Acetate 330 1.65 8.25

3 Bromine 280 1.40 7.00

4 Toluene 1130 5.65 28.25

5 Water 1065 5.33 26.63

6 N Methyl benzyl Amine 365 1.83 9.13

7 IPA.HCl 210 1.05 5.25

8 Palladium carbon 8 0.04 0.20

9 Methanol 670 3.35 16.75

10 Liq Ammonia 460 2.30 11.50

11 L Tartaric Acid 226 1.13 5.65

12 IPA 465 2.33 11.63

13 Acetic Anhydride 220 1.10 5.50

14 Sulfuric Acid 47 0.24 1.18

15 Methanolic HCl 200 1.00 5.00

16 Carbon 5 0.03 0.13

Total 5906

Output


2 Ethyl Acetate 280 1.40 7.00 Recycle



5 N Methyl benzyl Amine 160 0.80 4.00 Recycle

7 Residue 20 0.10 0.50


9 Effluent 2861 14.31 71.53

10 Carbon waste 10 0.05 0.25

11 Pd/C 15 0.08 0.38 Recycle

Total 5906

16. Product : 3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-

6-methyl-1,4-dihydropyridine-3,5-dicarboxylate : Amlodipine besylate


Mono Methyl Amine

4-(2-Chlorophenyl)-3-ethoxycarbonyl-5-methoxy

carbonyl-6-methyl-2-(phthalimidoethoxy)

methyl-1,4-dihydropyridine (Phthaloyl Amlodipine)

MW 538.98

N

H

CH3

H3COOC COOC2H5

Cl

ON

O

O

MW 31.05

3-ethyl 5-methyl 2-[(2-aminoethoxy)

methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro

pyridine-3,5-dicarboxylate

MW 408.87

N

H

CH3

H3COOC COOC2H5

Cl

ONH2

HCH3 N

O

O

+

2 Methyl-1-isoindole-1,3-dione

MW 161.16



pyridine-3,5-dicarboxylate amlodipine Besylate

N

H

CH3

H3COOC COOC2H5

Cl

ONH2

H



pyridine-3,5-dicarboxylate

MW 408.87

N

H

CH3

H3COOC COOC2H5

Cl

ONH2

H+

Benzene Sulfonic Acid

MW 158.17

SO3H

SO3H

.

MW 567.05


S T A G E 1

Evaporation Loss

Solvent Recovery

Effluent

Residue

Step 1

Benzene Sulfonic Acid

Ethyl Acetate

MethanolS T A G E 2

Evaporation Loss

Solvent Recovery

Residue

F I N I S H

P R O D U C T

Phthaloyl Amlodipine

Mono Methyl Amine

Methanol

Water


STAGE 1

• Charge Methanol, Phthaloyl Amlodipine and Mono Methyl amine in Reactor.

• Heat the reaction mass under stirring for several times.


material

• The solid was treated with water under stirring and heating. Cool the rm and filter the

solid



STAGE 2

• Charge Ethyl acetate and step 1 and in Reactor.

• Charge Benzene Sulfonic acid solution in ethyl acetate in above RM. Heat the mass.

• Heat the reaction mass under stirring for several time.


material

• The solid was treated with methanol under stirring and heating. Cool the rm and filter

the solid

• The crude solids are washed with methanol.





Working Days : 26

Sr.


Kg/Kg of


Input

1 Phthaloyl Amlodipine 435 1.09 5.44

2 Mono Methyl Amine 670 1.68 8.38

3 Methanol 1750 4.38 21.88

4 Ethyl Acetate 1235 3.09 15.44

5 Benzene Sulfonic Acid 150 0.38 1.88

6 Carbon 30 0.75 0.38

7 Water 3520 8.80 44.00

Total 7790

Output



3 Ethyl Acetate 1190 2.80 14.00 Recycle

4 Residue 45 0.11 0.56

5 Drying + Distillation loss 160 0.58 2.88

6 Effluent 4270 10.68 53.38


Total 7790

1 7 . P r o d u c t : 1 0 , 1 1 - d i h y d r o - 10 - o x o - 5 H - d i b e n z ( b , f ) a z e p i n e

- 5 - c a r b o x a m i d e : O x c a rb a z a p i n e


STAGE 1 : 10,11-dihydro- 10-oxo- 5H-dibenz(b,f)azepine-

5-carboxamide oxcarbazapine

MW 223.27

10-Metoxy-5H-di benz(b,f)azepin

NaOCN+

+ NaCl

MW 65.01

MW 58.44

N

H

O

CH3

N

O

ONH2

+ H2O

MW 18.02

+ HCl

MW 36.46

MW 252.26

10,11-dihydro- 10-oxo- 5H-dibenz(b,f) azepine- 5-carboxamide oxcarbazepine

+ CH3OH

MW 32.04


Toluene

10-Metoxy-5H-di benz(b,f)azepine

Sodium Cyanate

Acetic Acid

Water

Conc HCl

S T A G E

1Efflulent

F I N I S H

P R O D U C T

Stage 1

Methanol

Carbon

S T A G E

2

Evoparation Loss

Residue

Carbon



5-carboxamide oxcarbazapine Crude

• Charged Toluene, 10-Metoxy-5H-di benz(b,f)azepine and sodium cynate in Reactor at

RT.

• Charged acetic acid in above reaction mixture and Stir it

• The reaction mixture was heated and stirred. Add water in above Reaction Mass.

• Allow settling and separating it. Discard aqueous layer

• Hydrochloric acid was added to the reaction mixture and then heated


• The separated solid was filtered and wash with water and dried.



• Charged Methanol and Stage 1 in Reactor at RT.


• Add Carbon in above mixture and further heated under stirring.

• Filter the reaction mass in hot condition.








Working Days : 26

Sr.


