Minutes of the 652Nd Meeting of the State Level Expert Appraisal Committee Held on 30Th May 2020 Through Video Conference

Minutes of the 652nd meeting of the State Level Expert Appraisal Committee held on 30th May 2020 through Video Conference.

In the wake of recent crisis of COVID-19, lockdown situation, notification of MOEFCC regarding API and bulk drugs and subsequent OM issued on 11th March 2020, Notification on 27th March 2020 and OM dated 13th April 2020, Committee took a decision to scope and appraised the TOR and EC cases falling in CPA/SPA and non CEPI areas as per the guidelines issued by MOEFCC from time to time by video conferencing. It was decided that before commencement of online video conferencing the agenda is required to be mailed beforehand. Accordingly the agenda of the present meeting was mailed to expert committee in advance and a video conference meeting on NIC was organised in this regard on 30/05/2020 at 16.00 hrs.

The 652nd meeting of the State Level Expert Appraisal Committee (SEAC) was held online by Video conferencing on 30th May 2020 at 16.00 hrs. Following members joined the meeting:

1. Dr. Dinesh Misra, Chairman, SEAC 2. Shri S. C. Srivastav, Vice Chairman, SEAC 3. Shri V. N. Patel, Member, SEAC 4. Shri R. J. Shah, Member, SEAC 5. Dr. V.K. Jain, Member, SEAC 6. Shri A.K. Mule, Member, SEAC 7. Shri Rajesh Shah, Member, SEAC 8. Shri A. V. Shah, Secretary, SEAC

This meeting was conducted with reference to MoEF&CC‘s OM vide F. No. 19-21/2020-IA.III (Part) dated 11/03/2020 regarding consideration of projects or activities in respect of Bulk drugs (Active Pharmaceutical Ingredients and Bulk Drug intermediates), out of turn, as a preparedness to the outbreak of Novel Coronavirus (COVID-19).

During the meeting, the Committee took a note of MoEF&CC‘s Notification vide S.O. 1223 (E) dated 27/03/2020 regarding Active Pharmaceutical Ingredients (API).

As per the Notification, MoEF&CC deems it necessary to expedite the prior Environmental Clearances to the projects or activities in respect of bulk drugs and intermediates. As a part of comprehensive and robust system to handle the Novel Coronavirus (COVID-19) outbreak, drug availability or production to reduce the impact of the Novel Coronavirus (COVID-19) are to be ensured. The Ministry deems it necessary that all projects or activities in respect of bulk drugs and intermediates manufactured for addressing ailments such as Novel Coronavirus (COVID-19) and those with similar symptoms are categorized as ‗B2‘ for a period up to the 30th September 2020,

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“All proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API), received up to the 30th September 2020, shall be appraised, as Category „B2‟ projects, provided that any subsequent amendment or expansion or change in product mix, after the 30th September 2020, shall be considered as per the provisions in force at that time.”

In view of the above, all the projects referred in the agenda were presented before the committee along with the proposed mitigations proposed by PP as per guideline mechanism devised by MOEFCC with changed EMP and CER After case to case deliberation, the Committee took a decision to recommend all the cases to SEIAA for further action at their end. Further taking note of current scenario of Novel Coronavirus (COVID-19) outbreak in line to MoEFCC‘s OM dated 11/03/2020 and MoEFCC‘s Notification dated 27/03/2020,the Committee also unanimously decided the following:

“All proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API) which are already discussed and decided to recommend to MoEF&CC as per the OM dated 30/12/2019, however yet not recommended shall be now sent to SEIAA, Gujarat considering EIA Notification dated 27/03/2020.”

As per the MoEF&CC‘s OM dated 31/10/2020, B2 category projects shall be considered at State Level stipulating Environmental Clearance conditions as applicable for category B1 projects/activities.

The meeting was organized on a very short notice to facilitate the production of COVID-19 specific drugs which are presently in global demand. Looking to the grim situation arose due to COVID-19, Government of India has lifted the export ban of these drugs and a policy decision is taken to cater the global demand of these medicines.

The expert Committee felt the need to rise to the occasion and did the appraisal on a very short notice. Committee also felt to put a specific condition to start the production within a period of 45 days and also critically evaluate the EC after first six monthly compliance report submitted by PP.

The Committee considered the applications made by project proponents, additional details submitted as required by the SEAC/SEIAA and details furnished in the Form-1, PFR, EMP reports etc.

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Sr. Proposal no. Name and address of the unit. Remarks No . 1 SIA/GJ/IND2/151754/2020 M/s. Nigam Industries (Unit – II) Appraisal

Plot No. A-1/448, Ankleshwar GIDC, Dist: Bharuch, State: Gujarat Category of the unit: 5(f) Project status: Expansion

 Project proponent (PP) submitted online application vide no. SIA/GJ/IND2/151754/2020 dated 23/04/2020 for obtaining Environmental Clearance.  Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. Sr. Name Of The Products CAS Quantity MT/Month End Use Of No. No. /CI The Product No. Existing Propo Total se D GROUP- A :- EXISTING PRODUCT 1. Polyester Grey Cloth -- 550000 - 0 Textile Mill 55000 0 TOTAL 0 PROPOSED PRODUCT GROUP – B :- MISCELLANEOUS 1 C H Base 55-56-1 0 10 10 Disinfectant

2 Hydroxy Chloroquine Sulfate 747-36-4 0 3 3 used to treat certain auto- immune diseases (lupus, rheumatoid

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arthritis). 3 Olanzapine 132539- 0 5 5 Anti-Bacterial 06-1

4 4-Hydroxy Cumarine 1076-38-6 0 5 5 warfarin, a pharmaceutica l drug used to prevent formation of blood clots TOTAL 23 GROUP – C :- 3 MT/M 5 Thebromine Either /Or 83-67-0 0 5 5 Diuretic

6 Miconazol Nitrate Either /Or 22916-47- Anti-Fungal 8 Drugs

7 Oxfendazole Either /Or 53716-50- Anti-Fungal 0 Drugs 8 Frusemide Either /Or 54-31-9 Antifungal Drugs 9 Albendazole Either /Or 54965-21- Anthelmintic 8 Drugs TOTAL 5 GROUP – D :- 5 MT/M 0 5 5 10 6-Chloro Hexanon Either /Or 10297-06- Antibacterial 0

11 Tetiary Butyl Hydroquinone Either 1948-33-0 Antibacterial /Or 12 Esomeprazole Magnesium Either /Or 217087- Antibacterial 09-7

13 Methyl Nicotinate Either /Or 93-60-7 Antibacterial 14 Cetypyridinium Chloride Either /Or 123-03-5 Antibacterial

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15 1 (2,4 Di Chloro Phenyl)-2(1 09-07- Antibacterial Imidozaly) Ethanol Either /Or 7098 16 Levetiracetam Either /Or 102767- Antibacterial 28-2 17 Ambroxol Hydrochloride Either /Or 23828-92- Respiratory 4 Diseases

18 Vildagliptin Either /Or 274901- Anti- 16-5 Hyperglycaemi c 19 Rivaroxaban Either /Or 366789- Anti-Coagulant 02-8 20 Diacerein Either /Or 13739-02- Treat 1 Osteoartharitie s 21 Aglomealtine Either /Or 138112- Anti- 76-2 Depressant 22 Levosulpiride Either /Or 23672-07- Anti-Psychotic 3 23 Carbamazepine Either /Or 298-46-4 Treat Neuropathic Pain 24 Fesoteredon Either /Or 286930- Ant Muscarinic 02-7 25 Febuxostat Either /Or 144060- Treat Arthritis 53-7

26 2-Mercaptobenzimida Zole Either /Or 583-39-1 Pharma Intermediate For anti ulcer drug 27 3,4 Di Hydroxy-5-Nitro Benzald 116313- Pharma Either /Or 85-0 Intermediate use to prevent parkinson's

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28 1-(3 Chloro Phenyl) Either /Or 1111-97-3 Pharma Intermediate use to prevent insomnia , anti depressant drug 29 Bronopol Either /Or 52-51-7 Preservative Agent For Pharmaceutica l Formulation 30 2 Mercapto 5 Methoxy 37052-78- Preservative Benzimmidazole Either /Or 1 Agent For Pharmaceutica l Formulation 31 Acebrophylline Either /Or 179118- Preservative 73-1 Agent For Pharmaceutica l Formulation 32 Preservative Agent For Benzyl Acetate Either /Or 140-11-4 Pharmaceutica l Formulation 33 Preservative Agent For Benzyl Alcohol Either /Or 100-51-6 Pharmaceutica l Formulation 34 Preservative Agent For Benzyl Cynide Either /Or 140-29-4 Pharmaceutica l Formulation 35 Preservative Agent For Benzyl Benzoate Either /Or 120-51-4 Pharmaceutica l Formulation

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36 Preservative Agent For Naphthalene Acetic Acid Either /Or 86-87-3 Pharmaceutica l Formulation 37 4-Methoxy Phenyl Acetic Acid Either Preservative 104-01-8 /Or Agent TOTAL 5 38 R & D Product 0.1 MT/M GRAND TOTAL (A+B+C+D) 33.1 MT/M  The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The proposal was considered in the meeting dated 30/05/2020.  Salient features of the project including Water, Air and Hazardous waste management: Sr. Particulars Details no. A Total cost of Proposed Existing: 1.70 Project (Rs. in Crores): Proposed: 8.96

Total: 10.66 Details of EMP Detail of EMP is attached as a Separate file.

Details of CER as per OM As per OM dated 01/05/2018 Fund allotted for CER activity will dated 01/05/2018 be 1% of additional capital investment (Brownfield Field project). As project falls under CEPI area, unit will allot additional 1% fund towards CER activity. Therefore total fund allotted will be 2% of investment.(17.92 Lacs).

B Total Plot area Existing: 2702 Sq. m. ( sq. meter) Proposed: 0 Sq. m.

Total: 2702 Sq. m.

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Green belt area Existing: 692 Sq. m. ( sq. meter) Proposed: 361 Sq. m.

Total:1053 Sq. m. C Employment generation Existing: 20 Proposed: 100 Total:120 D Water i Source of Water Supply GIDC ANKLESHWAR (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the GIDC fresh water permission unit will submit after lockdown. concern authority. Existing water bill is attached as Annexure -18.

ii Water consumption (KLD)

Sr. Particulars Existing Proposed Total after Remarks No. KLD (Additional) Expansion KLD KLD 1. Domestic 3.0 0.0 3.00 Unit will use 3 KLD Fresh Water for domestic purpose. 2. Gardening 0 5 5 Fresh 3. Industrial Process 22 16 38 38 Fresh

washing 5 0 5 Fresh Boiler 6 0 6 Fresh Cooling 9 11 20 1.5 Fresh + 18.5 Recycle Other 0 0.35 0.35 Fresh

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Boiler 0 0.2 0.2 0.2 KLD Recycle Scrubber Industrial 42 27.55 69.55 50.85 Fresh + Total 18.7 Recycle Grand Total 45 32.55 77.55 58.85 Fresh + (1+2+3) 18.7 Recycle

1) Total water requirement for the project: 77.55 KLD 2) Quantity to be recycled: 18.7 KLD 3) Total fresh water requirement: 58.85 KLD (Total water requirement = Fresh water + Recycled water) iii Waste water generation (KLD)

Sr. Particulars Existing Proposed Waste Total Waste Remarks No. Waste water Generation Water Water KL/Day Generation Generation after KL/Day expansion KL/Day 1. Domestic 3.00 0.0 3.00 After treatment in ETP discharged into the NCTL. 2. Industrial Process 27.9 20.1 48 Subjected to ETP Washing 5 0.0 5 Subjected to ETP Boiler 0.1 0.1 0.2 Boiler Blow down will be used in Boiler Scrubber. Cooling 2 1.0 3 Subjected to ETP. Other 0 1.2 1.2 In which 1 KLD

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send to the ETP & 0.21 KLD reused in the production process of 2 Mercapto 5 methoxy benzidimidazol e Scrubber 0 0.2 0.2 0.2 KLD Boiler scrubber used for ash quenching Scrubbed 0 1 1 -- Solution Total 35 23.6 58.6 -- Industrial TOTAL 38 23.6 61.6 -- (Domestic + Industrial)

iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc..  ETP (Primary, Secondary, Tertiary) – 100 KLD  MEE - 55 KLD  RO - 30 KLD Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) ETP FLOW DIAGRAM

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EFFLUENT CHARACTERISTIC

ETP Prim Secon Sand Trea Low COD Inlet ary dary & ted Effluent Clarif Clarifi Carb Efflu Colle Fro ier er on ent ction m filer Sen Cum Inlet Util d to Sr Neutr MEE Para itie NCT . Un alizati (Rema mete s, N it on ining MEE r Scr o. Tank Efflue Conde ub (Strip nt) nsate ber per & Inlet ) wa shi ng 1 pH - 6.0- 6.5 – 6.5 – 7.0 6.5 7.0 – 7.0 – 7.0 – 7.0 – 8.0 8.0 8.0 0- – 8.0 8.0 8.0 8.0 9.0 8.5 0

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2 TDS mg 20000 20000- 300- 150 500 500 - 500 - 500 - 500 - /lit - 25000 500 0- - 1000 1000 1000 1000 25000 200 100 0 0 3 SS mg 200- 200- <10 50- 20 - <20 <20 <5 <5 /Lit 250 250 60 50 4 COD mg 25000 20000- 1000- 100 1000 <500 <500 <500 250 /lit - 25000 1500 0 - - - 35000 150 1500 350 0 5 BOD mg 8000 - 6000 - 400 - 400 400 - <150 <150 <150 80- /lit 12000 8000 500 - 500 100 500 7 Phen mg 1-10 1-10 1-10 <1 <5 <5 <5 <5 <5 olic /lit Com poun d 8 Amm mg 80- 80-100 <5 <5 <5 <5 <5 <5 <5 onica /lit 100 l Nitro gen EFFLUENT CHARACTERISTIC AT R.O

Parameters RO inlet RO Rejected RO Permeate

pH 7.00-8.00 7.00-8.00 7.00-8.00 TDS (ppm) <1000 2500-3500 100-200 COD (ppm) <300 1000-1500 10 Ammonical Nitrogen <5 <5 Nil (ppm)

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& quality will be the same So, direction under section 18 (1) (b) of the Water (Prevention and Control of Pollution) act, 1974 issued by CPCB regarding compliance of CETP is complied. Existing (Quality) Proposed (Quality) Parameters NCT Discharge norms Discharge Discharge pH 7.0 – 8.0 7.0 -8.0 6.5-8.5 TDS (mg/lit) 500-1000 500-1000 <10000 COD (mg/lit) <500 <500 <1000 BOD (mg/lit) <150 <150 <200 Ammonical Nitrogen <5 <5 <50 (mg/lit)

Brief note on adequacy of ZLD (In case of Zero Liquid Discharge):  Not Applicable v Mode of Disposal & Final meeting point

Domestic: After treatment in ETP discharged into the NCT.

Industrial: 63.7 KL/day effluent is treated in unit‘s own effluent treatment plant. In which generated ETP Sludge 1.2 KLD send to the TSDF site .After treatment 38 KLD effluent send to NCT and remaining 24.5 KLD will be send to RO. In which RO permeate 18.5 KLD will be reuse in Cooling tower blow down & Remain 6.0 KLD RO Reject will be send to the MEE. vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF) (For waste water treatment)  Narmada Clean Tech Membership of Common facility (CF) (For waste water treatment) Narmada Clean Tech – 38 KLD vii Simplified water balance diagram with reuse / recycle of waste water

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vii Reuse/Recycle details (KLD) [Source of reuse & application area] Total reuse 18.7 KLD - Source of waste Application area Characteristics of waste Remarks water for reuse with with quantity in water to be reused (COD, regardin quantity in KLD KLD (Where it is BOD, and TDS etc.) g (From where it is used) feasibilit coming) y to reuse i.e. 18.5 from RO 18.5 KLD in pH: 7-8 Reusable Permeate Cooling Tower COD: <50 mg/l Blow Down TDS: 1000-1500 mg/l 0.2 KLD From Boiler 0.2 KLD used in Reusable pH: 8 to 10 Blow down Boiler Scrubber for TDS: 3000-5000 coal handling & Ash quenching

E Air

652nd meeting of SEAC-Gujarat, dated 30.05.2020- VIDEO CONFERENCE (VC) on NIC Page 14 of 296 i Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed

Stack Stack Type Sr. Quantity of Permissible Attached Height APCM of No. Fuel Limit To (m) Emission AS PER Existing CCA No:-AWH-88685 Boiler-1 PM 120 mg/Nm3 Multi Cyclone 1. (3 MT/Hr.) SO2 80 ppm Coal - + Bag Filter + 30 NOX 40 ppm 6 MT/Day Water Thermic Fluid PM 120 mg/Nm3 Scrubber 2. Heater (15 SO2 80 ppm

Lac/Kcal) NOX 40 ppm AFTER PROPOSED EXPANSION D.G.Set PM 120 mg/Nm3 Diesel- 35 Acoustic 3. (200 KVA) 12 SO2 80 ppm lit/day Enclosure NOX 40 ppm - ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed - Sr. APCM attached Stack APCM Pollutant Permissible No. to Height Limit AS PER Existing CCA No:-AWH-88685 There is no flue gas emission After Proposed Expansion Reaction vessel( Water Scrubber + HCl 16 mg/Nm3 1 12 3 GLR) Caustic scrubber SO2 32 mg/Nm Reaction Vessel Water Scrubber + 3 2. 12 H2S 24 mg/Nm (GLR) Caustic scrubber - iii Fugitive emission details with its mitigation measures. Sr. Source Probable Control Measures/ APCM No. Pollutant Emission

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1 Solvent storage tank Air pollutant i) Carry out work place area (VOC) monitoring to find out concentration level in ambient air Close handling system. ii) Provision of breather valve cum flame arrester. 2 Solvent recovery Air pollutant i) Solvent recovery system system (VOC) with steam condensation system. ii) Pupmps & motors are Mechanical seal type. 3 Handling of raw Air pollutant i) Provision of exhaust material bags in (PM) ventilation storage area Provision ofPPE. ii) Provision of Job rotation to reduceexposure. 4 Flange joints of Air pollutant i) Routine &periodic pipeline, pump & (VOC) inspection to checkleakage. motors ii) Preventive maintenance, Follow SOP formaintenance. iii) Pumps & motors will be mechanical sealtype. iv) LDAR program will be followed. Provision of Flange guard. 5 Solid raw material Air pollutant Hopper will be provided with transferring to reactor (PM) powder transfer system.

