List of Annexures S. No Description Page No. Other Annexures

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1 List of Annexures S. No Description Page No. I Plant Layout 12 II Manufacturing Description & Flow Chart Details III Effluent Treatment Plant Flow Chart & Solid Waste Handling Details 26 IV Water Requirement and Wastewater generation details 27 V List of Hazardous Chemicals 28 VI Details of Hazardous / Solid Waste and other waste 29 VII Fuel Consumption and Emission Details 30 VIII Details of Emissions from Process Reactions 31 IX Environmental Clearance Other Annexures X Location Map 37 XI Topographical Map 38 XII Google Imagery Map 39 XIII CA Certificate 40 XIV Certificate of Incorporation 41 XV NOC from Gram Panchayat 42 XVI Agreement of Sale XVII Soil Analysis Report 45 XVIII Water Analysis Report 46 XIX Compliance to the EC Conditions XX Consent for Establishment XXI High Court Directions for Proposing CFE Application 60-64

2 12 ANNEXURE - I

3 13 ANNEXURE - II

4 14 ANNEXURE - II

5 15 ANNEXURE - II

6 16 ANNEXURE - II

7 17 ANNEXURE - II

8 18 ANNEXURE - II

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10 20 ANNEXURE - II

11 21 ANNEXURE - II

12 22 ANNEXURE - II

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15 25 ANNEXURE - II

16 ANNEXURE - III WASTEWATER TREATMENT METHOD AND SOLID WASTE HANDLING DETAILS Item Treatment Method Process Floor & Reactor washings Boiler, Cooling tower & D.M. Regeneration Scrubber & Q.C Domestic Shall be stripped off for Organics recovery Stripper condensate to distillate for separation of organic compounds followed by disposal to cement plants for co-processing & distilled effluents shall be routed to ETP. Stripped effluents for forced evaporation in MEE followed by ATFD. Condensate from MEE & ATFD will be sent to ETP. ATFD salts to TSDF. ETP shall be provided for primary & secondary treatment. Treated effluents from ETP will be filtered in the RO Plant. RO permeate to reuse and RO reject to MEE. Sent to Septic tank followed by soak pit Sl. Handling Source No. Method 1. Organic residue HDPE Drums 2. Inorganic & Evaporation salt (Process) HDPE Bags 3. Spent Carbon HDPE Drums 4. ETP Sludge HDPE Bags 5. Boiler Ash Stored in covered area 6. Designated Container and Container covered area liners 7. Spent solvents Stored in Drums / Tanks Disposal Sent to SPCB Authorized Cement industries / TSDF Sold to Cement Brick Manufacturers After complete detoxification, it will be disposed of to the outside agencies Recovery within the premises duly sending the residue to SPCB Authorized agencies Sent to SPCB Authorized agencies 8. Mixed solvents Stored in Drums / Tanks 9. Waste oils Stored in Drums Sent to SPCB Authorized agencies 10. Used Lead acid Batteries Designated Sent to suppliers on buy-back basis. covered area 26

17 ANNEXURE - IV WATER REQUIREMENT, WASTEWATER GENERATION AND ITS TREATMENT Item Water Requirement ( KLD) Wastewater Generation ( KLD) Treatment Method Process Floor & Reactor washings Boiler, Cooling tower & D.M. Regeneration Scrubber & Q.C Shall be stripped off for Organics recovery Stripper condensate to distillate for separation of organic compounds followed by disposal to cement plants for coprocessing & distilled effluents shall be routed to ETP. Stripped effluents for forced evaporation in MEE followed by ATFD. Condensate from MEE & ATFD will be sent to ETP. ATFD salts to TSDF. ETP shall be provided for primary & secondary treatment. Treated effluents from ETP will be filtered in the RO Plant. RO permeate to reuse and RO reject to MEE. Domestic Sent to Septic tank followed by soak pit Gardening Total

18 ANNEXURE - V LIST OF HAZARDOUS CHEMICALS Ammonia (20%) soln Chloroacetonitrile Chloroform Dimethyl Formamide Epichlorohydrin Formaldehyde (37%) Hydrochloric Acid Methyl Isobutyl Ketone Methylene Dichloride n-hexane Sulfuric Acid Toluene Triethyl Amine 28