Kg/Kg of


Input

1 10-Methoxy

benz(b,f)azepine 470 0.94 28.20

2 Sodium cynate 150 0.30 9.00

3 Toluene 1100 2.20 66.00

4 Acetic acid 60 0.12 3.60

5 Water 550 1.10 33.00

6 Conc HCl 240 0.48 14.40

7 Methanol 1000 2.00 60.00

8 Carbon 5 0.01 0.30

Total 3575

Output

1 Finished Product 500 1.00 30.00 Finished product




5 Residue 30 0.06 1.80

6 Effluent 870 1.74 52.20

7 Carbon 10 0.02 0.60

Total 3575

18. Product: 2, 3-Dibenzoyl-D-tartaric acid (DBDT)


+

Toluene

O

OH

OHO

OH

OH

D Tartaric Acid

MW 150.09

O Cl

Benzoyl Chloride

MW 127.55

2,3 Dibenzoyl D Tartaric Acid

MW 302.28

O

O

OHO

O

OH

+ HCl


Benzoyl Chloride

D Tartaric Acid

TolueneS T A G E

Evaporation Loss

Residue

Distillation Loss

Process Emission

F I N I S H

P R O D U C T


• Charge benzoyl chloride in GLR at RT.

• Charge D-(-)-tartaric acid in RM at RT.

• Heat Reaction Mass. Maintain this temp for 3 to 4 hrs.

• Charge Toluene in Reactor. Heat to reflux for 30 min.

• Cool RM to RT.

• Filter the RM and wash with Chilled toluene.

• Dry the product.




Working Days : 26

Sr.


Kg/Kg of


Input

1 Benzoyl Chloride 535 0.89 26.75

2 D Tartaric Acid 315 0.53 15.75

3 Toluene 900 1.50 45.00

Total 1750

Output




4 Residue 10 0.02 0.50

Total 1750

19. P ro d u c t : p An i s i c A l c o h o l


MW 136.15

4 Methoxy Benzaldehyde

Hydrogen Gas

Nickel Catalyst

CHO

OCH3

MW 138.17

4 Methoxy Benzyl Alcohol

CH2OH

OCH3


REACTOR Nickel Catalyst

F I N I S H

P R O D U C T

4 Methoxy Benzaldehyde

Nitrogen

Nickel Catalyst

Hydrogen


• Take 4 Methoxy Benzaldehyde in an autoclave.

• Then add Nickel (Ni) Catalyst in an autoclave.

• Then parching N2 gas in autoclave to removing O2 in autoclave.

• After passed Hydrogen for 10 to 12 hr.

• That time pressure is 7 to 7.5 Kg. Now checked conversion.

• When conversion is completed than filter of 4 Methoxy Benzyl Alcohol.




Working Days : 26

Sr.


Kg/Kg of


Input

1 4 Methoxy Benzaldehyde 1000 0.998 29.94

2 Nickel Catalyst 5 0.005 0.15

3 Hydrogen gas 270 M3 0.268 M

3 8040 M

3

4 Nitrogen 20 M3 0.019 M

3 597 M

3

Total 1019

Output


3 Filter Loss 1 0.003 0.09

4 Nickel Catalyst 11 0.010 0.30 Regenerated

Total 1019

20. Product : 2-Chloro-1,3-bis(dimentylamino) trimethinium

hexafluorophosphate [CDT Salt]


+

POCl3

NaOH

HPF6

CH3

O

N H

CH3

Dimethyl Formamide

MW 93.09

N

ClCH3

CH3

N+

CH3

CH3PF6

-

2-Chloro-1,3-bis(dimethylamino)

triethinium hexafluoro phosphate Salt

MW 306.62

Cl

O

Cl

Chloro Acetyl Chloride

MW 112.94


Dimethyl Formamide

Chloroacetyl Chloride

Phosphorus Oxychloride

Hexa Fluoro Phosphoric Acid

Caustic Lye

Water

S T A G EEvaporation Loss

Effluent

F I N I S H

P R O D U C T


• Charge Dimethylformamide, Chloroacetyl chloride and in above GLR.

• Charge Phosphorus Oxychloride) in above RM.

• RM is then heated to give a clear yellow solution

• After completion of the addition, the reaction mixture is cooled.

• Charged chilled Caustic solution and hexafluorophosphoric acid solution in water in

RM

• The RM is maintained at same temp for 2 hr, then the solids are collected by

Centrifuged.

• The crude solids are washed with water

• The light-yellow solids are collected by filtration, washed with cold water

• Dry the product to give 2-chloro-1,3-bis(dimethylamino) trimethinium

hexafluorophosphate (CDT Salt) as a light-yellow solid




Working Days : 26

Sr.


Kg/Kg of


Input

1 Dimethylformamide 107 0.36 10.70

2 Chloroacetyl chloride 120 0.40 12.00

3 Phosphorus Oxychloride 165 0.55 16.50

4 Water 250 0.83 25.00

5 Caustic Flakes 200 0.67 20.00

6 hexafluorophosphoric acid 270 0.90 27.00

Total 1112

Output


2 Drying loss 77 0.26 7.70

3 Effluent 735 2.45 73.50

Total 1312

2 1 . P r o d u c t : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-

amine : Brimonidine tartrate


STAGE 1 : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-amine brimonidine

Br

N

NN

S

MW 266.12

Stage 1 Compound

MW 292.13

Stage 1

Br

N

NNH

NH N

NH2

NH2

MW 60.10

Ethylene Diamine

+ + SH2

MW 34.08

STAGE 2 : Purification of STAGE 1

MW 292.13

Stage 1

Br

N

NNH

NH N

MW 292.13

Stage 1

Br

N

NNH

NH N

Crude Pure


Tartrate

MW 442.22

5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)

quinoxalin-6-amine brimonidine tartrate

MW 292.13

Stage 1

Br

N

NNH

NH N

OHO

OH O

OHOH

MW 150.09

L Tartaric Acid

+

Br

N

NNH

NH N

OHO

OH O

OHOH

.


