Annexure 1 Details of Products Proposed for EC As Per Submitted EIA Annexure - 1

Annexure 1 Details of Products proposed for EC as per submitted EIA Annexure - 1

Proposed Products and their Capacities

SI. Quantity Product Therapeutic Category No. (kg/day) (TPA) Proposed Products (as per EC 2007) and their Capacities 1. Sidenafil Citrate 100 36 Anti-erectile dysfunction agent 2. Omeprazole 100 36 Anti-ulcerative 3. Lansoprazole 100 36 Anti-ulcerative 4. Pantoprazole 100 36 Anti-ulcerative 5. Glimepiride 100 36 Antidiabetic 6. Clopidogrel Hydrogen Bisulfate 100 36 Anti-thrombotic Any 3 products on campaign basis 300 108 out of 6 products at a time Source: M/s. Saiteja Drugs and Intermidiates Private Limited Annexure 2 Revised Form 1 APPENDIX I (See paragraph – 6) FORM 1 (I) Basic Information

S. Item Details No. 1. Name of the Project M/s. Saiteja Drugs and Intermidiates Private Limited Active Pharmaceutical Ingredients (APIs) Manufacturing Unit 2. S.No. in the Schedule 5 (f) 3. Proposed capacity / area / length / tonnage Proposed APIs manufacturing (108 TPA) in to be handled / command area / lease area the existing premises. / number of wells to be drilled List of products and their production capacity are given Annexure-I. Total 6 products (any 3 products at a point of time) will be manufactured.

Total Area: 2.4897 Ha (6.16 Acres) 4. New/ Expansion / Modernization New (same as EC dated 22-8-2007) 5. Existing Capacity / Area etc. Production capacity : 18 TPA (as per latest CFO) (Existing premises) (Any 1 product out of 4 products will be manufactured at a time); Existing total area: 2.4897 Ha. Proposed to drop the existing products. 6. Category of Project i.e., ‘A’ or ‘B’ Category ‘A’ 7. Does it attract the general Condition? If No Yes, Please specify 8. Does it attract the specific condition? If Yes, No Please specify 9. Location Plot/Survey/Khasra No. Sy. No. 543 / A , 544 / A Village Seetavani Gudem Tehsil Bhoodan Pochampally District Yadadri Bhuvanagiri State Telangana 10. Nearest railway station / Bibinagar Railway Station – 14.2 Km (N) airport along with distance in km. Rajiv Gandhi International Airport, Shamshabad – 36 (SW) 11. Nearest Town, City, Bhoodan Pochampally – 2.3 Km (E) District Headquarters along with distance in District Headquarters–Bhongir – 20 Km (NNE) km. Hyderabad (ORR) – 12.2 Km (NW) 12. Village Panchayats, Zilla Parishad, Village Panchayat address (local body): Municipal Corporation, Local body Gram Panchayat Office, (complete postal addresses with telephone Seetavani Gudem Village, nos. to be given) Bhoodan Pochampally Mandal, Yadadri District

S. Item Details No. (Formerly Nalgonda District) Telangana State 13. Name of the applicant Authorized signatory: Mr. K. Chandrasekhara Reddy Managing Director 14. Registered Address M/s. Saiteja Drugs and Intermidiates Pvt Ltd Sy No. 543/A, 544/A Seetavani Gudem (Village) Bhoodan Pochampally (Mandal) Yadadri District (Formerly Nalgonda District) Telangana State 15. Address for correspondence: M/s. Saiteja Drugs and Intermidiates Pvt Ltd H. No. 8-3-333/154, Flat No. 101, Sapphire Apartment, Kamalapuri Colony, Phase-III, Srinagar Colony, Hyderabad – 500073 Telangana State Name Mr. K. Chandrasekhara Reddy Designation (Owner/Partner/ CEO) Managing Director Address M/s. Saiteja Drugs and Intermidiates Pvt Ltd Sy No. 543/A, 544/A Seetavani Gudem (Village) Bhoodan Pochampally (Mandal) Yadadri District (Formerly Nalgonda District) Telangana State Pin Code 508284 E-mail [email protected] Telephone No. 9949169990 / 040-40153151 Fax No. -- 16. Details of Alternative Sites examined, if Not Applicable as this is proposed project in any, Location of these sites should be the existing land as per EC (22-8-2007) issued shown on a topo sheet. products only. 17. Interlinked projects Nil 18. Whether separate application of interlined Not Applicable project has been submitted 19. If yes, date of submission Not Applicable 20. If no, reason Nil 21. Whether the proposal involves Nil 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, Act, 1991 22. Whether there is any Government Nil Order/Policy relevant/relating to the site 23. Forest land involved (hectares) Nil

S. Item Details No. 24. Whether there is any litigation pending Nil 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. *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.) S. Information/Checklist Yes/ Details thereof (with approximate No. confirmation No quantities /rates, wherever possible) with source of information data 1.1 Permanent or temporary change in Yes Additional Construction is based on

land use, land cover or topography Proposed Plant Layout . including increase in intensity of Please refer Annexure-II for Plant Layout. land use (with respect to local land use plan) 1.2 Clearance of existing land, No Not Envisaged. vegetation and buildings? Additional buildings in the open land of existing premises. 1.3 Creation of new land uses? Yes Please refer Annexure-II for Plant Layout. 1.4 Pre-construction investigations e.g. No Not envisaged. bore houses, soil testing? 1.5 Construction works? Yes Additional Construction is based on

Proposed Plant Layout . Please refer Annexure-II for Plant Layout. 1.6 Demolition works? No Not envisaged 1.7 Temporary sites used for No Construction Workers are coming from construction works or housing of nearby villages construction workers? 1.8 Above ground buildings, structures Yes Additional Construction is based on

or earthworks including linear Proposed Plant Layout . structures, cut and fill or Please refer Annexure-II for Plant Layout. excavations 1.9 Underground works including No Not envisaged mining or tunneling? 1.10 Reclamation works? No Not envisaged 1.11 Dredging? No Not envisaged 1.12 Offshore structures? No Not envisaged. 1.13 Production and manufacturing Yes Please refer Annexure–III for manufacturing processes? process 1.14 Facilities for storage of goods or Yes Storage yard facility available and additional

S. Information/Checklist Yes/ Details thereof (with approximate No. confirmation No quantities /rates, wherever possible) with source of information data materials? storage facilities will be provided. 1.15 Facilities for treatment or disposal Yes Proposed ETP will be upgraded for treatment of solid waste or liquid effluents? of effluent with Zero liquid discharge (ZLD) facility. Please refer Annexure-IV for effluent segregation and its treatment. Please refer Annexure-V for details of solid waste disposal 1.16 Facilities for long term housing of No Most of the workers are locals and nearby operational workers? villages. 1.17 New road, rail or sea traffic during No Not envisaged. construction or operation? 1.18 New road, rail, air waterborne or No Not envisaged. other transport infrastructure including new or altered routes and stations, ports, airports etc? 1.19 Closure or diversion of existing No Not envisaged. transport routes or infrastructure leading to changes in traffic movements? 1.20 New or diverted transmission lines No Not envisaged or pipelines? 1.21 Impoundment, damming, No Not envisaged culverting, realignment or other changes to the hydrology of watercourses or aquifers? 1.22 Stream crossings? No Not envisaged 1.23 Abstraction or transfers of water Yes Water requirement will be met from the from ground or surface waters? Ground water and ground water supply through private Tankers. 1.24 Changes in water bodies or the No Not envisaged. land surface affecting drainage or run-off? 1.25 Transport of personnel or materials Yes The construction material will be procured for construction, operation or locally and will be transported through roads. decommissioning? The sources of raw materials and machinery for operation will vary based on market driven forces, which will be transported via roads. 1.26 Long-term dismantling or No Not envisaged decommissioning or restoration works? 1.27 Ongoing activity during No Proposed construction will be temporary and decommissioning which could have short time. an impact on the environment? 1.28 Influx of people to an area in either Yes Workers /employees will be increased and temporarily or permanently? the working hours are in shifts/ general. 1.29 Introduction of alien species? No Nil. 1.30 Loss of native species or genetic No Nil. diversity? 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): S. Yes/ Details thereof (with approximate No. Information/checklist confirmation No quantities /rates, wherever possible) with source of information data 2.1 Land especially undeveloped or No Proposed project will be in the existing agricultural land (ha) area. 2.2 Water (expected source & competing Yes Water source: Ground Water will be users) unit: KLD used through Private tankers Quantity: 46 KLD Please refer Annexure-VI for Water Balance. 2.3 Minerals (MT) No Not applicable. 2.4 Construction material – stone, Yes Construction materials are procured from aggregates, sand / soil (expected the local market and construction is source – MT) based on the plant layout. Please refer Annexure-II for Plant Layout. 2.5 Forests and timber (source – MT) No Not applicable. 2.6 Energy including electricity and fuels Yes Proposed power (electricity) of 650 HP (source, competing users) Unit: fuel will be met from TSPDCL. (MT), energy (MW) Coal of about 16 TPD of coal will be used in the 3 TPH coal fired boiler and existing 1TPH coal fired boiler. Diesel of about 80 lit/hr will be used proposed 2x125 KVA including existing 62.5 KVA DG sets and existing 1 lakh Kcal/hr Diesel fired Thermic Fluid Heater and proposed 2 lakh Kcal/hr TFH. DG sets will be used as standby during power failure. 2.7 Any other natural resources (use No - appropriate standard units)

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.

S. Yes/ Details thereof (with approximate Information / Checklist No. No quantities/rates, wherever possible) confirmation with source of information data 3.1 Use of substances or materials, Yes List of Hazardous Chemicals used in the which are hazardous (as per proposed products are enclosed in MSIHC rules) to human health or Annexure-VII. the environment (flora, fauna, and water supplies) 3.2 Changes in occurrence of disease No Effluent will be sent to ETP-ZLD system. or affect disease vectors (e.g. Treated water will be reused in cooling insect or water borne diseases) towers. All solid waste will be stored in the covered platform with leachate collection system and sent to TSDF / Authorized agencies.

S. Yes/ Details thereof (with approximate Information / Checklist No. No quantities/rates, wherever possible) confirmation with source of information data Process emissions will be scrubbed in the scrubbers. 3.3 Affect the welfare of people e.g. by Yes The welfare of the people will have changing living conditions? positive effects as the industry will continue to participate in the village welfare measures. Developing the greenbelt in and around the plant site and vacant places of industry. 3.4 Vulnerable groups of people who No Not envisaged. could be affected by the project e.g. hospital patients, children, the elderly etc., 3.5 Any other causes No -

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

S. Information/Checklist confirmation Yes/ Details thereof (with Approximate No. No quantities/rates, wherever possible) with source of information data 4.1 Spoil, overburden or mine wastes No Not applicable. 4.2 Municipal waste (domestic and or Yes The commercial waste from the commercial wastes) administration building is generated and is sent to scrap vendors. 4.3 Hazardous wastes (as per Hazardous Yes Please refer Annexure-V for details of Waste Management Rules) Hazardous wastes generated from the proposed products. 4.4 Other industrial process wastes Yes Please refer Annexure-V for details of Hazardous wastes generated from the proposed products. 4.5 Surplus product No Production will be based on the market demand. Hence No surplus production will be generated. 4.6 Sewage sludge or other sludge from Yes Domestic wastewater is sent to ETP- effluent treatment ZLD. Please refer Annexure-V for ETP Sludge generation details. 4.7 Construction or demolition wastes Yes Construction is as per plant layout and ensures to reduce the construction or demolition waste. 4.8 Redundant machinery or equipment No Not envisaged. 4.9 Contaminated soils or other materials No Not envisaged. 4.10 Agricultural wastes No Not envisaged. 4.11 Other solid wastes Yes Please refer Annexure-V for details of Solid wastes generated from the proposed products.