6 Liquid raw material Air pollutant Feeding of liquid raw material transferring to reactor (VOC) will be carried out by closed pipeline and mechanical seal pump.

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7 Loading /unloading Air pollutant Unloading through pipeline to at storage area (VOC) tank in a close system.

F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Existing & Proposed i Sr. Type/Name Specific Cate Quantity Management of HW no. of Source of gory (MT/Annum) Hazardous generation and Exist Propo Tota waste0 (Name of the Sche ing sed l Activity, dule Product etc.) as per HW Rule s. 1. Empty From Packing 33.1 4.0 26 30 Collection, Storage, barrels/contai Material decontamination , ners/liners Disposal by send it to contaminate authorized with decontamination facility / hazardous recycler or reuse chemicals/wa or send back to supplier stes 2. Chemical From Effluent 35.3 12.0 426 438 Collection, storage within Sludge from treatment plant factory premises, waste water transportation and treatment Disposal at TSDF 3. MEE Salt From 35.3 0 402 475 Collection, Storage, Evaporator Transportation, Disposal at TSDF site authorized by the GPCB.

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4 Strip Solvent From Solvent 20.2 - 365 365 Collection, Storage, (Mix Solvent) Stripper Send for Co-Processing outside CEPI area.

5 Chemical Process waste 24.1 0.10 -0.10 0 Disposal at TSDF site of Residues BEIL.

6 Used or From 5.1 0.01 5 5.01 Collection, storage, Spent oil Lubrication transportation & Reuse in plant & machinery as lubricant or sell it to authorized re-refiners / Recycler. 7 Process solid Production 28.1 - 26 26 Collection, Disposal by waste process from sent it to Co-Processing Hydroxy outside CEPI Area. Chloroquine sulphate , Mrthyl Nicotinate 8 Residue Production 20.3 0 106 106 Collection, Storage, process of Send for Co-Processing Carbamazepin outside CEPI Area e 9 Recoverable From Process 20.2 0 9546 954 Collection, Storage, Solvent 6 Transportation & recover and reuse internally. 10 Spent Generates 28.3 0 15 15 Collection, Disposal by Carbon from sent it to Co-processing Production outside CEPI Area. process of Theobromine

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11 Spent Production 28.2 0 46 46 Collection, Storage, Catalyst process of Transportation & sell to Theobromine supplier for reactivation & & reuse. Levetiracetam 12 Sodium Scrub solution B15 0 77 77 Hydrosulfide Generates Collection, Storage and (NaHS) from 2- Reuse in 2- Mercapto 5- Solution: MERCAPTOB Methoxy benzimidazole Inorganic ENZIMIDA Waste ZOLE 13 Sodium Generates B15 0 25 25 Collection, Storage and Bromide from Bronopol disposal by sell out to Solution authorized vendor under Rule 9 permission outside CEPI area. 14 Date expired From premises 28.4 0 1 1 Collection, storage, Product transportation, Co- Processing outside CEPI Area. 15 Off- Production 28.5 0 1 1 Collection, storage, specification process transportation, Co- Product Processing outside CEPI Area.

ii Membership details of TSDF, CHWIF etc. Unit will submit membership (For HW management) Certificate after the lockdown. iii Details of Non-Hazardous waste & its disposal(MSW All non-hazardous waste will give to and others) scrap vendor G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format) Solvent Solvent Perce Sr. Name of Quantity recovered ntage No solvent (MT/Mon quantity Recov . Name of Propduct used th) (MT/Month ery

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)

Butanol 263.6 256 97 1 CHB Acetone 147.27 143 97 Ethyl Acetate 16.32 15.5 95 Toluene 12 11.4 95 2 Atorvastatin Ipa 1.83 1.7 95 Dimethyl Formamide 2.93 2.81 96 Tri Ethyl Amine (Tea) 0.50 0.48 96 Dimethyl 96 Sulphoxide 2.06 1.98 96 3 OLANZAPINE Methanol 4.69 4.51 Ethyl Acetoacetate 8.94 8.58 96 4-HYDROXY Petroleum 4 CUMARINE Ether 5.31 5.10 96 Acetic Acid 20.38 19.6 96 Dimethyl 5 THEOBROMINE Sulphate 6.59 6.33 96 Toluene 47.06 45.18 96 6 MICONAZOL NITRATE Methanol 22.9 22.05 96 7 OXFENDAZOLE Methanol 25.62 24.6 96 IPA 14.13 13.28 96 8 FRUSEMIDE Acetic Acid 1.12 1.05 96 Di Methyl Sulphate 0.43 0.41 96

Methanol 4.05 3.84 96

9 ALBENDAZOLE Acetic Acid 0.33 0.32 96 6- CHLORO 10 HEXANONE IPA 6.55 6.29 96 TERTIARY BUTYL 11 HYDROQUINON Toluene 0.25 0.24 96

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Acetic Acid 111.351 106.90 96 Acetone 44.749 42.96 96 Methanol 0.300 0.29 96 MDC 79.996 76.80 96 12 ESOMEPRAZOLE Toluene 49.873 47.87761 96

13 METHYL NICOTINATE Methanol 12.85 12.08 95 Methyl Ethyl ketone 20 18 96 14 CETYLPYRIDINIUM Acetone 20 18 96 1 (2,4 Di Chloro Hexane 2.46 2.21 96 Phenyl)-2(1 Imidozaly) 15 Ethanol Toluene 2.15 2.07 96 DCM 12 11.52 96 16 LEVETIRACETAM Ethyl Acetate 2.90 2.74 96 17 AMBROXOL IPA 50 47.5 96 IPA 25.2 23.94 95 Dichloro methane 106.25 100.9 95 18 VILDAGLIPTIN Acetone 65.6 63 96 19 RIVAROXABAN Acetic Acid 0.2 0.19 96 Methanol 21.87 20.99 96 20 DIACEREIN Acetone 21.88 20.01 96 21 AGOMEALTINE Acetic Acid 2.87 2.75 96 Mono Ethylene 22 LEVOSULPIRIDE Glycol 10.8 10.3 96 Methanol 5.07 4.87 96 Toluene 0.20 0.19 96 23 CARBAMAZAPINE Acetone 35.52 31.22 96 Acetone 0.0080 0.0077 96 24 FEBUXOSTAT Methanol 2.52 2.42 96 3,4 Di HYDROXY-5- MDC 123 118 96 25 NITRO DMF 86 82 96 Toluene 5.95 5.70 96 26 1-(3 Chloro Phenyl) Methanol 7.84 7.52 96

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27 BRONOPOL Methanol 5.49 5.27 96 28 Acebrophylline DMF 50 47.5 96 29 Benzyl Cynide TEA 0.059 0.056 96

30 BENZYL BENZOATE TEA 0.046 0.044 96 NEPTHALIN ACETIC 31 ACID TEA 0.135 0.13 96

ii VOC emission sources and its mitigation measures  Provision of mechanical seal in pump.  Regular inspection of tank roof seals.  Adequate measures for the minimization/prevention of the fugitive emission.  Regular maintenance of valves, pumps and other equipment to prevent leakage.  Entire process to be carried out in the closed reactor with proper maintenance of temperature.  Regular periodic monitoring of work area to check the fugitive emission.  Adequate stack heights as per the GPCB estimation will be provides at all locations to reduce GLCs of pollutants.  Air Pollution Control System will be installed in the plant H  Details regarding storage of Hazardous chemicals Storage Name of major Hazardous chemicals Remarks details(Cylinfer,Storage Tank, HDPE Storage Tank, Drum, Barel) Drum N- Butanol -- HDPE Storage Tank Hydrochloric Acid --- Drum Acetone -- Drum Methanol -- MS Storage Tank Sulphuric Acid -- Bags Oxalic Acid -- Drum Acetic Acid -- Drum Isopropyl alcohol -- Drum Methylene Chloride -- Drum Hexane -- Drum Nitric Acid -- Bottle Bromine --

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 Applicability of PESO :  Not Applicable  During the meeting dated 30/05/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & Environment Management Plan.  Committee noted that PP intends to manufacture Bulk Drug Intermediate & API.  Project proponent (PP) and technical expert remain present during video conference meeting.  PP mentioned that the proposal is for expansion of unit in GIDC Ankleshwar.  Committee noted that PP is going to surrender the existing production of polyester grey cloth however there is no any change in respective Air, Water & Hazardous Waste and they are kept as it is and asked PP to justify the same to which PP could not give any satisfactory reply.  After detailed discussion, Committee unanimously decided to defer the proposal and consider the same only after PP submits proper details after making necessary changes and correction in Air, Water & Hazardous Waste for surrendering the existing the production of Polyster Grey Cloth along with Revised Water Consumption & Water Water Generation and Discharge Details along with Justification of No Decrease in Fuel Consumption w.r.to Decrease in Existing Production Compared to Expansion Senario. 2 SIA/GJ/IND2/152669/2020 M/s. VIHITA CHEM (P) LTD Appraisal Plot No. 305, Ankleshwar GIDC,Tal: Ankleshwar,Dist: Bharuch-393002, Gujarat. Category of the unit: 5(f) Project status: Expansion  Project proponent (PP) submitted application by proposal no- SIA/GJ/IND2/152669/2020 on dated 09/05/2020 for obtaining Environmental Clearance (EC).  Project proponent has submitted Form – 1, Pre-Feasibility Report & relevant documents as per the Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This proposal is submitted by technical expert of PP, M/s. Jyoti Om Chemical Research Centre Pvt. Ltd.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. SR. NAME OF THE CAS no QUANTITY MT/MONTH END-USE OF THE NO. PRODUCTS PRODUCTS EXISTIN PROPOSE TOTAL G D GROUP-1 (Sr. NO:- 1 to 3) (Not more than 70 MT/Month) 1. 2,3,4,5–bis-O-[1-Methyl 20880-92- 60 10 70 For Topiramate Ethyl idene]B-D- 6 (API) Fructopyranose And/Or

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2. Di Methyl Formamide Di 4637-24-5 60 10 70 For Imatinib . (API) Methyl Acetal And/Or

3. 4-Methyl Catechol Di- 52589-39- 60 10 70 For API - acetic acid Dimethyl 6 (Chlorpromazine ester (API)) GROUP-2 (Sr No:-4 to 8 ) (Not More than 40 MT/Month) 4. 4-Methyl Catechol 452-86-8 20 20 40 For API- And/Or Chlorpromazine(API)

5. Methylene dioxy phenol 533-31-3 20 20 40 For Paroxetine . And/Or (API)

6. 4-Chloro-4‘Hydroxy 42019-78- 20 20 40 For Fenofibrate . Benzophenone And/Or 3 (API)

7. 2-Bromo Veratryl 53207-00- 20 20 40 For Pinaverium Bromide And/Or 4 Bromide (API)

8. 7-Ethyl tryptophol 41340-36- 0 40 40 For Etodolac . (API) 7

GROUP-3 (Sr No:-9 to 74) (Not More than 30 MT/Month) 9. Di Methyl Formamide Di 18503-89- 7 23 30 For Cocaine . (API) Iso Propyl Acetal 4 And/Or 10. 4-Methoxy 2186-92-7 7 23 30 For Benzaldehyde dimethyl Paclitaxel/Octinoxate Acetal And/Or . (API) 11. Benzaldehyde dimethyl 1125-88-8 7 23 30 For Rosuvastatin . Acetal And/Or (API)

12. Dimethyl Acetamide 018871- 0 30 30 For Zaleplon . (API) Dimethyl Acetal And/Or 66-4

13. O-Benzyl hydroxyl 2687-43-6 7 23 30 For Larsartan .(API) amine Hydrochloride And/Or 14. Endo-9-methyl-9- 76272- 0 30 30 For Granisetron . azabicyclo[3,3,1]nonane 56-5 (API) 3-amine And/Or 15. 2,3 Dihydrofuran And/Or 1191-99- 0 30 30 For Etodolac (API) 7

16. 2-Amino-4-fluoro 3800-06-4 0 30 30 For Pitavastatin . Benzophenone And/Or (API)

17. 2-(2-ethoxy 64464-07- 0 30 30 For Tamsulosin .(API) phenoxy)ethyl amine 9 HCL And/Or 18. 2-(2-ethoxy 6781-17-5 7 23 30 For Tamsulosin . phenoxy)ethyl amine (API) And/Or 19. N-(4-cyanophenyl)- 42288-26- 7 23 30 For Dabigatran . (API) glycin And/Or 6

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20. 1-(2,'5' Dimethoxy 3600-87-1 0 30 30 For Midodrine . (API) phenyl amino ethanol) And/Or 21. Guanidine hydrochloride 50-01-1 20 10 30 For Triazine . (API) And/Or

22. Guanidine Nitrate 506-93-4 20 10 30 For Trimethoprim . And/Or (API)

23. Guanidine thiocyante 593-84-0 20 10 30 For Triazine . (API) And/Or

24. O-benzyl hydroxyl amine 2687-43-6 0 30 30 For Azaindoles . (API) And/Or

25. Syringaldazine 14414-32- 0 30 30 For Veterinary (API) And/Or 5

26. 3-amino-2- 55341-87- 0 30 30 For Tyrosine thiophenecarboxylic acid 2 phosphatase (API) And/Or 27. Ethyl 2-(3-cyano-4- 125971- 0 30 30 For Atorvastatin . isobutoxyphenyl)-T-oxo- 96-2 (API) N,B- diphenylbenzenebutana mide And/Or 28. Sulfamerazine And/Or 127-79-7 0 30 30 For Antibiotic & Antimicrobial (API)

29. 2-amino-4- 108-52-1 0 30 30 For Sulfamerazine. methylpyrimidine (API) And/Or 30. Methyl-2-amino-3- 57113-91- 0 30 30 For Candesartan . nitrobenzoate And/Or 4 (API)

31. Guanidine carbonate 593-85-1 0 30 30 For Triazine . (API) & And/Or COVID-19 Testing Kit

32. N-hydroxyphthalimide 524-38-9 0 30 30 For Losartan (API) And/Or

33. Alpha –Bromo -2-Chloro 85259-19- 7 23 30 For Clopidogrel . Phenyl Acetic Acid 4 (API) Methyl Ester And/Or 34. 4-Methoxy-3- 592542- 7 23 30 For Ondansetron . nitrobenzylsulfonylacetic 51-3 (API) acid And/Or 35. 3,4-Dihydroxy Benzoic 99-50-3 7 23 30 For Protochuic Acid . Acid And/Or (API)

36. 3,4- Dihydroxy Benzoic 2150-43-8 0 30 30 For Protochuic Acid . Acid Methyl ester (API) And/Or 37. Piperonylic Methyl 326-56-7 7 23 30 For Protochuic Acid . Ester And/Or (API)

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38. Ethyl 3-[(pyridin-2-yl)- 103041- 7 23 30 ForDabigatran .(API) amino]- 38-9 propanoate And/Or 39. 3-nitro-4-methylamino 41263-74- 7 23 30 ForDabigatran .(API) benzoic acid And/Or 5

40. Hydroquinone dimethyl 150-78-7 0 30 30 Midodrine . (API) ester And/Or

41. Malonic Acid Methyl 38330-80- 0 30 30 Gycosylation . (API) Ester Potassium salt 2 And/Or 42. (1R,2R)-1,2 46022-05- 0 30 30 For LurasidonHcl . Cyclohexane 3 (API) Dicarboxylic Acid And/Or 43. 1-Methylindazole-3- 50890-83- 0 30 30 For GarnisetronHcl . Carboxylic acid And/Or 0 (API)

44. Isovanillic Acid And/Or 645-08-9 7 23 30 For Galantamine . (API)

45. 2-Methyl-3-Oxo- 759-66-0 0 30 30 For Etodolac .(API) Pentanoate And/Or

46. 2-(2-ethoxy phenoxy)- 106463- 7 23 30 For Tamsilosin HCl mesylate And/Or 17-6 ermediate

47. 3-(((2-methoxy-2- 106820- 0 30 30 For Tenoxicam .(API) oxoethyl)amino)- 63-7 sulfonyl)-2- thiopenecarboxylic acid methyl esterAnd/Or 48. methyl-6- 2519-37-1 7 23 30 For Etoricoxib . (API) methylnicotinate And/Or

49. 4-[(4-Methyl-1- 106261- 0 30 30 For Lematinib . (API) piperazinyl)-methyl]- 48-7 benzoic acid And/Or 50. 2-(((2'-cyano- 139481- - 30 30 For Cilexetile . (API) (1,1'biphenyl)-4-yl)- 28-0 methyl)amino)-3-nitro benzoic acid) And/Or 51. Ndlic anhydride (endo- 3853-88-1 0 30 30 For LurasidoneHcl . cis- bicyclo-(2.2.1)-5- (API) heptane-2,3- dicarboxylic acid) And/Or 52. 4- Methoxy-3-(3- 895240- 0 30 30 For Aliskiren (API) methoxypropoxy) 50-3 benzoic acid And/Or 53. 3- BUTYyl-3-oxo 32249-35- 0 30 30 For Pitavastatin . Propionic Acid Methyl 7 (API) Ester And/Or

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54. 4-hydroxy Benzyl 623-05-2 7 23 30 For Bisoprolol Alcohol And/Or Fumarate . (API)

55. 2,4,6 830-79-5 7 23 30 For Ondansetron . TrimethoxyBenzaldehyd (API) e And/Or 56. 4-Isopropyl catechol 2138-43-4 7 23 30 For Carbosynth . And/Or (API)

57. 3-Methoxy Phenol 150-19-6 7 23 30 For Antioxidants And/Or (Api)

58. Veratryl Alcohol And/Or 93-03-8 7 23 30 For Pinaverium Bromide . (API)

59. 3,4 139-85-5 7 23 30 For Protochuic Acid . DihydroxyBenzaldehyde (API) And/Or 60. 4-Propyl Catechol 2525-02-2 0 30 30 ermediate of And/Or Pharmaceutical Sanitizer 61. (3S,4R)-4-(4- 105812- 0 30 30 For Paroxetine . (API) Fluorophenyl)-3- 81-5 hydroxymethyl-1- methylpiperidine(- alcohol) And/Or 62. 3 – 37951-49- 0 30 30 For Tapentadol . MethoxyPropiophenone 8 (API) And/Or 63. 4-Hydroxy 123-08-0 0 30 30 ForBisoprololFumarat BenzaladehydeAnd/Or e(Api)

64. Piperonyl Alcohol 495-76-1 0 30 30 For Paroxetine (API) And/Or

65. 3,4-Dimethoxy phenol 2033-89-8 7 23 30 For Thalicarpine . And/Or (API)