Chloro Benzene

5 Bromo 6 Thio ureidoquinoxaline

Ethylene Diamine

Iso Propyl Alcohol

S T A G E 1

Solvent Recovery

Evaporation Loss

Organic Residue

Process Emissions

Stage 1

Sodium Hydroxide (20%)

Hydroxhloride Acid (20%)

Water

S T A G E 2 Effluent

Stage 2

Methanol

L Tartaric Acid

Carbon

S T A G E 3

Solvent Recovery

Evaporation Loss

Organic Residue

Carbon

F I N I S H

P R O D U C T



• Charged Chorobenzene in Reactor at RT.

• Charge 5-Bromo-6-thiouredo quinoxaline in Chlorobenzene

• Slowly charged a mixture of Chlorobenzene and Ethylene diamine in about mass at RT

• Heat Reaction Mass to 85-90oC. Maintain this temp for 20-22 hrs

• Remove excess of solvent under vacuum.

• Now cool the reaction mass and add Isopropyl alcohol in mass.



STAGE 2 : Pure from Crude

• Charged 20% HCl in Reactor at RT.

• Charge 5-Bromo-6-thiouredo quinoxaline Crude in above mass

• Slowly charged 20% Caustic lye in above mass at RT. Stir mass for 1 hrs

• Now cool the reaction mass.



• Wash the Mass with water till pH 6-7


tartrate

• Charged Methanol in Reactor at RT.

• Charge 5-Bromo-6-thiouredo quinoxaline pure and L tartaric acid and carbon in above

mass

• Slowly heat above mass to reflux. Stir mass for 4 hrs at reflux and filter in hot condition

• Now cool the reaction mass. Then chilled the mass



• Dry the material.




Working Days : 26

Sr.


Kg/Kg of


Input

1 Chorobenzene 800 8.00 80.00

2 5-Bromo-6-thiouredo

quinoxaline 80 0.80 8.00

3 Ethylene diamine 50 0.50 5.00

4 Isopropyl alcohol 200 2.00 20.00

5 20% HCl 400 4.00 40.00

6 20% Caustic Lye dilute 800 8.00 80.00

7 Methanol 900 9.00 90.00

8 L Tartaric Acid 55 0.55 5.50

9 Water 500 5.00 50.00

10 Carbon 10 0.10 1.00

Total 3795

Output


2 Chorobenzene (Recd) 770 7.70 77.00 Recycle

3 Isopropyl alcohol (Recd) 180 1.80 18.00 Recycle

4 Methanol (Recd) 865 8.30 83.00 Recycle


6 Effluent 1710 17.10 171.00

7 Residue 10 0.10 1.00


Total 3795

2 2 . P r o d u c t : ( S ) - N - { ( 3 , 4 - D i m e t h o x y b e n z o c y c l o b u t - 1- y l ) } - N -

( m e t h y l ) ] - N- ( m e t h y l ) a m i n e : I v a b ra d i n e


STAGE 1 : (S)-N-{(3, 4-Dimethoxybenzocyclobut-1-yl)}-N-(methyl)]-N-(methyl)

amine Ivabradine Crude

MW 466.57

Intermediate Step

NO

OO

I

CH3CH3

MW 387.21

IDDB

+

OO

NH

CH3

CH3CH3

.HCl

MW 243.72

MBC.HCl

N

O O

O

CH3

CH3

O

O

NCH3

CH3

CH3

MW 468.59

DBMMA Crude

N

O O

O

CH3

CH3

O

O

NCH3

CH3

CH3

K2CO

3

H2O HIKCl + ++CO

2+

H2

STAGE 1 : Crude to Pure

MW 468.59

DBMMA Crude

N

O O

O

CH3

CH3

O

O

NCH3

CH3

CH3

MW 468.59

DBMMA Pure

N

O O

O

CH3

CH3

O

O

NCH3

CH3

CH3


Acetone

Potassium carbonate

IDDB & MBC.HCl

Toluene

Water

IPA

Palladium Carbon

Conc HCl

S T A G E

1

Efflulent

Process Emissions

Solvent Recovery

Evaporation Loss

Crude Product

Methanol

Carbon

S T A G E

2

Solvent Recovery

Evaporation Loss

Waste Carbon

F I N I S H

P R O D U C T



amine Ivabradine Crude

• Charged Potassium carbonate and Acetone in Reactor at RT.

• Charged 3-(3-Iodopropyl)-7,8-dimethoxy-1,3-dihydro-2H-3-benzazepin-2-one (IDDB) in

above reaction mixture

• Charged Slowly 1-[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]-

Nmethylmethanamine hydrochloride (MBC.HCl) in above reaction mixture


• After completion of reaction, Acetone was distilled out to obtain thick slurry

• Charged water and Toluene. Separate both layers.

• Removed Toluene from reaction mass by distillation.

• The obtained syrup subjected for reduction reaction in autoclave by using Palladium

on Carbon in IPA at elevated temperature under hydrogen pressure

• Filter the mass and add Water and Conc HCl in above reaction mass.





amine Ivabradine Pure


• Charged Crude and carbon in above reaction mixture

• The reaction mixture was heated and stirred and filter in hot condition.





Batch Size, Kg : 50

Working Days : 26

Sr.