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S. Information / Checklist Yes / Details thereof (with Approximate No. confirmation No quantities/rates, wherever possible) with source of information data 5.1 Emissions from combustion of fossil Yes About 16 TPD of coal will be used in the fuels from stationary or mobile 3 & 1 TPH coal fired boilers. sources Diesel of about 80 lit/hr will be used proposed 2x125 KVA including existing 62.5 KVA DG sets and existing 1 lakh Kcal/hr Diesel fired Thermic Fluid Heater and proposed 2 lakh Kcal/hr TFH. Please refer Annexure-VIII for Emission details. 5.2 Emissions from production Yes Please refer Annexure-IX for emissions processes from process reactions of the proposed products. 5.3 Emissions from materials handling Yes Pumps will be used for handling liquid including storage or transport raw materials and trolleys will be used for Solid / Powder type raw materials. Vent condensers will be provided for all storage tanks, Centrifuges, catch pots. 5.4 Emissions from construction Yes It will be temporary and insignificant activities including plant and during the construction phase of project. equipment 5.5 Dust or odours from handling of Yes Dust will be generated due to materials including construction construction activities and transportation materials, sewage and waste of goods and materials. It will be reduced by water spray at construction waste and on roads. 5.6 Emissions from incineration of waste No Provision of incinerator not envisaged. Proposed to send all Incinerable Hazardous waste to TSDF for incineration / SPCB Authorized Cement Industries. 5.7 Emissions from burning of waste in No Not envisaged. All construction debris open air (e.g. slash materials, will be used as filling material for roads construction debris) and other waste materials are sold as scrap. 5.8 Emissions from any other sources No Not envisaged.

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

S. Information/Checklist confirmation Yes/ Details thereof (with Approximate No. No quantities/rates, wherever possible) with source of information data with source of information data 6.1 From operation of equipment e.g. Yes Noise will be generated from the utilities engines, ventilation plant, crushers section. Silencers & Acoustic panel will be provided for DG Sets and other utilities equipment and these will be installed in separate room. 6.2 From industrial or similar processes Yes Noise will be generated from the pumps,

S. Information/Checklist confirmation Yes/ Details thereof (with Approximate No. No quantities/rates, wherever possible) with source of information data with source of information data motors, centrifuges etc., which will be controlled by proper maintenance and procuring the sound proof equipments. 6.3 From construction or demolition. Yes Noise will be generated during construction phase, which will be temporary and for short time. 6.4 From blasting or piling No Not envisaged. 6.5 From construction or operational Yes Noise will be generated from the traffic transportation vehicles. 6.6 From lighting or cooling systems No Nil 6.7 From any other sources No Nil

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:

S. Information / Checklist Yes/ Details thereof (with Approximate No. confirmation No quantities/rates, wherever possible) with source of information data

7.1 From handling, storage, use or Yes Accidental spillages may occur. spillage of hazardous materials Spillages such as wastewater/solid wastes/raw materials are possible and the risk of this would be limited to within the premises of the manufacturing facility. Precautionary measures are implementing in the existing industry and will be continued for spillage control and to avoid contamination of land or water from the pollutants or raw materials. Suggestions from the safety consultants will be followed to avoid the risk and prevent accidents. 7.2 From discharge of sewage or other No Process effluents will be pumped to the effluents to water or the land above ground level R.C.C lined tanks for (expected mode and place of storage and neutralization then sent to discharge) ETP-ZLD. In-house treatment (ZLD) with primary treatment, secondary treatment and Tertiary treatment. Domestic wastewater will be sent to ETP- ZLD for treatment. 7.3 By deposition of pollutants emitted to Yes Possibility of deposition of pollutants air into the land or into water emitted to air into the land or into water cannot be ruled out and the precautions taken by the industry to control such emissions by adopting the suitable controlling equipment. 7.4 From any other sources No Nil

7.5 Is there a risk of long term build up of No Not envisaged. pollutants in the environment from these sources?

8. Risk of accidents during construction or operation of the Project, which could affect human health or the environment S. Information/Checklist confirmation Yes/ Details thereof (with Approximate No. No quantities/rates, wherever possible) with source of information data 8.1 From explosions, spillages, fires etc. Yes All safety precautions are taken by the from storage, handling, use or industry to avoid such accidents. production of hazardous substances 8.2 From any other causes Yes Proper earthing for Static Electricity provided for all equipment and same will be continued in the proposed project also. 8.3 Could the project be affected by No Not envisaged. natural disasters causing environmental damage (e.g. floods, earthquakes, landslides, cloudburst etc)?

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 S. Information/Checklist confirmation Yes/ Details thereof (with Approximate No. No quantities/rates, wherever possible) with source of information data 9.1 Lead to development of supporting facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: • Supporting infrastructure (roads, Yes • Supporting infrastructure such as power supply, waste or waste water Roads, Power supply, waste or treatment, etc.) wastewater treatment etc., may have impacts on the project activities. However the impact from such activities will be limited • housing development No • All employees will be coming from nearby villages. • extractive industries No • Not envisaged. • supply industries Yes • Raw material supplies will be increased. • other No • Not envisaged. 9.2 Lead to after-use of the site, which No Not envisaged. could have an impact on the environment 9.3 Set a precedent for later No Not envisaged. developments 9.4 Have cumulative effects due to No Not envisaged. proximity to other existing or planned projects with similar effects

(III) Environmental Sensitivity

S. Areas Name/ Aerial distance (within 15 km) Proposed No. Identity project location boundary 1. Areas protected under international Yes • Jalapur RF – 0.75 Km (SW) conventions, national or local • Meharnagar RF – 2.8 Km (SSW) legislation for their ecological, • Malkapuram RF – 6.5 (SSE) & 8.6 (SSE) landscape, cultural or other related • Lakkaram RF – 9.5 Km (SE) value 2. Areas which are important or No Not envisaged sensitive for ecological reasons - Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests 3. Areas used by protected, important No Not envisaged. or sensitive Species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration 4. Inland, coastal, marine or Yes • Musi River – 6 km (NW) & Chinna Musi underground waters River – 2.3 km (SE) • Pond near Maddivanigudem – 1.3 km (N) • Pond near Seetavanigudem – 1.5 km (NE) • Pond near BhoodanPochampally – 2.8 km (NE) • Pond near Revanpalli – 4.7 km (NE) • Pond near Mukthapuram – 2.5 km (NNE) • Pond near Alingar – 4.1 km (NNW) • Pond near Jolur – 4.4 km (NNW) • Pond near Peddagudem – 4.5 km (NW) • Pond near Yenkirala & Madaram – 7 km (NW) • Pond near Yenkirala – 8.3 km (NNW) • Pond near Raghavapuram – 9 km (N) • Ponds near Khapraipalli – 5.7 km (N), 6.5 km (NNE) & 5.5 km (NNE) • Pond near Ravulapalli Kalan–8.5 km (NE) • Pond near Ghauskonda – 5.7 km (NE) • Pond near Ramalingampalli – 7.3 km (NE) 5. State, National boundaries No Nil 6. Routes or facilities used by the Yes • National Highway – 65 (previously NH-9) public for access to recreation or (Hyderabad -Vijayawada) - 6.5 km (SSW) other tourist, pilgrim areas 7. Defence installations No Nil 8. Densely populated or built-up area Yes Bhoodan Pochampally – 2.3 Km (E) 9. Areas occupied by sensitive man- Yes Hospitals, schools, temples and other made land uses general community facilities exist in the (hospitals, schools, places of settlements in the study area. worship, community facilities)

S. Areas Name/ Aerial distance (within 15 km) Proposed No. Identity project location boundary 10. Areas containing important, high No Not applicable quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals) 11. Areas already subjected to pollution No Not applicable. or environmental damage. (those where existing legal environmental standards are exceeded) 12. Areas susceptible to natural hazard No The project area falls under seismic zone II which could cause the project to as per IS: 1893 (Part1):2002. present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

(IV). Proposed Terms of Reference for EIA studies:

Not Applicable. ToR is issued by MoEF&CC dated 14-11-2017. Revised Form 1 is submitted in reply to the Additional Details sought by MoEF&CC dated 8-3-2018

List of Annexures to Form 1 Annexure Pg. No. Annexure-I List of Products, capacities and its status 14 Annexure-II Plant Layout 15 Annexure-III Proposed Products Manufacturing Details 16 Annexure-IV Effluent Treatment flow as per Segregation 68 Annexure-V Proposed Solid / Hazardous Waste Details 69 Annexure-VI Proposed Water Balance, segregation and treatment method 70 Annexure-VII Hazardous Chemicals 71 Annexure-VIII Stack Emission Details 72 Annexure-IX Proposed Process Emissions 73

Annexure - I

Proposed Products and their Capacities SI. Quantity Status Product No. (kg/day) (TPA) in EC Proposed Products (same as per EC 2007) and their Capacities 1 Sidenafil Citrate 100 36 New 2 Omeprazole 100 36 New 3 Lansoprazole 100 36 New 4 Pantoprazole 100 36 New 5 Glimepiride 100 36 New 6 Clopidogrel Hydrogen Bisulfate 100 36 New Any 3 products on campaign basis out of 6 products at a 300 108 time Products as per Latest CFO and their Capacities – Proposed to Drop 1-Acetyl-4-(4-Hydroxy Phenyl) Piperzine 1. (manufactured in two stages and used as raw material in the 7th stage 50 18 Dropped of Ketaconazole) 5-Cyano Phthalide 2. (manufactured in three stages and used as raw material in the 4th 50 18 Dropped stage of Citalopram Hydro bromide) Cis-Bromo Benzoate 3. (manufactured in three stages and used as raw material in the 4th 50 18 Dropped stage of Ketaconazole) Cis-Tosylate 4. manufactured in two stages and used as raw material in the 6th stage 50 18 Dropped of Ketaconazole) Source: M/s. Saiteja Drugs and Intermidiates Pvt Ltd.

14 Annexure – II

Plant Layout

Annexure – III

Proposed Products Manufacturing Details

1. PRODUCT : Sildenafil Citrate

LIST OF RAW MATERIALS

Consumption/ Consumption/ Raw Material Kg Day Kg Kg 2-Ethoxy Benzoic Acid = 0.4 40.0 2-Pentanone = 0.3 30.0 Acetone = 6.25 625.0 Activated Carbon = 0.07 7.0 Ammonium Hydroxide (25%) = 2 200.0 Chloro Sulfonic Acid = 0.25 25.0 Citric acid = 0.32 32.0 Diethyl Oxalate = 0.51 51.0 Dimethyl Sulfate = 0.44 44.0 Hydrazine Hydrate = 0.2 20.0 Hydrochloric Acid (35%) = 0.4 40.0 Hydrogen = 0.01 1.0 Methanol = 4.5 450.0 Methylene Dichloirde = 12.5 1250.0 N-Methyl Piperazine = 0.25 25.0 Potassium Hydroxide = 0.15 15.0 Raney Nickel = 0.04 4.0 Sodium Hydroxide = 0.35 35.0 Sodium Nitrate = 0.25 25.0 Sulfuric Acid = 0.2 20.0 Thionyl Chloride = 0.59 59.0 Toluene = 6.55 655.0

PRODUCT : Sildenafil Citrate Description : 2-Pentanone is reacted with Diethyl Oxalate, Dimethyl Sulfate, Hydrazine Hydrate and Sodium Hydroxide in presence of Toluene to get Stage-1 Compound. Stage-1 Compound is reacted with Sodium Nitrate and Sulfuric Acid to get Stage-2 Compound. Stage-2 Compound is reacted with Thionyl Chloride and Ammonium Hydroxide in presence of Toluene to get Stage-3 compound. Stage-3 Compound is reacted with Hydrogen in presence of Methanol to get Stage-4 Compound. 2-Ethoxy Benzoic Acid is reacted with Thionyl Chloride in presence of Methylene Dichloride and Toluene to get Stage-5 Compound. Stage-5 is reacted with Stage-4 and Potassium Hydroxide in presence of Methylene Dichloride to get Stage-6 compound. Stage-6 is reacted with Chloro Sulfonic acid and N-Methyl Piperazine in presence of Methylene Dichloride to get Sildenafil Base. Sildenfil Base is reacted with Citric Acid in presence of Acetone to get Sildenafil Citrate.