66. 4- Methyl Guaiacol 93-51-6 0 30 30 ermediate of Vanillin And/Or (API)

67. Isovanillyl Alcohol 4383-06-6 0 30 30 Aliskiren (API) And/Or

68. 3-Methoxy benzyl 6971-51-3 7 23 30 Sarpogrelate . (API) alcohol And/Or

69. 2,5-dimethoxy 93-02-7 7 23 30 Midodrine . (API) Benzaldehyde And/Or

70. 5-Nitrovanillin And/Or 6635-20-7 0 30 30 Entacapone . (API)

71. 4-Hydroxy Anisole 150-76-5 0 30 30 For Vilazodone (API) And/Or

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72. Salicylaldehyde And/Or 090-02-8 0 30 30 Midodrine .(API)

73. Isovanillin And/Or 621-59-0 0 30 30 For Galantamine . (API)

74. Watermelone ketone 28940-11- 7 23 30 Use in 6 Pharmaceuticals SANITIZERS GROUP-4 (Sr No:-75 To 142) (Not More Than 30 MT/Month) 75. (1R,2R)-1,2- 65376-05- 0 30 30 For Lurasidone Hcl . cyclohexanedimethanol 8 (API) And/Or 76. 3‘,4‘-(methylenedioxy)- 3162-29-6 0 30 30 For Paroxetine Hcl . acetophenone And/Or (API)

77. 3,4-dihyroxy-5-nitro- 116313- 0 30 30 For Enatcapone . benzaldehyde And/Or 85-0 (API)

78. 2,4- 131-56-6 0 30 30 For Colmifene Citrate DiHydroxyBenzophenon (API) e And/Or 79. 2-hydroxy benzyl alcohol 90-01-7 0 30 30 For Imipramine . And/Or (API)

80. N-benzyl-4- 22065-85- 0 30 30 For Donepezil . (API) piperidinecarboxaldeh 6 yde And/Or 81. 5,6- Dimethoxyindanone 2107-69-9 0 30 30 For Donepezil . (API) And/Or

82. 3-(1-Piperaziny)-1,2- 87691-87- 7 23 30 For Ziprasidone . Benzisoxazole/Hydrochl 0/ 87691- (API) oride And/Or 88-1 83. 5-Chloroethyl-6-Chloro- 118289- 7 23 30 For Ziprasidone . 2-Oxindole And/Or 55-7 (API)

84. 4-[(4-Methyl-1- 106261- 0 30 30 For Imatinib . (API) piperazinyl)-methyl]- 64-7 benzoyl chloride dihydrochloride And/Or

85. 1-(Benzo 6329-73-3 0 30 30 For Proline . (API) (d)(1,3)dioxol-5-yl) )ethanol And/Or 86. 2 -Bromo 2‘,5‘ – 1204-21-3 7 23 30 For Midodrine . (API) dimethoxyacetophenone And/Or 87. (1R,2R)-1-2-bis 186204- 7 23 30 For LurasidoneHcl . (methane sulfonyloxy 35-3 (API) methyl) cyclohexane And/Or 88. Tert-butyl(4- 639520- 0 30 30 For Hexamidine bromophenyl) 70-0 Diisetionate (API) Methylcarbamate

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89. (2-cyclopropyl-4-(4- 121660- 0 30 30 For Pitavastatin . fluorophenyl)quinolone- 11-5 (API) 3yl)methanol And/Or 90. 2-Bromo-3‘-Chloro - 34911-51- 20 10 30 For Bupropion Hcl . Propiophenone And/Or 8 (API)

91. 3- Bromo- 4-Hydroxy 2973-78-6 0 30 30 For Bromoxynil . (API) Benzaldehyde And/Or

92. 3,4-(methylenedioxy) 2635-13-4 0 30 30 For Paroxetine . bromo benzene And/Or (API)

93. 3-Methoxy Benzyl 824-98-6 0 30 30 Sarpogrelate . (API) chloride And/Or

94. 4- ChloroGuaiacol 16766-30- 0 30 30 For Verapamil API And/Or 6 ermediate

95. 4- ChloroVeratrole 16766-27- 0 30 30 For Verapamil API And/Or 1 ermediate

96. 2-Bromo-4- Chloro 695-96-5 0 30 30 For Eltrombopag API Phenol And/Or ermediate

97. 4- Bromo Anisole 104-92-7 0 30 30 For Eltrombopag API And/Or ermediate

98. 4-BromoPhenetole 588-96-5 0 30 30 For Eltrombopag API And/Or ermediate

99. Endo-9-methyl-9- 135906- 0 30 30 For Granisetron Hcl . azabicyclo[3,3,1]nonane 03-5 (API) 3-amine 2 HCL And/Or 100. 2-Bromo-4-Cyanophenol 82380-17- 0 30 30 For Elentriptan . (API) And/Or 4

101. 2-Chloro-4,6-dimethoxy- 3140-73-6 0 30 30 For Pemetrexed [1,3,5]-triazine And/Or Disodium . (API)

102. Bicyclo[2.2.1]hep-tane- 14805- 7 23 30 For Lurasidone . (Api) 2,3-exo-dicarboximide 29-9 And/Or 103. 4-Bromo Phenol And/Or 106-41-2 0 30 30 For Eltrombopag API ermediate

104. 2-(2-ethoxy phenoxy) 3259-03-8 7 23 30 For Tamsulosin . ethyl bromide And/Or (API)

105. Ethyl-3[1-(3 amino-4- 212322- 7 23 30 For Dabigatran . (API) (methyl amino)-phenyl)- 56-0 n-(pyridine-2-yl)- foramido)proponate] And/Or And/Or 106. Ethyl-n-[2-((4- 211915- 7 23 30 For Dabigartan . cyanophenyl)-amino)- 84-3 (API) methyl-1-methyl-1H- benzimidazol-5-yl)-

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carbonyl-n-pyridine-2-yl- b-alanimate And/Or

107. 6-chloro 2-oxindole 56341-37- 0 30 30 For Ziprasidone . And/Or 8 (API)

108. 6-chloro-5-(chloroactyl)- 118307- 0 30 30 For Ziprasidone . 1-3-dihydro-2H-indole-2- 04-3 (API) one And/Or 109. 3,4-(methylenedioxy)- 7145-99-5 7 23 30 For Paroxetine (API) toluene And/Or

110. 2-chloro-4,6- 18093-05- 0 30 30 For Fenoldopam dimethoxybenzaldehyde 5 Mesylate (API) And/Or 111. 2-chloro-2',5'-dimethoxy 1204-22-4 0 30 30 For Midodrine (API) Acetophenone And/Or

112. 4-fluoro-alpha-(2-methyl- 125971- 0 30 30 For Atorvastatin . 1-oxopropyl)-t-oxo- 96-2 (API) N,B,Diphenylbenzenebut anamide And/Or 113. 5-Bromo-6- 5434-47-9 0 30 30 For Iloperidone . bromomethyl-1,3- (API) benzodioxole And/Or 114. 6-Fluoro-3-(4- 84163-77- 7 23 30 For Resperidone piperidinyl)1,2- 9 (API) benzisoxazole And/Or 115. 2,4-dimethoxy benzyl 55791-52- 0 30 30 For Coumestan chloride And/Or 1 (ermediate)

116. methyl-4-(Bromomethyl)- 2417-72-3 0 30 30 For Eprosartan . (API) benzoate And/Or

117. 1,2,3,4- tetrahydro-9- 27387-31- 0 30 30 For Ondansetron methyl-4H-carbazol-4- 1 (API) one And/Or 118. 4,5-dimethoxy-2- nitro 7509-11-7 0 30 30 For Gefitinib API toluene And/Or ermediate

119. Alpha-bromo-ortho- 29270-30- 0 30 30 For Clopidogrel (API) chloro-phenyl acetic acid 2 And/Or 120. 3,4-(Dimethoxy)-6- 34523-76- 0 30 30 For NCE Molecule methylbenzyl chloride 7 (Antibiotics) And/Or 121. Anisole And/Or 100-66-3 0 30 30 For Bufuralol (API)

122. Veratrol And/Or 91-16-7 0 30 30 For Salmeterol . (API)

123. Vanillin And/Or 121-33-5 0 30 30 For Vanilla Bean (API)

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124. Ethyl Vanillin And/Or 121-32-4 0 30 30 For Using as flavouring agent in Syrup.) 125. 3,4-methylenedioxy 120-57-0 0 30 30 For Tadalafil . (API) Benzaldehyde (piperonal) And/Or 126. 1-[3-(benzyloxy)propyl]- 1375180- 0 30 30 For Silodosin . (API) 5-formylindoline-7- 30-5 carbonitrile And/Or 127. Dimethylformamide di- 36805-97- 0 30 30 For Veterinary (API) tert-butyl Acetal And/Or 7

128. 2-(2-methoxy 1836-62-0 0 30 30 For Carvedilol . (API) phenoxy)ethyl amine And/Or 129. 3-ethoxy-4-hydroxy 80018-50- 0 30 30 For Repaglinide . phenyl Acetic Acid 4 (API) And/Or 130. 4-[(4-Methyl-1- 106261- 0 30 30 For Imatinib . (API) piperazinyl)-methyl]- 49-8 benzoic acid 2HCL And/Or

131. 6- Bromo Piperonal 15930-53- 0 30 30 For Paroxetine (API) And/Or 7

132. Hydroxyl novaldiamine 69559-11- 0 30 30 Hydroxychloroquine And/Or 1 API

133. 4,7-Dichloroquinoline 86-98-6 0 30 30 Hydroxychloroquine And/Or API

134. Hydroxychloroquine 118-42-3 0 30 30 Antimalarial And/Or Covid 19 API

135. Amiioacetaldehyde 22483-09- 0 30 30 For Dolutegravir . Dimethylacetal And/Or 6 (API)

136. 3-(4-chlorobutyl)1H- 143612- 7 23 30 Vilazodone API indol-5-carbonitrile 79-7 ermediate And/Or 137. Ethyl -2-cyclopropyl-4- 148516- 7 23 30 Pitavastatin API (4-fluorophenyl)-quinolyl- 11-4 ermediate 3-carboxylate And/Or 138. 3-methyl catechol 488-17-5 7 23 30 Use in And/Or Pharmaceuticals SANITIZERS 139. Piperonylic acid And/Or 94-53-1 7 23 30 For Paroxetine . (API)

140. 5-(1- 183288- 7 23 30 Vilazodone API piperazinyl)benzofuran- 46-2 2-carboximide And/Or 141. Ethyl-2-(3cyano-4- 160844- 7 23 30 Febuxostat API isobutoxyphenyl)-4- 75-7 methyl-5-

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thiazolecarboxylate And/Or

142. Dihydronopol 4747-61-9 0 30 30 Pinaverium API ermediate

143. Sodium Sterile Fumerate -- 7 -7 0

144. Pregabline -- 7 -7 0

145. Atorvastine -- 7 -7 0

146. Levocitrazine -- 7 -7 0

147. Rabeprazole -- 7 -7 0

GROUP-5 R&D PRODUCTS 148. Various New Product - 2 3 5 - developed by In-House R & D Total 96 79 175

 The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The proposal was considered in the SEAC Video conference meeting dated 30/05/2020 as per the submission by PP via E-mail dated 26/05/2020.  Salient features of the project including Water, Air and Hazardous waste management:

Sr Particulars Details . no . A Total cost of Proposed Project Existing:9.95 (Rs. in Crores): Break-up of proposed project Cost: Proposed: 5

Total: 14.95 Details of Environmental Management Plan (EMP) As below:

ENVIRONMENT MANAGEMENT COST

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COMPONENT CAPITAL COST OF EMP RECURRING COST OF EMP (per Month) TOTAL COST 47 Lacs 794.52 Lacs

BIFURCATION OF EMP Sr. Unit Installed Capital Operating Cost Operating Cost No Capacity Cost (Rs. (Lacs /Month) + (Lacs /Annum) (KLD) in Lacs ) Maintenance Cost 1 Air pollution -- 5 2.00 24 control 2 Water pollution 25 KLD 10 45 540 control 3 Noise pollution -- 1.5 0.01 0.12 monitoring 4 Solid and -- 15 18 216 hazardous waste management 5 Environment -- -- 0.5 6 monitoring and management 6 Green belt -- 0.5 0.2 2.4 7 Occupational -- 15 0.5 6 health (OHC) & Safety Equipments TOTAL 47 794.52

Details of CER as per OM dated 01/05/2018 As below:

BUDGETARY ALLOCATION FOR CER ACTIVITIES

The unit has planned to spend 2% of the total cost of the project over a period of five years towards CER activity. So, as per the project cost Rs. 40 Lakhs used in the CER activities. Budgetary allocation is given in below table. SR. ACTIVITY FUND EARMARKED FOR ACTIVITY IN LAKHS Time NO. FOR 5 Y1 Y2 Y3 Y4 Y5 Schedule Years

1 Solar Light 10 2 2 2 2 2 Installation

2 Laying of pewer 10 4 2 2 1 1 blocks on road

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sides.

TOTAL Rs. 20Lakh

 Unit will carry out CER activity in vicinity village.  Unit will install 20 LED Bulb solar light facility every year. Approximate cost for 1 LED bulb solar light facility is Rs 10000.  Unit will lying approximately 1000 Sq. mt pewer block in 5 years. Approximately cost for lying of pewer block per one Sq. mt is Rs 1000.

B Total Plot area Existing: 4740 Sq. m. ( sq. meter) Proposed: …….Sq. m.

Total: 4740 Sq. m.

Brief note onArea adequacy in line to proposed project activities:  Total plot area of the unit is 4740. mt.  Unit is having two process plant. One plant consists 598 Sq.mt & Other is 256 Sq.mt  ETP area of the unit is 340 Sq.mt.  Utility area of the unit is 391 Sq.mt.  Ware house area of the unit is 231 Sq.mt. Green belt area Existing: 1106.Sq. m. ( sq. meter) Proposed: 790 Sq. m.

Total: 1896 Sq. m.

(40% of total area) C Employment generation Existing:100 Proposed: 60 Total: 160 D Water i Source of Water Supply GIDC Water

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(GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern authority. Will be obtained.

ii Water consumption (KLD)

Existing Proposed Total after Remarks KLD (Additional) Expansion KLD KLD (A) Domestic 2.3 1.7 4 (B) Gardening 6 6 12

Process 10.5 24.5 35 Washing 2 1 3 Boiler 1 1 2 Cooling 9 23 32 Fresh Water:- 9 KLD + Recycled Water:- 23 KLD Process Scrubber 1 7 8 Others -- 24 24 Unit will purchase 24 KLD steam from M/s. AEEL. 23.5 80.5 104 Industrial Total 31.8 88.2 120 Fresh Water:- 73 Grand Total (A+B+C) KLD + Recycled Water:- 23 KLD+ 24 KLD steam from M/s. AEEL

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GROU PRODUCT TOTAL KL WATER KL/ KL/ P NO NAME PRODUC CONSUMPTI MONT DAY TION ON/ MT OF H CAPACIT PRODUCT Y AFTER EXPANSI ON (MT/MON TH) I 4-Methyl 70 2.96 207.2 6.9 Catechol Di-acetic acid Dimethyl ester (Product No:-3) II 4-Methyl 40 6.4 256 8.5 Catechol (Product No:-4) III Veratryl 30 12.4 372 12.4 Alcohol (Product No:-58) IV 1,2,3,4- 30 7.2 216 7.2 tetrahydro- 9-methyl- 4H- carbazol-4- one (Product No:-117) TOTAL (KL/DAY) 35

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Summary of Existing Proposed Total after Remarks water KLD (Additional) Expansion requirement KLD KLD Total water 31.8 88.2 120 requirement for the project (A)

Quantity to be --- 47 47 Recycled recycled (B) Water:- 23 KLD + 24 KLD steam from M/s. AEEL Total fresh water 31.8 41.2 73 requirement (C)

Ensure Total water requirement = Fresh water + Recycled water i.e. A = B + C

iii Waste water generation (KLD)

Category Existing Proposed Total after Remarks KLD (Additional) Expansion KLD KLD  Domestic 2 2 4

 Industrial

Process 7.2 32.8 40 4 KLD effluent will be subjected to conventional ETP. 36 KLD high COD effluent will be subjected

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to stripper. 2 KLD strip solvent will be removed.34 KLD remaining effluent will be subjected to CMEE of M/s. BEIL- Dahej after neutralization. Washing 2 1 3 In house ETP Boiler 0.5 0.5 1 To In-house RO. Cooling 0.3 3.7 4 To In-house RO. Process Scrubber 1 7 8 To CMEE of M/s. BEIL- Dahej. Others -- 24 24 To in-house RO. 2 KLD steam loss is due to handling and leakages. Total 27 KLD(22 KLD steam condensate + 1 KLD Boiler Blow Down + 4 KLD Cooling Tower Blow Down) will be subjected to in-house RO. Ro permeate(23 KLD) will be reused. RO- rejected (4 KLD) will be subjected to In-house ETP. 11 69 80 Total Industrial waste water 13 71 84 Reused:-23 KLD

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Strip Solvent :- 2 KLD CMEE of M/s. BEIL-Dahej:- 42 KLD M/s. ETL after inhouse ETP:-11 KLD Soak Pit :- 4 KLD Steam Loss :- 2 KLD

*We may inform you that unit will purchase 24 KL/Day steam from Steam House facility M/s. AEEL. This steam will not come in the direct contact of process. It will be used to increase the temperature of reactors & stripper. After use, steam condensate will be subjected to RO. Only 2 KLD steam loss will occur during handling. Brief Note on worst case scenario for waste water generation(Qualitative and Quantitative): GROU PRODUCT TOTAL KL WATER KL/ KL/ CHARACTERI P NO NAME PRODUC CONSUMPTI MONT DAY STICS TION ON/ MT OF H (GROUP CAPACIT PRODUCT WISE) Y AFTER EXPANSI ON (MT/MON TH) I 4-Methyl 70 5.5 385 12.8 COD:- > Catechol 30,000 mg/l Di-acetic TDS: > 11,000 acid mg/l Dimethyl ester (Product No:-3) II 4-Chloro- 40 3 120 4 COD:- < 4‘Hydroxy 30,000 mg/l Benzophe TDS: < 6,000 none mg/l

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(Product No:-6) III Guanidine 30 10.6 318 10.6 COD:- > HYDROC 30,000 mg/l HLORIDE TDS: > 11,000 (Product mg/l No:-21) IV 2-chloro- 30 12.6 378 12.6 COD:- > 4,6- 30,000 mg/l dimethoxy TDS: > 11,000 benzaldeh mg/l yde (Product No:-110) TOTAL (KL/DAY) 40

* Effluent of low COD will be treated into inhouse ETP only. Remaining effluent will be subjected to CMEE of M/s. BEIL-Dahej after neutralization and reducing COD.