Kg/Kg of


Input


2 Acetone 100 2.00 20.00

3 IDDB 45 0.90 9.00

4 MBC.HCl 30 0.60 6.00

5 Water 450 9.00 90.00

6 Toluene 150 3.00 30.00

7 Palladium on Carbon 4 0.08 0.80

8 IPA 60 1.20 12.00

9 Conc HCl 75 1.50 15.00

10 Methanol 300 6.00 60.00

11 Carbon 5 0.10 1.00

Total 1231

Output


2 Acetone (Recd) 90 1.80 18.00 Recycle



5 Palladium on Carbon 7 0.14 1.40 Recycle


7 Effluent 628 12.56 125.60

8 Residue 2 0.04 0.40


Total 1231

23. P r o d u c t : 3-Trifluoromethyl Cinnamic Acid


MW 208.57

Intermediate Step

NH2

F3C

MW 161.12

3 Trifluoro methyl Aniline

NaNO2+ + 2 HCl

MW 68.99MW 36.46

2 H2O+ + NaCl

MW 18.02

MW 58.44

N+

N

F3C

Cl-

MW 216.16

3 Trifluoromethyl Cinnamic Acid

+

O OH

F3C

+

MW 53.06

H2O

MW 18.02

+

NaCl

MW 58.44

N2 +

MW 28.01

CH2 CN

NaOH

MW 39.99

+

+NH3

MW 17.03


3 Trifluoomethyl Aniline

Sodium Nitrile

Conc HCl

Water

Acrylonitrile

Caustic Flakes

Conc Sulfuric Acid

S T A G E Effluent

Process Emissions

F I N I S H

P R O D U C T


• Charged Hydrochloric acid, Water and 3 Trifluoromethyl Aniline in Reactor at RT.

• Charged aqueous Sodium Nitrite in above reaction mixture at RT

• Charged slowly Acrylonitrile in above reaction mixture.

• Add Caustic flakes and water in above reaction mass.

• The reaction mixture was heated and stirred. Now cool the reaction mass.

• Dilute Sulfuric Acid was added to the reaction mixture






Working Days : 26

Sr.


Kg/Kg of


Input

1 3 Trifluoromethyl Aniline 160 0.80 8.00

2 Conc HCl 265 1.33 13.30


4 Acrylonitrile 58 0.29 2.90

5 Water 200 1.00 10.00

6 Caustic Flakes 50 0.25 2.50

7 Conc Sulfuric Acid 70 0.35 3.50

Total 883

Output


2 Drying Loss 50 0.25 2.50

3 Effluent 633 3.17 31.70

Total 883

2 4 . P r o d u c t : ((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)

phenyl]propan-1-amine : Cinacalcet hydrochloride


STAGE 1 : Intermediate Stage

MW 216.16

3 Trifluoromethyl Cinnamic Acid

MW 171.24

NH2 CH3

+

MW 371.39

Intermediate Stage

O

NHF3C

CH3

O

OHF3C

+OH2

MW 18.01

H2

+

Naphthyl Ethyl Amine

STAGE 2 : ((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-

1-amine cinacalcet hydrochloride

MW 393.87

((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)

phenyl]propan-1-amine cinacalcet hydrochloride

NHF3C

CH3

+NaBO2

MW 65.80

NaBH4

MW 371.39

Intermediate Stage

O

NHF3C

CH3

ClH

HCl


Trifluoro Methyl Cinnamic Acid

Raney Nickel

Hydrogen

Methanol

Naphthyl Ethyl Amine

Toluene

Boric Acid

Water

S T A G E

1

Solvent Recovery

Evaporation Loss

Effluent

F I N I S H

P R O D U C T

Stage 1

Sodium Borohydride

MDC

Methanol

Conc HCl

Water

Carbon

S T A G E

2

Solvent Recovery

Evaporation Loss

Effluent

Carbon Waste


STAGE 1 : Intermediate Stage

• Charged Methanol and 3 Trifluoro methyl cinnamic acid in Reactor at RT.

• Charged Raney Nickel in above reaction mixture

• Pass Hydrogen gas in above reaction mixture under pressure

• The reaction mixture was heated and stirred and then filter.

• Remove excess of solvent by distillation from filtrate.

• Charge toluene, Boric Acid and Naphthyl ethyl amine in above reaction mixture




STAGE 2 : ((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-

1-amine cinacalcet hydrochloride


• Charged Stage 1 and Sodium Borohydride in above reaction mixture


• Remove excess of solvent by distillation from Reaction Mass.

• Charge MDC and Conc HCl in above reaction mixture


• After completion of reaction, charged water in RM and stir it.

• Separate the organic layer and aqueous layer.

• Add carbon in aqueous layer and stir at RT. Filter it by Sparkler.

• Chilled the aqueous layer.

• The separated solid was filtered and dried




Working Days : 26

Sr.


Kg/Kg of


Input

1 Trifluoro methyl Cinnamic

acid 150 0.75 7.50

2 Methanol 600 3.00 30.00

3 Raney Nickel 25 0.13 1.30

4 Toluene 300 1.50 15.00

5 Boric Acid 5 0.03 0.30

6 Naphthyl ethyl amine 115 0.58 5.80

7 Sodium Borohydride 35 0.18 1.80

8 MDC 150 0.75 7.50

9 Conc HCl 250 1.25 12.50

10 Water 600 3.00 30.00

11 Carbon 15 0.08 0.80

Total 2245

Output




4 MDC (Recd) 145 0.58 5.80 Recycle


6 Residue 10 0.05 0.50

7 Effluent 975 4.88 48.80


Total 2245

2 5 . P r o d u c t : 1 - { 4- [ 2 - I s o p r o p o x y e t h o x y ) m e t h y l ] p h e n o x y } - 3 -

( i s o p r o p y l am i n o ) p ro p a n o l : B i s o p r o l o l f u m a r a t e


STAGE 1 :

MW 124.14

4 Hydroxy Benzyl alcohol

O

CH3

CH3

OH

MW 104.15

2 Isopropoxy ethanol

+

OH

OH

OH

OO

CH3

CH3

MW 210.27

Stage 1

STAGE 2 :

+

MW 266.33

Stage 2

OH

OO

CH3

CH3

MW 210.27

Stage 1

ClO

O

OO

CH3

CH3

O

NaOH

MW 92.52

Epichloro hydrine

STAGE 3 :

+NH2

CH3

CH3

MW 59.11

Iso Propyl Amine

MW 266.33

Stage 2

O

OO

CH3

CH3

O

1-{4-[2-Isopropoxyethoxy)methyl]phenoxy}

-3-(isopropylamino) propanol bisoprolol

MW 325.44

O NH

OHCH3CH3

OO

CH3 CH3

STAGE 4 :


-3-(isopropylamino) propanol bisoprolol

MW 325.44

O NH

OHCH3CH3

OO

CH3 CH3

Fumeric Acid

MW 441.51

O NH

OHCH3CH3

OO

CH3 CH3 O

OH

O

OH

.

