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CONSENT ORDER FOR ESTABLISHMENT Order No. 468 /APPCB/CFE/RO-VSP/HO/2019 Dt:21.06.2019

Sub: APPCB – CFE - M/s. SSV Pharma Pvt. Ltd., Plot No. 1 A, De-Notified Area, APSEZ, Atchutapuram, 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 OCMMS on 25.05.2019. 2) R.O’s inspection report dt. 31.05.2019. 3) CFE Committee meeting held on 11.06.2019. 4) Industry’s lr. dt. 11.06.2019.

1.

In the reference 1st cited, an application was submitted to the Board seeking Consent for Establishment (CFE) to produce the following products with installed capacities as mentioned below, with a project cost of Rs. 20 Crore.

S. No.

Name of the Product Capacity (kg/day)

No.of Stages

Name of the Key Raw Material

Quantity of Raw Material

(kg/day)

1 (1R,2S)-1-Phenyl-2-(1-Pyrrolidinyl)-1-Propanol

789.0 III Propiophenone 1214.2

2 2-bromo-3'-benzyloxyaceto phenone

789.0 II 3-Hydroxy acetophenone 419.7

3 4-(4-methoxy phenyl)-1-(4-nitrophenyl) piperazine

493.2 II Diethanolamine 197.3

4 Acyclovir 197.3 I Guanine 147.9

5 Atazanavir 82.2 I L-tert-Leucine 38.3

6 Atorvastatin Calcium 82.2 II (4R-cis)-1,1,-dimethylethyl-6-cynomethyl-2,2-dimethyl-1,3-dioxane-4-acetate

67.3

7 Celecoxib 821.9 III 4-Methyl acetophenone 365.3

8 Chloromethyl isopropyl carbonate

1315.1 I Chloromethyl chloro formate 1131.0

9 Cis bromo benzoate 986.3 I 2,4-dichloroacetophenone 424.1

10 Clopidogrel 147.9 II Methyl(+)-alpha-amino(2-chlorophenyl) acetate tartaric acid salt

202.5

11 Drotaverine HCl 246.6 V 1,2-diethoxy benzene 133.2

12 Effavirenz 197.3 II 2'-Amino-5'-chloro-2, 2, 2-trifluoro acetophenone

176.7

Website :www.appcb.ap.nic.in

ANDHRA PRADESH POLLUTION CONTROL BOARD

D.No. 33-26-14 D/2, Near Sunrise Hospital, Pushpa Hotel Centre,

Chalamalavari Street, Kasturibaipet, Vijayawada – 520010.

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13 Emtricitabine 98.6 I

(2R,5S)-5-(4-amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl-[1,3]oxathiolane -2-carboxylic acid(1R,2S,5R)-menthyl ester

171.6

14 Ethyl Methoxy crylene 657.5 I 4-methoxy benzophenone 455.2

15 Indinavir 328.8 I

[2R-[3(S*)1(2S*,3R*)]]2-Benzyl-1-(2,2-dimethyl-2,3,3a,8a-tetrahydro- 8H-indeno[1,2-d]oxazol-3-yl)-3-(2-oxiranyl)-1-propanone

187.1

16 Irbesartan 164.4 I 2-butyl-1,3-diazaspiro[4,4]non-1-ene-4-one hydrochloride

94.6

17 Itraconazole 394.5 I

2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methoxy propyl)-3H-1,2,4-triazol-3-one

239.7

18 Lamovudine 1315.1 I

(2R-Cis)-5-(4-Amino-1,2-dihydro-2-oxo-1-pyrimidinyl)-1,3-oxathiolane-2-carboxylic acid (2S,5R)-menthyl ester