17 PRODUCT : Sildenafil Citrate Flow Chart 2-Pentanone Diethyl Oxalate Sol.Recovery Dimethyl Sulfate Evaporation Loss Hydrazine Hydrate Effluent Sodium Hydroxide Stage I Organic Residue Hydrochloric Acid (35%) Toluene Water

Stage-1 Sodium Nitrate Effluent Sulfuric Acid Stage II Organic Residue Water

Stage-2 Thionyl Chloride Sol.Recovery Ammonium Hydroxide (25%) Stage III Evaporation Loss Toluene Effluent Water Organic Residue Process Emissions

Stage-3 Methanol Stage IV Sol.Recovery Hydrogen Evaporation Loss Raney Nickel Effluent Water Organic Residue

2-Ethoxy Benzoic Acid Thionyl Chloride Stage V Sol.Recovery Methylene Dichloride Evaporation Loss Toluene Organic Residue Process Emissions

Stage-5 Stage-4 Stage VI Sol.Recovery Methylene Dichloirde Evaporation Loss Potassium Hydroxide Effluent Hydrochloric Acid (35%) Organic Residue Water

Stage-6 Chloro Sulfonic Acid Stage VII Sol.Recovery Methylene Dichloride Evaporation Loss N-Methyl Piperazine Effluent DM Water Organic Residue Process Emissions

Sildenafil Base Acetone Sol.Recovery Citric acid StageVIII Evaporation Loss Activated Carbon Organic Residue Spent Carbon

Sildenafil Citrate

18 SILDENAFIL CITRATE

Stage-I

3CH CH3 COOC2H5 + + (CH3)2SO4 + H2NNH2.H2O + 2 NaOH O COOC2H5

2-Pentanone Diethyl Oxalate Dimethyl Sulfate Hydrazine Hydrate Sodium Hydroxide ( M.Wt : 86 ) ( 146 ) ( 126 ) ( 50 ) ( 2 X 40 )

CH3 HOOC N N + Na2 SO4 + 2 C2H5OH + CH3 OH + 3 H2 O

CH3 1-Methyl-3-propyl pyrazolo Sodium Ethanol Methanol Water -5-carboxylic acid Sulfate ( M.Wt : 168 ) ( 142 ) ( 2 X 46 ) ( 32 ) ( 3 X18 )

Stage-II CH CH3 3 N HOOC N HOOC N N Na SO 2 + 2 NaNO3 + H2SO4 2 + 2 4 + 2 H2 O O N CH CH3 2 3 1-Methyl-3-propyl pyrazolo Sodium Sulfuric acid 1-Methyl-3-propyl-4-nitro Sodium Water -5-carboxylic acid Nitrate pyrazolo -5-carboxylic acid Sulfate ( M.Wt : 2 X 168 ) ( 2 X 85 ) ( 98 ) ( M.Wt : 2 X 213 ) ( 142 ) ( 2 X18 )

Stage-III

CH3 CH3 HOOC N H NOC N N 2 N (NH ) SO 2 NH Cl 3 H O H + SOCl2 + 5 NH4 OH + 4 2 4+ 4 + 2 + 2

O2N CH3 O2N CH3

1-Methyl-3-propyl-4-nitro Thionyl Ammonium 1-Methyl-4-nitro-3 n-propyl Ammonium Ammonium Water Hydrogen pyrazolo-5-carboxylic acid Chloride Hydroxide pyrazolo -5-carboxamide Sulfate Chloride ( M.Wt : 213 ) ( 119 ) ( 5 X 35 ) ( M.Wt : 212 ) ( 132 ) ( 2 X 53.5 ) ( 3 X 18 ) ( 2 )

Stage-IV

CH3 CH3 N N H2NOC H2NOC N + 3 H2 N + 2 H2 O

O2N CH3 2NH CH3

1-Methyl-4-nitro-3 n-propyl Hydrogen 4-Amino-1-Methyl-3 n-propyl Water pyrazolo-5-carboxamide pyrazolo-5-carboxamide

( M.Wt : 212 ) ( 3 X 2 ) ( M.Wt : 182 ) ( 2 X18 )

19 SILDENAFIL CITRATE

Stage-V

COOH COCl

+ SOCl2 + SO2 + HCl

OC2H5 OC2H5

2-Ethoxy Benzoic acid Thionyl Chloride 2-Ethoxy Benzoyl chloride Sulfur Dioxide Hydrochloric acid

( M.Wt : 166 ) ( 119 ) ( M.Wt : 184.5 ) ( 64 ) ( 36.5 )

Stage-VI

CH3 COCl H NOC N 2 N + + KOH

OC2H5 2NH CH3

4-Amino-1-Methyl-3 n-propyl 2-Ethoxy Benzoyl chloride Potassium Hydroxide

Pyrazolo-5-carboxamide ( 184.5 ) ( 56 )

( M.Wt : 182 )

O CH3 N NH N + KCl + 2 H2O N

CH3 OC2H5

5-(2-Ethoxy phenyl)-1-methyl-3-n-propyl-1,6- Potassium Chloride Water dihydro-7H-pyrazolo-[4,3,d]-pyrimidine-7-one

( M.Wt : 312 ) ( 74.5 ) ( 2 X18 )

20 Stage-VII O CH3 N NH N + SO2(OH)Cl + 3CH N NH N

CH3 OC2H5

5-(2-Ethoxy phenyl)-1-methyl-3-n-propyl-1,6- Chloro Sulfonic acid N-Methyl Piperazine dihydro-7H-pyrazolo-[4,3,d]-pyrimidine-7-one ( 116.5 ) ( 100 )

( M.Wt : 312 )

O CH3 N NH O O N S + HCl + H O N N 2

N CH3 3CH OC2H5

Sildenafil Base Hydrochloric aicd Water

( M.Wt : 474 ) ( 36.5 ) ( 18 )

Stage-VIII O CH3 COOH N NH O O N S + OH COOH N N COOH N CH3 3CH OC2H5

Sildenafil Base Citric Acid

( M.Wt : 474 ) ( 192 )

O CH3 COOH N NH O O N . S OH COOH N N COOH N CH3 3CH OC2H5

Sildenafil Citrate ( M.Wt : 666 )

PRODUCT : Sildenafil Citrate Stage : 1

Material Balance:

INPUT Kg OUTPUT Kg

2-Pentanone = 0.300 Stage-1 = 0.500

Diethyl Oxalate = 0.510 Toluene = 1.580

Dimethyl Sulfate = 0.440 Toluene Loss = 0.050

Hydrazine Hydrate = 0.200 Effluent = 5.500

Sodium Hydroxide = 0.350 Sodium Sulfate 0.490

Hydrochloric Acid = 0.300 Sodium Chloride 0.100 (35%) Toluene = 1.650 Ethanol 0.320

Water = 3.990 Methanol 0.110

Hydrazine Hydrate 0.030

Hydrochloric Acid 0.040

Water from Hydrochloric Acid 0.200

gen.water 0.220

Water 3.990

Organic Residue = 0.110

Organic Impurities 0.090

Toluene 0.020

Total Input = 7.740 Total Output = 7.740

Stage : 2

Material Balance:

INPUT Kg OUTPUT Kg

Stage-1 = 0.500 Stage-2 = 0.550

Sodium Nitrate = 0.250 Effluent = 3.020

Sulfuric Acid = 0.200 Sodium Sulfate 0.210

Water = 2.700 Sulfuric Acid 0.060

gen.water 0.050

Water 2.700

Organic Residue = 0.080

Organic Impurities

Total Input = 3.650 Total Output = 3.650

Stage : 3

Material Balance:

INPUT Kg OUTPUT Kg

Stage-2 = 0.550 Stage-3 = 0.500

Thionyl Chloride = 0.310 Toluene = 3.170

Ammonium Hydroxide (25%) = 2.000 Toluene Loss = 0.100

Toluene = 3.300 Effluent = 4.800

Water = 2.500 Ammonium Sulfate 0.340

Ammonium Chloride 0.270

Ammonium Hydroxide 0.050

gen.water 0.140

Water from Ammonium 1.500 Hydroxide Water 2.500

Organic Residue = 0.080

Organic Impurities 0.050

Toluene 0.030

Process Emissions = 0.010

Hydrogen

Total Input = 8.660 Total Output = 8.660

Stage : 4

Material Balance:

INPUT Kg OUTPUT Kg

Stage-3 = 0.500 Stage-4 = 0.400

Methanol = 4.500 Methanol = 4.230

Hydrogen = 0.010 Methanol Loss = 0.200

Raney Nickel = 0.040 Raney Nickel = 0.040

Water = 2.000 Effluent = 2.150

Methanol 0.070

gen.water 0.080

Water 2.000

Organic Residue = 0.030

Organic Impurities

Total Input = 7.050 Total Output = 7.050

23 Stage : 5

Material Balance:

INPUT Kg OUTPUT Kg

2-Ethoxy Benzoic Acid = 0.400 Stage-5 = 0.400

Thionyl Chloride = 0.280 Methylene Dichloride = 1.900

Methylene Dichloride = 2.000 Methylene Dichloride Loss = 0.070

Toluene = 1.600 Toluene = 1.500

Toluene Loss = 0.080

Organic Residue = 0.090

Organic Impurities 0.040

Methylene Dichloride 0.030

Toluene 0.020

Process Emissions = 0.240

Sulfur Dioxide 0.150

Hydrochloric Acid 0.090

Total Input = 4.280 Total Output = 4.280

Stage : 6

Material Balance:

INPUT Kg OUTPUT Kg

Stage-5 = 0.400 Stage-6 = 0.600

Stage-4 = 0.400 Methylene Dichloirde = 3.800

Methylene Dichloirde = 4.000 Methylene Dichloirde Loss = 0.140

Potassium Hydroxide = 0.150 Effluent = 2.870

Hydrochloric Acid (35%) = 0.100 Potassium Chloride 0.200

Water = 2.500 Hydrochloric Acid 0.010

gen.water 0.090

Water form Hydrochloric Acid 0.070

Water 2.500

Organic Residue = 0.140

Organic Impurities 0.070

Methylene Dichloirde 0.060

Stage-4 0.010

Total Input = 7.550 Total Output = 7.550

24 Stage : 7

Material Balance:

INPUT Kg OUTPUT Kg

Stage-6 = 0.600 Sildenafil Base = 0.800

Chloro Sulfonic Acid = 0.250 Methylene Dichloride = 6.200

Methylene Dichloride = 6.500 Methylene Dichloride Loss = 0.200

N-Methyl Piperazine = 0.250 Effluent = 2.120

DM Water = 2.000 N-Methyl Piperazine 0.060

Chloro Sulfonic Acid 0.030

gen.water 0.030

Water 2.000

Organic Residue = 0.210

Organic Impurities 0.110

Methylene Dichloride 0.100

Process Emissions = 0.070

Hydrochloric Acid

Total Input = 9.600 Total Output = 9.600

Stage : 8

Material Balance:

INPUT Kg OUTPUT Kg

Sildenafil Base = 0.800 Sildenafil Citrate = 1.000

Acetone = 6.250 Acetone = 5.950

Citric acid = 0.320 Acetone Loss = 0.200

Activated Carbon = 0.070 Organic Residue = 0.220

Organic Impurities 0.120

Acetone 0.100

Spent Carbon = 0.070

Activated Carbon

Total Input = 7.440 Total Output = 7.440

25 POLLUTION LOAD GENERATED PER KG (PER DAY) IN THE PRODUCTION OF Sildenafil Citrate Batch Size 1 Kg Production Capacity : 3000 Kg/month : 100.00 Batch/day

100.00 Kg/day

POLLUTION LOAD GENERATION PER DAY Total Theoretical Emissions Water Org.res./ Inorganics Water in Spent Total Input per Volatile Total Semi + Effluent TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Per Day day Organics solid EVA salt Per Day PerDay Load Load Load ( Kgs) (Litres) (Litres) mg/L mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs Kgs EVA. 1729.00 1807.00 89442.82 183.00 56.00 41055.72 84.00 2046.00 96.00 183.00 7.00 286.00 32.00 104.00 Total 1729.00 1807.00 89442.82 183.00 56.00 41055.72 84.00 2046.00 96.00 183.00 7.00 286.00 32.00 104.00

26 2 PRODUCT : Omeprazole LIST OF RAW MATERIALS

Consumption/ Consumption/ Raw Material Kg Day Kg Kg 2-Mercapto-5-Methoxy Benzimidazole = 0.7 70 3,5-Lutidine = 0.6 60 Acetic Acid = 1.62 162 Acetone = 2.6 260 Activated Carbon = 0.07 7 Ammonium Persulfate = 1 100 Catalyst I = 0.01 1 Catalyst II = 0.01 1 Dimethyl Sulfate = 0.6 60 EDTA = 0.01 1 Hydrogen Peroxide (50%) = 0.66 66 Hydrose = 0.01 1 Methanol = 10.65 1065 Methylene Dichloride = 14.9 1490 Nitric Acid = 0.35 35 Pet Ether = 3.7 370 Sodium Hydroxide = 1.03 103 Sulfuric Acid = 1.4 140 Thionyl chloride = 0.46 46 Toluene = 6.95 695 Triethyl Amine = 0.01 1

PRODUCT : OMEPRAZOLE Description:

3,5-Lutidine is reacted with Hydrogen Peroxide and Nitric Acid in presence of Acetic Acid to give 4- Nitro-3,5-Dimethyl Pyridine-N-Oxide.