MW 116.07


-3-(isopropylamino) propanol bisoprolol fumarate


4 Hydroxy Benzyl Alcohol

2 Isopropoxy ethanol

Amberlyst-15

Sodium Carbonate

S T A G E 1Solvent Recovery

Evaporation Loss

Stage 1

Sodium Hydroxide (20%)

Epichloro Hydrine

Toluene

Water

S T A G E 2

Solvent Recovery

Evaporation Loss

Organic Residue

Effluent

S T A G E 3

Solvent Recovery

Evaporation Loss

Organic Residue

Carbon

Stage 3

Acetone

Fumaric Acid

Carbon

S T A G E 4

Solvent Recovery

Evaroparation Loss

Residue

Waste Carbon

F I N I S H

P R O D U C T

Stage 2

Methanol

Sodium Borohydride

Iso Propyl amine

MDC


STAGE 1 :

• Charged 4-hydroxy benzyl alcohol and 2- Isopropoxy ethanol in Reactor at RT

• Amberlyst-15 is added slowly in above reaction mass

• The Amberlyst-15 resin is filtered and washed with 2-Isopropoxy ethanol

• The reaction mixture is treated with sodium carbonate

• The sodium carbonate is filtered and the reaction mixture is taken for distillation to

recover excess of 2-Isopropoxy ethanol to obtain Stage 1

STAGE 2 :

• Charged 20% Sodium Hydroxide solution and stage 1 in reactor.

• The aqueous solution of sodium salt of stage 1 is reacted with epichlorohydrin

• The reaction mixture is then extracted twice with Toluene

• The combined Toluene extract is stirred with solid sodium hydroxide to convert the

intermediate stage

• The reaction mixture is washed with water three times and the Toluene layer is taken

for distillation

• The product is further purified by high vacuum distillation to obtain purified Stage 2

STAGE 3 :

• Charged stage 2 and methanol in reactor.

• Catalytic amount of sodium borohydride is added to it in small lots.

• The reaction mixture is stirred for 1 hr and added to cooled isopropyl amine. The

reaction mixture is stirred hrs and heated to reflux

• The excess of Isopropyl amine and methanol is removed by distillation

• The residual oil is taken in dichloromethane and washed thrice with water

• Bisoprolol base is obtained as an oil after removal of solvent by distillation

STAGE 4 :

• Charged Acetone in Reactor at RT

• Charged 1-{4-[(2-Isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino) Propanol in

above solvent


• Charged Fumaric Acid in above solvent

• The reaction mixture was heated and then add carbon and stirred. filter the RM


• Then Chilled the reaction mixture






Working Days : 26

Sr.


Kg/Kg of


Input

1 4-hydroxy benzyl alcohol 150 0.38 3.75

2 2- Isopropoxy ethanol 140 0.35 3.50

3 Amberlyst-15 50 0.13 1.25

4 Sodium Carbonate 140 0.35 3.50


6 Epichlorohydrin 115 0.29 2.88

7 Toluene 1100 2.75 27.5

8 Sodium borohydride 15 0.04 0.38

9 Methanol 1250 3.13 31.25

10 Isopropyl amine 110 0.28 2.75

11 MDC 850 2.13 21.25

12 Acetone 1600 4.00 40.00

13 Fumaric Acid 130 0.33 3.25

14 Carbon 12 0.03 0.30

15 Water 1500 3.75 37.50

Total 963

Output


2 Toluene Recd 1040 2.60 26.00 Recycle

3 Methanol Recd 1190 2.98 29.75 Recycle

4 MDC Recd 760 1.90 19.00 Recycle

5 Acetone Recd 1490 3.73 37.25 Recycle


7 Residue 20 0.05 0.50


9 Effluent 1872 4.68 46.80

Total 963

26. Product : 5-Methyl-1-phenylpyridin-2(1H)-one: Pirfenidone


+K

2CO

3

5 Methyl 1 H

Pyrrolin-2-One

MW 109.12

Br

Bromo Benzene

MW 157.01

CH3

NH

O

5-Methyl-1-phenyl

pyridin-2(1H)-one pirfenidone

MW 185.22

CH3

N O

MW 138.21

+ KBr + H2O + CO

2


Bromo Benzene

5 Methyl 1 H Pyridin-2-One

Potassium Carbonate

Copper Oxide

Dimethyl Formamide

Toluene

Sodium Hydroxide

Conc HCl

Water

S T A G E

Evaporation Loss

Effluent

Process Emissions

Residue

F I N I S H

P R O D U C T


• Charge Dimethylformamide, Bromobenzene and Potassium Carbonate in Reactor.

• Charge Copper Oxide and 5-Methyl-1H-pyridin-2-one in above RM. Heat the mass.

• Remove Dimethylformamide under vacuum.

• After completion of the reaction, extracted the product in Toluene.

• Solvent was removed under vacuum to get crude material

• The solid was treated with aqueous Hydrochloric acid and isolated by adjusting pH to

basic using Sodium Hydroxide to get solid.






Working Days : 26

Sr.


