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Cover Letter Annexure-01 Copy of EC Certificate Annexure-02 Copy of CCA NO-62538 of dated-05.07.2014 GUjARAT POLLUTION CONTROL BOARD PARYAVARAN BHAVAN Sector-10-A, Gandhinagar-382 021, ~"" .., Website, www.gpcb.gov.in GPCB B¥R.P.A.D NO.GPCB/ANK/CCA-14B(10J/ID-15119/ DT: Amendment to Consolidated Consent & Authorization (CCA),Order No: AWH·62538 dated 05/07/2014. TO. M/s. GLENMARK PHARMACEUTICALS LIMITED .. PLOT NO: 3102/C to 3109/A, G.I.D.C. ESTATE ANKLESHWAR, DIST. BHARUCH. SUB: Consolidated Consent & Authorization (C(&1\J under various Environmental ACLsj Rules. REF: 1) eCA order No: AWH-62538 Dated: 29/05/2014 under various Environmental Acts/Rules. 2) Your Letter dated: 02/07/2015. Sir, This has reference to the eeA order No: AWH-62538, issued vide letter NO. GPCBjANKjCCA-148{B)jlD-15119/218375, dated 05/07/2014 under the provisions of the various Environmental Act/ Rules, which stands amended as under. 1. Name of the industry shall now be read as M/S. "GLENMARK PHARMACEUTICALS LIMITED" in place ofM/S. GLENMARK GENERICS LTD, from the date of issue of this letter. 2. All other conditions of CCA order No: AWH-62538, issued vide letter NO. GPCB/ANK/CCA-148(B)/ID-15119/218375 dated 05/07/2014 will remain same. For and on behalf of GUJARATPOLLUTION CONTROLBOARD «Y'V J (T.B.SHAH) Outward No:322673,29/07/2015ENVIRONMENT ENGINEER Clean Gujarat Green Gujarat ISO - 9001 - 2008 & ISO - 14001 - 2004 Certified Organisation GU]ARAT POLLUTION CONTROL BOARD - PARYAVARAN BHAVAN Sector-10-A, Gandhinagar-382 021. Website: www.gpcb.gov.in Date: No, GPCB/BRCH-CC&A-14S(S)/ID-15119/ PLOT NO: 3102/C, 3103 TO GIDC ESTATE ANKlESHWAR, QIST, BHARUCH. SUB: Amendment in CCA No. AWH -62538 dated : 05/07/2014 REF: (1) CC & A No. Order No AWH - 62538 vide letter No. GPCB/BRCH~CC&A-148(8)/ID- 15119/218375 dated 5/7/2014 (2) Your letter NOMGGL/ ANKjGPCB-CCA/]ULY /2014-15 dated 22-07-2014 Dear Sir, This has reference to the CCA order A\VlI- 62538issued vide leuer '\lo. C;PCBjBRCH-CC&A-148(8)/ID- 15119/218375, dated; 05/07/2014 amended from time to time under the provision of the various Environmental Act/ Rules which is amended as under. 1) Condition NO.2 is amended and shall now be read as under' SeNo N arne of Product -kG/Month 1 Butanif11le lleL 2 Fsome )fazole pellets 225"/0 60{)O 3 Esomeprazole pellets 8.5%, flucanazolc 4 (Sr No.1 to 6) 5 Trandola)1"il 6 Trospium chloride 7 ...\lfuzosin HCL S Loratadine 9 Burro Jion l1CL 10 Perindo Jril Erbumine 11 Amiodaronc BCL 12 ES01neprazolc Base 13 Deferosttox , Esomeprawle ~Jg. Trihvdrate 4(J()() 14 ~~------ 15 Desloratadine 16 Topttamate (Sr No.7 to 27) 17 ZolJidemtartrate 18 Glimeottide Colisomethate 19 -~ 20 Rami)ril _._-_. ---- -------- 21 CRC-15300 22 OutwardTtraconazole No:312287,29/04/2015 23 Zohnitriptan Clean Gujarat Green Gujarat ISO - 9001 - 2008 & ISO - 14001 - 2004 Certified Organisation -I 3000 35 Rosuvastatin Calcium (Sr No, 28 to 40) 36 GRC-I0693 1 37 Zoni~amide J 38 Fosapre. itant I 39 Lcvocetrizinc 2HCL --i 40 Adapalene I 41 Oxcarbazc inc =r 42 Linezo~d.. .' ~ ~ ~~:~:~ITtan~C~I_' 1 45 Atovaquonc l 46 Cilostazol ~ 47 SolifenacineSuccinate 4000 48 Extamibe (Sr No. 41 to 55) 49 Rosi.gJitazone T\1alatc 50 Palonosetron Hel 51 Bosentan Monohvdrate 