4-Nitro-3,5-Dimethyl Pyridine -N-Oxide is reacts with Methanol, Sodium Hydroxide and DMS in presence of Methanol and Toluene to get Stage-2 Compound.

State-2 Compound is reacted with Methanol and Sodium Hydroxide in presence of Methanol, Pet ether and Methylene Dichloride to get Stage-3 Compound.

Stage-3 Compound is reacted with Thionyl Chloride in presence of Methylene Dichloride and Toluene to get Stage-4 Compound.

Stage-4 Compound is reacted with 2-Mercapto-5-Methoxy Benzimidazole and Sodium Hydroxide in presence of Methylene Dichloride to get Stage-5 Compound.

Stag-5 Compound is reacted with Hydrogen Peroxide in presence of Methanol and Acetone to get Omeprazole.

28 Flow Chart:

3,5-Lutidine Acetic Acid Sol.Recovery Hydrogen Peroxide (50%) Evaporation Loss Sulfuric Acid Stage I Spent Acid Nitric Acid Organic Residue Water

Nitro Compound Sodium Hydroxide Sol.Recovery Methanol Stage II Evaporation Loss Toluene Effluent Dimethyl Sulfate Organic Residue Water

Methoxy DMS salt + Toluene (1.2+0.15) Sol.Recovery Methanol Stage III Evaporation Loss Ammonium Persulfate Effluent Sodium Hydroxide Organic Residue Methylene Dichloride Spent Carbon Pet Ether Activated Carbon Water

Hydroxy Methyl Base Sol.Recovery Thionyl chloride Evaporation Loss Methylene Dichloride Stage IV Organic Residue Toluene Process Emissions

Chloro compound Sol.Recovery 2-Mercapto-5-Methoxy Evaporation Loss Benzimidazole Stage V Effluent Methylene Dichloride Organic Residue Sodium Hydroxide Water

Omeprazole Sulphide Sol.Recovery Methanol Evaporation Loss Hydrogen peroxide (50%) Effluent Catalyst I Organic Residue Catalyst II Spent Carbon Methylene Dichloride Stage IV Acetone EDTA Hydrose Triethyl Amine Sodium Hydroxide Acetic Acid Activated Carbon Water

OMEPRAZOLE

29 OMEPRAZOLE

Stage-I

NO2 CH CH 3 3 3CH CH3 H O + 2 2 + HNO3 + 2 H2O N N O 3,5-Lutidine Hydrogen Nitric acid 4-Nitro-3,5-Di Methyl Water Peroxide Pyridine-N-Oxide ( M.Wt : 107 ) ( 34 ) ( 63 ) ( M.Wt : 168 ) ( 2 X 18 )

Stage-II

NO2 OMe CH CH 3 3 3CH CH3

+ CH OH + NaOH + (CH ) SO + NaNO + H2O 3 3 2 4 .(CH ) SO 2 N N 3 2 4 O O 4-Nitro-3,5-Di Methyl Methanol Sodium DMS 4-Methoxy-3,5-Di Methyl Sodium Water Pyridine-N-Oxide Hydroxide Pyridine-N-Oxide.DMS Salt Nitrite ( M.Wt : 168 ) ( 32 ) ( 40 ) ( 126 ) ( M.Wt : 279 ) ( 69 ) ( 18 )

Stage-III

OMe OMe CH CH 3 3 3CH CH3 + CH3OH + 2 NaOH + Na2SO4 + 2 CH3OH + H2O .(CH ) SO N 3 2 4 N CH2OH O 4-Methoxy-3,5-Di Methyl Methanol Sodium 2-Hydroxy Methyl-4-Methoxy Sodium Methanol Water Pyridine-N-Oxide.DMS Salt Hydroxide 3,5-Di Methyl Pyridine Sulfate ( M.Wt : 279 ) ( 32 ) ( 2 X 40 ) ( M.Wt : 167 ) ( 142 ) ( 2 X 32 ) ( 18 )

Stage-IV

OMe OMe CH CH 3CH CH3 3 3

+ SOCl2 + SO2 N CH Cl N CH2OH 2 . HCl

2-Hydroxy Methyl-4-Methoxy Thionyl 2-Chloro Methyl-4-Methoxy Sulfur 3,5-Di Methyl Pyridine Chloride 3,5-Di Methyl Pyridine.HCl Dioxide ( M.Wt : 167 ) ( 119 ) ( M.Wt : 222 ) ( 64 )

30 OMEPRAZOLE

Stage-V

OMe OMe CH CH 3CH CH3 OMe 3 3 N + SH + 2 NaOH OMe N N +2 NaCl + 2 H2O N CH Cl H N C S 2 H N . HCl 2 H

2-Chloro Methyl 2-Mercapto-5-Methoxy Sodium 5-Methoxy-2-[(4-Methoxy-3,5-Di Methyl Sodium Water 4-Methoxy-3,5-Di Benzimidazole Hydroxide Pyridinyl) Methyl Thio]-1H-Benzimidazole Chloride Methyl Pyridine.HCl ( M.Wt : 222 ) ( 180 ) ( 2 X 40 ) ( M.Wt : 329 ) ( 2 X 58.5 ) ( 2 X18 )

Stage-VI

OMe OMe CH 3CH CH3 3CH 3 OMe O OMe H O N + 2 2 N + H O N C S N C S 2 H N H N 2 H 2 H

5-Methoxy-2-[(4-Methoxy-3,5-Di Methyl Hydrogen Omeprazole Water Pyridinyl) Methyl Thio]-1H-Benzimidazole Peroxide ( M.Wt : 329 ) ( 34 ) ( M.Wt : 345 ) ( 18 )

PRODUCT : Omeprazole Stage : 1

Material Balance:

INPUT Kg OUTPUT Kg

3,5-Lutidine = 0.600 Nitro Compound = 0.800

Acetic Acid = 1.500 Acetic Acid = 1.410

Hydrogen Peroxide (50%) = 0.420 Acetic Acid Loss = 0.060

Sulfuric Acid = 1.400 Send to Auth.party = 6.080

Nitric Acid = 0.350 Sulfuric Acid 1.400

Water = 4.250 Hydrogen Peroxide 0.020

gen.water 0.200

Water from Hydrogen Peroxide 0.210

Water 4.250

Organic Residue = 0.170

Organic Impurities 0.140

Acetic Acid 0.030

Total Input = 8.520 Total Output = 8.520

Stage : 2

Material Balance:

INPUT Kg OUTPUT Kg

Nitro Compound = 0.800 Methoxy DMS salt + Toluene = 1.350 Sodium Hydroxide = 0.250 (1.2+0.15)

Methanol = 2.800 Methanol = 2.550

Toluene = 5.000 Methanol loss = 0.060

Dimethyl Sulfate = 0.600 Toluene = 4.680

Water = 2.500 Toluene loss = 0.100

Effluent = 3.010

Sodium Nitrite 0.330

Sodium Hydroxide 0.060

Methanol 0.040

gen.water 0.080

Water 2.500

Organic Residue = 0.200

Organic Impurities 0.130

Toluene 0.070

Total Input = 11.950 Total Output = 11.950

Stage : 3

Material Balance:

INPUT Kg OUTPUT Kg

Methoxy DMS salt + Hyroxy Methyl Base = 0.650 = 1.350 Toluene (1.2+0.15) Methanol = 4.230

Methanol = 4.600 Methanol loss = 0.230

Ammonium Persulfate = 1.000 Methylene Dichloride = 4.510

Sodium Hydroxide = 0.350 Methylene Dichloride Loss = 0.170

Methylene Dichloride = 4.750 Pet ether = 3.500

Pet Ether = 3.700 Pet ether loss = 0.150

Activated Carbon = 0.020 Toluene = 0.140

Water = 9.000 Toluene Loss = 0.010

DMS =

Effluent = 10.970

Ammonium Persulfate 1.000

Sodium Sulfate 0.610

Sodium Hydroxide 0.010

Methanol 0.270

gen.water 0.080

Water 9.000

Organic Residue = 0.190

Organic Impurities 0.070

Methylene Dichloride 0.070

Pet Ether 0.050

Spent Carbon = 0.020

Activated Carbon

Total Input = 24.770 Total Output = 24.770

Stage : 4

Material Balance:

INPUT Kg OUTPUT Kg

Hydroxy Methyl Base = 0.650 Chloro compound = 0.800

Thionyl chloride = 0.460 Methylene Dichloride = 1.570

Methylene Dichloride = 1.650 Methylene Dichloride Loss = 0.060

Toluene = 1.950 Toluene = 1.830

Toluene loss = 0.090

Organic Residue = 0.110

Organic Impurities 0.060

Methylene Dichloride 0.020

Toluene 0.030

Process Emissions = 0.250

Sulfur Dioxide

Total Input = 4.710 Total Output = 4.710

33 PRODUCT : Omeprazole Stage : 5

Material Balance:

INPUT Kg OUTPUT Kg

Chloro compound = 0.800 Omeprazole Sulphide = 1.050

2-Mercapto-5-Methoxy Methylene Dichloride = 3.100 = 0.700 Benzimidazole Methylene Dichloride Loss = 0.100

Methylene Dichloride = 3.250 Effluent = 3.860

Sodium Hydroxide = 0.350 Sodium Chloride 0.420

Water = 3.250 Sodium Hdyroxide 0.060

gen.water 0.130

Water 3.250

Organic Residue = 0.240

Organic Impurities 0.140

2-Mercapto-5-Methoxy 0.050 Benzimidazole

Methylene Dichloride 0.050

Total Input = 8.350 Total Output = 8.350

Stage : 6

Material Balance:

INPUT Kg OUTPUT Kg

Omeprazole Sulphide = 1.050 Omeprazole = 1.000

Methanol = 3.250 Methanol = 3.080

Hydrogen peroxide (50%) = 0.240 Methanol loss = 0.120

Catalyst I = 0.010 Acetone = 2.500

Catalyst II = 0.010 Acetone loss = 0.070

Methylene Dichloride = 5.250 Methylene Dichloride = 5.040

Acetone = 2.600 Methylene Dichloride Loss = 0.130

EDTA = 0.010 Effluent = 4.130

Hydrose = 0.010 Hydrogen peroxide 0.010

Triethyl Amine = 0.010 EDTA 0.010

Sodium Hydroxide = 0.080 Hydrose 0.010

Acetic Acid = 0.120 Catalyst I 0.010

Activated Carbon = 0.050 Catalyst II 0.010

Water = 3.650 Methanol 0.050

Sodium Acetate 0.160

gen.water 0.100

Water from Hydrogen Peroxide 0.120

Water 3.650

Organic Residue = 0.220

Organic Impurities 0.100

Methylene Dichloride 0.080

Acetone 0.030

Triethyl Amine 0.010

Spent Carbon = 0.050

Activated Carbon

Total Input = 16.340 Total Output = 16.340

POLLUTION LOAD GENERATED PER KG (PER DAY) IN THE PRODUCTION OF Omeprazole Batch Size : 1 Kg Production Capacity : 3000 Kg/month

100.00 Batch/day

100.00 Kg/day

POLLUTION LOAD GENERATION PER DAY Total Theoretical Emissions Water Org.res./ Inorganics Water in Spent Total Input per Volatile Total Semi + Effluent TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Per Day day Organics solid EVA salt Per Day PerDay Load Load Load ( Kgs) (Litres) (Litres) mg/L mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs Kgs EVA. 2265.00 1891.00 119254 262.00 44.00 30041 66.00 2197.00 113.00 262.00 7.00 382.00 25.00 135.00 Total 2265.00 1891.00 119254 262.00 44.00 30041 66.00 2197.00 113.00 262.00 7.00 382.00 25.00 135.00

3 PRODUCT : Lansoprazole

LIST OF RAW MATERIALS

Raw Material Consumption/ Consumption/ Kg Day Kg Kg 2,3-Lutidine = 0.45 45.0 2-Mercapto Benzimidazole = 0.49 49.0 Acetic acid = 1.33 133.0 Acetic Anhydride = 1.30 130.0 Acetone = 1.25 125.0 Activated Carbon = 0.03 3.0 Catalyst = 0.01 1.0 Chloroform = 4.65 465.0 Hydrochloric Acid gas = 0.14 14.0 Hydrogen Peroxide (50%) = 0.54 54.0 Isopropyl Alcohol = 2.5 250.0 Methylene Dichloride = 1.75 175.0 MIBK = 1.30 130.0 Nitric Acid = 0.26 26.0 Potassium Carbonate = 0.53 53.0

Sodium Hydroxide = 0.60 60.0

Sulfuric Acid = 1.05 105.0 TBAB = 0.01 1.0 Thionyl Chloride = 0.41 41.0 Toluene = 4.60 460.0 Tri Fluoro Ethanol = 0.39 39.0 PRODUCT : LANSOPRAZOLE

Description:

2,3-Lutidine is reacted with Hydrogen Peroxide and Nitric Acid in presence of Acetic Acid to get Stage-1 Compound.