Kg/Kg of


Input

1 Di methyl formamide 450 2.25 22.50

2 Bromo benzene 215 1.08 10.80


4 5-Methyl-1H-pyridin-2-one 38 0.19 1.90

5 Copper Oxide 140 0.70 7.00

6 Toluene 320 1.60 16.00


8 Conc HCl 180 0.90 9.00

9 Water 100 0.50 5.00

Total 1613

Output


2 Di methyl formamide 395 1.98 19.80 Recycle


4 Residue 15 0.08 0.80

5 Drying loss 130 0.65 6.50

6 Effluent 593 2.97 29.70

Total 1613

27. Product: Ursodeoxycholic acid


O

OH

O

OH

CH3 H

CH3

H

H

CH3

H

H

3-Hydroxy-7-Ketocholanic Acid

MW 390.56

Ursodeoxycholic Acid Imidazole Salt

MW 461.64

OH

OH

O

OH

CH3 H

CH3

H

H

CH3

H

H

N

NH

Sodium

Phosphoric Acid

Imidazole

OH

O

O

OH

CH3 H

CH3

H

H

CH3

H

H

CH3

MW 406.60

OH

OH

O

OH

CH3 H

CH3

H

H

CH3

H

H

Ursodeoxycholic Acid

MW 392.57

Ursodeoxycholic Acid methyl ester

Phosphoric Acid

Methanol Sodium hydride


Butanol

3-Hydroxy-7-ketocholanic acid

Sodium Metal

Phosphoric acid 85%

Imidazole

Water

S T A G E 1

Solvent Recovery

Evaporation Loss

Effluent

Stage 1

Butanol

Phosphoric acid 85%

Methanol

Conc HCl

S T A G E 2

Stage 2

Sodium Hydroxide

Water

Methanol

Conc HCl

S T A G E 3

Solvent Recovery

Evaporation Loss

Organic Residue

Effluent

F I N I S H

P R O D U C T

Solvent Recovery

Evaporation Loss

Organic Residue

Effluent


S t e p 1

• Charged butanol and 3-hydroxy-7-ketocholanic acid into a reactor.

• The mass was brought to reflux temperature then metallic sodium was added in

portions.

• The mass was maintained at reflux for about 30 minutes, and then removed solvent

under vacuum.

• Water and phosphoric acid 85% were subsequently added. The mass was heated to

around 70°C.

• Charged imidazole in to the Reaction mass.

• The suspension was brought at a temperature of 5°-10°C, and then centrifuged and

the solid residue was washed with water.


S t e p 2

• Charged step 1, butanol and phosphoric acid 85% into a reactor.

• The mixture was heated until complete dissolution. The lower aqueous phase was

separated and eliminated.

• The organic phase was brought to dryness by distillation, and the residue added or

dissolved with methanol and hydrochloric acid.

• The mass was cooled to 0°-5°C, then the suspension was centrifuged and the solid

washed with chilled methanol.


S t e p 3

• Charged step 2, water and sodium hydroxide were into a reactor.

• The mass was heated at reflux and maintained for 2 hours, and then water was added.

• The solution was brought to 60-65 °C then methanol and Conc HCl were added

• The suspension was stirred at 60°-65°C for at least 15 minutes, then cooled to 20°-25°C

and stirred at this temperature for at least 30 minutes. The suspension was

centrifuged and the solid washed with methanol and water.





Working Days : 26

Sr.


Kg/Kg of


Input

1 3-hydroxy-7-ketocholanic acid 215 1.08 10.80

2 Butanol 450 2.25 22.50

3 Sodium metal 30 0.15 1.50

4 Phosphoric acid 85% 185 0.93 9.30

5 Imidazole 45 0.23 2.30

6 Methanol 950 4.75 47.50


8 Conc HCl 210 1.05 10.50

9 Water 200 1.00 10.00

Total 2315

Output


2 Butanol 435 2.08 20.80 Recycle


4 Residue 15 0.08 0.80

5 Drying loss 68 0.63 6.30

6 Effluent 685 3.43 34.30

Total 2315

ANNEXURE – IV

_______________________________________________________________________

DETAILS OF WATER CONSUMPTION AND WASTEWATER GENERATION

Note: Domestic waste water is to be sent to Septic Tank & Soak Pit.

Sr.

No.

Category Proposed Scenario (m3/day)

Water Consumption Waste Water

Generation

1. Industrial

Process 9.0 18.9

Boiler 10 1

Cooling 10 1

Washing 1 1

APCM 2 2

2. Gardening 2 -

3. Domestic 5 4

Total (Industrial) 32.0 23.9

Total 39.0 27.9

WATER BALANCE

Raw Water 39.0 KL/Day

Domestic 5.0 KL/Day

Industrial 32.0 KL/Day

Gardening 2.0 KL/Day

Process: 9.0 KL/Day

Cooling 10 KL/Day

4.0 KL/day Septic Tank &

Soak Pit

18.9 KL/Day

23.3 KL/Day ETP (Primary treatment & Secondary Treatment)

1.0 KL/Day

CETP for further treatment &

disposal

Washing 1.0 KL/Day

1.0 KL/Day

APCM- 2.0 KL/Day

2.0 KL/Day

Boiler 10 KL/Day

1.0 KL/Day

High COD & High TDS � 0.6 KL/Day

Common MEE for further

treatment & disposal

ANNEXURE - V

EFFLUENT TREATMENT SYSTEM

Stream I (Low COD & TDS Stream) = 24 KL/Day

First all non-toxic and biodegradable streams (low & medium COD& TDS) of wastewater shall

pass through Screen Chamber (SC-01) where floating material shall be removed with help of

Screen (S-01). Then effluent shall be passed through Oil & Grease Removal Tank (OGRT-01).

Automatic mechanical Oil Skimmer shall be provided in the OGRT to remove floating oil and

grease from the wastewater to Oil & Grease Collection Tank (OGCT-01). Then effluent shall be

collected in Collection cum Equalization tank-1 (CET-01). Pipe grid is provided at bottom of the

CET-01 to keep all suspended solids in suspension and to provide proper mixing. 2 nos. of Air

Blowers (1W+1 stand-by) shall supply air through to pipe grid.

