FORM-1 FOR PROPOSED API PLANT AT MADURAI, TAMIL NADU. Name of Products. Products. 1 Metformin Hydrochloride Paracetamol Bronopol 25

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1 3 ANNEXURES Annexure 1: Production Details Name of Products Products Production Capacity in MT/Month 1 Metformin Hydrochloride Paracetamol Bronopol 25 By-Products Total Acetic acid (dilute) NaBr solution 55 3 NaCl Salt 800 Total 3255 KADAM ENVIRONMENTAL CONSULTANTS JUNE

2 Annexure 2: Site Location shown on google image KADAM ENVIRONMENTAL CONSULTANTS MAY

3 Annexure 3: Site Layout Map KADAM ENVIRONMENTAL CONSULTANTS MAY

4 Table 1: Area breakup at Site Particular Area in m2 % Area Breakup 1 Boiler House Raw Material Ware House Metformin HCl Plant Finished Goods Ware House Packaging Material Ware House ETP + MEE For Utility Mix Xylene Tank Boiler Stack 33m Cooling Tower Metformin Distillation Area Hazardous Waste (Solid) Storage Yard Hazardous Waste Tank Methanol Storage Area Water Tank QC Lab Bronopol Plant Acetic Acid Storage Tanks Acetic Anhydride Storage Tanks Acid/Alkali Storage Tanks Chilling Unit Salt Recovery System & It's Storage Paracetamol Plant Power House DG sets Diesel Tank Transformer Yard Hydrogen Plant Admin Building Employee Building Sewage Treatment Plant Bromine Tank Sodium Bromide Tank Road Area Greenbelt Area Open Plot Area Total KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

5 Annexure 4: Manufacturing Processes and Mass Balance 1. Metformin Hydrochloride Dicyandiamide and Dimethylamine hydrochloride undergo chemical reaction in Mix Xylene as solvent medium. The product formed is extracted in water. The Mix xylene is sent for solvent recovery. A solution of the product in water is treated with activated charcoal then filtered and crystallized by removing water. Methanol is added and then the product is centrifuged. The centrifuged product is washed in methanol and dried to give Metformin HCL of suitable purity. Hydrochloric acid is used for ph adjustments of the product solution during isolation / purification. The mother liquors from the centrifuge are sent for solvent recovery. Figure 1: Process Flow diagram of Metformin Hydrochloride KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

6 Table 2: Mass balance of Metformin Hydrochloride Raw Materials Input/MT of Product Quantity (MT) 1 Dicyandiamide Dimethylamine hydrochloride Mix Xylene Water Activated Carbon Hyflosupercel Methanol Hydrochloric acid Product Metformin Hydrochloride Recovered Mix Xylene Recovered Methanol Waste (Spent carbon and Hyflow) Recovered Water Water Evaporation Loss Total Output MT/MT of Product Liquid Effluent Air Emission Recovery/ Product Solid Waste Remark 1.00 Product Recycled back in process To be sent to TSDF / AFR / Cement Industries 2.02 Recycled back in process 0.23 To atmosphere 7 Solvent Loss 0.20 To atmosphere 8 Process / Distillation Residue Total 2. Paracetamol Stage I - Manufacture of Para amino phenol from Para nitro chloro benzene To be sent to TSDF / AFR / Cement Industries Para nitro chloro benzene is treated with caustic lye in aqueous medium under temperature/pressure and undergoes hydrolysis. The reaction mixture is subsequent neutralized with Hydrochloric acid to form Para nitro phenol. Paranitrophenol is reduced using Hydrogenation (which is generated in-house using methanol) in the presence of catalyst to form Para amino phenol which is isolated for further processing. The aqueous effluent containing NaCL is concentrated to recover water for reuse and subsequently handled by the ETP. Stage II - Manufacture of Paracetamol from Para amino phenol Para aminophenol is acetylated using acetic anhydride to form Paracetamol (Tech). This is further charcoal treated, filtered, crystallized, isolated, washed and dried to give Paracetamol (Pharma grade). The MLs from Paracetamol (Tech) isolation are recycled / used to produce Acetic acid (dilute) which is sold as a byproduct. The MLs from Paracetamol (Pharma) isolation are further treated to recover Paracetamol (Tech) which is recycled back to earlier purification stage. KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