Stage-1 Compound is reacted with Trifluoro Ethanol, Potassium Carbonate, Acetic Anhydride. Sodium Hydroxide and Hydrochloric Acid in presence of MIBK and Toluene to get Stage-2 Compound.

Stage-2 Compound is reacted with Thionyl Chloride in presence of Toluene and Methylene Dichloride to get Stage-3 Compound.

Stage-3 Compound is reacted with 2-Mercapto Benzimidazole and Sodium Hydroxide to get Stage-4 Compound.

Stage-4 Compound is reacted with Hydrogen Peroxide in presence of Isopropyl Alcohol, Chloroforma nd Acetone to get Lansoprazole.

Flow Chart:

2,3-Lutidine Acetic acid Sol.Recovery Hydrogen peroxide(50%) Evaporation Loss Sulfuric Acid Stage I Send to Auth. Party Nitric Acid Organic Residue Water

Lansoprazole Nitro Sodium Hydroxide Sol.Recovery Potassium Carbonate Evaporation Loss Tri Fluoro Ethanol Effluent MIBK Organic Residue Stage II Acetic Anhydride Spent Carbon TEBAC Toluene Hydrochloric Acid gas Activated Carbon Water

Hydroxy Methyl Hydrochloride Methylene Dichloride Sol.Recovery Toluene Stage III Evaporation Loss Thionyl Chloride Organic residue Process Emissions

Lansoprazole Chloro 2-Mercapto Benzimidazole Stage IV Effluent Sodium Hydroxide Organic residue Water

Lansoprazole sulphide Isopropyl Alcohol Sol.Recovery Hydrogen Peroxide (50%) Evaporation Loss Catalyst Stage V Effluent Chloroform Organic Residue Acetone Sodium Hydroxide Acetic Acid Water

LANSOPRAZOLE

37 LANSOPRAZOLE

Stage-I

NO2 CH 3 CH3 H O + 2 2 + HNO3 + 2 H2O N CH 3 N CH3 O 2,3-Lutidine Hydrogen Nitric Acid 4-Nitro-2,3-Di Methyl Water Peroxide Pyridine-N-Oxide ( M.Wt : 107 ) ( 34 ) ( 63 ) ( M.Wt : 168 ) ( 2 X 18 )

Stage-II

NO2

CH3 K CO (CH CO) O NaOH HCl + CF3CH2OH + 2 3 + 3 2 + +

N CH3 O 4-Nitro-2,3-Di Methyl Tri Fluoro Potassium Acetic Sodium Hydrochloric

Pyridine-N-Oxide Ethanol Carbonate Anhydride Hydroxide Acid ( M.Wt : 168 ) ( 100 ) ( 138 ) ( 102 ) ( 40 ) ( 36.5 )

OCH2CF3

CH3 CH COONa CH COOH + KHCO3 + KNO2 + 3 + 3

N CH2OH .HCl 4-(2,2,2-Tri Fluoro Ethoxy) Potassium Potassium Sod.Acetate Acetic Acid

2-Hydroxy Methyl-3-Methyl Bicarbonate Nitrite Pyridine Hydrochloride

( M.Wt : 257.5 ) ( 100 ) ( 85 ) ( 82 ) ( 60 )

Stage-III

OCH2CF3 OCH2CF3

CH3 CH3 SO + SOCl2 + 2 + HCl

N CH2OH N CH2Cl .HCl .HCl

4-(2,2,2-Tri Fluoro Ethoxy) Thionyl 4-(2,2,2-Tri Fluoro Ethoxy) Sulfur Hydrochloric 2-Hydroxy Methyl-3-Methyl Chloride 2-Chloro Methyl-3-Methyl Dioxide Acid Pyridine Hydro Chloride Pyridine Hydro Chloride ( M.Wt : 257.5 ) ( 119 ) ( M.Wt : 276 ) ( 64 ) ( 36.5 )

38 LANSOPRAZOLE

Stage-IV

OCH2CF3 OCH2CF3 CH H CH3 3 N + SH + 2 NaOH H 2 NaCl 2 H O N N + + 2 N C S N CH2Cl H2 N .HCl

4-(2,2,2-Tri Fluoro 2-Mercapto Sodium 2[[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Sodium Water Ethoxy)-2-Chloro Benzimidazole Hydroxide Pyridinyl] Methyl Thio]-1H-Benzimidazole Chloride Methyl-3-Methyl Pyridine Hydro Chloride ( M.Wt : 276 ) ( 150 ) ( 2 X 40 ) ( M.Wt : 353 ) ( 2 X 58.5 ) ( 2 X 18 )

Stage-V

OCH CF OCH2CF3 2 3 CH CH3 3 O H + H2O2 H + H O N N 2 N C S N C S H N H2 N 2

2[[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Hydrogen Lansoprazole Water Pyridinyl] Methyl Thio]-1H-Benzimidazole Peroxide

( M.Wt : 353 ) ( 34 ) ( M.Wt : 369 ) ( 18 )

39 Stage : 1

Material Balance:

INPUT Kg OUTPUT Kg

2,3-Lutidine = 0.450 Lansoprazole Nitro = 0.650

Acetic acid = 1.150 Acetic Acid = 1.080

Hydrogen peroxide(50%) = 0.320 Acetic Acid Loss = 0.050

Sulfuric Acid = 1.050 Aqueous Send to Auth.Party = 4.580

Nitric Acid = 0.260 Sulfuric Acid 1.050

Water = 3.200 Hydrogen peroxide 0.020

gen.water 0.150

Water from Hydrogen 0.160 Peroxide Water 3.200

Organic Residue = 0.070

Organic Impurities 0.050

Acetic acid 0.020

Total Input = 6.430 Total Output = 6.430

Stage : 2

Material Balance:

INPUT Kg OUTPUT Kg

Hydroxy Methyl Lansoprazole Nitro = 0.650 = 0.900 Hydrochloride Sodium Hydroxide = 0.180 MIBK = 1.230

Potassium Carbonate = 0.530 MIBK Loss = 0.040

Tri Fluoro Ethanol = 0.390 Toluene = 2.150

MIBK = 1.300 Toluene Loss = 0.050

Acetic Anhydride = 1.300 Acetic Anhydride = 0.870

TEBAC = 0.010 Acetic Anhydride Loss = 0.040

Toluene = 2.250 Effluent = 11.040

Hydrochloric Acid gas = 0.140 Potassium Nitrate 0.330

Activated Carbon = 0.030 Potassium Bicarbonate 0.390

Water = 9.750 Sodium Acetate 0.310

Sodium Hydroxide 0.030

Acetic Acid 0.230

Water 9.750

Organic Residue = 0.180

Organic Impurities 0.090

Toluene 0.050

MIBK 0.030

TEBAC 0.010

Spent Carbon = 0.030

Activated arbon

Total Input = 16.530 Total Output = 16.530

40 Stage : 3

Material Balance: INPUT Kg OUTPUT Kg

Hydroxy Methyl = 0.900 Lansoprazole Chloro = 0.900 Hydrochloride Methylene Dichloride = 1.750 Toluene = 2.250

Toluene = 2.350 Toluene loss = 0.060

Thionyl Chloride = 0.410 Methylene Dichloride = 1.650

Methylene Dichloride Loss = 0.070

Organic Residue = 0.130

Organic Impurities 0.060

Toluene 0.040

Methylene Dichloride 0.030

Process Emissions = 0.350

Sulfur Dioxide 0.220

Hydrochloric Acid 0.130

Total Input = 5.410 Total Output = 5.410

Stage : 4

Material Balance: INPUT Kg OUTPUT Kg

Lansoprazole Chloro = 0.900 Lansoprazole sulphide = 1.050

2-Mercapto Benzimidazole = 0.490 Effluent = 4.540

Sodium Hydroxide = 0.300 Sodium Chloride 0.380

Water = 4.000 Sodium Hydroxide 0.040

gen.water 0.120

Water 4.000

Organic Residue = 0.100

Organic Impurities

Total Input = 5.690 Total Output = 5.690

Stage : 5

Material Balance: INPUT Kg OUTPUT Kg

Lansoprazole sulphide = 1.050 Lansoprazole = 1.000

Isopropyl Alcohol = 2.500 Isopropyl Alcohol = 2.370

Hydrogen Peroxide (50%) = 0.220 Isopropyl Alcohol Loss = 0.090

Catalyst = 0.010 Chloroform = 4.500

Chloroform = 4.650 Chloroform loss = 0.100

Acetone = 1.250 Acetone = 1.200

Sodium Hydroxide = 0.120 Acetone Loss = 0.030

Acetic Acid = 0.180 Effluent = 4.270

Water = 3.750 Hydrogen Peroxide 0.010

Sodium Acetate 0.250

Isopropyl Alcohol 0.040

Catalyst 0.010

gen.water 0.100

Water from Hydrogen 0.110 Peroxide Water 3.750

Organic Residue = 0.170

Organic Impurities 0.100

Chloroform 0.050

Acetone 0.020

Total Input = 13.730 Total Output = 13.730

POLLUTION LOAD GENERATED PER KG (PER DAY) IN THE PRODUCTION OF Lansoprazole Batch Size : 1 Kg Production Capacity : 3000 Kg/month

100.00 Batch/day

100.00 Kg/day

Total Theoretical Emissions Water Water in Org.res./ Inorganics Spent Total Input per Effluent Volatile Total Semi + TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Stage Batch Per Organics solid EVA salt Batch Per Kg (Litres) Load Load Load (Litres) (Litres) mg/L mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs Kgs I 3.2 0.000 0 0.000 0.000 0 0.000 0.000 0.070 0.000 0.000 0.070 0.000 0.050 II 9.75 9.750 81522 0.900 0.390 44384 0.490 11.040 0.180 0.900 0.030 1.110 0.000 0.130 III 0 0.000 0 0.000 0.000 0 0.000 0.000 0.130 0.000 0.000 0.130 0.350 0.130 IV 4 4.120 92511 0.420 0.000 0 0.000 4.540 0.100 0.420 0.000 0.520 0.000 0.000 V 3.75 3.960 32787 0.140 0.170 67916 0.290 4.270 0.170 0.140 0.000 0.310 0.000 0.220 Total 20.700 17.830 73552 1.460 0.560 39295 0.780 19.850 0.650 1.460 0.030 2.140 0.350 0.530

POLLUTION LOAD GENERATION PER DAY Theoretical Emissions Total Water Org.res./ Inorganics Water in Spent Total Input per Volatile Total Semi + Effluent TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Per Day day Organics solid EVA salt Per Day PerDay ( Kgs) Load Load Load (Litres) (Litres) mg/L mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs Kgs EVA. 2070.00 1783.00 73552 146.00 56.00 39295 78.00 1985.00 65.00 146.00 3.00 214.00 35.00 53.00 Total 2070.00 1783.00 73552 146.00 56.00 39295 78.00 1985.00 65.00 146.00 3.00 214.00 35.00 53.00

43 4 PRODUCT : Pantoprazole

LIST OF RAW MATERIALS

Consumption/ Consumption/ Raw Material Kg Day Kg Kg 5-Difluoromethoxy-2-mercapto = 0.7 70.0 benzimidazole Acetic acid = 0.4 40.0 Acetic anhydride = 0.400 40.0 Acetone = 10.000 1000.0 Ammonium carbonate = 0.650 65.0 Carbon = 0.100 10.0 Dimethyl sulphate = 0.450 45.0 Ethylene dichloride = 3.600 360.0 Hydrogen peroxide (50%) = 0.400 40.0 Maltol = 0.850 85.0 Methanol = 4.150 415.0 Methylene dichloride = 7.150 715.0 n-Hexane = 4.000 400.0 Phosphorus oxychloride = 0.350 35.0 Potassium carbonate = 0.550 55.0 Sodium hydroxide = 0.720 72.0 Sodium Hypochlorite = 0.200 20.0 Sodium Methoxide = 0.230 23.0 Thionyl chloride = 0.390 39.0 Toluene = 11.050 1105.0

PRODUCT : Pantoprazole

Description :

Maltol is reacted with Diemthyl Sulfate and Potassium Carbonate in presence of Acetone to get (Stage-1) Compound. Stage 1 compound is reacted with Ammonium Carbonate in presence of Toluene to get Stage-2 Compound.