Then after, equalized wastewater shall be pumped to Neutralization Tank-1 (NT-01) where the

continuous addition and stirring of Caustic solution is done to maintain neutral pH of

wastewater from Caustic Dosing Tanks (CDT-01) as per requirement by gravity. Then after,

neutralized wastewater shall go to Flash Mixer-1 (FM-01) by gravity. Alum and Polyelectrolyte

shall be dosed from Alum Dosing Tank (ADT-01) and Polyelectrolyte Dosing Tank (PEDT-01)

respectively by gravity into FM-1 to carry out coagulation by using a Flash Mixer. Then after,

coagulated wastewater shall be settled in Primary Clarifier (PCF-01). Clear supernatant from

PCL shall be passed in Aeration Tank (AT-01)

Here, biodegradation of organic matter of the wastewater shall be carried out by bacteria

(suspended growth) in the AT-01 and for that oxygen shall be supplied by 2 nos. of air blowers

(B-02) through diffusers. Air blowers also keep MLSS in suspension. Treated effluent will be

sent to CETP for further treatment.

Then after, wastewater shall go to Secondary Clarifier-1 (SCL-01) from AT-1. Here, the

suspended solids shall be settled. Sludge shall be removed from bottom of SCL-01 and pumped

to AT-1 to maintain MLSS and excess activated sludge shall be sent to Sludge Sump (SS-01).

SIZE OF TANKS (Stream I)

SIZE OF TANKS (Stream I)

S.N. Name of unit Size (m x m x m) No

.

MOC/ Remark

Stream I (Low COD & TDS Stream) 24 M3/D

1 Screen Chamber (SC-01) [0.5x0.5x1 depth] 1 RCC M25+A/A Bk.

Lining

2 Collection cum Equalization

Tank-1 (CET-01)

[2.5x2.5x 4 depth] 1 RCC M25+A/A Bk.

Lining

3 Neutralization Tank (NT-01) [2.5x2.5x 4 depth] 1 RCC M25+A/A Bk.

Lining

4 Flash Mixer-1 (FM-01) 0.8 x 0.8 x (1.5 LD +0.5

FB)

1 RCC M25

5 Primary Clarifier (PCL-01) [2.5x2.5x 3 Height] 1 RCC M25

6 Aeration Tank-1 (AT-01) [5.0 x5.0 x 7.0 (4.0

depth+ 3.0 above ground

level)]

1 RCC M25

7 Secondary Clarifier-1 (SCL-

01)

[2.5x2.5x 3 Height] 1 RCC M25

RCC M25 = REINFORCED CEMENT CONCRETE (M 25 GRADE)

PCC = PLAIN CEMENT CONCRETE

PP = POLYPROPELENE

MSEP = MILD STEEL EPOXY PAINTED

SS = STAINLESS STEEL

BLOCK DIAGRAM FOR EFFLUENT TREATMENT PLANT (Stream -I)

Screen Chamber Oil & Grease

Trap

Collection cum

equalization

tank

Neutralization

tank

Primary Settling

tank

Aeration tank

Secondary

Settling tank

CETP

EXPECTED CHARACTERISTIC OF EFFLUENT (STREAM-I)

Sr.

No.

Category of Wastewater Before Treatment After Treatment

1 pH 3.5-6.5 6.5-8.0

2 COD (mg/L) 20000 10000 [CETP –ETL grant

permission]

3 BOD3 (mg/L) 7000 3000

4 TDS (mg/L) 3500 3500

5 Ammonical Nitrogen (mg/L) 100 50

EXPECTED CHARACTERISTIC OF EFFLUENT (STREAM-II)

Sr.

No.

Category of Wastewater Before Treatment

1 pH 2-10

2 COD (mg/L) 55000

3 BOD3 (mg/L) 12000

4 TDS (mg/L) 40000

5 Ammonical Nitrogen (mg/L) 500

ANNEXURE - VI

HAZARDOUS WASTE GENERATION AND DISPOSAL

CAT.

NO.

HAZARDOUS

WASTE

PROPOSED

TOTAL

(MT/Month)

METHOD OF DISPOSAL

5.1 Used Oil 0.02 Collection, Storage, Transportation Re use or Sent to GPCB

approved recycler

33.1 Discarded barrels/

containers/ liners

2 Collection, Storage, Transportation, decontamination and

Sent back to supplier / to GPCB approved recycler

35.3 ETP Sludge 10 Collection, Storage, Transportation and Sent to TSDF site for

secured land filling

20.3 Distillation Residue 6 Collection, Storage, Transportation and sell to Cement

Industries for Co-processing or Disposal at Common

Incineration Site

28.3 Spent Carbon 4

Collection, Storage, Transportation and co-processing in

cement industries or disposal at Common Incineration Site

28.2 Spent Catalyst 1 Collection, Storage, Transportation and give to manufacturer

for regeneration for reuse or sell to end user.

28.6 Spent solvents 150 Collection, Storage, recovered through in house distillation

and or sent for distillation job work to authorized recycler

then reuse in process.

ANNEXURE-VII

_______________________________________________________________________

DETAILS OF STACK AND VENT and FUEL & ENERGY REQUIREMENT

DETAILS OF FLUE GAS EMISSION THROUGH STACK ATTACHED TO BOILER

SR.

NO.

TYPE

OF

STACK

PARTICULAR STACK

HEIGHT

(M)

STACK

DIAMETER

(M)

AIR EMISSION FUEL APCM

POLLUTANT CONC.

1. Thermic

Fluid

Heater

(6 Lac

Kcal)

STACK-1 30 0.6

PARTICULATE

MATTER

SO2

NOX

≤ 150

MG/NM3

≤ 100

PPM

≤ 50

PPM

Natural

Gas

--

2. Steam

boiler(3

TPH)

Agro

Waste

Multi

cyclone

Separator

with Bag

Filter

DETAILS OF PROCESS EMISSION THROUGH VARIOUS VENTS

SR.

NO.

TYPE OF

STACK

AIR POLLUTION

CONTROL SYSTEM

HEIGHT (M) AIR EMISSION

POLLUTANT CONC.

1. Process Vet

Two Stage Scrubber 12.5 HCL

SO2

HBR

NH3

≤ 20 MG/NM3

≤ 40 MG/NM3

≤ 5 MG/NM3

≤ 175 MG/NM3

APCM:

MODE OF DISPOSAL OF SCRUBBING MEDIA:

All the SO2 gas emitted from sulfonator reactor is being pulled in by wet scrubbers and let

out in atmosphere as a clean gas as per the model Diagram given below.

