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24. Godavari Labs Pvt Ltd APSEZ Rambilli VSP Dist CFE Order DS

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24. Godavari Labs Pvt Ltd APSEZ Rambilli VSP Dist CFE Order DS ANDHRA PRADESH POLLUTION CONTROL BOARD D.No. 33-26-14 D/2, Near Sunrise Hospital, Pushpa Hotel Centre, Chalamalavari Street, Kasturibaipet, Vijayawada – 520010. Website :www.appcb.ap.nic.in CONSENT ORDER FOR ESTABLISHMENT Order No. 471 /APPCB/CFE/RO- VSP/HO/2019 Dt: 28.06.2019 Sub: APPCB – CFE - M/s. Godaavari Labs Pvt Ltd, Plot No. 22, APSEZ, De- Notified Area, Lalamkoduru (V), Rambilli (M), Vishakhapatnam District - Consent for Establishment (CFE) of the Board under Sec.25 of Water (P & C of P) Act, 1974 and under Sec.21 of Air (P&C of P) Act, 1981 - Issued - Reg. Ref: 1) Industry’s CFE application received through AP Single Desk Portal on 06.06.2019. 2) R.O’s inspection report dt. 08.06.2019. 3) CFE Committee meeting held on 11.06.2019. 1. In the reference 1st cited, an application was submitted to the Board seeking Consent for Establishment (CFE) to produce the products with installed capacities as mentioned below, with a project cost of Rs. 28.0 Crore. Quantity No. of Name of the Starting Quantity S.No Product Name (Kg/Day) Stages Raw Materials (Kg/Day) 1 Omeprazole 200 4 3,5-Dimethyl-4- 203.6 nitropyridine-1- oxide 2 Pentaprazole Sodium 150 9 3-Hydroxy -2- methyl-4H- 125.1 pyran-4-one (Maltol) 3 Domperidone 250 6 N-carbethoxy-4-piperidone 399.9 4 Itraconazole 150 10 1-(4-Methoxy phenyl) 108.1 Piperazine 5 Eltrombopag Olamine 100 2 3'-Amino-2'-hydroxy-[1,1'- 95.6 biphenyl]-3- carboxylic acid hydrochloride 6 Ledipasvir 150 1 6-(7-(2-((S)-5- 157.5 azaspiro[2.4]heptan-7-yl)- 1Himidazol-5-yl)-9,9- difluoro-9H-fluoren-2-yl)-2- ((1R,4S)-2- azabicyclo[2.2.1] heptan- 3-yl)-1H- benzo[d] imidazole tetra hydrochloride 7 Pirfenidone 100 2 5-methyl-2-aminopyridine 72.7 8 Chlorothalidone 300 4 2-(4-chlorobenzoyl) 289.6 benzoic acid 9 Mycophenolatemofetil 100 1 Mycophenolic acid 105.3 Page 1 of 10 10 Tadalafil 300 1 (1R,3R)-methyl 416.2 1(benzo(d)(1,3) diioxol- 6yi)-2- (2-Chloroacetyl)- 2,3,4,9-tetrahydro-1H- pyridol {3,4-b) indole-3- carboxylate (KSM) 11 Dolutegravir 100 16 3-Hydroxy-2-methyl-4H- 66.0 pyran-4-one 12 Darunavir 120 6 Tert-Butyl(s)-1-(s)- -2-yl)-2 82.4 phenyl ethyl carbamate 13 Biperiden Hydrochloride 500 4 1.3-Cyclopentadiene 176.7 14 Quatiapine Fumarate 240 5 Thio Phenol 138.7 15 Fexofenadine 490 3 Fexofenadine Base 696.6 Hydrochloride 16 R&D, Pilot Plant Validation 100 Products (APIs and Intermediates) Total 3350 kg/day Intermediates 17 Omeprazole Sulfate 700 1 3,5-Dimethyl-4- 480.4 nitropyridine-1- oxide 18 3-Methoxy2-2methyl-4H- 250 1 3-Hydroxy -2- methyl-4H- 245.3 pyran-4- one (Pantoprazole pyran-4-one (Maltol) Stage 1) 19 3-Methoxy-2-methylpyridin 250 2 3-Hydroxy -2- methyl-4H- 277.9 -4 (1H)-one (Pantoprazole pyran-4-one (Maltol) Stage 2) 20 4-Chloro-3-methoxy-2- 250 3 3-Hydroxy -2- methyl-4H- 297.9 methyl pyridine pyran-4-one (Maltol) (Pantoprazole Stage 3) 21 5-Chloro-1-(4-piperidinyl)- 