Stage 2 compound is reacted with Phosphorus Oxychloride in presence of Ethylene Dichloride to get (Stage-3) compound

Stage-3 compound is reacted with Hydrogen Peroxide in presence of Methylene Dichloride and n- Hexane to get Stage-4 Compound.

Stage -4 compound is reacted with Sodium Methoxide in presence of Methanol to get Stage-5 Compound.

Stage-5 compound is reacted with Acetic Anhydride to get Stage-6 Compound. Stage-6 compound is reacted with Sodium Hydroxide in presence of Acetic Acid to get Stage-7 Compound.

Stage-7 compound is reacted with Thionyl Chloride in presence of Methylene Dichloride to get Stage-8 Compound.

Stage -8 compound is reacted with 5-Difluoromethoxy -2 -mercapto Benzimidazole and Sodium Hydroxide in presence of Acetone and Toluene to get Stage-9 Compound.

Stage-9 Compound is reacted with Sodium Hypochlorite in presence of Tolune to get Pantoprazole.

45 PANTOPRAZOLE

Stage-I

O O OH OMe 2 (CH ) SO K SO CO + 3 2 4 + K2CO3 2 + 2 4 + 2 + H2O O CH O CH 3 Dimethyl Potassium 3 Potassium Carbon Water Maltol Sulfate Carbonate 3-Methoxy-2-methyl-4-pyrone Sulfate Dioxide

( M.Wt : 126 ) ( 126 ) ( 138 ) ( M.Wt : 140 ) ( 174 ) ( 44 ) ( 18 )

Stage-II O O OMe OMe

+ (NH4)2CO3 + NH4OH+ CO2 + H2O O CH N CH 3 H 3 3-Methoxy-2-methyl Ammonium 3-Methoxy-2-methyl Ammonium Carbon Water -4-Pyrone Carbonate -4-pyridine Hydroxide Dioxide ( M.Wt : 140 ) ( 96 ) ( M.Wt : 139 ) ( 35 ) ( 44 ) ( 18 )

Stage-III O Cl OMe OMe 3 H PO 3 + POCl3 + 3 4

N CH N CH3 H 3 3-Methoxy-2-methyl Phosphorus 3-Methoxy-2-methyl Phosphoric -4-pyridine Oxychloride -4-chloro pyridine Acid

( M.Wt : 139 ) ( 153.5 ) ( M.Wt : 157.5 ) ( 98 )

Stage-IV Cl Cl OMe OMe

+ H2O + H2O2 N CH3 N CH3 O 3-Methoxy-2-methyl Hydrogen 3-Methoxy-2-methyl Water -4-chloro pyridine Peroxide -4-chloro pyridine-N-oxide

( M.Wt : 157.5 ) ( 34 ) ( M.Wt : 173.5 ) ( 18 )

Stage-V

Cl OMe OMe OMe

+ CH3ONa + NaCl N CH N CH3 3 O O

3-Methoxy-2-methyl Sodium 3,4-Dimethoxy-2-methyl Sodium

-4-chloro pyridine-N-oxide Methoxide Pyridine-N-oxide Chloride ( M.Wt : 173.5 ) ( 54 ) ( M.Wt : 169 ) ( 58.5 )

PRODUCT : Pantoprazole Stage : 1

Material Balance:

INPUT Kg OUTPUT Kg

Maltol 0.85 Stage - 1 = 0.85 =

Dimethyl Sulfate 0.45 Acetone = 7.75 = Potassium carbonate = 0.55 Acetone Loss = 0.38

Acetone = 8.25 gen.Water loss = 0.06

Organic Residue = 0.24

Organic Impurities 0.12

Acetone 0.12

Inorgainc Solid Waste = 0.67

Potassium Sulfate 0.59

Potassium carbonate 0.08

Process Emissions = 0.15

Carbon Dioxide

Total Input = 10.10 Total Output = 10.10

Stage : 2

Material Balance:

INPUT Kg OUTPUT Kg

Stage-1 0.85 Stage-2 = 0.75 =

Ammonium carbonate 0.65 Toluene = 4.85 = Water = 2.50 Toluene Loss = 0.2

Toluene = 5.15 Effluent = 2.89

Ammonium Hydroxide 0.21

Ammonium carbonate 0.07

gen.water 0.11

Water 2.5

Organic Residue = 0.19

Organic Impurities 0.09

Toluene 0.1

Process Emissions = 0.27

Carbon Dioxide

Total Input = 9.15 Total Output = 9.15

Stage : 3

Material Balance: INPUT Kg OUTPUT Kg

Stage-2 = 0.75 Stage-3 = 0.75

Phosphorus oxychloride = 0.35 Ethylene dichloride = 3.38

Water = 3.25 Ethylene dichloride Loss = 0.15

Sodium hydroxide = 0.10 Effluent = 3.6

Ethylene dichloride = 3.60 Phosphoric acid 0.18

Phosphorus Oxychloride 0.07

Sodium Hydroxide 0.1

Water 3.25

Organic Residue = 0.17

Organic Impurities 0.1

Ethylene Dichloride 0.07

Total Input = 8.05 Total Output = 8.05

Stage : 4

INPUT Kg OUTPUT Kg

Stage-3 = 0.75 Stage-4 = 0.75

Hydrogen peroxide (50%) = 0.40 Methylene dichloride = 4.18

Acetic acid = 0.40 Methylene dichloride Loss = 0.15

Sodium hydroxide = 0.22 n-Hexane = 3.78

Water = 3.40 n-Hexane loss = 0.16

Methylene dichloride = 4.40 Effluent = 4.34 n-Hexane = 4.00 Sodium acetate 0.45

Acetic acid 0.07

Hydrogen peroxide 0.04

gen.water 0.18

Water from Hydrogen 0.20 Peroxide Water 3.40

Organic Residue = 0.21

Organic Impurities 0.08

Methylene dichloride 0.07

n-Hexane 0.06

Total Input = 13.57 Total Output = 13.57

Stage : 5

INPUT Kg OUTPUT Kg

Stage-4 = 0.75 Stage-5 = 0.65

Sodium Methoxide = 0.23 Methanol = 3.9

Methanol = 4.15 Methanol Loss = 0.17

Organic Residue = 0.16

Organic Impurities 0.08

Methanol 0.08

Inorgainc Solid Waste = 0.25

Sodium Chloride

Total Input = 5.13 Total Output = 5.13

48 Stage : 6

Material Balance: INPUT Kg OUTPUT Kg

Stage-5 = 0.65 Stage-6 = 0.75

Acetic anhydride = 0.40 Acetic acid = 0.21

Acetic acid loss = 0.01

Organic Residue = 0.08

Organic Impurities 0.06

Acetic anhydride 0.01

Acetic acid 0.01

Total Input = 1.05 Total Output = 1.05

Stage : 7

Material Balance: INPUT Kg OUTPUT Kg

Stage-6 = 0.75 Stage-7 = 0.55

Sodium Hydroxide = 0.15 Methylene dichloride = 2.6

Methylene dichloride = 2.75 Methylene dichloride Loss = 0.11

Water = 2.00 Effluent = 2.3

Sodium acetate 0.29

Sodium Hydroxide 0.01

Water 2

Organic Residue = 0.09

Organic Impurities 0.05

Methylene dichloride 0.04

Total Input = 5.65 Total Output = 5.65

Stage : 8

Material Balance: INPUT Kg OUTPUT Kg

Stage-7 = 0.55 Stage-8 = 0.65

Thionyl chloride = 0.39 Acetone = 1.64

Toluene = 3.50 Acetone Loss = 0.08

Acetone = 1.75 Toluene = 3.3

Toluene Loss = 0.15

Organic Residue = 0.16

Organic Impurities 0.08

Toluene 0.05

Acetone 0.03

Process Emissions = 0.21

Sulfur Dioxide

Total Input = 6.19 Total Output = 6.19

49 Stage : 9

Material Balance:

INPUT Kg OUTPUT Kg

Stage-8 = 0.65 Stage-9 = 1

5-Difluoromethoxy-2- = Toluene = 2.28 0.70 mercapto benzimidazole Toluene Loss = 0.08

Sodium Hydroxide = 0.25 Effluent = 5.46

Water = 5.00 Sodium Chloride 0.34

Toluene = 2.40 Sodium Hydroxide 0.02

gen.water 0.10

Water 5.00

Organic Residue = 0.18

Organic Impurities 0.06

5-Difluoromethoxy-2- 0.08 mercapto benzimidazole

Toluene 0.04

Total Input = 9.00 Total Output = 9.00

Stage : 10

Material Balance:

INPUT Kg OUTPUT Kg

Stage-9 = 1.00 Pantoprazole = 1

Sodium Hypochlorite = 0.20 Effluent = 3.66

Water = 3.50 Sodium Chloride 0.16

Carbon = 0.10 Water 3.5

Organic Residue = 0.04

Organic Impurities

Spent Carbon = 0.1

Carbon

Total Input = 4.80 Total Output = 4.80

50 POLLUTION LOAD GENERATED PER KG (PER DAY) IN THE PRODUCTION OF Pantoprazole Batch Size : 1 Kg Production Capacity : 3000 Kg/month

100.00 Batch/day

100.00 Kg/day

Total Theoretical Emissions Water Water in Org.res./ Inorganics Total Spent Total Input per Effluent Volatile Semi + TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Stage Batch Per Organics solid EVA salt Per Kg Batch (Litres) Load Load (Litres) (Litres) mg/L Load Kg mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kg Kg I 0 0.000 0 0.000 0.000 0 0.000 0.000 0.240 0.670 0.000 0.910 0.150 0.380 II 2.50 2.610 96886 0.280 0.000 0 0.000 2.890 0.190 0.280 0.000 0.470 0.270 0.200 III 3.25 3.250 97222 0.350 0.000 0 0.000 3.600 0.170 0.350 0.000 0.520 0.000 0.150 IV 3.40 3.780 59908 0.260 0.300 99078 0.430 4.340 0.210 0.260 0.000 0.470 0.000 0.310 V 0 0.000 0 0.000 0.000 0 0.000 0.000 0.160 0.250 0.000 0.410 0.000 0.170 VI 0 0.000 0 0.000 0.000 0 0.000 0.000 0.080 0.000 0.000 0.080 0.000 0.010 VII 2.00 2.000 65217 0.150 0.150 100000 0.230 2.300 0.090 0.150 0.000 0.240 0.000 0.110 VIII 0 0.000 0 0.000 0.000 0 0.000 0.000 0.160 0.000 0.000 0.160 0.210 0.230 IX 5.00 5.100 65934 0.360 0.000 0 0.000 5.460 0.180 0.360 0.000 0.540 0.000 0.080 X 3.50 3.500 43716 0.160 0.000 0 0.000 3.660 0.040 0.160 0.100 0.300 0.000 0.000 Total 19.650 20.240 70112 1.560 0.450 29663 0.660 22.250 1.520 2.480 0.100 4.100 0.630 1.640 POLLUTION LOAD GENERATION PER DAY Total Theoretical Emissions Water Org.res./ Inorganics Water in Total Spent Total Input per Volatile Semi + Effluent TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Per Day day Organics solid EVA salt Per Day PerDay Load Load ( Kg) (Litres) (Litres) mg/L Load Kg mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kg Kg EVA. 1965.00 2024.00 70112 156.00 45.00 29663 66.00 2225.00 152.00 248.00 10.00 410.00 63.00 164.00 Total 1965.00 2024.00 70112 156.00 45.00 29663 66.00 2225.00 152.00 248.00 10.00 410.00 63.00 164.00

5 PRODUCT :Glimepiride

LIST OF RAW MATERIALS

Raw Material Consumption/ Consumption/ Kg Day Kg Kg 3-Ethyl-4-Methyl-3-Pyrroline-2-one = 0.43 43.0 2-Phenyl Ethyl Isocyanate = 0.51 51.0 Acetic acid = 7.95 795.0 Acetone = 19 1900.0 Activated Carbon = 0.1 10.0 Chlorosulfonic Acid = 1.1 110.0

Diisopropyl Ether = 0.43 43.0

Dimethyl Formamide = 13.15 1315.0 Liq.Ammonia (25%) = 11 1100.0 Methanol = 7.95 795.0 MIBK (10%) = 4.3 430.0 n-Hexane = 4.3 430.0 Potassium Carbonate = 0.75 75.0 Trans-4-Methyl Cyclohexy Iso Cyanate = 0.36 36.0

52 PRODUCT :Glimepiride

Description : 3-Ethyl-4-Methyl-3-Pyrroline-2-one is reacted with 2-Phenyl Ethyl Isocyanate in presence of n-Hexane and Methanol to get (Stage-1) Compound. Stage 1 compound is reacted with Chlorosulfonic Acid and Ammonia to get (Stage-2) Compound.