19 ANNEXURE - VI HAZARDOUS SOLID WASTE GENERATION FROM THE PLANT Sl. No. Source Quantity TPD* 1. Organic residue Inorganic & Evaporation salt (Process) 3. Spent Carbon Handling Method HDPE Drums 0.84 HDPE Bags HDPE Drums Disposal Sent to SPCB Authorized Cement industries / TSDF 4. ETP Sludge HDPE Bags 5. Boiler Ash 4.8 Total Stored in covered area Sold to Cement Brick Manufacturers Sl. Source No. Other Solid Waste Handling Method Disposal 6. Container and Container liners Designated covered area After complete detoxification, it will be disposed of to the outside agencies 7. Spent solvents 8. Mixed solvents 9. Waste oils Stored in Drums / Tanks Stored in Drums / Tanks Stored in Drums Recovery within the premises duly sending the residue to SPCB Authorized agencies Sent to SPCB Authorized agencies Sent to SPCB Authorized agencies 10. Used Lead acid Batteries Designated covered area Sent to suppliers on buy-back basis. * Maximum solid waste quantities on various combinations i.e., (any 3 Bulk Drug products will be manufactured at a time). 29

20 ANEXURE - VII FUEL CONSUMPTION AND EMISSIONS DETAILS Source Stack Height (m) Diameter (m) Temperature in o K Flue Gas Flow rate (m 3 /Hr) Exit Gas Velocity in m/sec SPM SO2 NOx Kg/hr 3.0TPH Coal fired Boiler 2.0 Lac Kilo cal /hr Traces Coal is used in the proposed boiler of 1 No. of 3 TPH. The Coal consumption is about 12 TPD. Diesel will be used in the proposed 2 Nos. of 250 KVA & 125 KVA D.G. Sets, which will be about 75 Ltrs/hr at full operation load. Furnace oil will be used in the proposed 2.0 lac K.cal/hr Thermic Fluid heater, which will be about 19 Ltrs/hr. 30

21 ANNEXURE - VIII PROCESS EMISSIONS-PRODUCT WISE Sl. No. Product Proposed Bulk Drugs Name of the Process Emission Quantity in Kg/day Treatment Method 1. Carvedilol H Diffused with flame arrestor 2. Fluconazole HCl 36.0 Scrubbed with water 3. Quetiapine Hemifumarate CO Dispersed into atmosphere 4. Sibutramine Hydrochloride CO Dispersed into atmosphere 5. Lansoprazole Nil Zotepine H Diffused with flame arrestor 7. Itraconazole Nil H Diffused with flame arrestor Fenoterol Hydrobromide CO Dispersed into atmosphere 9. Omeprazole Nil Olanzapine Nil Rabeprazole Sodium Nil Pantoprazole Sodium Nil

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25 35 ANNEXURE - IX

26 36 ANNEXURE - IX

27 37 ANNEXURE - X

28 38 ANNEXURE - XI

29 ANNEXURE - XII Google Image of Nucleus Drugs Pvt. Ltd. 39

30 40 ANNEXURE - XIII

31 41 ANNEXURE - XIV

32 42 ANNEXURE - XV

33 43 ANNEXURE - XVI

34 44 ANNEXURE - XVI

35 ANNEXURE - XVII PHYSICAL AND CHEMICAL PROPERTIES OF SOIL Sl.No. Parameters Project Site 1. Color Brown 2. PH (1:5) E C (µ mhos ) Texture Silty clay 5. Moisture in % Sand in % Silt in % Clay in % Organic Matter in % Nitrogen as N kg/ha Phosphorus as P kg/ha Potassium as K kg/ha Sodium as Na in % Calcium as Ca in % Magnesium as Mg in % Iron as Fe in % Manganese as Mn ppm Boron as B ppm Lead as Pb ppm Zinc as Zn ppm 10 45

36 ANNEXURE - XVIII WATER QUALITY IN THE STUDY AREA (GROUND WATER) Sl. LOCATIONS Units Project Site No. Physical Parameters 1 PH Elec. Cond. µmhos/cm Turbidity NTU Total Dis. Solids mg/l Total Sus. Solids mg/l Nil Chemical Parameters 6 Total Hardness as CaCO 3 mg/l Total Alkalinity as CaCO 3 mg/l Chlorides as Cl mg/l Fluorides as F mg/l Nitrate as NO 3 mg/l Sulphate as SO 4 mg/l Calcium as Ca mg/l Magnesium as Mg mg/l Sodium as Na mg/l Potassium as K mg/l 1.56 Nutrients & Organics 16 DO mg/l