52 I.ercandi )il1e Het r#--- Dcdfcnacin l-Ivdrobromide :54 fehnisartan 1 55 Aprepitant - 56 ImiguiOlod ~ ~7 \~oriconazole -----1 ~_ C,R~-4039 I r-22---- ~rok I Ivdruchlo~~ ,_-=1 400 :~ ~;~e_l~~r36 --i Sr ~o. 56 to 64) 62 EszoDidone -1 6:':> Candcsartan Cilcxetil 64 Tazarotcne Total 14000l KG/Month I BYPRODUCT f MT/Month Recovered Solvents ~ __ 450 Outward No:312287,29/04/2015 ¥ Clean Gujarat Green Gujarat ISO - 9001 - 2008 & ISO - 14001 - 2004 Certified Organisation j GU]ARAT POLLUTION CONTROL BOARD PARYAVARAN BHAVAN Sector-1 a-A, Gandhinagar-382 021. ~ Website: www.gpcb.gov.in CONlMlJI'{JNDER THE AIR ACT 2) ti~)fi No, 4.1 is amended and shall now be read as under: The following shall be used as fud in Boiler / Furnace & Heater respectively: No Name afCuel Consum tion 1 Natural Gas OR 700 ~P/ llrs OR Furnace Oil (J.7lUKL/Hrs Diesel 400 Liter /I-Irs AUTHORISATION FOR THE MANAGEMENT & HANDLING OF HAZARDOUS WASTES Form-2 (See role 3 (e) & 5 (5)) 3) Condition No. 6.2 Sr NO.5 is amended and shall no\v read as undel S, Description of Waste Category Quantity Facility No No Collection, Distillation and sellin-'- to N \Ij s. Vivek Chemicals. \I/s. Bht7.kr:iegOrganics and Ind. 54 Spent Solvent 28.6 l\U/Month 6) I'vrjs Shivam Organics, GIDC, A,nkleshwar 7) T'vi/s Rhyt11m Chemicals Pvt Ltd, CIDe, Sachin, Surat :NlixSolvent Generated from (~ol1ection, Storage, Transportr.tion Solvent stripper 43.2 and tinal disposal at common 28.6 J'vIT/Month incineration of BElL/ SEPPL/ Dis )Osal to Co- Processin . 4) All other conditions of CCA Order No. AWH- 62538 issued vide order no. GPCB/BRCH-CC&A. 148(8)/ID-15119/218375 Dated:05/7/2014 shall remain unchanged. For and on behalf of GUJRAT POLLUTlO::70 BOARD (K.c~ry) SENIOR ENVIRNMENT SCIENTIST Outward No:312287,29/04/2015 Clean Gujarat Green Gujarat ISO - 9001 - 2008 & ISO - 14001 - 2004 Certified Organisation ~~,., GPCB ByR.PA.D. NO: GPCB/BRCH-CC&A-148(8)IID-15119/2 I 8]7, DT:~l) CCA NO: AWH-62538 In exercise of the power conferred under section-25of the Water (Prevention and Control of Pollution) Act-1974, under sectioll-21 of the Air (Prevention and Control of Pollution) Act-19B1 and Authorization under "Hazardous Waste (Management, Handling & Trans-boundary Movement) Rule- 200S," And whereas Board has received consolidated application dated 18/2/2014 and inward no. 77281 for the consolidated consent and authorization (CC & A renewal) of this Board under the provisions / rules of the aforesaid Acts Consent & Authorization is hereby granted as under. CONSENT AND AUTHORISATION: (Under the provisions / rules ofthe aforesaid environmental acts) To, ~/s. GLENMARK GENERICS LTD., PLOT NO: 3102/C,3103 TO 3109/A & 3109/A, GIDC ESTATE ANKLESHWAR, D1ST: BHARUCH. 1. Consent Order No.: AWH- 62538, date oflssue 29/5/2014. 2. The consent under Water Act -1974, The consent under Air Act - 1981 & Authorization under Environment (Protection) Act, 1986 shall be valid up to 21/1/2019 to operate industrial plant for manufacture of the following products: Sr,No. Name of Product 1 Butanifine HCL 2 EsomeprazoJe pellets 22.5% 6000 3 Esomeprazole pellets 8.5% (Sr, No 1 to 6) 4 Flucanazole 5 Trandolapril 6 Trospium chloride .