2205.1

19 Levetracetum 1315.1 I (S)-2-Amino butyramide. Hydrochloride

1121.9

20 Lopinovir 263.0 1 2S-(1-Tetrahydro-pyrimid-2- onyl)-3-methylbutanoic acid

163.2

21 Mebeverine HCl 394.5 III 3,4-dimethoxy benzoic acid 197.3

22 Nevirapine 723.3 II 2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3-pyridine carboxamide

960.7

23 OTBN 986.3 II P-Chloro Toluene 540.1

24 Pantoprazole sodium 295.9 II 5-(Difluoromethoxy)-1H-benzimidazole-2-thiol

195.3

25 Piperanal 295.9 I 1,3-benzodioxole 253.5

26 Pregabalin 986.3 I 3-(Carbamoylmethyl)-5-methylhexanoic acid

1183.9

27 Ritanovir 263.0 I

(2S,3S,5S)-2-Amino-3-hydroxy- 5-(t-butyloxy carbonylamino)- 1,6-diphenyl hexane

263.4

28 Sitagliptin 295.9 II ATP acid benzylamine salt 365.2

29 Stavudine 986.3 II 3',5'-Bis(methanesulfonyl)-2,2'-anhydro-5-methyluridine

2525.5

30 Telmisartan 197.3 II 4-Methyl-6-(1-methylbenzimidazole-2-yl)-2-propylbenzimidazole

167.8

31 Tenofovir Disoproxil 164.4 II Adenine 72.3

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32 Valcyclovir 197.3 II 2-(Acetylamino)-1,9-dihydro-9-[[2-(acetyloxy)ethoxy]methyl]-6H-purin-6-one

283.9

33 Valsartan 246.6 II 4-Bromo methyl-2-cyanobiphenyl

273.4

34 Verapamil HCl 279.5 V 1,2-dimethoxy benzene 268.3

35 Zidovudine 986.3 I 5’-O-trityl-2, 3’-anhydro thymidine

1795.1

36 Validation Products 50.0

Total quantity 12 Products at a time

12166.7

The proponent is permitted to manufacture any 12 products at any point of time with a maximum production capacity of 12166.70 kg/day. By Products:

S. No.

Name of the Bi Product Quantity (kg/day)

Name of the product

1 (1S,2R)-1-phenyl-2-(1-pyrrolidinyl)-1-propanol L-(+)-Tartrate salt

1484.8 (1R,2S)-1-Phenyl-2-(1-Pyrrolidinyl)-1-Propanol

2 Sodium salt of D-(-)-Tartaric acid

651.8 (1R,2S)-1-Phenyl-2-(1-Pyrrolidinyl)-1-Propanol

3 Potassium carbonate 170.2 2-bromo-3'-benzyloxyaceto phenone

4 Potassium Chloride 176.3 2-bromo-3'-benzyloxyaceto phenone

5 Sodium Bromide 88.8 Mebeverine HCl

6 3-Methyl1 -1,3,5,7-tetrabicyclo [3,3,1] nonane HCl

352.1 Piperanal

7 5-chloromethyl-1,3-benzodioxole

76.9 Piperanal

8 Potassium Bromide 96.9 Telmisartan

Total 3097.8 kg/day

2. As per the application, the above activity is to be located at Plot No. 1A, De-Notified

Area, APSEZ, Atchutapuram, Vishakhapatnam District District in an area of 3,64,400.0 Sq m.

3. The above site was inspected by the Asst. Environmental Engineer - II, Regional Office,

A.P Pollution Control Board on 30.05.2019 and observed that the site is surrounded by North : Plot No. 1 South : Plot No. 18 B East : Road West : Plot No. 1B

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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. SSV Pharma Pvt Ltd., Dr No. 8-3-945, Flat No. 509, Srinilaya Estate, Yellareddiguda, Ameerpet, Hyderabad. svspharma2016@gmail.com

Copy to: 1. The JCEE, Z.O: Visakhapatnam for information and necessary action. 2. The EE, R.O: Visakhapatnam for information and necessary action.