Brief justification in case of no process effluent generation or no industrial effluent generation or no high concentration effluent generation from proposed project (Whichever is applicable). - Not applicable. HIGH COD & HIGH TDS effluent will be subjected to CMEE of M/s. BEIL after passing from stripper and neutralization. iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc.  For LOW COD effluent:- Primary treatment + Chemical Treatment  FOR HIGH COD effluent :- After stripper + neutralization send to CMEE of M/s. BEIL- Dahej. Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed. STEP-I :- COLLECTION

 Collect the raw effluent in to collection tank from Plant.  Remove in-soluble compounds by filter press. STEP-II :- CHEMICAL TREATMENT

 Filtrate effluent will be subjected to collection tank for chemical treatment.

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 Add the hypo chloride to collection tank for chemical treatment maintain & stirrer it 24 hours  Give the sample for COD testing, if require than add more hypo & check COD further.  Transfer the effluent to collection tank –III for second stage chemical treatment  Make the pH 4.0 for second stage HP Treatment.  Add ferrous sulphate & Hydrogen paroxide for second stage treatment ratio (4.5:1) maintain it by 24 hours  Send the sample for COD Testing, if required than give the more time for treatment .  After required COD Result, neutral the effluent, filter the effluent & transfer in to final treated effluent tank for disposal at ETL. EFFLUENT SCHEME FOR HIGH COD & TDS

High COD process stream will be segregated at the source point. Than after it will be subjected to stripper. Here, we will get strip solvent. After it, mixing this solvent free effluent with scrubber solution and neutralized. After neutralization, send it to CMEE of M/s.BEIL- Dahej.

ETP TREATMENT FOR HIGH COD STEAM (AFTER PROPOSED EXPANSION)

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CHARECTERISTICS OF LOW COD EFFLUENT (AFTER PROPOSED EXPANSION)

CHARECTERISTICS OF EXISTING EFFLUENT (IN HOUSE ETP)

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COMPLIANCE OF 18(1)-B CONDITION

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Brief note on adequacy of ZLD (In case of Zero Liquid Discharge):  Not applicable. v Mode of Disposal & Final meeting point(Existing and Proposed)

Domestic: To soak Pit

Industrial: M/s. ETL & M/s. BEIL-Dahej (CMEE)

vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF)(For waste water treatment)  M/s. BEIL-Dahej (CMEE) Membership of Common facility (CF) (For waste water treatment) Unit has obtained its membership certificate. Certificate is attached as ANNEXURE-XV on page no:-524. vii Simplified water balance diagram with reuse / recycle of waste water(Existing and Proposed)

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EXISTING WATER BALANCE DIAGRAM

* We may inform you that we are a member of M/s. ETL. We are having 11 KLD effluent discharge permission. Earlier, we were sending total 11 KLD effluent to M/s. ETL. Based on our effluent characteristics mainly TDS & COD, either M/s. ETL was treating our effluent into its facility (conventional ETP) or sending to its other facility CMEE of M/s. BEIL to bring down the value of TDS & COD. Now, based on the recommendation of M/s.ETL, we are ourselves segregating the effluent based on the characteristics and sending to either M/s. ETL or CMEE of M/s. BEIL. We may further inform you that the ultimate mode of CMEE M/s. BEIL is also a M/s. ETL after reducing TDS & COD.

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PROPOSED WATER BALANCE DIAGRAM

vii Reuse/Recycle details (KLD) with feasibility. [Source of reuse & application area] Total reuseKLD - Source of waste Application Characteristics of waste Remarks water for reuse area with water to be reused regarding with quantity in quantity in KLD (COD, BOD, TDS etc.) feasibility to KLD (From where (Where it is reuse i.e. it is coming) used) 23 KLD Ro- For Cooling TDS:- < 200 mg/l Feasible Permeate Tower - 23 TSS :- < 5 mg/l KLD COD:- < 50 mg/l 24 KLD steam Used to No TDS, BOD & COD Feasible from steam house provide heating medium in process (Comes in Indirect

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Contact)

E Air i Brief Note on fuel based heat energy requirement and worst case scenario thereof: SR NO FUEL Calorific Value Existing Permission 1 Natural Gas 8500 KCal/m3 6600 Nm3/Day

UTILI STEAM NATURAL TOTAL ACTUAL ORIGINAL TY GENERATIO GAS NATURAL EFFICIE REQUIREM N REQUIREM GAS NCY OF ENT OF (REQUIREM ENT FOR REQUIREM BOILER NATURAL ENT/ GENERATI ENT BY RUNNIN GAS BY DAY) ON OF 1 T CONSIDER G CONSIDER (A) STEAM ING 100% BOILER ING BOILR (B) EFFICIENC EFFICIENC Y OF Y BOILER (C:- A*B) EXISTING CONDITION BOIL 20 TP 70 Nm3 1400 68%-70% 2000 ER Nm3/Day Nm3/Day (2 TPH) PROPOSED CONDITION BOIL 46 TP 70 Nm3 3220 Nm3 68%-70% 4680 ER Nm3/Day (2 TPH)

* We may inform you that in existing condition we require only 2000 Nm3/Day natural gas however we are having surplus permission for natural gas. Furthermore, our natural gas requirement after proposed expansion will also be catered by existing gas quantity. Additional steam requirement will be served by M/s. AEEL.

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UTILI ENERGY NATURAL TOTAL ACTUAL ORIGINAL TY (REQUIREM GAS NATURAL EFFICIE REQUIREM ENT/ REQUIREM GAS NCY OF ENT OF DAY) ENT FOR REQUIREM BOILER NATURAL (A) GENERATI ENT BY RUNNIN GAS BY ON OF 1 CONSIDER G CONSIDER Lac Energy ING 100% BOILER ING BOILR (B) EFFICIENC EFFICIENC Y OF Y BOILER (C:- A*B) EXISTING CONDITION TFH 48 Lac 12 Nm3 576 58%-60% 960 Nm3/Day Nm3/Day (4lakh Kcal/ Hr) PROPOSED CONDITION TFH 96 Lac 12 Nm3 1152 58%-60% 1920 Nm3/Day Nm3/Day (4lakh Kcal/ HR)

* No need for additional natural gas. Unit is having surplus permission. Natural gas requirement of the unit after proposed expansion will also be catered by existing gas quantity. Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed - Air Source of Type of Stack Quantity Pollution Sr. emission Type emissions Height of Fuel Control no. With of Fuel i.e. Air (meter) MT/Day Measures Capacity Pollutants (APCM)

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EXISTING Adequate 1 Boiler (2 Natural 4680 15 3 stack TPH) gas m /Day height TFH PM Natural 1920 2 (4 lac 15 Sox gas m3/Day Kcal/hr) Nox Acoustic 3 D.G.Set 9 Diesel 30 Lit/Hr Enclosure

AFTER PROPOSED EXPANSION Adequate 1 Boiler (2 Natural 4680 15 3 stack TPH) gas m /Day height TFH PM Natural 1920 2 (4 lac 15 Sox gas m3/Day Kcal/hr) Nox Acoustic 120 3 D.G.Set 9 Diesel Lit/Hr Enclosure - As above said no need of additional natural gas. Unit will also not install extra utility. Unit will take additional steam from M/s. AEEL. ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed - Specific Source of emission Stack/Vent Air Pollution Control Sr. Type of (Name of Height Measures no. emission the (meter) (APCM) Product & Process) EXISTING Reaction HCl 12 Water scrubber 1 Vessel Cl2 followed by alkali scrubber Reaction HCl 12 Water scrubber 2 Vessel Cl2 followed by alkali scrubber AFTER PROPOSED EXPANSION Reaction HCl 12 Water scrubber Vessels Br2 followed by alkali connected SO2 scrubber 1 through HBr header line with scrubber

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(Plant-I)

Reaction HCl 12 Water scrubber Vessels Br2 followed by alkali connected SO2 scrubber through HBr 2 header line with scrubber (Plant-II)

Gro PRODUCT NAME TOTAL HCl HCl KL/ % up PRODU Gas Gas Month concentr No CTION Genera Genera scrubs ation of CAPACI tion in tion in olution HCl TY KG/ KG/ requir AFTER MT of MT of ed ( EXPANS product product Water) ION per (Solub (MT/MO month ility of NTH) HCl is :- 720 g/ l in water at 20OC) II 4-CHLORO-4- 40 100 4000 40 KL < 10% HYDROXY BENZOPHENONE (Product No:-6) III (3S,4R)-4-(4- 30 20 600 6 KL < 10% Fluorophenyl)-3- hydroxymethyl-1- methylpiperidine (Product No:-61) IV 4-fluoro-alpha-(2- 30 100 3000 30 KL < 10% methyl-1-oxopropyl)-t- oxo-

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N,B,Diphenylbenzenebu tanamide (Product No:- 112) TOTAL (KL/DAY) 76 KL

Gro PRODUCT NAME TOTAL Sulfur Sulfur KL/ % up PRODU Dioxide Dioxide Month concentr No CTION Gas Gasin scrubs ation of CAPACI Genera KG/ olution SBS TY tion in per requir AFTER KG/ month ed EXPANS MT of (10 % ION product Causti (MT/MO c NTH) Solutio n) IV 4-fluoro-alpha-(2- 30 87 2610 85 KL 4% to methyl-1-oxopropyl)-t- 5% oxo- N,B,Diphenylbenzenebu tanamide (Product No:- 112) TOTAL (KL/DAY) 85 KL % SBS Solution:- <5%

Gro PRODUCT NAME TOTAL HBr HBr KL/ % up PRODU Genera Gasin Month concentr No CTION tion in KG/ scrubs ation of CAPACI KG/ per olution Hydrobro TY MT of month requir mic acid AFTER product ed ( solution EXPANS Water) ION (Solub (MT/MO ility of

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NTH) HBr is :- 193 g/ 100 ml in water at 20OC) III 1-(2,'5' Dimethoxy 30 125 3750 45 KL <10 % phenyl amino ethanol) (Product No:-20) IV 2-Bromo-3‘-Chloro - 30 91 2730 30 KL < 10 % Propiophenone (Product No:- 90) TOTAL (KL/DAY) 75 KL HBr concentr ation is < 10%

Gro PRODUCT NAME TOTAL Bromin Bromin KL/ % up PRODU e Gas e Month concentr No CTION Genera Gasin scrubs ation of CAPACI tion in KG/ olution Sodium TY KG/ per requir Bromide AFTER MT of month ed Solution EXPANS product (10 % ION Causti (MT/MO c NTH) Solutio n) III 3 – 30 10 300 10 KL <5% MethoxyPropiophenone (Product No:- 62) TOTAL (KL/DAY) 10 KL Sodim Bromide solution concentr

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ation is <5%

Note:  Unit will use only Hydrogen and Nitrogen gases. iii Fugitive emission details with its mitigation measures.  Sr. Source Probable Control Measures/ APCM No. Pollutant Emission 1 Flange joints of Air pollutant  Routine & periodic inspection to pipeline, pump & (VOC) check leakage motors  Preventive maintenance, follow SOP for maintenance  Pumps & motors mechanical seal type  LDAR program is followed. 2 Liquid raw material Air pollutant  Feeding of liquid raw material is transferring to (VOC, Acid carried out by closed pipeline and reactor fumes) mechanical seal pump. 3 Loading /unloading Air pollutant  Unloading through pipeline to tank in at storage area (VOC) a close system.  F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note: Existing & Proposed i Sr Type/Na Specific Categ Quantity Management of . me Source of ory HW (MT/Annum) N of Generatio and o. Hazardo n (Name Sched Existi Propos Total us of ule as waste The Per ng ed Activity, HW Product Rules etc.) 1. ETP From 35.3 1.8 1598.2 1600 Collection, Sludge Effluent Storage, Treatment Transportation, Plant Disposal at TSDF site authorized by the GPCB. 2. Recover Due to in- 20.2 - 6000 6000 Collection, able house Storage, Spent distillation Transportation &

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Solvents (From all recover and reuse process) internally. 3. Spent From 20.2 120 910 1030 Collection, Solvents stripper Storage, (Mix Transportation & Solvent) Send for Co- Processing or sell to distillation units those who are having permission of rule-9 or who have applied under rule-9. 4. Distillati Due to the 20.3 66 234 300 on distillation Collection, Residue of Storage, solvents Transportation & (From Send for co- fractional Processing. Distillation ) 5. Empty From 33.1 9 111 120 Collection, barrels/c packing storage, ontainer decontamination s/liners transportation & contami disposal by selling nate to GPCB with authorized hazardo recycler or reused us in-house. chemica ls/waste s 6. Used or From 5.1 0.6 4.4 5 Collection, Spent lubrication storage, oil of plant transportation & and disposal by selling machinery to GPCB authorized recycler/refiner. 7. Spent From 28.3 - 40 40 Collection, Carbon/ Process- Storage & Charcoa (Hydroxyc Disposal by sent it l hloroquine to Co-Processing. ) & charcoal tower 8. Spent From 28.2 - 36 36 Collection, Catalyst manufactu Storage, ring Transportation & process ( send to Endo-9- regeneration unit methyl-9- who are having azabicyclo permission of rule-

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[3,3,1]non 9 or who have ane 3- applied under rule- amine, 9. ethyl-N-[2- (((4- Cyanophe nyl)- amino)- methyl)-1- methyl- 1H- benzimida zol-5-yl)- carbonyl)- N-Pyridin- 2-yl-B- alanimate) 9. Hyflow From 28.3 - 40 40 Collection, manufactu Storage, ring Transportation, process Disposal at TSDF (Dihydron site authorized by opol) the GPCB. 10. Process From 28.1 120 2520 2640 Collection, Salt manufactu Storage, ring Transportation, process Disposal at TSDF site. 11. Formic From B15 714 1188 1284 acid manufactu solution( ring 50 to process ( 60% Product soln); no:-5, 27) 12. Zinc From B2 1560 1704 3264 chloride manufactu Solution ring Collection, (20 to process( Storage , 22% Product Transportation and soln); no:-5, 83) sell to those units 13. Sodium From B2 2424 2736 5160 who are having Bromide manufactu permission of rule- Solution ring 9 or who have (10 to process ( applied under rule- 12% Product 9. soln); no:-4, 56) 14. Aluminiu From B2 1052 1827.84 2880 m manufactu .16 Chloride ring Solution process ( Product no:- 6,65,78)

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15. Acetic From B2 414 558 972 Acid manufactu (35% to ring 40% process ( solu) Product no:- 34) 16. Hydroch From -- 396 516 912 Collection, loric Scrubber Storage and send acid into CMEE of M/s. solution BEIL-Dahej after 17. Hydrobr From -- 156 744 900 neutralization. omic Scrubber acid solution 18. Sodium From -- 0 1020 1020 Bisulphit Scrubber e solution 19. Sodium From -- 0 120 120 bromide Scrubber solution

20. Sodium From -- 1020 -1020 0 This salt has been bisulpha Process included in te salt process salt. 21. Date From 28.4 - 1 1 Collection, expired Process storage, Product transportation and send for Co- Processing. 22. Off- From 28.5 - 1 1 Collection, specific Process storage, ation transportation and Product send for Co- Processing. ii Membership details of TSDF, CHWIF etc. Unit has obtained Membership (For HW management) certificate of M/s. BEIL-Dahej. iii Details of Non-Hazardous waste & its disposal(MSW --- and others) G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format)

Name of Product Name of Boiling Vapou Total Quan Quant % Solvent Point r Quan tity ity Reco Press tity Fresh recov very

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ure ered (MT/ (MT/ (MT/ MT) MT) MT) 2,3,4,5–bis-O-[1- Acetone 56 30.6 k 2 0.1 1.9 95 Methyl Ethyl Pa idene]B-D- (25 °C Fructopyranose ) Toluene 111 2.8 0.6 0.02 0.58 96 kPa (20 °C ) 4-Methyl Methanol 54 13.02 5 0.15 4.85 97 Catechol Di- kPa acetic acid (at Dimethyl ester 20 °C) Toluene 111 2.8 2 0.06 1.94 97 kPa (20 °C ) 4-Methyl N-butanol 116 6 1.4 0.05 1.35 98 Catechol mmHg (20 °C

) Methylene dioxy Methelyen 39.8 2 kPa 1.6 0.1 1.5 94 phenol dichloride (−40 °C) Toluene 111 2.8 3.3 0.08 3.22 97.5 kPa (20 °C ) 4-Chloro- 1,2 Di 180.19 1 1.6 0.06 1.54 96.2 4‘Hydroxy Chloro °C mmHg Benzophenone benzene (20° C) 2-Bromo Veratryl ethelyen 39.8 2 kPa 1 0.5 0.95 95 Bromide dichloride (−40

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°C) Toluene 111 2.8 1 0.04 0.96 96 kPa (20 °C ) 7-Ethyl tryptophol Toluene 111 2.8 1 0.05 0.95 95 kPa (20 °C ) 2 -Bromo 2‘,5‘- Methelene 39.8 2 kPa 1.2 0.05 1.1 95 dimethoxyacetop chloride (−40 henone °C) 4-Methoxy Methanol 54 13.02 1.4 0.07 1.33 95 Benzaldehyde kPa Dimethyl Acetal (at 20 °C) Benzaldehyde Methanol 54 13.02 1.4 0.07 1.33 95 dimethyl Acetal kPa (at 20 °C) 4-Hydroxy Benzyl Methanol 54 13.02 2 0.08 1.92 96 Alcohol kPa (at 20 °C) O-Benzyl Methelene 39.8 2 kPa 3 0.15 2.85 95 hydroxyl amine dichloride (−40 Hydrochloride °C) Toluene 111 2.8 1.6 0.05 1.55 97 kPa (20 °C ) Methanol 54 13.02 2 0.1 1.9 95 kPa (at 20 °C) Alpha –Bromo -2- Toluene 111 2.8 4 0.2 3.8 95