300 5 N-carbethoxy-4-piperidone 533.6 2- benzimidazolinone (Domperidone Stage 5) 22 Ethyl-4-Aminopiperidine -1- 300 1 N-carbethoxy-4-piperidone 341.6 Carboxylate (Domperidone Stage 1) 23 Ethyl 4-[(4-chloro-2- 300 2 N-carbethoxy-4-piperidone 252.8 nitrophenyl) Amino]Piperidine -1- Carboxylate (Domperidone Stage 2) 24 4-[4-[4-(4-hydroxyphenyl)- 150 7 1-(4-Methoxy 171.5 1- piperzinyl] phenyl-2,4- phenyl)Piperazine dihydro-2- (1- Methylpropyl)-3H-1,2,4- triazol- 3-one (Itra Stage 7) Page 2 of 10 25 [(2S,4S-2-(2,4- 150 9 1-(4-Methoxy 164.9 dichlorophenyl)-2- (1,2,4- phenyl)Piperazine triazol-1-yl methyl)-1,3- dioxolan-4-yl] methyl methane sulfonate (Itra Stage 9) Sub-total 2650 kg/day Grand Total(I+II) 6000.0 kg/day By-Products: Name of the S.No Name of the By-product Quantity Quantity product 1 Ammonium persulphate Dimethyl sulphate salt 120 Omeprazole 200 2 Dimethyl sulfide ammonium persulfate 222.2 3 Succinimide 45.1 Dolutegravir 100 4 m-Chloro Benzoic Acid 58.7 5 Sodium Methoxide 54.2 6 1-(3-(dimethyl amino) Propyl)-3-ethylurea 55.2 7 Dihydroxymanganese 27.3 8 N-chlorosulfamate 38.3 9 1-(3-(dimethyl amino) Propyl)-3-ethylurea 48.8 10 Benzyl-2,2,2-trifluoro acetate 48.7 11 N-hydroxy Succinimide 29.3 Darunavir 120 12 N-Hydroxy Succinimide 25.2 13 Piperzene ML (15%) 809.1 Quatiapine 240 Fumarate Total 1582.1 2. As per the application, the above activity is to be located at Plot No. 22, APSEZ, De- Notified Area, Lalamkoduru (V), Rambilli (M), Vishakhapatnam District in an area of 30,610.27 Sq m. 3. The above site was inspected by the Asst. Environmental Engineer-II, Regional Office, Visakhapatnam, A.P Pollution Control Board on 07.06.2019 and observed that the site is surrounded by North : Road, APIIC greenbelt, compound wall followed by Krishnampalem tank South : Road East : M/s. Yenovus Pharma., & M/s. Lee Pharma West : Proposed Road Page 3 of 10 4. The Board, after careful scrutiny of the application, verification report of Regional Officer and recommendations of the CFE Committee, hereby issues CONSENT FOR ESTABLISHMENT to the project under Section 25 of Water (Prevention & Control of Pollution) Act 1974 and Section 21 of Air (Prevention & Control of Pollution) Act, 1981 and the rules made there under. This order is issued to manufacture the products as mentioned at para (1) only. 5. This Consent order issued is subject to the conditions mentioned in the Annexure. 6. This order is issued from pollution control point of view only. Zoning and other regulations are not considered. 7. This order is valid for period of 7 years from the date of issue. Encl: Annexure CHAIRMAN To M/s. Godaavari Labs Pvt. Ltd., Dr. No. 50-28-16/1, Vummanani Sadan, TPT Colony, Seethammadhara Visakhapatnam. [email protected] Copy to: 1. The JCEE, Z.O: Visakhapatnam for information and necessary action. 