~ '1 ,yr Clean Gujarat Green Gujarat " ISO _ 9001 _ 2008 & ISO - 14001 - 2004 Certified Organisation . • 7 Alfuzosin HCL 8 Loratadine 9 Bupropion HCL 10 Perindopril Erbumine 11 Amiodarone HCL 12 Esomeprazole Base ~' 13 Deferosirox 14 Esomeprazole Mg. Trihydrate 15 Desloratadine 16 Topiramate 17 Zolpidem tartrate 4000 (Sr. N07t027) 18 Glimepiride 19 Colisomethate 20 Ramipril 21 GRC-15300 22 Itraconazole 23 Zolmitriptan 24 Moexipril HCL 25 Paliperidone 26 Rizatriptan 27 Tadalafil 28 Olmesartan Medoxomil 29 Riluzole 30 Dofetilide 31 Gemifloxacin 32 Sterontium Ranelate 33 GPL-820C 3000 34 Terbinafine HCL (Sr. No 7to 27) 35 Rosuvastatin Calcium 36 GRC-l0693 37 Zonisamide 38 Fosaprepitant 39 Levocetrizine 2HCL 40 Adapalene 41 Oxcarbazepine 42 Linezolid 43 Frovatriptan Succinate 44 Cilazapril 4000 45 Atovaquone (Sr. No 41 to 55) 46 Cilostazol 47 Solifenacine Succinate 48 Exetamibe 49 Rosiglitazone Malate I 50 Palonosetron Hel 51 Bosentan Monohydrate 52 Lercandipine Hel 53 Derifenacin Hydrobromide 54 Telmisartan 55 Aprepitant 56 Imiquimod 57 VoriconazoJe 58 GRC-4039 59 Ropinirole Hydrochloride 400 60 CroEelmer (Sr No. 56 to 64) 61 GRC-17536 62 Eszopiclone 63 Candesartan CiJexetil 64 Tazarotene Total 14000 KG BYPRODUCT 1- I Recovered Solvents 450 MT » The Permission for utilization of pilot plant of SOD Kg/Month capacity is granted hereby with a condition that the pilot plant will not be used for any commercial production but for the purpose of trial production on kilo scale basis, trouble shooting and yield improvement processing. 3. CONDITION UNDER WATER ACT: 3.1 The quantity of industrial effluent shall not exceed 140 MJ I Day. 3.2 The quantity of domestic effluent shall not exceed 60 M3/Day. 3.3 The Total water consumption for industrial processes and other ancillary operation shall not exceed 340 KLD, water consumption for domestic purpose shall not exceed 60 KLD. 3.4 TRADE EFFLUENT 3.4.1 The Industrial effluent shall conform to following standards. PARAMETERS PERMISSIBLE LIMIT oH 6.5 to 8.5 Temoerature 40C Colors (nt.co.scale 100 units Total Suspended Solids I 100 mg!l Clean Gujarat Green Gujarat .' ISO _ 9001 - 2008 & ISO - 14001 - 2004 Certified Organisation • Total Dissolved solids 2100 m BOD 3 da sat 27.C 30 m I COD 100 m I Oil and Grease 10 m I Phenolic Com ounds 1 m I SuI hides 0.5 m I Ammonical Nitro en 50 m I Flourides 1.5 m I Chlorides 600 m I Sui hates 1000 I Iron 3.0 M Zinc 5.0M Total Residual Chlorine 1.0M Total Hea Metal 7.0M Percent Sodium 60 % Bioassay test 90% Survival of fish after 96 hours 100% effluent 3.4.2 The effluent conforming to above standards shall be discharged in to GlDC underground drainage system and conveyed to Narmada Clean Tech Limited (NCTL) -Final Effluent Treatment Plant for further treatment and disposal. 3.4.3 Sewage effluent shall be treated separately in STP plant and" 80 KLD of GIDC water, 40 KLD RO permeate water and 60 KLD treated sewage water will be used for gardening purpose, which shall conform to the following standards" BOD (5days at 20"C) Less than 20 mg/L Suspended Solids Less than 30 mgjL Residual Chlorine Less than 0.5 mg/L 3.4.4 The Industry is hereby granted the permission to send SO KljMonth of High Ammonical Nitrogen containing effluent to Enviro Technology Limited (ETL) for further treatment, by Tankers.
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