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Chloro Phenyl kPa Acetic Acid (20 °C Methyl Ester ) Methanol 54 13.02 1.4 0.05 1.35 96 kPa (at 20 °C) Chloro 131 °C 9 2 0.1 1.9 95 benzene mmHg Methelene 39.8 2 kPa 1 0.05 0.95 95 dichloride (−40 °C) 3-(1- Methanol 54 13.02 7 0.1 6.9 97.5 Pleperazinuyl)- kPa 1,2 Hydrochloride (at 20 °C) Toluene 111 2.8 8 0.5 7.5 94 kPa (20 °C ) 5-Chloroethyl-6- Methelene 39.8 2 kPa 1.4 0.1 1.3 96 Chloro-2- dichloride (−40 Oxindole °C) DIMETHYL 189 °C 0.46 2 0.1 1.9 95 SULFOXID mm E (DMSO) Hg @ 20 deg C Methanol 54 13.02 2 0.05 1.95 97.5 kPa (at 20 °C) 2,4,6 Trimethoxy Methanol 54 13.02 2 0.1 1.9 95 Benzaldehyde kPa (at 20 °C)

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4-Methoxy-3- Chlorobenz 131 °C 9 3.8 0.12 3.68 97 nitrobenzylsulfon ene mmHg ylacetic acid Methanol 54 13.02 3 0.3 2.87 96 kPa (at 20 °C) (1R,2R)-1-2-bis Methelyen 39.8 2 kPa 2 0.2 1.8 90 (methane dichloride (−40 sulfonyloxy °C) methyl) Tetrahydrof 66 °C 132 m 1 0.04 0.96 96 cyclohexane uran (THF) mHg 4-Isopropyl Methelyne 39.8 2 kPa 2 0.1 1.9 95 catechol dichloride (−40 °C) N-Butanol 116 6 2.8 0.06 2.74 98 mmHg (20 °C

) Copper decom -- 2 0.1 1.9 95 sulfate poses 3-Methoxy Toluene 111 2.8 2 0.1 1.9 95 Phenol kPa (20 °C ) Veratrol Alcohol Toluene 111 2.8 3.76 0.26 3.5 93 kPa (20 °C ) Methanol 54 13.02 2 0.1 1.9 95 kPa (at 20 °C)

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Methelyen 39.8 2 kPa 1 0.1 0.9 90 dichloride (−40 °C) 4-Propyl N-Butanol 116 6 2.8 0.06 2.74 98 Catechol mmHg (20 °C

) Methelyen 39.8 2 kPa 2 0.1 1.9 95 dichloride (−40 °C) Dimethyl Methanol 54 13.02 1 0.02 0.98 98 Acetamide kPa Dimethyl Acetal (at 20 °C) Tert-butyl(4- Dimethyl 152 to 516 1 0.05 0.95 95 bromophenyl) Formamide 154 °C Pa (DMF) Methylcarbamate Methelyen 39.8 2 kPa 3 0.2 2.8 95 dichloride (−40 °C) 4-[(4-Methyl-1- Methelyen 39.8 2 kPa 1 0.05 0.95 95 piperazinyl)- dichloride (−40 methyl]-benzoyl °C) chloride Thionyl 76 4.7 kP 4 0.1 3.9 97.5 dihydrochloride chloride a chloroforom 61.15 ° 7.89 2 0.1 1.9 95 C kPa (0 °C) (2-cyclopropyl-4- Methanol 54 13.02 1.2 0.05 1.15 96 (4- kPa fluorophenyl)quin (at olone- 20 °C) 3yl)methanol Toluene 111 2.8 4 0.1 3.9 97.5 kPa (20 °C )

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Cyclohaxen 80.74 ° 78 1 0.05 0.95 95 C mmHg (20 °C) (-) Alcohol Iso propyl 82.6 ° 44 2 0.1 1.9 95 alcohol C hPa (20 °C) DIMETHYL 152 to 516 0.4 0.02 0.38 95 FORMAMID 154 °C Pa E (DMF) 3 –Methoxy EDC 84 °C 65mm 2 0.1 1.9 95 Hg @29 deg C Propiophenone DIMETHYL 152 to 516 0.6 0.05 0.55 96 FORMAMID 154 °C Pa E (DMF) Toluene 111 2.8 2 0.1 1.9 95 kPa (20 °C )

ii Brief Note on LDAR proposed: Details are attached as ANNEXURE-XVII on page no 540. iii VOC emission sources and its mitigation measures

Sr. Source Probable Control Measures/ APCM No. Pollutant Emission 1 Flange joints of Air pollutant  Routine & periodic inspection to pipeline, pump & (VOC) check leakage motors  Preventive maintenance, follow SOP for maintenance  Pumps & motors mechanical seal type  LDAR program is followed. 2 Liquid raw material Air pollutant  Feeding of liquid raw material is transferring to (VOC, Acid carried out by closed pipeline and reactor fumes) mechanical seal pump.

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3 Loading /unloading Air pollutant  Unloading through pipeline to tank in at storage area (VOC) a close system.

H SAFETY details i  Details regarding storage of Hazardous chemicals (For tank storages only) Storage details Name of major Remarks Hazardous chemicals Storage tanks (If any) No. Unit will store all ---- solvents in drums.

ii Process safety details : (If applicable) Details are attached. Unit will carry out hydrogenation. Safety details are given in said annexure.

 During the meeting dated 30/05/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & Environment Management Plan.  During the Video conference meeting dated 30/05/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & relevant document.  Committee noted that the proposal is expansion project in GIDC Ankleshwar area. Source of water is GIDC.  During video conference meeting, committee asked technical expert of project proponent regarding proposal for API is in line with MoEF&CC Notification dated 27/03/2020 as most of API intermediates products seems to be basic organic chemicals instead of API intermediates. Also Committee insisted for submit revised proposal with mentioning existing products expansion and proposed new products expansion separately, group of proposed products is based on process and pollution load instead of market of proposed products and discontinue of proposed R & D production as unit is having CCA for R & D production 2 MT/Month , technical expert of PP confessed regarding this and submit revised product profile and proposal with submission of revised PFR, Form-1, EMP and CER etc. as per MoEF & CC Notification dated 27/03/2020.  After detailed discussion, Committee decided to defer the proposal and consider the same in one of the upcoming meeting of SEAC after submission of following details, 1. Submit revised product profile and proposal with submission of revised PFR, Form-1, EMP and CER in line with MoEF & CC Notification dated 27/03/2020 and subsequent change in Water, Air and Hazardous Waste Management. 2. Submit revised proposal with mentioning existing products expansion and proposed new products separately, group of proposed products is based on process and pollution load instead of market of proposed products and discontinue of proposed R & D production as

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unit is already having CCA for R & D production 2 MT/Month. 3 SIA/GJ/IND2/151134/2020 M/s. VIHITA BIO CHEM PVT. LTD. EC-Reconsideration Plot No. 304/A, GIDC Industrial Estate, Ankleshwar, Tal-Ankleshwar, Dist- Bharuch.

Category of the unit: 5(f) Project status: Expansion  Project proponent (PP) submitted application no- SIA/GJ/IND2/151134/2020 on dated 16/04/2020 for obtaining Environmental Clearance (EC).  Project proponent has submitted Form – 1, Pre-Feasibility Report & relevant documents as per the Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below.

Quantity CAS no. (MT/Month) Sr. Name of the / Remark End-use of the No. Products s products CI no. Exis Propo Total ting sed 1. Veratric Acid 93-07-2 Pharma Intermediate Dimethyl 4637- Group A 5.00 -- 5.00 2. Formamide - Pharma Intermediate 24-5 Dimethyl Acetal Guanidine 506-93- 200. 200. 3. Group B -- Pharma Intermediate Nitrate 4 00 00 4. Veratrol 91-16-7 Pharma Intermediate 5. Sesamol ‎533-31-3 Pharma Intermediate 3 – Hydroxy – 4 – Methoxy 110037- Group 6. Pharma Intermediate Cinnamaldehyd 35-9 C: e Either 6635- indi. OR 7. 5 – Nitro Vanillin Pharma Intermediate 20-7 total producti 3, 4 – Dihydroxy 10.0 10.0 116313- on of Sr. -- 8. – 5 - Nitro 0 0 Pharma Intermediate 85-0 No. 4 to Benzaldehyde 18 shall 4 - Chloro – 4 - not 42019- 9. Hydroxy exceed Pharma Intermediate 78-3 Benzophenone 10 4 - Fluoro 403-42- MT/M 10. Pharma Intermediate Acetophenone 9 4 - Bromo 11. 99-90-1 Pharma Intermediate Acetophenone

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2 – Chloro - 3, 4 12. - Dihydroxy 99-40-1 Pharma Intermediate Acetophenone 621-59- 13. Isovanilline Pharma Intermediate 0 2 - (2 - Methoxy 64464- 14. Phenoxy) Ethyl Pharma Intermediate 07-9 Amine HCl 2 - (2 - Methoxy 1836- 15. Phenoxy) Ethyl Pharma Intermediate 62-0 Amine 2‘ – Bromo – 4 - 2632- 16. Methoxy Pharma Intermediate 13-5 Acetophenone 2, 3,4,5 – Bis –O - (1 - 106881- 17. Methylethyliden Pharma Intermediate 35-0 e) –Beta – D - Fructopyranose 4 - Hydroxy 52602- 18. Pharma Intermediate Carbazole 39-8 Sodium 7757- Group 19. Pharma Intermediate Sulphate 82-6 C: Ammonium 7783- Either 20. Pharma Intermediate Sulphate 20-2 indi. OR total producti 81.8 81.8 on of Sr. -- 3 3 No. 19 Poly Aluminium 1327- 21. to 21 Pharma Intermediate Chloride 41-9 shall not exceed 81.83 MT/M Various new Product 22. -- Group C 1.00 -- 1.00 Pharma Intermediate developed by in- house R & D Phenyl – 2 - Hydroxy 4, 5 - 877997- Part 1: 23. API Intermediate Dimethoxy 98-3 Either Benzoate indi. OR 2 - Hydroxy 4, 5 total 5722- 24. - Dimethoxy producti API Intermediate 93-0 -- Benzoic Acid on of Sr. 8.00 8.00 No. 23 2, 4, 5 - 490-64- to 27 25. Trimethoxy API Intermediate 2 shall not Benzoic Acid exceed 461432- 8 MT/M 26. 5 – Bromo – 2 – API Intermediate Chloro – 4 – 22-4

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Ethoxy Benzophenone 5 – Bromo – 2 – 21739- 27. Chloro Benzoic API Intermediate 92-4 Acid 2, 6 - Dimethyl Part 2: 13335- 28. Phenoxy Acetic Either API Intermediate 71-2 Acid indi. OR total producti on of Sr. 25.0 -- 25.00 No. 28 0 2 - Methyl 2 - 1120- 29. to 29 API Intermediate Oxazoline 64-5 shall not exceed 25 MT/M 297. 322. Total 25.00 -- 83 83

Note: A. Proposed product will manufacture as per either Part 1 or Part 2. Part 1 and Part 2 products will not be manufactured at the same time. B. Unit shall continue to manufacture its all Existing Products. C. There will be no change in existing products with added new proposed products. End-use of Proposed Products’s API & its intermdediates

Type / Category Name of API Sr in which of Said API is used . Name of the CAS No. Intermediate CAS No. Product for / End Use of N Product Used / End (Product) (API) said API o. (API / use of said Intermedi Intermediate ate) Used as Antiemetic Phenyl – 2 - API 185106- agent For Stomach, Hydroxy 4, 5 877997- 23 Intermedia Acotiamide 16-5 Abdominal pain, - Dimethoxy 98-3 te Nausea and Benzoate vomiting Used as Antiemetic 2 - Hydroxy API 185106- agent For Stomach, 4, 5 - 24 5722-93-0 Intermedia Acotiamide 16-5 Abdominal pain, Dimethoxy te Nausea and Benzoic Acid vomiting Used as Antiemetic 2, 4, 5 - API 185106- agent For Stomach, 25 Trimethoxy 490-64-2 Intermedia Acotiamide 16-5 Abdominal pain, Benzoic Acid te Nausea and vomiting

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Used For type 2 diabetes. 5 – Bromo – Dapagliflozin works 2 – Chloro – API 461432- 461432- on your kidneys. 26 4 –Ethoxy Intermedia Dapagliflozin 22-4 26-8 Used For COVID- Benzopheno te 19 patients with ne diabetes at Risk & Complications Used For type 2 diabetes. Dapagliflozin works 5 – Bromo – API 21739-92- 461432- on your kidneys. 27 2 – Chloro Intermedia Dapagliflozin 4 26-8 Used For COVID- Benzoic Acid te 19 patients with diabetes at Risk & Complications It is used for 2, 6 - Treatment of API Dimethyl 13335-71- 192725- Corona Virus 28 Intermedia Lopinavir Phenoxy 2 17-0 Infection Patient. It te Acetic Acid is used against HIV infections also. Used to treat high blood pressure, API 2 - Methyl 2 - 72956-09- congestive heart 29 1120-64-5 Intermedia Carvedilol Oxazoline 3 failure, and left te ventricular dysfunction.

 The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The proposal was considered in the SEAC Video conference meeting dated 28.04.2020.  During the Video conference meeting dated 28/04/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & relevant document.  Project proponent (PP) authorized technical expert Mr. Sanjay Patel, Envirocare Technocrats Pvt. Ltd. to represent proposal and give presentation. Technical expert remain present during video conference meeting.  Committee noted that the proposal is for expansion. Unit has valid CC&A for existing plant. Copy of CC&A, its compliance report is submitted. PP ensured that there are no court cases pending and no public complaints against the project. PP submitted details regarding area adequacy. Source of water is GIDC. PP submitted that one SCN issued by GPCB in last three years and PP has submitted compliance of SCN reply submitted to GPCB.  PP submitted that after proposed expansion, entire effluent (20.3 KLPD) generated from process and utilities will be treated in in-house primary treatment (ETP) and treated effluent will be sent to CETP of ETL, Ankleshwar for final treatment and disposal. At present unit is discharging 6 KLPD waste water after primary treatment to CETP of M/s ETL as per existing CCA and PP submitted that unit has

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obtained permission from GPCB as per their dual discharge policy letter no. GPCB/ANK/C-1144-479160 of dated 19/12/2018 and unit is eligible for discharge of additional wastewater to CETP of M/s. ETL.  PP submitted that they have proposed one steam boiler and one Thermopack. Fuel used will be Natural Gas. Two stage scrubbers will be provided with each Process stack.  PP submitted Hazardous Waste Matrix as per HWR – 2016.  Committee noted that PP submitted R & D production expansion from 1 MT/Month to 3 MT/Month for which committee disagrees with this proposal. Committee insisted for submission of revised product profile with discontinue of proposed R & D product as unit is having aleady existing R & D production 1 MT/Month.  Committee deliberated on Product profile along with specific end- use of the products. Upon asking, technical expert could not explain specific end use of each products and why as to consider proposed products in line with the Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API).  Committee asked for waste water generation quantity and water consumption with considering worst case scenario and effluent characteristic. Committee also noted that PP has not submitted adequate safety and mitigation measures details for Nitration process and also not mentioned nitration process stack even though submission of nitration process safety measures.  After detailed discussion, it was decided to consider the proposal only after submission of the following documents: 1. Submit specific end-uses of proposed product profile. Also submit an undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API). 2. Submit revised product profile with discontinue of proposed R & D product as unit is having existing R & D production 1 MT/Month. Revised project details with all relevant changes in case of change in product profile. 3. Submit waste water generation quantity and water consumption with considering worst case scenario and its effluent characteristic and treatability report with technical justification regarding drastic reduction of BOD and COD value after primary treatment while TDS value increase only 100 mg/l. 4. Submit adequate safety and mitigation measures details for Nitration process like auto dumping system, installation of safety valve with rupture disc etc and also justification regarding not mentioning nitration process stack in process stack matrix even though submission of nitration process safety measures for proposed expansion.  Project proponent made presentation for the above mentioned query vide e-mail dated 26/05/2020 for the above mentioned points.  PP presented replied as below:

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1. PP presented specific end-uses of proposed product profile and Also submit an undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API).. 2. PP presented revised product profile with discontinue of proposed R & D product as unit is having existing R & D production 1 MT/Month. 3. PP presented revised water balance diagram with waste water generation quantity and water consumption with considering worst case scenario and its effluent characteristic. 4. PP presented adequate safety and mitigation measures details for Nitration process like auto dumping system, installation of safety valve with rupture disc etc. PP submitted justification regarding not mentioning nitration process stack in process stack matrix even though submission of nitration process safety measures for proposed expansion.  This case was reconsidered in SEAC VC meeting dated 30/05/2020.  Revised product profile as above and salient features for project details and water, Air and Hazardous Waste Management(Revised) are as below: Sr Particulars Details . no . A Total cost of Proposed Project Existing: 3.5256 (Rs. in Crores): Crores Break-up of proposed project Cost:  As below Proposed: 2.11 Crores

Total: 5.6356 Crores

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Details of Environmental Management Plan (EMP) As below:

Details of CER as per OM dated 01/05/2018 As below:

• As project falls under CEPI area, unit will allot additional 1% (Normally Required 1%)

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fund towards CER activity. Therefore total fund will be allotted 2% of investment, which will be Rs. 4.22 Lacs.

B Total Plot area Existing: 3900.00Sq. ( sq. meter) m.

Proposed: --

Total: 3900.00 Sq. m.

Brief note onArea adequacy in line to proposed project activities:  Unit is going for expansion of project and expansion will be carried out within existing premises. Total plot area is 3900.00 m2.  At present, open space available within plant premises is 2606.38 m2.  At present, unit is manufacturing Pharma Intermediate having production capacity 297.83 MT/month. Now proposed for production of additional Pharma Intermediate having production capacity 26.00 MT/month. After expansion, total production capacity will be 331.83 MT/month.  At present, 400.53 m2 area is allotted for production area. And after expansion 350.00 m2 area is proposed at ground floor, 350 m2area at first floor and 350 m2 area at second floor is proposed production plant so, total production area will be 1450.53 m2.  Total floor area utilized for production activity: 77+ 62 +61 = 200.00 m2which is below than 1450.53 m2 area proposed.Therefore, area available for production plant is adequate for proposed expansion  At present, 153.50 m2 area is allotted for raw material storage and 82.00 m2 area is allotted for tank storage.  Additional 194.00 m2area will be allotted for raw material storage.  At present, 117.52 m2 area is allotted for storage of finished goods. 170.00 m2 area will be provided for finished product storage area / packing area for proposed expansion project.

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 For utilities 72.80 m2area is allotted and additional 87.00 m2 area will be allotted. Therefore, area available for utilities will be 159.80 m2.  Total area required for storage of raw material is 188.80 m2 (151 + 37.80) which is below than 194 m2 area as proposed for raw material storage.Thus, area allotted for storage of raw materials is adequate. Green belt area Existing: 160.00 Sq. ( sq. meter) m.