Stage 2 compound is reacted with Trans-4-Methyl Cyclohexyl Iso Cyanate in presence of Acetone and Acetic acid to get Glimepiride Crude.

Glimepiride (Crude) is Purified in Dimethyl Formamide and MIBK to get Glimepiride (Pure).

Flow Chart

3-Ethyl-4-Methyl-3-Pyrroline- 2-one Sol.Recovery 2-Phenyl Ethyl Isocyanate Stage I Evaporation Loss n-Hexane Organic Residue Methanol

Stage-1 Chlorosulfonic Acid Effluent Liq.Ammonia (25%) Stage II Organic Residue Water Process Emissions

Stage-2 Acetone Sol.Recovery Potassium Carbonate Stage Evaporation Loss Trans-4-Methyl Cyclohexyl III Organic Residue Iso Cyanate Acetic acid

Glimepiride (Crude) Dimethyl Formamide Sol.Recovery Activated Carbon Stage IV Evaporation Loss D.M.Water Effluent MIBK (10%) Organic Residue Diisopropyl Ether Spent Carbon Methanol

Glimepiride

53 GLIMEPIRIDE

Stage-I O O O

3CH NH + 3CH N N NC H O 3CH 3CH

3-Ethyl-4-methyl 3-Ethyl-4-methyl-2-oxo-2,5-dihydro -3-pyrroline-2-one 2-Phenyl Ethyl Isocyanate pyrrole-1-carboxylic acid phenethyl amide

( M.Wt : 125 ) ( 147 ) ( M.Wt : 272 )

Stage-II

O O

3CH N N + Cl SOH + NH H 3 3

3CH

3-Ethyl-4-methyl-2-oxo-2,5-dihydro pyrrole-1-carboxylic acid phenethyl amide Chlorosulfonic Acid Ammonia

( M.Wt : 272 ) ( 116.5 ) ( 17 )

O O S O O NH2 HCl H O CH N N + + 2 3 H

3CH

3-Ethyl-4-methyl-2-oxo-2,5-dihydro pyrrole-1- carboxylic acid [2-(4-sulfamoyl phenyl) ethyl] amide Hydrochloric Acid Water

( M.Wt : 351 ) ( 36.5 ) ( 18 )

54 Stage-III

O O S O O NH N O 2 C + 3CH N N H 3CH

3CH

3-Ethyl-4-methyl-2-oxo-2,5-dihydro pyrrole-1- carboxylic acid [2-(4-sulfamoyl phenyl) ethyl] amide Trans-4-methyl cyclohexyl Isocyanate

( M.Wt : 351 ) ( 139 )

CH3 O O O S O O N N H H CH N N 3 H

3CH

Glimepiride

( M.Wt : 490 )

55 GLIMEPIRIDE

Stage-IV (Purification)

CH3 O O O S O O N N H H CH N N 3 H

3CH

Glimepiride(Crude) ( M.Wt : 490 )

CH3 O O O S O O N N H H CH N N 3 H

3CH

Glimepiride(Pure) ( M.Wt : 490 )

56 PRODUCT :Glimepiride Stage : 1

Material Balance:

INPUT Kg OUTPUT Kg

Stage-1 = 0.800 3-Ethyl-4-Methyl-3-Pyrroline-2-one = 0.430 n-Hexane = 4.050

2-Phenyl Ethyl Isocyanate = 0.510 n-Hexane Loss = 0.200 n-Hexane = 4.300 Methanol = 4.000

Methanol = 4.300 Methanol Loss = 0.220

Organic Residue = 0.270

Organic Impurities 0.140

n-Hexane 0.050

Methanol 0.080

Total Input = 9.540 Total Output = 9.540

Stage : 2

Material Balance:

INPUT Kg OUTPUT Kg

Stage-1 = 0.800 Stage-2 = 0.900

Chlorosulfonic Acid = 1.100 Effluent = 18.520

Liq.Ammonia (25%) = 11.000 Ammonium Sulfate 0.860

Water = 7.000 Ammonia 2.480

Water from Liq.Ammonia 8.250

gen.water 0.050

Water 7.000

Organic Residue = 0.130

Organic Impurities

Process Emissions = 0.350

Hydrochloric Acid

Total Input = 19.900 Total Output = 19.900

Stage : 3

Material Balance:

INPUT Kg OUTPUT Kg

Stage-2 = 0.900 Glimepiride (Crude) = 1.100

Acetone = 19.000 Acetone = 17.900

Potassium Carbonate = 0.750 Acetone Loss = 0.900

Trans-4-Methyl Acetic acid = 7.500 = 0.360 Cyclohexyl Iso Cyanate Acetic acid Loss = 0.350

Acetic acid = 7.950 Potassium Carbonate = 0.750

Organic Residue = 0.460

Organic Impurities 0.160

Acetone 0.200

Acetic Acid 0.100

Total Input = 28.960 Total Output = 28.960

Stage : 4 (Purification)

Material Balance:

INPUT Kg OUTPUT Kg

Glimepiride (Crude) = 1.100 Glimepiride (Pure) = 1.000

Dimethyl Formamide = 13.150 Dimethyl Formamide = 12.300

Activated Carbon = 0.100 Dimethyl Formamide Loss = 0.650

D.M.Water = 2.000 MIBK = 4.050

MIBK (10%) = 4.300 MIBK Loss = 0.250

Diisopropyl Ether = 0.430 Diisopropyl Ether = 0.400

Methanol = 3.650 Diisopropyl Ether loss = 0.020

Methanol = 3.400

Methanol Loss = 0.180

Effluent = 2.200

Dimethyl Formamide 0.200

Water 2.000

Organic Residue = 0.180

Organic Impurities 0.100

Diisopropyl Ether 0.010

Methanol 0.070

Spent Carbon = 0.100

Activated Carbon

Total Input = 24.730 Total Output = 24.730

POLLUTION LOAD GENERATED PER KG (PER DAY) IN THE PRODUCTION OF Glimepiride Batch Size : 1 Kg Production Capacity : 3000 Kg/month

100.00 Batch/day

100.00 Kg/day

POLLUTION LOAD GENERATION PER DAY Total Theoretical Emissions Water Org.res./ Inorganics Water in Spent Total Input per Volatile Total Semi + Effluent TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Per Day day Organics solid EVA salt Per Day PerDay Load Load Load ( Kgs) (Litres) (Litres) mg/L mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs Kgs EVA. 900.00 1718.00 161197 334.00 20.00 14961 31.00 2072.00 104.00 334.00 10.00 448.00 35.00 277.00 Total 900.00 1718.00 161197 334.00 20.00 14961 31.00 2072.00 104.00 334.00 10.00 448.00 35.00 277.00

59 6 PRODUCT : Clopidogrel Hydrogen Bisulfate

LIST OF RAW MATERIALS

Consumption/ Consumption/ Raw Material Kg Day Kg Kg Acetone = 4.6 460.0 Camphor Sulfonic Acid = 1.3 130.0 Formaldehyde (37%) = 0.7 70.0 Hydrochloric Acid (35%) = 1.27 127.0 Liq.Ammonia (25%) = 1 100.0 Methanol = 15.9 1590.0 Methyl-2-Bromo-O-Chloro Phenyl Acetate = 1.87 187.0 Sodium Hydroxide = 0.79 79.0 Sulfuric Acid = 0.26 26.0 Thionyl Chloride = 0.93 93.0 Thiophene Ethanol = 1 100.0 Thiophene Ethylamine = 0.9 90.0 Toluene = 5 500.0

PRODUCT : Clopidogrel Hydrogen Bisulfate

Description :

Thiophene Ethanol is reacted with Thionyl Chloride and Ammonia in presence of Toluene to get Stage-1 Compound.

Stage 1 compound is reacted with Methyl-2-Bromo-O-Chloro Phenyl Acetate and Sodoium Hydroxide in presence of Methanol to get (Stage-2) Compound.

Stage 2 compound is reacted with Formaldehyde in presence of Methanol to get DL-Clopidogrel Base.

DL-Clopidogrel Base is isomerised with Camphor Sulfonic Acid in presence of Methanol to get S(+) Clopidogrel.

S(+) Clopidogrel is reacted with Sulfuric acid in presence of Acetone to get Clopidogrel Hydrogen Bisulfate.

PRODUCT : Clopidogrel Hydrogen Bisulfate

Flow Chart

Thiophene Ethanol Thionyl Chloride Sol.Recovery Toluene Stage I Evaporation Loss Liq.Ammonia (25%) Effluent Water Organic Residue Process Emissions

Thiophene Ethylamine Methyl-2-Bromo-O-Chloro Sol.Recovery Phenyl Acetate Stage II Evaporation Loss Sodium Hydroxide Effluent Methanol Organic Residue Water

Stage-2 Formaldehyde (37%) Sol.Recovery Hydrochloric Acid (35%) Evaporation Loss Methanol Stage III Effluent Sodium Hydroxide Organic Residue Water

DL-Clopidogrel Base Camphor Sulfonic Acid Sol.Recovery Sodium Hydroxide Stage IV Evaporation Loss Methanol Effluent Hydrochloric Acid (35%) Organic Residue Water

S(+) Clopidogrel Acetone Sol.Recovery Sulfuric Acid Stage V Evaporation Loss Organic Residue

Clopidogrel Hydrogen Bisulfate

61 CLOPIDOGREL HYDR0GEN BISULFATE

Stage-I

OH NH2 + SOCl2 + NH3 + SO2 + 2 HCl S S

Thiophene Thionyl Thiophene Sulfur Hydrochloric Ethanol Chloride Ammonia Ethyl amine Dioxide Acid

( M.Wt : 128 ) ( 119 ) ( 17 ) ( M.Wt : 127 ) ( 64 ) ( 2 X 36.5 )

Stage-II COOCH3 COOCH3 NH NH2 Br + + NaOH + NaBr + H2O S Cl S Cl Thiophene Methyl-2-Bromo-O- Sodium Thiophene ethyl amine Sodium Water Ethyl amine Chloro Phenyl acetate Hydroxide Derivative Bromide ( M.Wt : 127 ) ( 263.5 ) ( 40 ) ( M.Wt : 309.5 ) ( 103 ) ( 18 )

Stage-III COOCH3 COOCH3

NH N + CH2O + H2O S Cl S Cl Thiophene ethyl amine derivative Formaldehyde DL-Clopidogrel Base Water

( M.Wt : 309.5 ) ( 30 ) ( M.Wt : 321.5 ) ( 18 )

Stage-IV COOCH3 COOCH3

N Camphor Sulfonic Acid N 2 2 S Cl S Cl

DL-Clopidogrel Base S(+) &R(-) Clopidogrel ( M.Wt : 2 X 321.5 ) ( M.Wt : 2 X 321.5 )