2. The EE, R.O: Visakhapatnam for information and necessary action. Page 4 of 10 Annexure 1. The proponent shall obtain Consent for Operation (CFO) from APPCB, as required Under Sec.25/26 of the Water (P&C of P) Act, 1974 and under sec. 21/22 of the Air (P&C of P) Act, 1981, before commencement of the trail runs. 2. The applicant shall provide separate energy meters for Effluent Treatment Plant (ETP) and Air pollution Control equipments to record energy consumed. An alternative electric power source sufficient to operate all pollution control systems shall be provided. 3. The industry shall construct separate storm water drains. No effluents shall be discharged in to the storm water drains. Water: 4. The source of water is APSEZ, Atchutapuram and the maximum permitted water consumption is as following: S. No. Purpose Quantity (KLD) 1 Process 115.00 2 Washings 5.00 3 DM Plant 10.00 4 Boiler Makeup 50.00 5 Cooling towers Makeup 110.00 6 Scrubbing system 5.00 7 Green belt 5.00 8 Domestic 5.00 TOTAL 305.00 Separate meters with necessary pipe-line shall be provided for assessing the quantity of water used for each of the purposes mentioned above. 5. The maximum waste water generation shall not exceed the following: Quantity (KLD) S.No. Source HTDS LTDS Total 1. Process 129.0 0.0 129.0 2. Washings 5.0 0.0 5.0 3. Boiler Blow down 0.0 12.0 12.0 4. Cooling towers Bleed off 0.0 15.0 15.0 5. Scrubbing System 5.0 0.0 5.0 6. Domestic 0.0 4.5 4.5 7. RO/DM Rejects 10.0 0.0 10.0 Total 149.0 31.5 180.5 Page 5 of 10 Treatment & disposal: S. Effluent Source Treatment Mode of Final Disposal No 1 HTDS & HCOD Equalization tank & CETP of M/s. AETL, Atchutapuram. effluent Neutralization 2 LTDS effluent Equalization tank & CETP of M/s. AETL, Atchutapuram. including utilities Neutralization blow down 3 Domestic waste Septic tank Overflow to the CETP of M/s. AETL, water Atchutapuram along with LTDS effluent 6. Effluents shall not be discharged on land or into any water bodies or aquifers under any circumstances. 7. The industry shall provide magnetic flow meters with totalisers at the outlet of the unit. 8. The industry shall install online real time monitoring system along with web camera facilities and shall ensure that it shall be connected to APPCB / CPCB websites as per CPCB directions. 9. Floor washing shall be admitted into the effluent collection system only and shall not be allowed to find their way in storm drains or open areas. All pipe valves, sewers, drains shall be leak proof. Air: 10. The Air pollution Control equipment shall be installed along with the commissioning of the activity and shall comply with the following for controlling air pollution: Sl. Stacks – Details of Stack Stack – I Stack – II Stack – III No IV to VII a) Attached to Coal fired Coal fired Thermic fluid D.G. Sets Boiler Boilers heaters b) Capacity 1 X 5.0 TPH 2 X 3 TPH 2 x 2 Lakh 2 X 250 KVA & K.cal/hr 2 X 500 KVA c) Fuel Coal Coal Oil HSD d) Quantity 2.5 TPD 2.5 TPD 110 L/hr 40 L/hr e) Stack height 30 m 30 m 12 m 3.16 m each & (common (common ) 4.5 m each chimney) g) Details of Air Multicone Multicone --- Acoustic Pollution Control cyclone cyclone enclosures with Equipment separators separators and Silencers and bag filters bag filters Page 6 of 10 11.
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