7 Figure 2: Process Flow diagram of Paracetamol KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

8 KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

9 Table 3: Mass balance of Paracetamol Raw Materials Input/MT of Product Quantity (KMT) 1 Para nitro chloro benzene (PNCB) Caustic lye (48%) HCL (30% w/w) Reduction catalyst Methanol (for H2 generation plant) Acetic anhydride Activated Carbon Hyflosupercel Sodium hydrosulphite Water 6 Product Total 10.4 Output MT/MT of Product Liquid Effluent Air Emission Recovery/ Product Solid Waste Remark 1 Paracetamol Final Product 2 Acetic acid (dilute) To be sold as by product 3 Solid Waste Aqueous effluent for ETP Process residue for disposal Evaporation loss (water) To be sent to TSDF / AFR / Cement industries To ETP To be sent to TSDF / AFR / Cement industries To atmosphere 7 Recovered Water 3 Recycled back to process 8 9 Reduction catalyst (Recovered) from process for reuse CO2 vent from Hydrogen generation plant Total 3. Bronopol Recycled back to process To atmosphere Nitromethane and formaldehyde and taken together in aqueous medium and caustic soda flakes are added. Bromine is added to the mixture to form the final product and NaBr. The product is isolated from NaBr solution and then treated with activated charcoal. The charcoal treated product is crystallized, isolated and washed with water, dried to give Bronopol of suitable purity. The NaBr solution is sold as by product to Industries engaged in Bromine recovery / production. The washings and mother liquors are collected to recover water for reuse in process. KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

10 Figure 3: Process Flow diagram of Bronopol KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

11 Table 4: Mass balance of Bronopol Raw Materials Input/MT of Product Quantity (MT) 1 Nitromethane Formaldehyde (37%) Caustic soda (NaOH) (flakes) Liquid Bromine Activated charcoal Hyflosupercel Water 2 Product Total 3.9 Output MT/MT of Product Liquid Effluent Air Emission Recovery/ Product Solid Waste Remark 1 Bronopol Final Product 2 Spent Carbon To be sent to TSDF / AFR / Cement industries 3 NaBr solution By product for sale 4 Evaporation loss (Water) 5 Water (recovered) Distillation Residue Total To atmosphere Water For reuse in Process To be sent to TSDF / AFR / Cement industries KADAM ENVIRONMENTAL CONSULTANTS MAY 2016

12 Annexure 5: Storage Details Table 5: Storage Details of Raw Material No Chemical Name State Consumption (MT / month) Means of storage Capacity No of storage 1 Dicyandiamide Solid 600 Bags Dimethylamine hydrochloride Solid 650 Bags Mix Xylene Liquid 15 Tank 12 MT 1 4 Activated Carbon Solid 23 Bags 5 MT 1 5 Hyflosupercel Solid 15 Bags 4 MT 1 6 Methanol Liquid 447 Tank 50 MT 3 7 Hydrochloric acid (30% w/w) Liquid 1152 Tank 100 MT 3 8 Para Nitro chloro benzene Solid 1380 Bags / Bulk 150 MT 3 9 Caustic Lye (48 % w/w) Liquid 1523 Tank 150 MT 3 10 Reduction catalyst Solid 0 Drums Acetic anhydride Liquid 912 Tank 100 MT 3 12 Sodium hydrosulphite Solid 12 Bags 4 MT 1 13 Nitromethane Liquid 9 Drums 3 MT 1 14 Formaldehyde (37% w/w) Liquid 9 Tank 12 MT 2 15 Caustic soda (flakes) Solid Bags 20 MT 1 16 Liquid bromine Liquid 24 Tank 5 KL 2 Table 6: Storage Details of Products No Chemical Name State Means of storage Capacity No of storage 1 Metformin Hydrochloride Solid Bags/Drums 100 MT 1 2 Paracetamol Solid Bags/Drums 100 MT 1 3 Bronopol Solid Bags/Drums 5 MT 1 KADAM ENVIRONMENTAL CONSULTANTS MAY