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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 142.70

2 Washings 11.30

3 Boiler Makeup 120.00

4 Cooling towers Makeup 150.00

5 Scrubbing system 2.50

6 Green belt 15.00

7 Domestic 12.00

Total 453.50

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:

S. No.

Source Quantity (KLD)

HTDS LTDS Total

1. Process 139.80 2.84 142.64

2. Washings 0.00 11.26 11.26

3. Boiler Blow down 0.00 6.00 6.00

4. Cooling towers Bleed off 0.00 7.50 7.50

5. Scrubbing System 2.50 0.00 2.50

6. Domestic 0.00 10.00 10.00

Total 142.30 37.60 179.90

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Treatment & disposal:

Source of effluent Treatment

Mode of final disposal

HTDS & HCOD effluent Equalization tank & Neutralization

Sent to M/s. AETL, CETP of APSEZ

LTDS effluent including utilities blow down

Equalization tank & Neutralization

Sent to M/s. AETL, CETP of APSEZ

Domestic waste water Septic tank Over flow to M/s. AETL, CETP of APSEZ

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. No

Details of Stack Stack – I Stack – II Stack - III

a) Attached to Coal fired Boiler Thermic Fluid Heater

D.G. Set

b) Capacity 1 X 10.0 TPH 1 x 4 Lakh K.Cal

1 X 750 KVA & 2 X 1250 KVA

c) Fuel form Coal HSD HSD

d) Stack height 30 m 20 m 11.5 m common stack

e) Details of Air Pollution Control Equipment:

Multi cyclone separator followed by suitable pack of Bag filters

--- Silencer and Acoustic

enclosures

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11. A sampling port with removable dummy of not less than 15 cm diameter shall be provided

in the stack at a distance of 8 times the diameter of the stack from the nearest constraint such as bends etc. A platform with suitable ladder shall be provided below 1 meter of sampling port to accommodate three persons with instruments. A 15 AMP 250 V plug point shall be provided on the platform.

12. The industry shall provide the monitoring system to all the stacks / vents in the plant. Regular monitoring shall be carried out and report shall be submitted to the Regional officer.

13. The industry shall provide multi-stage scrubbers to the process vents to control the process emissions. The industry shall provide online pH measuring facility with auto recording system to the scrubbers provided to treat the process emissions.

14. The industry shall provide VOC monitoring system with auto recording facility.

15. The industry shall implement adequate measures to control all fugitive emissions from the plant.

16. The proponent shall ensure compliance of the National Ambient Air quality standards notified by MoEF, GoI vide notification No. GSR. 826 (E), dated. 16.11.2009 during construction and regular operational phase of the project at the periphery. The generator shall be installed in a closed area with a silencer and suitable noise absorption systems. The ambient noise level shall not exceed 75 dB(A) during day time and 70 dB(A) during night time.

17. The proponent shall not use or generate odour causing substances or Mercaptans and cause odour nuisance in the surroundings.

18. The industry shall send the used / spent solvents to the recyclers (or) process them at their own solvent recovery facility within the premises.

19. The evaporation losses in solvents shall be controlled by taking the following measures: i) Chilled brine circulation shall be carried out to effectively reduce the solvent losses

into the atmosphere. ii) Transfer of solvents shall be done by using pumps instead of manual handling. iii) Closed centrifuges shall be used to reduce solvent losses. iv) All the solvent storage tanks shall be connected with vent condensers to prevent

solvent vapours. v) The reactor vents shall be connected with primary & secondary condensers to

prevent escaping of solvent vapour emissions into atmosphere.

20. The emissions containing Bromine gases shall be routed through water scrubber, caustic scrubber provided in series. The vent of the caustic scrubber shall be dipped into dilute caustic soda lye for effective removal of Bromine in the emissions. Two stage Caustic scrubbers shall be provided to control acid emissions.

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Solid / Hazardous waste:

21. The industry shall comply with the following for disposal of Solid waste:

S. No

Name of solid waste Quantity Method of disposal

1. Process Organic Residues

3215.60 kg/day

To the authorized Cement industries for co-processing (or) TSDF, Parawada for incineration

2. Spent Carbon 203.10 kg/day

To the authorized Cement industries for for co-processing (or) TSDF, Parawada for incineration

3. Inorganic Residue 1492.10 kg/day

To TSDF, Parawada for secured land filling.