37 ANNEXURE - XIX CONDITION-WISE COMPLIANCE REPORT OF ENVIRONMENTAL CLEARANCE Ministry of Environment and Forests, Govt. of India EC Order No. : J-11011/511/2007-IA II(I) dated SI. Specific Conditions No. A. Specific Conditions 1 This environmental clearance is subject to measures to be taken by the industrial associations as identified by the Andhra Pollution Control Board vide its letter no. 45/PCB/CFE/BO/EC/2007 dated 15 th June, Cyclone separator followed by wet scrubber shall be provided to control the air emissions from the boiler. The reactors shall be provided with appropriate stack height for the dispersion of pollutants as per the CPCB guidelines to control acid mist and HCl. HCl and Ammonia shall be scrubbed using water scrubber and dilute solutions shall be either reused after neutralization or evaporated along with other high TDS effluent in the evaporator. SO 2 shall be scrubbed using caustic lye solution and sold to authorized parties or neutralized and sent to CETP, Patancheru for further treatment. 3 Solvent recovery system shall be installed and recovery shall not be less than 95 percent. All the solvents shall be handled in closed conditions and vent condensers shall be provided to the solvent storage tanks to reduce the evaporation losses. All the venting equipments shall have vapour recovery system and condensers used for solvent recovery. All the vents should be monitored for the solvents regularly and report submitted. Chillers shall be provided for chilled brine circulation to condensate the solvent vapors and reduce solvent losses. Volatile Organic compounds (VOCs) shall also be monitored in solvent storage areas along with other parameters. Action shall be taken to reduce the fugitive emissions as far as possible. 4 Solvents generated from the vents and in the work zone environment shall be monitored and reports submitted to the APPCB, CPCB and Ministry s Regional Office at Bangalore. 5 Total ground water requirement and wastewater generation shall not exceed 74.9 m 3 /day and m 3 /day respectively. Prior permission for the drawl of ground water shall be obtained from the SGWB/CGWA. Effort shall be made to recycle and reuse maximum treated wastewater in the process. The effluent shall be segregated into high TDS and low TDS streams. The high TDS effluent shall be forced evaporated in the forced evaporator and condensate from the evaporator shall be used in cooling towers or sent to CETP, Patancheru of M/s PETL alongwith the Low TDS effluent. The salts from the evaporation system shall be sent to TSDF of M/s Hyderabad Waste Management Project (HWMP), Dundigal for incineration. The Low effluent shall be treated in Effluent Treatment Plant (ETP) and sent to CETP Patancheru after primary treatment. Domestic effluent shall be treated in septic tanks followed by soak pit. Compliance APPCB accorded CFE on and planning to initiate the Construction activity. We have noted and will install the proper pollution control equipment to control the air emissions. We have noted and will comply with the condition. We have noted and will comply with the condition. We have noted and we will install the Zero Liquid Discharge to the effluent. Treated water reused in the Boiler / Cooling tower makeup. 47

38 ANNEXURE - XIX 6 If the common effluent treatment plant (CETP) is not operational by the time project is commissioned, full-fledged effluent treatment plant (ETP) with primary, secondary and tertiary treatment plant shall be installed. 7 All the solid waste from the process, ETP Sludge and salts from the evaporation system, shall be sent to Treatment, Storage and Disposal Facility (TSDF) of M/s Hazardous Waste Management Plant (HWMP) at Dundigal, Hyderabad. Organic residue shall be incinerated in the incinerator of common incinerator facility. Fly ash shall be given to local brick manufacturers. 8 Out of total ha., green belt shall be developed in ha. with suitable species of the plants as per the CPCB guidelines to mitigate the effect of fugitive emissions. B. General Conditions 1 The project authorities shall strictly adhere to the stipulations made by the Andhra Pradesh Pollution Control Board (APPCB). 2 No further expansion or modifications in the plant shall be carried out without prior approval of the Ministry of Environment and Forests. In case of deviations or alterations in the project proposal from those submitted to this Ministry for clearance, a fresh reference shall be made to the Ministry to assess the adequacy of conditions imposed and to add additional environmental protection measures required, if any. 3 The gaseous emissions (SO 2, NO X, H 2 S, HCl, NH 3 ) and particulate matter from various process units shall conform to the standards prescribed by the concerned authorities from time to time. At no time, the emission levels shall go beyond the stipulated standards. In the event of failure of pollution control system(s) adopted by the unit, the respective unit shall not be restarted until the control measures are rectified to achieve the desired efficiency. 4 Ambient air quality monitoring stations shall be set up in the downwind direction as well as where maximum ground level concentration are anticipated in consultation with the APPCB 5 Fugitive emissions in the work zone environment, product, raw materials storage area shall be controlled. The emissions shall conform to the limits imposed by APPCB. Fugitive emissions including HCl concentrations shall be monitored in work zone environment We have noted and we will install the Zero Liquid Discharge to the effluent. Treated water reused in the Boiler / Cooling tower makeup. We have noted and solid waste generated from the activity will be sent to TSDF, Dundigal / SPCB Authorized Cement Industries. We will develop greenbelt as per CPCB Guidelines. We are strictly adhering to the stipulations made by the State Pollution Control Board and ensure that we will not violate the norms prescribed by the Board. We have noted and we are submitting the Form-I application for EC validity extension. We have noted and we will comply with the condition. Regular monitoring will be carried out through Authorized Laboratories. We have noted and will comply with the condition. Regular Ambient Air Quality monitoring is carried out through authorized laboratories. We have noted and we will comply with the condition. Regular monitoring carried out through Authorized Laboratories. 48