13 . Annexure 6 : Water Consumption and Effluent Generation Details Table 7: Water Consumption and Effluent Generation Pattern Description Water Consumption in KLD Wastewater Generation in KLD Wastewater Treatment Facility A Process 1 Bronopol RO Plant i RO Reject Water 122 a Cooling Tower b Domestic Use (Bathing & Flushing ) Go with NaBr solution as By Product Used for cooling tower make up and Bathing/Flushing activities Blow Down to ETP followed by MEE To STP & treated sewage will be reused for Gardening ii RO Permeate Water 122 a Metformin (HCL) b Paracetamol B Boiler 24 5 C Domestic (Canteen ) Reused for Cooling Tower Make up after distillation Go to Salt Recovery System and condensate will be reused in process & Salts will be sold as by product Blow Down to ETP followed by MEE To STP & treated sewage will be reused for Gardening Total Water Consumption & wastewater Generation KLD - will be treated in STP and treated sewage will be reused for gardening. 30 KLD - will be treated in ETP followed by MEE and condensate from MEE will be reused for boiler make up & Gardening. The MEE salts will be sent to TSDF facility. The surplus 170 KLD wastewater are reused in process. KADAM ENVIRONMENTAL CONSULTANTS MAY

14 Figure 4: Water Balance KADAM ENVIRONMENTAL CONSULTANTS MAY

15 Annexure 7: Details of Wastewater Treatment Philosophy Details of wastewater generation, treatment scheme and disposal/reuse is given below: Wastewater stream Source Treatment Scheme Provided Remarks Washing and Cleaning Production areas - Reused back in respective process Salt Water Paracetamol Salt Recovery system Reused back in process Process Water Metformin Distillation Reused back in Cooling tower Utility blow down Cooling tower and Boiler Effluent treatment plant with primary treatment and MEE Reused back in utility Domestic sewage Domestic Sewage Treatment Plant Gardening Salt Recovery System Water containing almost pure sodium chloride (NaCl) from manufacturing process of paracetamol will be processed in salt recovery system consisting of Multiple Effect Evaporation (MEE) and reuse of condensates. Crystallized salt will be sold as byproduct. Distillation Process water from evaporative crystallization of Metformin will be processed in a distillation system and condensate will be reused in cooling tower make up. Distillation residue will be sent to TSDF/AFR/Cement plant. Effluent Treatment plant Utility blowdown from cooling tower and boiler will undergo primary treatment followed by Evaporation and reuse of condensate in boiler and gardening. ETP sludge will be sent to TSDF/AFR/Cement plant. Sewage Treatment Plant Domestic wastewater will be treated in STP and used for gardening within site premises. KADAM ENVIRONMENTAL CONSULTANTS MAY

16 Annexure 8: Fuel Consumption Table 8: Fuel Consumption Details Sr. Stack Attached to Capacity Stack Nos. Stack Height 1 Boiler 5 T/Hr Boiler 5 T/Hr Boiler 1.5 T/Hr Type of Fuel used Firewood/ agrowaste briquettes Firewood/ agrowaste briquettes Firewood/ agrowaste briquettes Fuel consumption 15 MT/Day 15 MT/Day 5 MT/Day 4 DG Set 500 KVA 3 9 HSD 60 Lit/Hr each Table 9: Details of Process Vents Vent Attached to Air Pollution Control Measures System attached Proposed Height of Vents Pollutants Emitted Central Absorption System in paracetamol Plant Alkali/Water Scrubber Building height + 6 m HC Central Absorption System in Bronopol Plant Alkali/Water Scrubber Building height + 6 m Bromine vapors KADAM ENVIRONMENTAL CONSULTANTS MAY

17 Annexure 9: Hazardous Waste Generation Table 10: Hazardous Waste Generation Details Type of Waste Hazardous Waste Category Quantity MT per Year Source 1 Used/spent oil Industrial Operations 2 using mineral/synthetic Wastes/Residues oil as lubricant in containing oil hydraulic system 3 Distillation Residues Production/Industrial Use of solvents 4 Residues and wastes Spent catalyst/spent Carbon Date expired, discarded and off specification drugs Discarded containers/ barrels, liners, contaminated with hazardous wastes/chemicals Chemical sludge from waste water treatment Production/Formulation of drugs/ Pharmaceuticals & health care product Disposal of barrels containers used for handling of hazardous waste chemicals Purification and treatment of air, water & waste water from the processes in this schedule and common industrial effluent treatment Plants (ETPs) Treatment / Disposal To authorized recycler To TSDF/AFR/Cement industry To TSDF/AFR/Cement industry To TSDF/AFR/Cement industry/ recycler To TSDF/AFR/Cement industry KADAM ENVIRONMENTAL CONSULTANTS MAY