Proposed: 1090.00 Sq. m. (inhouse) + 312.00 Sq. m. (outside premises within 5 km radius from project site)

Total: 1562.00 Sq. m.

(40.05.% of total area) C Employment generation Existing: 54 (Male-51, Female-03) Proposed: 36 (Male- 34, Female-02) Total: 90 (Male - 85, Female - 05) D Water i Source of Water Supply GIDC, Ankleshwar (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern authority. Unit has requested to GIDC for additional water supply ii Water consumption (KLD)

Existing Proposed Total Remarks KLD (Additional) after

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KLD Expans ion KLD (D) Domestic 1.50 2.50 4.00

(E) Gardening 2.00 3.00 5.00

(F) Industrial

Process 3.65 12.30* 15.95 * Considering Maximum process water consumption in product no. 28 (i.e. 2, 6 - Dimethyl Phenoxy Acetic Acid) as only one part products will be manufacture at a time. Washing 2.35 0.40 2.75

Boiler 6.00 6.00 12.00

Cooling 5.00 4.00 9.00

Others -- 1.00 1.00

17.00 23.70 40.70 Industrial Total 20.50 29.20 49.70 Grand Total (A+B+C)

Brief Note on worst case scenario for water consumption: Brief Note on worst case scenario for water consumption:  For calculating worst case scenario, Maximum process water consumption in product no. 28 (i.e. 2, 6 - Dimethyl Phenoxy Acetic Acid) as only one part products will be manufacture at a time and the same is taken into

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consideration. Said products water consumption is taken into consideration because applied product is divided in two part and only 01 part products will be manufacturedat a time on either/or basis.First all proposed product water consumption is calculated by considering fully applied production capacity and compared both part water consumption and from that we have identified that products in both parts, which will consume more water with respect to other products and the same is taken into consideration. In addition maximum boiler working hour, washing water requirement per day is also taken into consideration. For inhouse gardening around 4 L/m2 water is considered. For domestic purposed around 45 Li/person/day water is considered. Based on this our maximum water consumption shall not exceed 49.70 KLD. - Summary of Existing Proposed Total after Remarks water KLD (Additional) Expansion requirement KLD KLD 20.50 29.20 49.70 Total water requirement for the project (A) Quantity to be ------recycled (B) Total fresh 20.50 29.20 49.70 water requirement (C)

Ensure Total water requirement = Fresh water + Recycled water i.e. A = B + C

In case of no reuse/recycle of waste water, Give brief note on justification as why no reuse/recycle.  Treated water will be used for preparation of dosing chemicals and condensate recover will be reused again in boiler makeup water.  As our unit is API intermediate product unit. Process, washing waste water is not feasible to reuse in any part of the reaction because of from applied intermediate products, API products will be manufactured and it will use for

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life saving purposes and may be useful in many parts of the human body. So that high grade products only been requirement. For boiler blow down it may have high TDS and in cooling waste water slightly high COD may present. Hence, no water reuse feasible.

iii Waste water generation (KLD)

Category Existing Proposed Total Remarks KLD (Additional) after KLD Expansi on KLD  Domestic 1.00 2.00 3.00

 Industrial

Process 3.40 13.00** 16.40 ** Considering Maximum process wastewater generation from product no. 25 OR 28 (i.e. 2, 4, 5 - Trimethoxy Benzoic Acid OR 2, 6 - Dimethyl Phenoxy Acetic Acid) as only one part products will be manufacture at a time. Washing 2.35 0.25 2.60

Boiler 0.10 0.10 0.20

Cooling 0.15 0.05 0.20

Others -- 0.90 0.90

6.00 14.30 20.30

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Total Industrial waste water

Brief Note on worst case scenario for waste water generation(Qualitative and Quantitative): For calculating worst case scenario, Maximum process wastewater generation from product no. 25 OR 28 (i.e. 2, 4, 5 - Trimethoxy Benzoic Acid OR 2, 6 - Dimethyl Phenoxy Acetic Acid) as only one part products will be manufacture at a time and the same is taken into consideration. Said products waste water generation is taken into consideration because applied product is divided in two part and only 01 part products will be manufacturedat a time on either/or basis.First all proposed product waste water generation is calculated by considering fully applied production capacity and compared both part wastewater generation and from that we have identified that products in both parts, which will generate more water with respect to other products and the same is taken into consideration. In worst case we have taken consideration boiler blow down, cooling waste water and scrubber waste water including washing waste water. In any case our industrial waste water generation shall not exceed 20.30 KLD.

Quality of Raw Effluent – Existing

Quality of Raw Effluent – After Expansion

Brief justification in case of no process effluent generation or no industrial effluent

652nd meeting of SEAC-Gujarat, dated 30.05.2020- VIDEO CONFERENCE (VC) on NIC Page 76 of 296 generation or no high concentration effluent generation from proposed project (Whichever is applicable). Not Applicable iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc.  In-house ETP of 30.00 KLD capacity having primary treatment. Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed. • Industrial effluent generated from manufacturing process and other ancillary operation shall be allowed into in-house ETP for primary treatment. Primary treated water will be sent to CETP of M/s. ETL, Ankleshwar.

Quality of Raw Effluent – Existing

Quality of Raw Effluent – After Expansion

Note: (In case of CETP discharge) : Management of waste water keeping in view direction under section 18 (1) (b) of the Water (Prevention and Control of Pollution) act, 1974 issued by CPCB regarding compliance of CETP.  In view of permission available from GPCB as per their dual discharge policy letter no. GPCB/ANK/C-1144-479160 of dated 19/12/2018, we are

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eligible to get additional quantity of treated waste water discharge into common ETP (List of Priority 3C, Sr. No. 1). M/s. ETL has also given NOC for acceptance of additional discharge of 14.30 KLD. Quality of treated effluent will not exceeds inlet norms of CETP. Brief note on adequacy of ZLD (In case of Zero Liquid Discharge):  Not Applicable v Mode of Disposal & Final meeting point(Existing and Proposed)

Domestic: At present and after expansion, generated domestic effluent shall be disposed in to Septic tank / Soak pit system Industrial: At present and after expansion, industrial effluent generated from manufacturing process and other ancillary operation shall be allowed into in-house ETP for primary treatment. Primary treated water will be sent to CETP of M/s. ETL, Ankleshwar vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF)(For waste water treatment)  CETP – M/s. ETL, Ankleshwar Membership of Common facility (CF) (For waste water treatment) Unit has taken membership of common ETP of M/s. Enviro Technology Limited, Ankleshwar vii Simplified water balance diagram with reuse / recycle of waste water(Existing and Proposed)

Existing:

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Proposed:

vii Reuse/Recycle details (KLD) with feasibility. [Source of reuse & application area] Total reuse Nil - Source of waste Application Characteristics of Remarks water for reuse area with waste water to be regarding with quantity in quantity in reused (COD, BOD, feasibility KLD (From KLD (Where it TDS etc.) to reuse i.e. where it is is used) coming)

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------

Treated effluent will be utilized for preparation of dosing chemicals Solution for ETP.

E Air i Brief Note on fuel based heat energy requirement and worst case scenario thereof:  At present existing power requirement is 150 HP and additional 150 HP power will be required.At present one steam boiler (Capacity: 0.60 TPH) and one thermopack (Capacity 3 Lac Kcal/hr) are exist. Unit will install one more Steam Boiler (Capacity: 2 TPH), one more thermopack (Capacity: 5 Lac Kcal/hr) and one DG Set of 250 KVA will be installed.  In worst case QUANTITY OF FUEL USED:  Existing: Gaseous – Natural Gas – 600.60 m3/day  Additional: Gaseous – Natural Gas - 1200 m3/Day,Liquid – HSD – 840 Lit/Day  In worst case maximum steam requirement from steam boiler will be around 2000 kg/hr and heat energy requirement from thermopack will be around 6.00 Lac Kcal/hr. Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed - Air Source of Type of Stack Quantity Pollution Sr. emission Type of emissions Height of Fuel Control no. With Fuel i.e. Air (meter) MT/Day Measures Capacity Pollutants (APCM) Existing Industrial PM Adequate Boiler Natural 600 stack 1 11.0 SO (Capacity: Gas SCM/day 2 height is 600 Kg/Hr) NOX provided Adequate Thermopack PM Natural 0.60 stack 2 (Capacity: 3 11.0 SO Gas SCM/Day 2 height is Lacs KCal/hr) NOX provided Proposed

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Adequate Steam Boiler PM stack Natural 1000 3 (Capacity: 2 11.0 SO height will Gas SCM/Day 2 TPH) be NOX provided Adequate Thermopack PM stack Natural 200 4 (Capacity: 5 11.0 SO height will Gas SCM/Day 2 Lacs Kcal/hr) be NOX provided Adequate D.G Set PM stack 840 5 (Stand By) 9.00 HSD SO height will Lit/Day 2 250 KVA be NOX provided

- ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed - Specific Source of Air Pollution Sr. emission Type of Stack/Vent Control no. (Name of the emission Height (meter) Measures Product & Process) (APCM) Existing -- Proposed Reaction Vessels – 1 (Product No. 29, Two Stage Acid 1 NH 12.0 Process: 3 Scrubber Condensation) SO Two Stage Alkali Reaction Vessels – 2 2 12.0 (Product No. 26, Scrubber 2 Process: Friedel- Two Stage Water Crafts Acylation & HCl, Cl2 12.0 Scrubber followed Alkylation) by Alkali Scrubber Reaction Vessels – 3 Two Stage Alkali 3 Product No. 23-26 Br 12.0 2 Scrubber Process: Bromination

• NH3 gas generated from reaction column will be scrubbed in to acid scrubber and ammonium sulphate solution generated will be collected and sell to end user as per Haz. Waste Rule-9 after getting prior permission from GPCB.

• HCl & Cl2 gas generated from reaction column will be scrubbed into two stage water scrubber to recover HCl solution. Recover sodium hypochlorite solution will be sell to Authorized end user as per Hazardous waste rule 9 permission

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and after getting prior permission from GPCB.

• Concentration of SO2 gas generation will be very low thus there shall be no

Na2SO3 recovery in alkali scrubber. Therefor entire solution will be allowed into ETP for treatment.

• Br2 gas generated from reaction column will be scrubbed into two stage alkali scrubber and generated sodium bromide and sodium bromate solution will be collected and sell to end user as per Haz. Waste Rule-9. • Unit will provide CEMS which will be connected with GPCB/CPCB server.

Note:  Details of gaseous raw materials used in proposed project Sr. Product No. Gaseous Raw No. Material 1. -- --

 Estimation of process gas emission (Product wise and Total) Sr. Product Type of emission Max. Max. No. No. Emission Emission (MT/Day) (MT/Annum) 1. 29 3.15 1134 NH3

2. 26 SO2 0.0039 1.404 HCl, Cl 0.08 28.8 2 3. 23 0.013 4.68

24 0.014 5.04 Br 25 2 0.008 2.88

26 0.016 5.76

 Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total) Requirement of Sr. Type of Name of Scrubbing Media Scrubbing No. emission media (Kl/Day)

1. NH3 Two Stage Acid Scrubber 1.35

SO 2. 2 Two Stage Alkali Scrubber 0.0017

3. Two Stage Water Scrubber 0.10 HCl, Cl 2 4. Alkali Scrubber 0.03

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 Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix. Type / Specific Source of Quantity Sr. Name of generation (Name (MT/Annu Management of HW No. Hazardous of the Activity, m) Waste Product etc.) Sodium Bromide Scrubber 1 Solution (Product No. 16,23- 6.00 26) (15-55%) Collection, Storage, Sodium Scrubber Transportation (Through GPS Bromate 2 (Product No. 16,23- 2.10 mounted vehicles) and Solution (15 26) Disposed by selling to - 20 %) Authorized end user as per Ammonium Haz. Waste Rule-9 and after Scrubber 3 Sulphate 1621.50 getting prior permission from (Product No. 29) (60-70%) GPCB. Sodium Hypochlorite Scrubber 4 3.60 Solution (5 (Product No. 26) to 7 %)

iii Fugitive emission details with its mitigation measures.  Sources of fugitive emissions will be from raw material storage area, handling of chemicals, manufacturing process and from vehicle movement on internal road.  To minimize fugitive emission, powder material will be allowed in a vessel through closed loop while liquid material will be charged through pipeline.  Transportation of raw materials & products will be carried out by trolley within premises and minimum manual material handling will be carried, so the fugitive emission due to process activity and material handling will be negligible. F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and calculations shall be incorporated in EMP details separately.  Disposal to scrap vendors/vendors/traders is not allowed

Existing & Proposed

652nd meeting of SEAC-Gujarat, dated 30.05.2020- VIDEO CONFERENCE (VC) on NIC Page 83 of 296 i Sr Type/Nam Specific Catego Quantity Management of . e of Source ry and (MT/Annum) HW n Hazardou of Sched o. s waste generati ule as Existi Propos Total on per HW ng ed (Name Rules. of the Activity, Product etc.) 1 Collection, Storage, Transportation (Through GPS Effluent ETP 35.3 mounted Treatme 72.00 59.00 131.00 Sludge (Sch. I) vehicles) and nt Plant Disposal at TSDF site of M/s. BEIL – for secured landfill 2 Collection, Storage, Transportation Empty (Through GPS Barrels / Raw mounted Containers material vehicles) and / Liners & 33.1 Disposal by Contami- Finished 14.40 15.60 30.00 (Sch. I) selling to nated with product registered Hazardous packing recycler Chemicals material approved by / Wastes GPCB / CPCB OR reuse within premises. 3 Collection, storage, Process recovered Spent (Product 28.6 960.0 1287.4 327.45 through in-house Solvent No. 23 (Sch. I) 0 5 distillation and & 27) 100% reuse within premises. 4 Collection, Process Storage, (Product Transportation Distillation No. 1, 4, 20.3 119.4 1.20 118.20 (Through GPS residue 9, 10, (Sch. I) 0 mounted 11, 14, vehicles) and 15, 29) Disposal for co-

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processing 5 Reuse as lubricant in plant & machinery OR Thermopa Used or 5.1 Disposal by ck & 0.60 0.80 1.40 Spent Oil (Sch. I) selling to D. G. Set authorized Re- Refiners /recycler 6 Process Collection, (Product 28.1 1409.4 Storage, No. 23 & (Sch. I) 0 Transportation 24) (Through GPS mounted Sodium vehicles) & Bromide 1415.4 Disposal by Scrubber -- Solution 0 selling to (Product (15-55%) 28.4 Authorized end No. 6.00 (Sch. I) user whom have 16,23- valid permission 26) from GPCB as per Haz. Waste Rule-9 7 Collection, Storage, Transportation (Through GPS mounted Sodium Scrubber vehicles) & Bromate (Product Disposal by 28.4 Solution No. -- 2.10 2.10 selling to (Sch. I) (15 - 20 16,23- Authorized end %) 26) user whom have valid permission from GPCB as per Haz. Waste Rule-9from GPCB 8 Collection, Storage & reuse of 1147.22 MT/year within premises in product no. 1, 9 to 12, 26 & AlCl Process 3 28.1 3760.9 3760.9 balance quantity Solution (Product -- (Sch. I) 0 0 2613.68MT/Year (50-55%) No. 26) Disposal by selling to Authorized end user whom have valid permission from GPCB as per Haz. Waste

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Rule-9 9 Collection, Storage, Transportation (Through GPS mounted Ammoniu vehicles) & Scrubber m 28.1 1621.5 1621.5 Disposal by (Product -- Sulphate (Sch. I) 0 0 selling to No. 29) (60-70%) Authorized end user whom have valid permission from GPCB as per Haz. Waste Rule-9 10 Collection, Storage and Dil. HCl Scrubber B-15 100% reuse Solution (Product (Sch. -- 36.00 36.00 within premises (22-25 %) No. 26) II) (in Product No. 23, 24, 25). 11 Collection, Storage, Transportation (Through GPS mounted Sodium Scrubber vehicles) & Hypochlori ( 28.1 Disposal by -- 3.60 3.60 te Solution (Product Sch.1 selling to (5 to 7 %) No. 26) Authorized end user whom have valid permission from GPCB as per Haz. Waste Rule-9 12 Collection, Storage, Transportation (Through GPS Off 28.4 mounted Specificati Process -- 2.00 2.00 Sch. I vehicles) and on Product Disposal at CHWIF for incineration / for co-processing

- ii Membership details of TSDF, CHWIF etc. Unit has got membership (For HW management) from BEIL for disposal of hazardous waste. iii Details of Non-Hazardous waste & its disposal(MSW and As below

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others)

Categor Sr. Source of Type of Waste y Disposal No. Generation of Waste 1. Concrete and Proposed C & D Temporary store, reuse to Bricks material construction Waste increase plinth level and in activity road area Steel, glass, wood To be sell local scrap vendor 2. Domestic Waste Employees MSW Collected in separate bin and (Food waste, working in disposed to bin of GIDC. Plastic, Paper etc.) the premises 3. Industrial Waste Steam Pipe & ISW Sell to local scrap vendor (Glass wool Vessels [Insulating Material, Scrap]) 4. Industrial Waste From Raw ISW Sell to local scrap vender (Wooden pellets) Material & Product storage area 5. E-waste Entire Plant E-waste Collection, Storage and disposal to GPCB authorized E-Waste Management facility G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format) Name of Input Recovered Recovery Product Name of the Quantity Quantity Efficiency No. Product Solvent (MT/Month) (MT/Month) (%) Phenyl – 2 - Methanol 18.38 18.07 98.30 Hydroxy 4, 5 - 23 97.43 Dimethoxy Phenol 6.00 5.85 Benzoate Toluene 3.62 3.52 97.24 2, 4, 5 - 25 Trimethoxy Methanol 32.37 31.82 98.30 Benzoic Acid 5 – Bromo – 2 – Chloro – 4 – 26 Toluene 16.00 15.36 96.00 Ethoxy Benzophenone 5 – Bromo – 2 – Toluene 27 Chloro Benzoic & Other 20.57 20.22 98.32 Acid Solvent ii Brief Note on LDAR proposed:

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In addition to LDAR program, following safety measures will be taken to prevent losses of solvent in atmosphere;  To achieve more than 95% recovery, unit will provide vacuum distillation, double condensers with second condenser using chilled water as cooling media. The condensers shall be provided with sufficient Heat Transfer Area and residence time for maximum recovery.  VOC detectors will be installed to detect any solvent leakages during storage and handling.  In warding, storage and consumption of solvents in various products shall be measured through Level Transmitters and Load cells weighing systems resp. The quantity at each stage shall be reconciled periodically to arrive at Losses.  Periodic monitoring of work area will be carried out to check the fugitive emission. iii VOC emission sources and its mitigation measures  Source: VOCs generation will be from storage and usage of raw materials.  VOC analysers will be provided to detect any solvent leakages during storage and handling.  Regular maintenance of valves, pumps, flanges, joints and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs.  Entire process will be carried out in the closed reactors with proper maintenance of pressure and temperature.  Ensure minimum number of flanges, joints and valves in pipelines.  Proper preventive maintenance of roofs and seals for tanks

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 Monitoring and preventive maintenance of valves, flanges, joints, etc.  VOC detectors will be installed to detect any solvent leakages during storage and handling. H SAFETY details i  Details regarding storage of Hazardous chemicals (For tank storages only) Storage details Name of major Remarks Hazardous chemicals Storage tanks (If any) Dimethyl Sulphate, Sodium Hypochlorite

 Safety details of Hazardous chemicals (To be stored in storage tanks) Safety precautions for Storage and Handling of Dimethyl Sulphate: Dimethyl Sulphate is toxic and corrosive in nature. It is colorless and liquid instate. Its boiling point is 188 deg. C and flash point is 83 deg C. It will be stored in a MS tank.  Before handling, Wear personal protective equipment/face protection. Do not get in eyes, on skin, or onclothing.  Use only under a chemical fume hood. Do not breathe mist/vapors/spray. Do notingest.  If swallowed then seek immediate medical assistance. Keep away from openflames, hot surfaces and sources of ignition.  For storage, keep tank tightly closed in a dry, cool and well-ventilated place.  Keep away fromheat, sparks and flame.  tore under an inert atmosphere.