Stage-V COOCH3 COOCH3

N N . + H2SO4 H2SO4 S Cl S Cl

S(+) Clopidogrel Sulfuric acid Clopidogrel Hydrogen Bisulfate ( M.Wt : 321.5 ) ( 98 ) ( M.Wt : 419.5 )

62 PRODUCT : Clopidogrel Hydrogen Bisulfate Stage : 1

Material Balance: INPUT Kg OUTPUT Kg

Thiophene Ethanol = 1.000 Thiophene Ethylamine = 0.900

Thionyl Chloride = 0.930 Toluene = 4.700

Toluene = 5.000 Toluene Loss = 0.200

Liq.Ammonia (25%) = 1.000 Effluent = 2.870

Water = 2.000 Ammonia 0.120

Water from Liq.Ammonia 0.750

Water 2.000

Organic Residue = 0.190

Organic Impurities 0.090

Toluene 0.100

Process Emissions = 1.070

Sulfur Dioxide 0.500

Hydrochloric Acid 0.570

Total Input = 9.930 Total Output = 9.930

Stage : 2

Material Balance: INPUT Kg OUTPUT Kg

Thiophene Ethylamine = 0.900 Stage-2 = 2.000

Methyl-2-Bromo-O-Chloro Phenyl Methanol = 4.230 = 1.870 Acetate Methanol Loss = 0.180

Sodium Hydroxide 0.300 Effluent = 5.470

Methanol 4.500 Sodium Bromide 0.730

Water 4.500 Sodium Hydroxide 0.020

Methanol 0.090

gen.water 0.130

Water 4.500

Organic Residue = 0.190

Orgnaic Impurities

Total Input = 12.070 Total Output = 12.070

63 Stage : 3

Material Balance: INPUT Kg OUTPUT Kg

Stage-2 = 2.000 DL-Clopidogrel Base = 1.800

Formaldehyde (37%) = 0.700 Methanol = 3.380

Hydrochloric Acid (35%) = 0.700 Methanol Loss = 0.150

Methanol = 3.600 Effluent = 5.260

Sodium Hydroxide = 0.270 Sodium Chloride 0.390

Water = 3.600 Formaldehyde 0.070

Methanol 0.070

gen.water 0.230

Water from Formaldehyde 0.440

Water from Hydrochloric 0.460 Acid Water 3.600

Organic Residue = 0.280

Organic Impurities

Total Input = 10.870 Total Output = 10.870

Stage : 4

Material Balance: INPUT Kg OUTPUT Kg

DL-Clopidogrel Base = 1.800 S(+) Clopidogrel = 0.850

Camphor Sulfonic Acid = 1.300 Methanol = 7.400

Sodium Hydroxide = 0.220 Methanol Loss = 0.250

Methanol = 7.800 Camphor Sulfonic Acid = 1.300

Hydrochloric Acid (35%) = 0.570 Effluent = 5.590

Water = 4.650 Sodium Chloride 0.320

Methanol 0.150

gen.water 0.100

Water from Hydrochloric 0.370 Acid Water 4.650

Organic Residue = 0.950

Organic Impurities 0.100

R(-) Clopidogrel 0.850

Total Input = 16.340 Total Output = 16.340

Stage : 5

Material Balance: INPUT Kg OUTPUT Kg

Clopidogrel Hydrogen S(+) Clopidogrel = 0.850 = 1.000 Bisulfate Acetone = 4.600 Acetone = 4.320

Sulfuric Acid = 0.260 Acetone Loss = 0.200

Organic Residue = 0.190

Organic Impurities 0.110

Acetone 0.080

Total Input = 5.710 Total Output = 5.710

POLLUTION LOAD GENERATED PER KG (PER DAY) IN THE PRODUCTION OF Clopidogrel Hydrogen Bisulfate Batch Size : 1 Kg Production Capacity : 3000 Kg/month

100.00 Batch/day

100.00 Kg/day

POLLUTION LOAD GENERATION PER DAY Total Theoretical Emissions Water Org.res./ Inorganics Water in Spent Total Input per Volatile Total Semi + Effluent TDS TDS COD COD Effluent Carbon S.W. Process Fugitive Per Day day Organics solid EVA salt Per Day PerDay Load Load Load ( Kgs) (Litres) (Litres) mg/L mg/L (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs Kgs EVA. 1475.00 1723.00 82335 158.00 38.00 28140 54.00 1919.00 180.00 158.00 0.00 338.00 107.00 98.00 Total 1475.00 1723.00 82335 158.00 38.00 28140 54.00 1919.00 180.00 158.00 0.00 338.00 107.00 98.00

POLLUTION LOAD FOR THE PRODUCTS

EFFLUENT DETAILS/DAY SOLID WASTE / DAY EMISSIONS / DAY PRODUCTION Water Total Theoretical Water Org.res./ Inorganics Input per Spent Total in Total Semi + Process Fugitive Product day TDS COD Effluent Carbon S.W. Tons / Per day Effluent solid EVA salt Per Day Per Day Month (Kg) ( Kgs) Load Load (Litres) (Litres) (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kgs Kgs

Sildenafil Citrate 3 100.0 1729 1807 183 84 2046 96 183 7 286 32 104 Omeprazole 3 100.0 2265 1891 262 66 2197 113 262 7 382 25 135 Lansoprazole 3 100.0 2070 1783 146 78 1985 65 146 3 214 35 53 Pantoprazole 3 100.0 1965 2024 156 66 2225 152 248 10 410 63 164 Glimepiride 3 100.0 900 1718 334 31 2072 104 334 10 448 35 277 Clopidogrel Hydrogen 3 100.0 1475 1723 158 54 1919 180 158 0 338 107 98 Bisulfate

Maximum Pollution Load For The Proposed Products On Various Combinations

EFFLUENT DETAILS/DAY SOLID WASTE / DAY EMISSIONS / DAY PRODUCTION Water Water input in Theoretical Org.res./ Inorganics Per Effluent Total Spent Total Product Volatile Semi + Process Fugitive Per Day Per Day TDS COD Effluent Carbon S.W. Tons / Organics solid EVA salt day Per Day Month Load Load (Kg) (Kg) (Kg) Load Kg (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) (Kg) Kg Kg Sildenafil 3 100 1729 1807 183 56 84 2046 96 183 7 286 32 104 Citrate Omeprazole 3 100 2265 1891 262 44 66 2197 113 262 7 382 25 146 Lansoprazole 3 100 2070 1783 146 56 78 1985 65 146 3 214 35 53 Pantoprazole 3 100 1965 2024 156 45 66 2225 152 248 10 410 63 164 Glimepiride 3 100 900 1718 334 20 31 2072 104 334 10 448 35 277 Clopidogrel Hydrogen 3 100 1475 1723 158 38 54 1919 180 158 0 338 107 98 Bisulfate Max. any 3 products at 9 300 6300 5722 779 157 228 6494 445 844 27 1240 205 587 a time

67 Annexure - IV

Effluent Treatment Flow for as per Segregation Effluent Quantity Treatment Flow Characteristics (KLD) Collection Equalization  Neutralization  Settling  Holding  Steam stripper  MEE along with HTDS effluent  Condensate to ETP (biological treatment)  Process, Concentrate to ATFD Scrubber & DM plant HTDS/HCOD & ATFD Condensate to ETP (Biological Treatment) along 7.7 (HTDS) with domestic wastewater  Pressure Sand Filter  HTDS > 5000 mg/l Activated Carbon Filter  R.O  R.O rejects to MEE.

HCOD > 5000 mg/l R.O Permeate & MEE Condensate to cooling tower

ATFD Salts to TSDF and stripped solvents to SPCB authorized cement industries

Washings, Boiler, Cooling Tower, QC & R&D Collection Equalization  Neutralization ETP 3.8 LTDS / LCOD (Biological Treatment) along with MEE Condensate LTDS < 5000 mg/l LCOD < 5000 mg/l

Collection Tank  sent to ETP (Biological Treatment) Domestic 1.5 along with MEE Condensate

68 Annexure - V

Proposed Hazardous / Solid Waste Generation from the Proposed Products Sl. Source TPD Disposal method No. 1. Organic residue 0.445* Sent to SPCB Authorized Cement industries for use as 2. Spent Carbon 0.027* alternate fuel (or) TSDF if any shut down of cement industries. 3. Inorganic & Evaporation Salt 0.844* Sent to SPCB Authorized Cement industries (or) TSDF 4. ETP Sludge 0.02 based on calorific value 5. Boiler Ash 6.4 Sold to Brick Manufacturers

* Solid waste quantities maximum on 3 out of 6 products at a point of time

69 Annexure - VI

Proposed Water Balance, Segregation and Treatment Method Input (KLD) Output (KLD) Generation / Segregation type Description Fresh Recycled Evaporation / Total of Wastewater Water Water Handling Wastewater Loss Process 6.3 -- (0.2) 6.5* HTDS/HCOD (3 products at a time) Washings 1.5 - -- 1.5 LTDS/LCOD

Boiler 19 1.3 (20 % - 18.7 Utilities (4 TPH) (Blow down) Makeup) (LTDS/LCOD) Cooling Tower 14 11.5 25 0.5 (Bleed) DM Regeneration 0.2 -- - 0.2 HTDS / LCOD Scrubber 1 - - 1 HTDS / LCOD Q.C and R&D 0.5 -- - 0.5 LTDS/LCOD Domestic 1.5 -- - 1.5 LTDS/LCOD Greenbelt 1 -- 1 - -- Reuse: 11.5 KLD (Total water loss is Total 46 11.5 44.5 13 1.5 KLD = 11 %) Sludge moisture, Stripper condensate

Note: * Max. on various combinations as per material balance.

70 Annexure – VII

List of Hazardous Chemicals S.No. as per MSIHC Hazardous Chemicals Rules 1989 and Amended in 2000 Acetic Acid 2 Acetic Anhydride 3 Acetone 4 Ammonia gas 31 Benzoyl Chloride 65 Bromine 84 Chloro Sulfonic Acid 136 Chloroacetyl Chloride 124 Chloroform 130 Diethanol Amine 196 Ethyl Acetate 247 Formaldehyde (37%) 295 Formic Acid 287 Hydrochloric Acid 313 Hydrogen 314 Hydrogen Peroxide (50%) 318 Isopropyl Alcohol 334 Methanol 377 Methylene Dichloirde 380 n-Hexane 413 Nitric Acid 423 Phosphorus oxychloride 504 Potassium Hydroxide 522 Sodium Hydroxide 571 Sulfuric Acid 591 Thionyl Chloride 620 Toluene 628 Triethyl Amine 652

71 Annexure - VIII

Stack Emission Details Flue Gas Stack Exit Gas PM SO2 NOx Diameter Temperature Flow Source Height Velocity (m) (oC) rate (m) (m/sec) kg/hr (m3/hr) Proposed Boiler 3 TPH 30 0.5 150 7985 11.3 0.41 4.25 2.43 Existing Boiler 1 TPH 30 0.3 150 2662 10.4 0.135 1.42 0.81 Proposed Diesel fired thermic fuel heater 2 lakh 30 0.2 150 868 7.68 0.004 0.088 0.094 Kcal/hr Existing Diesel fired thermic fuel heater 1 lakh 30 0.1 150 434 15.4 0.002 0.044 0.047 Kcal/hr DG Sets 125 KVA 7 0.1 150 706 24.9 0.008 0.16 0.17 125 KVA 7 0.1 150 706 24.9 0.008 0.16 0.17 62.5 KVA 6 0.1 150 353 12.5 0.004 0.08 0.084

72 Annexure - IX

Process Emissions from Proposed Products

Maximum Quantity on Sl. Process various combinations Treatment No. Emission (kg/day) 1. HCl 108 Scrubbed with water / CS lye solution H 2. 2 97 Diffused with flame arrestor SO 3. 2 1 Scrubbed by using CS lye solution CO 4. 2 42 Dispersed into Atmosphere

73 Annexure 3 EC Certified Compliance Report for by Regional Office of MoEF&CC ANNEXURE - 3 ANNEXURE - 3 ANNEXURE - 3 ANNEXURE - 3 ANNEXURE - 3 ANNEXURE - 3 ANNEXURE - 3 ANNEXURE - 3