4. ETP Sludge 220.00 kg/day

TSDF, Parawada for secured land filling.

5. Spent Solvents 1.28 KL/Day

Recovery within the premises / to authorised agency for recovery.

6. Mixed Spent Solvents 1.4 KL/day To authorized recovery units / Authorized cement plant for co-processing.

7. Spent Catalyst To the Supplier for recovery

8. Used Oil 30 Ltrs/Annum

Used as lubricant within the premises / to authorized Re-processors / Recyclers / to the Cement industries for co-processing.

9. Waste oils & grease (LPA)

400 LPA APPCB Authorized agencies for Reprocessing / Recycling

10. Containers & Container Liners

100 Nos./Month

To outside agencies, after complete detoxification for re-use/ recycle.

11. Used Lead Acid Batteries

4 Nos./Annu

m

To dealers on buy back system

12. Discarded Centrifuge cloth

10 Nos./ Month

Disposed to TSDF for Incineration

13. Process salts 195.0 kg/day

Disposed to TSDF

14. Boiler Ash 7.680 TPD To Brick Manufacturers.

22. The proponent shall place the chemical drums and / or any drums in a shed provided with concrete platform only. The Platform shall be provided with sufficient dyke wall and effluent collection system. The industry shall provide containers detoxification facility. Container & Container liners shall be detoxified at the specified covered platform with dyke walls and the wash wastewater shall be routed to low TDS collection tank.

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23. The following rules and regulations notified by the MoEF&CC, GoI shall be implemented.

a) Regulation of Persistent Organic Pollutants Rules, 2018.

b) Hazardous waste and other wastes (Management and Transboundary Movement)

Rules, 2016.

c) Plastic Waste Management Rules, 2016.

d) Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989

e) Fly Ash Notification, 2016.

f) Batteries (Management & Handling) Rules, 2010.

g) E-Waste (Management) Rules, 2016.

h) Construction and Demolition waste Management Rules, 2016.

i) Solid Waste Management Rules, 2016.

Other Conditions:

24. The proponent is not permitted to send the effluents to CETP, JNPC as it is

reached its maximum capacity. The effluents shall be sent to CETP, M/s. AETL only. If M/s. AETL is not commissioned, the proponent has to establish their own ETP.

25. Green belt shall be developed all along the boundary & vacant spaces with tall growing trees with good canopy and it shall not be less than 22% of the total area.

26. The industry shall submit the information regarding usage of Ozone Depleting Substance once in six months to the Regional Office and Zonal Office of the Board.

27. Concealing the factual data or submission of false information / fabricated data and failure to comply with any of the conditions mentioned in this order attracts action under the provisions of relevant pollution control Acts.

28. Notwithstanding anything contained in this conditional letter or consent, the Board hereby reserves its right and power Under Sec. 27(2) of Water (Prevention and Control of Pollution) Act, 1974 and Under Sec.21(4) of Air (Prevention and Control of Pollution) Act, 1981 to revoke the order, to review any or all the conditions imposed herein and to make such modifications as deemed fit and stipulate any additional conditions.

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29. Any person aggrieved by an order made by the State Board under Section 25, Section

26, Section 27 of Water Act, 1974 or Section 21 of Air Act, 1981 may within thirty days from the date on which the order is communicated to him, prefer an appeal as per Andhra Pradesh Water Rules, 1976 and Air Rules,1982, to such authority (hereinafter referred to as the Appellate Authority) constituted under Section 28 of Water (Prevention and Control of Pollution)Act,1974 and Section 31 of the Air (Prevention and Control of Pollution) Act, 1981.

CHAIRMAN

To M/s. SSV Pharma Pvt Ltd., Dr No. 8-3-945, Flat No. 509, Srinilaya Estate, Yellareddiguda, Ameerpet, Hyderabad. svspharma2016@gmail.com