39 ANNEXURE - XIX 6 The company shall undertake following Waste Minimization measures :- Metering and control of quantities of active ingredients to minimize waste. Reuse of by-products from the process as raw materials or as raw material substitutes in other processes. Use of automated filling to minimize spillage. Use of Close Feed system into batch reactors. Venting equipment through vapour recovery system. Use of high pressure hoses for equipment clearing to reduce wastewater generation. 7 The project authorities shall strictly comply with the rules and regulations under Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 as amended in October 1994 and January Authorization from the APPCB shall be obtained for collection, treatment, storage, and disposal of hazardous wastes. 8 The project authorities must strictly comply with the rules and regulations with regard to handling and disposal of hazardous wastes in accordance with the Hazardous Wastes (Management and Handling) Rules, Authorization from the A.P. Pollution Control Board must be obtained for collections/treatment/storage/disposal of hazardous wastes. 9 The overall noise levels in and around the plant area shall be kept well within the standards (85 dba) by providing noise control measures including acoustic hoods, silencers, enclosures etc. on all sources of noise generation. The ambient noise levels shall conform to the standards prescribed under Environment (Protection) Act, Rules, 1989 viz. DBA (day time) and 70 dba (night time). 10 Occupational health surveillance of the workers shall be done on a regular basis and records maintained as per the Factories Act. 11 The company shall undertake eco-developmental measures including community welfare measures in the project area for the overall improvement of the environment. 12 The company shall adopt suitable surface as well as roof top rain water harvesting measures to harvest the run off water for recharge of ground water. Methods shall also be adopted for the conservation of water through and recycling and reusing the treated wastewater. 13 The project proponent shall also comply with all the environmental protection measures and safeguards recommended in the EIA report. We have noted and we will take all necessary precautions to minimize the Waste. We have noted the condition. We have noted the condition. We have taken all possible measures to control the noise and we will ensure that the noise levels will not exceed the standards prescribed by the Board. Regular monitoring will be carried out through authorized laboratories. Noted and will comply with the factories act. Noted and will comply with the proposed condition. We have noted and will comply with the condition. We have noted and comply with the condition. 49

40 ANNEXURE - XIX 14 A separate Environmental Management Cell equipped with fullfledged laboratory facilities shall be set up to carry out the Environmental Management and Monitoring functions. 15 As proposed in EIA/EMP, Rs Lakhs earmarked towards environmental pollution control measures shall be utilized to implement the conditions stipulated by the Ministry of Environment and Forests as well as the State Government and an implementation schedule shall be submitted to Ministry s Regional Office at Bangalore for implementing all the conditions stipulated herein. The funds so provided shall not be diverted for any other purpose. 16 The implementation of the project vis-à-vis environmental action plans shall be monitored by Ministry s Regional Office at Bangalore / APPCB / CPCB. A six monthly compliance status report shall be submitted to monitoring agencies. 17 The project proponent shall inform the public that the project has been accorded environmental clearance by the Ministry and copies of the clearance letter are available with the APPCB/Committee and may also be seen at Website of the Ministry at This shall be advertised within seven days from the date of issue of the clearance letter, at least in two local newspapers that are widely circulated in the region of which one shall be in the vernacular language of the locality concerned and a copy of the same shall be forwarded to the Ministry`s Regional Office at Bhopal. 18 The project authorities shall inform the Regional Office as well as the Ministry, the date of financial closure and final approval of the project by the concerned authorities and the date of start of the project. 19 The Ministry may revoke or suspend the clearance, if implementation of any of the above conditions is not satisfactory. 20 The Ministry reserves the right to stipulate additional conditions, if found necessary. The company in a time bound manner will implement these conditions. 21 The above conditions will be enforced, inter-alia under the provisions of the Water (Prevention & Control of Pollution) Act, 1981, the Environment (Protection) Act, 1986 Hazardous Wastes (Management and Handling) Rules, 2003 and the Public Liability Insurance Act, 1991 along with their amendments and rules. Laboratory facilities for analyzing effluent samples before and after treatment will be provided. Environmental Management cell consisting of Environmental Engineer, supervisors and helpers will be set up. We have noted the condition. We have noted and complying with the condition. We have already published in two local news papers and the same is submitted to the Regional office. We have received for Consent for Establishment and will keep inform regularly the project status to the Regional Office of the Ministry the date of financial closure and final approval and date of start of the project. We have noted the condition. We have noted and will comply with the condition. We have noted and comply with the rules and regulations of the applicable acts along with their amendments. 50

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50 60 ANNEXURE - XXI

51 61 ANNEXURE - XXI

52 62 ANNEXURE - XXI

53 63 ANNEXURE - XXI

54 64 ANNEXURE - XXI