The

gas absorbed by

scrubber is

passed through

water flow and

that converts

water acidic. This

acidic water is neutralized with proper base (NaOH or CaCo3).

The resultant is salt and water. This water is changed periodically and again neutralized, if

required and allowed to evaporate in the Natural dehydrating pit.

The resultant Scrubbing media is salt solution, scrubbing media is very much minimal and

Scrubbing media use in resinex as raw material.

• TOTAL POWER REQUIREMENT (KW) (PROPOSED)

Sr.

No. Scenario Power Requirement (KVA)

1 Power 500

SOURCE OF POWER (KW)

FUEL REQUIREMENT

Sr.

No.

Fuel Fuel Quantity

1 Natural Gas 4,200 NM3/Day

2 Agro waste 10 MT/Day

3 HSD 20 Liters/Hr

Sr. No. Scenario SEB/Grid DG Sets

(emergency used only)

1 Proposed DGVCL 250 KVA

ANNEXURE-VIII

______________________________________________________________________________

STORAGE DETAILS OF HAZARDOUS LIQUID CHEMICALS

Sr.

No.

Name of the

Hazardous

Substance

Maximum

Storage

Mode of

Storage

Actual

Storage

State &

Operating

pressure &

temperature

Possible type of

Hazards

1 Methanol 20 MT Tank 20 MT x 1 NTP Flammable/

Toxic

2 EDC/MDC 20 MT Tank 20 MT x 1 NTP Flammable/

Toxic

3 DMF 10 MT Tank 20 MT x 1 NTP Flammable/

Toxic

4 Toluene 20 MT Tank 20 MT x 1 NTP Flammable

5 Acetone 20 MT Tank 20 MT x 1 NTP Flammable

6 Ethyl Acetate 20 MT Tank 20 MT x 1 NTP Flammable

7 IPA 20 MT Tank 20 MT x 1 NTP Flammable

ANNEXURE-IX

_______________________________________________________________________

SOCIO - ECONOMIC IMPACTS

1) EMPLOYMENT OPPORTUNITIES

During construction phase, skilled and unskilled manpower will be needed. This will

temporarily increase the employment opportunity. Secondary jobs are also bound to be

generated to provide day-to-day needs and services to the work force. This will also

temporarily increase the demand for essential daily utilities in the local market.

The manpower requirement for the proposed expansion is expected to generate some

permanent jobs and secondary jobs for the operation and maintenance of plant. This will

increase direct / indirect employment opportunities and ancillary business development to

some extent for the local population.

This phase is expected to create a beneficial impact on the local socio-economic

environment.

2) INDUSTRIES

During construction of the project, the required raw materials and skilled and unskilled

laborers will be utilized maximum from the local area. The increasing industrial activity will

boost the commercial and economical status of the locality, to some extent.

3) PUBLIC HEALTH

During construction period, workers will be provided with basic amenities like safe water

supply, low cost sanitation facilities, first aid, required personal protective equipment, etc.

Otherwise, there could be an increase in diseases related to personal hygiene.

Emission, if uncontrolled from process and utility stacks may cause discomfort, burning of

eyes to the recipients in the down wind direction. This may be caused due to the failure of

control equipment / process. The company regularly examines, inspects and tests its

emission from sources to make sure that the emission is below the permissible limit.

Hence, there will not be any significant change in the status of sanitation and the

community health of the area, as sufficient measures have been taken and proposed under

the EMP.

4) TRANSPORTATION AND COMMUNICATION

Since the existing factory is having proper linkage for the transport and communication, the

development of this project will not cause any additional impact.

In brief, as a result of the expansion there will be no adverse impact on sanitation,

communication and community health, as sufficient measures have been proposed to be

taken under the EMP. The proposed expansion is not expected to make any significant

change in the existing status of the socio - economic environment of this region.

ANNEXURE-X

___________________________________________________________________________

PROPOSED TERMS OF REFERENCE FOR EIA STUDIES

1. Project Description

• Justification of project.

• Promoters and their back ground

• Project site location along with site map of 5 km area and site details providing various

industries, surface water bodies, forests etc.

• Project cost

• Project location and Plant layout.

• Existing infrastructure facilities

• Water source and utilization including proposed water balance.

• List of Products & their capacity

• Details of manufacturing process of proposed products

• List of hazardous chemicals

• Mass balance of each product

• Storage and Transportation of raw materials and products.

2. Description of the Environment and Baseline Data Collection

• Micrometeorological data for wind speed, direction, temperature, humidity and rainfall

in 5 km area.

• Other industries in the impact area

• Prevailing environment quality standards

• Existing environmental status Vis a Vis air, water, noise, soil in 5 km area from the project

site.

• Ground water quality at 5 locations within 5 km.

• Complete water balance

3. Socio Economic Data

• Existing socio-economic status, land use pattern and infrastructure facilities available in

the study area were surveyed.

4. Impacts Identification And Mitigatory Measures

• Identification of impacting activities from the proposed project during construction and

operational phase.

• Impact on air and mitigation measures including green belt

• Impact on water environment and mitigation measures

• Soil pollution source and mitigation measures

• Noise generation and control.

• Solid waste quantification and disposal.

• Control of fugitive emissions

5. Environmental Management Plan

• Details of pollution control measures

• Environment management team

• Proposed schedule for environmental monitoring including post project

6. Risk Assessment

• Objectives, Philosophy and methodology of risk assessment

• Details on storage facilities

• Process safety, transportation, fire fighting systems, safety features and emergency

capabilities to be adopted.

• Identification of hazards

• Consequence analysis

• Recommendations on the basis of risk assessment done

• Disaster Management Plan.

7. Information for Control of Fugitive Emissions

8. Information on Rain Water Harvesting

9. Green Belt Development plan

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