Safety precautions for Storage and Handling of Sodium Hypochlorite:  Take all precautions to avoid personal contact.  Keep container closed except when transferring material. Locate safety shower and eyewash station close to chemicalhandling area.  Use normal good industrial hygiene and housekeeping practices, wash thoroughly after handling.  Store in a cool, dry, well-ventilated area, away from incompatibles (minimum distance of 20-25 feet per NFPA Code 1) and directsunlight.  Keep container properly labeled at all times. Vented containers must be used and must be kept closed when notbeing used.  Long-term storage is impossible without decomposition.  Only use containers made from tinted glass,polyethylene & FRP. Keep out of

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reach of children.  Store containers below 29 °C and above freezing point. Do not expose sealed containersabove 40°C.  Try to store in the dark at the lowest possible temperature, but keep from freezing, to slow-down decomposition.

 Applicability of PESO :  Not Appicable ii Process safety details : (If applicable) 1. Hydrogenation process - -- 2. Nitration process SAFETY PRECAUTIONS FOR NITRATION PROCESS: • Nitric acid storage away from autoclave reactor. • Nitration is done in closed S.S vessels. Total enclosed process system is provided. Adequate plant air system is also provided. • Open well ventilated and fragile roofs are provided to on reactor. • Nitric acid is used for nitration process. Nitric acid is an extremely corrosive acid capable of causing severe chemical burns very rapidly. Because of the hazards posed by nitric acid, it is important to take safety measures whenever handling it. • Safety valve and Rupture Disc (Bursting Disc) is also been provided on reactor for zero process leakage to the atmosphere. Adequate pressure relief valve is provided for each vessels having pressure release capacity will be kept below -3 kg/cm2 than that of reaction vessels. • In our nitration process, exothermic reaction is controlled by adequate dosing of reaction chemicals in a fixed time (not short duration) having adequate cooling water circulation in jacket of reaction vessels. Thus, any energy generated due to exothermic reaction is controlled by external cooling circulation and therefore vessels are not pressurized. • The nitration reaction is controlled by systematic cooling design to withdraw the energy evolved. • Dumping vessel arrangement is made.

3. Chlorination process  Unit will not using chlorine gas but thionyl chloride will be used as a raw material in some products. It is mainly like chlorinating agent and it is toxic in nature. For

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chlorination process proper scrubber system is mainly requirement and before charging of thionyl chloride, scrubber system need to check and then only go ahead for charging and reaction.  Provision of Chlorine gas detector at chlorine tonner storage area as well as near/in process plant area. Its detecting limit will be set at 5 ppm level to detect any leakages.  Thionyl chloride drum size caustic solution pit will be provided near its storage and near production area.  A provision of life save kit containing oxygen mask is mandatory requirement to person whom are working near process area. So in case any leakages or blast first aid treatment shall be given immediately.

4. Exothermic Reaction Exothermic reaction will be controlled by adequate dosing of reaction chemicals in a fixed time (not short duration) having adequate cooling water circulation in jacket of reaction vessels. Thus, any energy generated due to exothermic reaction will be controlled by external cooling circulation and therefore vessels will not be pressurized.  During VC meeting dated 30/05/2020, Committee deliberated on the reply submitted by PP and found that revised product profile for end use of API intermediates is not in line with MoEF & CC Notification dated 27/03/2020 and also unit has not submitted treatability report of ETP with technical justification regarding drastic reduction of BOD and COD value after primary treatment while TDS value increase only 100 mg/l and only mentioning change in TDS value in characteristic of effluent.  After detailed discussion, Committee decided to consider the revised proposal in one of the upcoming meeting of SEAC after submission of following details, 1. Submit revised product profile and proposal with submission of revised PFR, Form-1, EMP and CER and subsequent change in Water, Air and Hazardous waste etc, in line with MoEF & CC Notification dated 27/03/2020. 2. Submit treatability report of ETP with technical justification regarding drastic reduction of BOD and COD value after primary treatment while TDS value increase only 100 mg/l. 4 SIA/GJ/IND2/150938/2020 M/s. Sulaksh Chemicals Unit-I Reconsideration Survey No. 71/1, At. & Po. Maghasar, Bh. Appraisal Hotel Navjeevan, Halol-Godhra Road and [Expansion case] Taluka: Halol, District: Panchmahal

Category of the unit: 5(f) Project status: Expansion  Project proponent (PP) submitted online application vide SIA/GJ/IND2/150938/2020 dated 16/04/2020

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for obtaining Environmental Clearance (EC).  Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. Production Capacity, Sr. Name of CAS No. MT/Month End Use of Product No. Products Existing Proposed Total Existing Inorganic Products Ferrous 1 7720-78-7 200 -- 200 Inorganic chemical use in Pharma and Sulphate chemical industries 2 Zinc Sulphate 7733-02-0 200 -- 200 Proposed Products - Intermediates and API 3-Nitro 3 121-89-1 -- 100 100 Acetophenone 3-Amino Used in Phenylephrine HCl which is 4 99-03-6 Acetophenone used as Decongestant. Used for the 3-Hydroxy temporary relief of stuffy nose, sinus, 5 121-71-1 Acetophenone and ear symptoms caused by the 3-Acetoxy common cold, flu, allergies, or other 6 2454-35-5 Acetophenone breathing illnesses (e.g., sinusitis, -- 50 50 Alpha Methyl- bronchitis). This medication works by M-Hydroxy decreasing swelling in the nose and acetophenone ears, thereby lessening discomfort and 7 679394-62-8 Sulphate making it easier to breathe. (MAAP Sulphate) Used in Tizanidine which is a short- 5-Chloro-4- acting muscle relaxer. It works by Amino-2,1,3- blocking nerve impulses (pain 8 30536-19-7 -- 0.5 0.5 Benzothiadia sensations) that are sent to your brain. zole Tizanidine is used to treat spasticity by temporarily relaxing muscle tone. Used in Ambroxol which is indicated as "secretolytic therapy in broncho pulmonary diseases associated with Trans-4- abnormal mucus secretion and Amino 9 27489-62-9 -- 5 5 impaired mucus transport. It promotes Cyclohexanol mucus clearance, facilitates (4-TACH) expectoration and eases productive cough, allowing patients to breathe freely and deeply Used in Dextromethorphan Hydro bromide which is along with Cyclohexenyl Promethazine HCl Syrup make a 10 Ethyl Amine 3399-73-3 -- 2 2 combination of an antihistamine and a (CHEA) cough suppressant used to treat cough, itching, runny nose, sneezing, and itchy or watery eyes caused by

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colds or allergies. Clindamycin is used to treat a wide Clindamycin variety of bacterial infections. It is an 11 58207-19-5 -- 1 1 Hydrochloride antibiotic that works by stopping the growth of bacteria. Methyl cobalamin is a form of vitamin B12. Vitamin B12 is important for the brain and nerves, and for the production of red blood cells. Methyl Methyl 12 288315-09-3 -- 1 1 cobalamin is used to treat vitamin B12 cobalamin deficiency. Methyl cobalamin is sometimes used in people with pernicious anemia, diabetes, and other conditions. Minocycline is a tetracycline antibiotic that fights bacteria in the body. Minocycline is used to treat many 13 Minocycline 10118-90-8 -- 1 1 different bacterial infections, such as urinary tract infections, respiratory infections, skin infections, severe acne, chlamydia, tick fever, and others Mitomycin is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Mitomycin is used in combination with other 14 Mitomycin 50-07-7 -- 0.5 0.5 cancer medications to treat cancer of the stomach and pancreas. Mitomycin treats only the symptoms of stomach or pancreatic cancer Methyl Thionium It is being used to treat malaria, as well 15 Chloride 61-73-4 -- 10 10 as methemoglobinemia and other (Methylene conditions. Blue) Gadobutrol is used to help diagnose certain disorders of the brain and spine (central nervous system), the blood 16 Gadobutrol 770691-21-9 -- 2 2 vessels of the kidneys, and the heart. Gadobutrol is also used with MRI of the breast to help detect breast cancer. Dexamethasone sodium phosphate is a corticosteroid used to treat a number of conditions including arthritis, Dexamethaso blood/hormone/immune system 17 n Sodium 2392-39-4 -- disorders, allergic reactions, certain Phosphate skin and eye conditions, breathing 5 5 problems, certain bowel disorders, and certain cancers. This medication is used to treat a Beta variety of skin conditions (e.g., 18 Methasone 5593-20-4 -- eczema, dermatitis, allergies, rash). Dipropionate Betamethasone reduces the swelling, itching, and redness that can occur in

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these types of conditions. Betamethasone Sodium Phosphate/Acetate Suspension, Injection. This medicine is given by Beta injection (shots) into a muscle, a joint, Methasone 19 151-73-5 -- or a sore on the skin. It is used to Sodium reduce inflammation, irritation, and Phosphate pain. It is also used to treat skin problems, arthritis, and other joint or tendon problems. This medication is used to treat a variety of skin conditions (e.g., Beta eczema, dermatitis, allergies, rash). 20 Methasone 2152-44-5 -- Betamethasone reduces the swelling, Valerate itching, and redness that can occur in these types of conditions. This medication is used to treat a variety of skin conditions (e.g., Beta eczema, dermatitis, allergies, rash). 21 378-44-9 -- Methasone Betamethasone reduces the swelling, itching, and redness that can occur in these types of conditions. Dexamethasone is used to treat conditions such as arthritis, blood/hormone/immune system Dexamethason disorders, allergic reactions, certain 22 50-02-2 -- e skin and eye conditions, breathing problems, certain bowel disorders, and certain cancers. It is also used as a test for an adrenal gland disorder Deflazacort is a steroid that reduces inflammation in the body. Deflazacort is used to treat Duchenne muscular 23 Deflazacort 14484-47-0 -- dystrophy in adults and children who are at least 5 years old. Deflazacort is not a cure for muscular dystrophy This medication is used to treat skin conditions such as eczema, psoriasis, Momentason 24 105102-22-5 -- allergies, and rash. Mometasone Furate decreases swelling (inflammation), itching, and redness. This medication is used to treat a variety of skin conditions (e.g., Triamcinolone eczema, dermatitis, allergies, rash). 25 76-25-5 -- Acetonide Triamcinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is used to treat a variety of skin conditions (e.g., Clobestasol eczema, psoriasis, dermatitis, 26 25122-46-7 -- Propionate allergies, rash). Clobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. 27 Phenylephrine 61-76-7 -- 5 5 It is used for the temporary relief of

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Hydrochloride stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Ambroxol is indicated as "secretolytic therapy in broncho pulmonary diseases associated with abnormal Ambroxol mucus secretion and impaired mucus 28 23828-92-4 -- 2 2 Hydrochloride transport. It promotes mucus clearance, facilitates expectoration and eases productive cough, allowing patients to breathe freely and deeply Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and Tigecycline skin structure infections caused by 29 197654-04-9 -- 2 2 HCl susceptible isolates of Escherichia coli, Enterococcus faecalis (vancomycin- susceptible isolates), Staphylococcus aureus This medication is used to prevent pain caused by injections and minor surgical procedures. It is also used for Ethyl 30 75-00-3 -- 5 5 the temporary relief of minor sports Chloride injuries. Ethyl chloride also helps to relieve deep muscle pain when used with muscle stretching techniques. R & D Products / Pilot Plant 31 -- -- 2 2 -- Batches/ Development Batches Total 400 194 594

 The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The presentation was considered in the meeting dated 01/05/2020.  Salient features of the project including Water, Air and Hazardous waste management(Revised):

Sr. no. Particulars Details A Total cost of Proposed Project Existing:1.0 (Land: 0.5, (Rs. in Crores): Building: 0.2, Plant & Break-up of proposed project Cost: Machineries: 0.3) 

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Proposed:3.0 (Building: 0.5, Plant & Machineries: 2.5)

Total: 4.0 Crores Details of Environmental Management Plan As below: (EMP)

Capital Recurring S. Pollution Control Cost, Rs. Cost, Rs. In Remarks No. Measures In Lakh Lakh/annum Environmental Capital, operation and Management systems maintenance cost of ETPs (with 1 for Air and water and 85.0 98.0 MEE, ATFD, RO), Scrubber, Noise Pollution noise control enclosures Control Cost of in-house parameter Environment measuring equipments, NABL 2 Monitoring 0.7 2.0 laboratory for regular and Management monitoring Cost of Designated area with First aid facilities, Periodical 3 Occupational Health 2.0 1.5 medical check-up through doctor/ hospital Cost of tree species, manure, 4 Green Belt 0.6 1.2 tree planting and regular maintenance Cost of designated storage Solid waste 5 2.5 3.0 area, storage, handling and management disposal cost Cost of Rain water collection Rain Water collection 6 1.0 0.2 system, storage tank and system regular maintenance Total 91.8 105.9

Details of CER as per OM dated 01/05/2018 As below:

Component As per Norms Allocation CER Rs. 3 Lakh (1 %) Rs. 3 Lakh (1 %)

Action Plan for Activities under CER Type of activity Budgetary cost Remarks Time Period Provision of RO plant, To be provided to Water cooler, fan, 1.5 Lakh Schools under Maghasar 2020-21 stationary items, Village Panchayat uniforms, Books etc Medical camp and To be carried out in Area provide free medicine 1.5 Lakh under Maghasar Village 2021-22 during camp Panchayat

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3.0 Lakh

B Total Plot area Existing: 2732 Sq. m. Proposed: 0 Sq. m. ( sq. meter) Total: 2732 Sq. m. Brief note on Area adequacy in line to proposed project activities:  In existing unit, two inorganic products were proposed for the same CTE fresh was obtained in January 2020. Unit has sufficient area for proposed expansion regarding proposed intermediates and API products. The same can be justified from Plant layout. Green belt area Existing: 50 Sq. m. ( sq. meter) Proposed: 855 Sq. m. Total: 905 Sq. m. (33.1% of total area) C Employment generation Existing: 5 Proposed: 35 Total: 40 D Water i Source of Water Supply Bore well (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern authority. Unit has obtained CTE in January 2020. After obtaining EC, unit will obtain CGWA permission. ii Water consumption (KLD)

Proposed Total after Existing Particular (Additional) Expansion Remarks KLD KLD KLD (A) Domestic 2.30 0.20 2.50 Fresh water (B) Gardening 1.25 3.25 4.50 Fresh water (C) Industrial Process 0.00 5.00 5.00 RO water Equipment washing 0.00 0.50 0.50 RO water Laboratory 0.00 0.50 0.50 RO water Total 4.3 KLD Boiler 2.30 2.00 4.30 treated water will be used Cooling 0.00 5.20 5.20 Treated water

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Total 0.25 KLD treated Floor Washing 0.15 0.10 0.25 water will be used Scrubbing 0.00 0.25 0.25 Treated water RO reject 0.00 2.00 2.00 Fresh water 10 KLD treated water Industrial Total 2.45 15.55 18.00 and 8.0 KLD fresh water 10 KLD treated water Grand Total (A+B+C) 6.00 19.00 25.00 and 15 KLD fresh water

Brief Note on worst case scenario for water consumption:  There is no water requirement for manufacturing process of existing inorganic products. For proposed products, wherever, unit has proposed cumulative production, worst case scenario has been taken into consideration.  As there will be a reusable treated water generation in considerable quantity, unit has changed total water balance after expansion for utilizing treated waste maximum as possible.  Here, we have submitted existing water balance same as per CTE fresh and after considering maximum use of treated water, we have prepared water balance for total after expansion.  So in some applications like utility and floor washing where we had considered fresh water in CTE, we have replaced the same with treated water in total water balance after proposed expansion.  Worst case scenario considered while calculating water requirement and wastewater generation from process is given hereunder.

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- Summary of Existing Proposed Total after Remarks water KLD (Additional) Expansion requirement KLD KLD Total water requirement for 6 19 25 the project (A) Quantity to be 00 10 10 recycled (B) Total fresh 6 9 15 water requirement (C)

Ensure Total water requirement = Fresh water + Recycled water i.e. A = B + C

In case of no reuse/recycle of waste water, Give brief note on justification as why no reuse/recycle.

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 Total 10 KLD treated water will be reused in utility, washing, scrubbing activities.

iii Waste water generation (KLD) Proposed Total after Existing (Additional Particular Expansion Remarks ) KLD KLD KLD Septic tank followed (A) Domestic 2.00 0.20 2.20 by soak pit (B) Gardening 0.00 0.00 0.00 (C) Industrial Process 0.00 12.10 12.10 Equipment washing 0.00 0.50 0.50 Laboratory 0.00 0.50 0.50 Boiler 0.05 0.15 0.20 Cooling 0.00 0.15 0.15 Floor Washing 0.15 0.10 0.25 Scrubbing 0.00 0.30 0.30 RO reject 0.00 2.00 2.00 Total Industrial Treated in ETP and 0.20 15.80 16.00 wastewater to be recycled Total wastewater 2.20 16.00 18.20 (A+B+C)

Brief Note on worst case scenario for waste water generation(Qualitative and Quantitative): Worst case scenario considered for water requirement and wastewater generation is given above in tabulated form. Wastewater characteristic is given in reply of following point.

Brief justification in case of no process effluent generation or no industrial effluent generation or no high concentration effluent generation from proposed project (Whichever is applicable). Process effluent will be generated as described in above points. High concentrated stream generated from process, laboratory and vessel washing, total @ 13.1 KLD will be first taken to solvent stripper for removal of solvent traces. iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc. . Process effluent will be generated as described in above points. High concentrated stream generated from process, laboratory and vessel washing, total @ 13.1 KLD will be first taken to solvent stripper for removal of solvent traces. . After stripping of solvent, almost solvent free process effluent will be taken for

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primary chemical treatment where it will be mixed with other effluent streams. . Neutralized and chemically treated effluent, after chemical sludge separation, will be taken to MEE. Reason to take all effluent in MEE is the TDS concentration. Process streams, RO reject, utility reject, scrubbed liquor will have high TDS which will be separated as salt in MEE. . Concentrated semi liquid stream will be dried in ATFD (Agitated Thin Film Dryer) and dried sludge will be sent to TSDF. . Condensate water of MEE, which may contain COD in lower concentration, will be taken to biological treatment and tertiary treatment followed by RO plant. RO permeate @ 10 KLD will be reused in utility, washing and scrubbing activities. . Dried Sludge from primary and secondary treatment of ETP will be sent to TSDF. Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed.

ETP Units: Sr. Particular Qty. Capacity No. 1 Collection tank 1 15 KL 2 Solvent stripper 1 0.75 KL/hr effluent intake 3 Collection tank 1 20 KL 4 Primary settling tank 1 3 KL 5 MEE Feed tank 1 10 KL 6 Multiple effect evaporator 1 1 KL/hr 7 ATFD (Agitated thin film dryer) 1 300 Kg/hr 8 Intermediate Collection Tank 1 5 KL 9 Aeration tank 1 20 KL 10 RO feed tank 1 5 KL 11 RO Plant 1 0.75 KL/hr 12 Treated water storage tank 1 15 KL 13 Filter Press 1 18‖ X 18‖ x 18 plates

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ETP Schematic flow diagram:

Effluent from process, lab & vessel washing

Collection Tank Other Effluents

Collection cum Primary MEE Feed Multiple Condensate Solvent Collection Equalization Settling Tank Effect Stream Stripper Tank Tank Tank Evaporator

Stripped Concentrated Solvents Sludge Collection Stream Tank ATFD Aeration Tank with MBR Sludge Reject Filtrate water Sludge Filter Press TSDF Site

Water to be reused for RO Feed Permeate RO Plant Tank utility, washing, scrubbing

Process, washing, After solvent Particular Unit laboratory stripping Quantity KLD 13.1 12.1 pH -- 4.0-6.0 4.0-6.0 Total Suspended Solids mg/l 150-200 150-200 Chemical Oxygen mg/l 70,000-80,000 20000-25000 Demand Total Dissolved Solids mg/l 1,00,000-1,20,000 30,000-40,000

Scrubbe Boiler & Process, d liquid cooling Floor washing, from Composite Particular Unit Blow Washing laboratory RO reject scrubber water down after solvent s stripping

Quantity KLD 0.35 0.25 0.3 12.1 2.0 15.0 pH -- 6.0-7.0 6.0-7.0 6.0-7.0 4.0-6.0 6.5-7.5 4.5-6.5 Total Suspended Solids mg/l 50-100 150-200 80-100 150-200 50-60 140-180 Chemical Oxygen 18000- mg/l -- 400-500 100-150 20000-25000 -- Demand 22000 2500- 1000- 2000- 3500- 28000- Total Dissolved Solids mg/l 30000-40000 3000 1200 2500 4000 38000

After secondar Composite After ETP MEE MEE y, Reuse Particular Unit water to Primary RO Condens Inlet tertiary water ETP treatment reject ate treatmen t and RO Quantity KLD 15.0 15.0 4.5 19.5 14.5 10 10 pH -- 4.5-6.5 6.0-7.0 6.5-7.5 6.0-7.0 6.0-7.0 7.0-8.0 For

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Total Suspended utility, mg/l 140-180 < 80 <50 <80 <50 <10 Solids washing Chemical Oxygen 18000- 15000- < and mg/l <100 <5000 < 50 Demand 22000 20000 18000 scrubbin 28000- 30000- <3800 g Total Dissolved Solids mg/l <1000 < 500 < 100 38000 40000 0

Note: (In case of CETP discharge) : Management of waste water keeping in view direction under section 18 (1) (b) of the Water (Prevention and Control of Pollution) act, 1974 issued by CPCB regarding compliance of CETP.  Not applicable Brief note on adequacy of ZLD (In case of Zero Liquid Discharge):  Stream segregation and various treatment like solvent stripping, MEE, ATFD, Primary, secondary and tertiary ETP followed by RO will be provided to achieve zero liquid discharge as all treated water @ 10 KLD will be used for utility, washing and scrubbing. Details of treatment units, flow diagram, stream-wise characteristics has already been provided in earlier points. v Mode of Disposal & Final meeting point(Existing and Proposed)

Domestic: Septic tank followed by Soak pit

Industrial: Total industrial wastewater shall be treated in ETP having MEE, ATFD and RO. Treated water will be used for utility,

washing and scrubbing vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF)(For waste water treatment)  Not applicable Membership of Common facility (CF) (For waste water treatment) Not applicable vii Simplified water balance diagram with reuse / recycle of waste water(Existing and Proposed)

 There is no water requirement for manufacturing process of existing inorganic products. For proposed products, wherever, unit has proposed cumulative production, worst case

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scenario has been taken into consideration.  As there will be a reusable treated water generation in considerable quantity, unit has changed total water balance after expansion for utilizing treated waste maximum as possible.  Here, we have submitted existing water balance same as per CTE fresh and after considering maximum use of treated water, we have prepared water balance for total after expansion.  So in some applications like utility and floor washing where we had considered fresh water in CTE, we have replaced the same with treated water in total water balance after proposed expansion.

Existing scenario:

Total after expansion:

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vii Reuse/Recycle details (KLD) with feasibility. [Source of reuse & application area] Total reuse 10 KLD - Source of waste Application Characteristics Remarks regarding water for reuse area with of waste water to feasibility to reuse i.e. with quantity in quantity in be reused (COD, KLD (From where KLD (Where BOD, TDS etc.) it is coming) it is used) ETP treated water Utility: 9.5 RO treated water: Treated water from RO from RO KLD pH:7 – 8 will be reused in utility, Scrubbing: SS <10 ppm washing and 0.25 KLD COD < 50 ppm scrubbing. based on Washing: TDS < 100 ppm outlet quality, it will be 0.25 KLD feasible

E Air i Brief Note on fuel based heat energy requirement and worst case scenario thereof:  For existing inorganic product, energy requirement is about 1,00,000 Kcal/hr which will be fulfilled from 0.9 TPH boiler. So, 0.2 TPH capacity utilized for existing requirement and spare 0.7 TPH will be used for MEE requirement (for

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1000 L/hr evaporation 400 Kg/hr steam will be required).  For proposed product, energy requirement @ 3,20,000 Kcal/hr will be fulfilled from proposed 0.8 TPH boiler.

Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed

Source of Air Pollution Stack Quantity of Type of Sr. emission Type of Control Height Fuel emissions i.e. no. With Fuel Measures (meter) MT/Day Air Pollutants Capacity (APCM) Cyclone Boiler Briquette 140 Separator 1 (0.9 TPH) - s/ Wood Kg/Hour followed by Existing chips adequate Stack 15 Particulate Boiler Cyclone Briquette Matter ≤ 150 (0.8 TPH) - 130 3 Separator 2 s/ Wood mg/Nm Proposed Kg/Hour followed by chips SO2 ≤ 100 ppm NOx ≤ 50 ppm adequate Stack D.G. Set Diesel Adequate Stack 3 (125 KVA) 8 25 Lit/Hour - Proposed height

ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed - Specific Source of Stack/ Air Pollution Sr. emission Type of Vent Control Measures no. (Name of the Product & emission Height (APCM) Process) (meter) Proposed Water scrubber Reactor 1 Acid Fumes 10 followed by Alkali (Reduction process) Scrubber

Reactor 2 Ammonia 10 HCl scrubber (Amination process)

Note:  Details of gaseous raw materials used in proposed project Ammonia gas @ 17.8 MT/Month, HCl gas @ 2.9 MT/Month, Nitrogen Gas @ 4 MT/Month, Hydrogen Gas @ 11.4 MT/Month

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AMMONIA:  Estimation of process gas emission (Product wise and Total) No specific emission of ammonia as per chemical reaction but Ammonia will be used in Cyclohexenyl Ethyl Amine (CHEA), Dexamethason, Phenylephrine Hydrochloride, in total @ 667 KG/day as per worst case and fullest capacity. If we consider 0.5% emission at maximum side then it will be around 3.34 Kg/day.  Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total) 100 L, 12-15% HCl solution (50 L, 25-30% HCl + 50 L water) per day will be used to scrub this ammonia resulting into ammonium chloride solution.  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix. Maximum 36.5 MT/Annum @ 0.1 MT/day of bleed liquor generation is taken into consideration which will be taken to ETP and treated with other effluent and ultimately treated water will be reused in utility and scrubber and gardening. Acidic Fumes:  Estimation of process gas emission (Product wise and Total) No specific emission of HCl as per chemical reaction but HCl gas will be used in Ethyl Chloride @ 98 KG/day as per worst case and fullest capacity. If we consider 0.5% emission at maximum side then it will be around 0.49 Kg/day. As HCl (30%) and Sulphuric acid will be used as raw material. Considering chances of its fumes, it is also taken into consideration.  Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total) 100 Liter water for water scrubber and 100 Liter alkali media will be provided as scrubbing media.  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix. Maximum 36.5 MT/Annum @ 0.1 MT/day of bleed liquor generation from water scrubber and Maximum 36.5 MT/Annum @ 0.1 MT/day of bleed liquor generation from alkali scrubber are taken into consideration which will be taken to ETP and treated with other effluent and ultimately treated water will be reused in utility and scrubber and gardening. iii Fugitive emission details with its mitigation measures.

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. Powdered Raw materials charging will be done in closed system and in covered area. . All necessary safety precautions will be taken while charging of raw materials. . Raw materials and products will be stored in designated storage area as per its characteristics. . Reactor and solvent handling pumps will have mechanical seals to prevent leakages. . Reactors shall also be provided with breather valve to prevent losses. . Pucca flooring will be provided on the inner roads of the factory to control SPM concentration in ambient air. . The unit will developed Green Belt in the industrial premises as well will participate in greenbelt development program in nearby area. . All the raw materials will be pneumatically transfer to the reactor. . Care will be taken to store construction material properly to prevent fugitive emissions, if any. . Plantation will be done around the project area and along the roads. . Adequate ventilation will be provided. . Regular maintenance of valves, pumps and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs. . Entire process will be carried out in the closed assembly with proper maintenance of pressure and temperature. . Periodic monitoring of work area will be carried out to check the fugitive emission as per the norms of Gujarat Factory Rules. . To eliminate chances of leakages from glands of pumps, mechanical seal will be provided at all solvent pumps. . Solvent recovery will not be less than 90% under any case. . Spent solvents will be distilled at atmospheric pressure and distillation facility shall include condensers with sufficient Heat Transfer Area and residence time so as to achieve more than 95% recovery. . All necessary fire fighting systems shall be provided with alarm system. Flame proof wiring and flame proof electrical accessories shall be provided to avoid any mishap. . All the vents will be connected to a common carbon adsorber for removing traces of solvent from vent gases. . Nomenclature and proper label pasted on them indicating name of solvent will be made on each of the storage unit. . Reactor and solvent handling pump will have proper seals to prevent leakages.

F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and calculations shall be incorporated in EMP details separately.  Disposal to scrap vendors/vendors/traders is not allowed

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Existing & Proposed i Specific Quantity (MT/Annum) Source of Catego generatio ry and Type/ Name n Sr. Schedu Management of of Hazardous (Name of Existin Propose no. le as Total HW waste the g d per HW Activity, Rules. Product etc.) 1 Used /spent Plant & 5.1 0.005 0.025 0.03 Collection, Oil Machineri storage, and es reuse within premises for lubrication or disposal to registered recycler. 2 Discarded Raw 33.1 3.3 300.7 304 Collection, Containers/ materials storage, bags Transportation & sell to authorized recycler 3 ETP Sludge Wastewat 0.35 69.65 70 er Evaporation 35.3 4 treatment 0.05 266.95 267 Collection, salt systems storage, Process waste Mfg 28.1 00 623 623 Transportation (Inorganic Process and Disposal to 5 salts) (product TSDF no. 14,15,27) 6 Spent Carbon Mfg 28.3 00 78 78 Process (product no. 5,8,9, 11, Collection, 13,22,27,2 storage, 8, 29) Transportation 7 Distillation Solvent 20.2 00 105 105 and Disposal to residue recovery CHWIF 8 Hyflo Mfg -- 00 13.1 13.1 Process (product no. 8,9, 13, 28, 29) 9 Iron sludge Mfg -- 00 775 775 Collection, Process storage, (product Transportation no. 4,8, and Sent to 15) cement

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manufacturing unit 10 Spent Catalyst Mfg 28.2 00 8.5 8.5 (Raney Nickel) Process Collection, (product storage, no. 8,9, Transportation 10) and Disposal to 11 Spent Catalyst Mfg 28.2 00 3.6 3.6 metal re- (Metal Process of processor under Chloride) Ethyl Rule 9 Chloride 12 Spent Solvent Mfg 28.6 00 15255.0 15255.0 Process Recovery and (Product reuse in next no. 1, 5- batch 18, 20-27) 13 Spent Mfg SC-II- 00 3571 3571 Collection, Sulphuric acid Process B15 storage and (70-80%) (product reuse within no. 3, 7, 8, premises for 29) manufacturing ferrous and zinc sulphate 14 Spent HCl Mfg SC-II- 00 19.6 19.6 Collection, (25-30%) Process of B15 reused for ethyl ammonia chloride scrubbing and to be taken in in- house ETP for treatment and ultimately reused and if extra then Transportation and Disposal to actual user under Rule 9 15 Scrubbed Water SC-II- 00 36.5 36.5 liquor Scrubber B15 (HCl (10- 12%)) 16 Scrubbed Alkali -- 00 36.5 36.5 liquor (8 -10% scrubber solution Collection and to contains be taken in in- sodium house ETP for sulphate, treatment and sodium ultimately reused chloride) 17 Scrubbed Ammonia -- 00 36.5 36.5 liquor (4 -5% scrubber solution containing ammonium chloride)

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18 Off Mfg 28.4 00 2.0 2.0 Collection, specification Process storage, Transportation and Disposal to CHWIF 19 Mixed solvent Solvent -- 00 300 300 Collection, stripper storage, Transportation and Disposal to solvent recovery unit under Rule 9 ii Membership details of TSDF, CHWIF etc. We will obtain membership of (For HW management) TSDF and CHWIF iii Details of Non-Hazardous waste & its Non-hazardous waste will be disposal(MSW and others) collected and stored and ultimately given to respective authorized vendors G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format)

Sr. Quantity (MT/Month) % Name of Solvent No. Fresh Recovered Total Recovery 1 Ethylene Dichloride 8.0 194.0 202.0 96.0 2 Methanol 6.7 241.9 248.6 97.3 3 Methylene chloride 1.3 48.8 50.0 97.5 4 Methylene Dichloride 8.3 231.5 239.7 96.6 5 Iso Propyl Alcohol 7.5 227.0 234.5 96.8 6 Ethyl Acetate 0.3 11.1 11.4 97.0 7 Dimethyfomamide 0.6 19.7 20.4 96.9 8 Toluene 2.9 76.9 79.7 96.4 9 Ethanol 1.0 39.0 40.0 97.5 10 Acetone 3.2 86.6 89.7 96.5 11 Chloroform 0.8 23.4 24.3 96.6 12 Tetrahydro furan (THF) 2.9 71.3 74.2 96.1 Total 43.4 1271.0 1314.5 Avg: 96.8 Product wise solvent details are given in LDAR document ii Brief Note on LDAR proposed:  Attached as separate document iii VOC emission sources and its mitigation measures  Due to Manufacturing process and solvent distillation and handling chances of VOC emissions. Entire process and material charging has been carried out in closed loop. Regular work place monitoring will be done. Standard SOP will be followed to handle powder and liquid raw materials.

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H SAFETY details i  Details regarding storage of Hazardous chemicals (For tank storages only)

Storage Name of major Remarks details Hazardous chemicals Storage tanks Sulphuric Acid (2 No other hazardous (If any) Nos.) - 5 KL each chemicals will be stored in tanks. Looking to the quantity, it will be received and stored in drums.

Toxicity Name of (Oral LD50 Hazardous characteristics chemical mg/kg) • Products of combustion are not available since material is non- flammable. • Concentrated Sulphuric Acid will react Sulphuric with many organic material and may 2140 Acid cause fire due to the heat of the reaction. • Not flammable, but reacts with most metals to form explosive/flammable hydrogen gas. Storage & Handling: . Keep container dry. . Do not digest. . Do not breathe gas/fumes/vapor/spray. . In case of sufficient ventilation, wear suitable respiratory equipment. . If ingested, seek medical advice immediately and show the container or the label. . Avoid contact with eyes. . Keep away from incompatibles such as oxidizing agents, organic materials, metals, alkalis, moisture.

Personnel Protective Equipments: . Face shield, full suit, vapor respirators. . Be sure use approved certified respirators Gloves, Boots.

 Safety details of Hazardous chemicals (To be stored in storage tanks)  Applicability of PESO :  Permission will require for methanol and will obtain PESO permission for the same.

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ii Process safety details : (If applicable) 1. Hydrogenation process 2. Nitration process- NA 3. Chlorination process-NA 4. Exothermic Reaction -NA Safety measures for Hydrogenation process: . To maintain the maximum pressure Rupture disk shall be placed on Hydrogenetor. . It will develop a good precaution to have a secondary safety instrument on the hydro generator in the context advantage to have pressure safety valve (PSV) on the hydro generator tank below or equivalent of the design pressure of the hydro generator. . Provision of N2 line in the Hydro Generator to control the Flame or any process in the Hydro generator in case of any eventuality. . Hydro Generator works to be placed in a closed room to avoid damages and the room will be design to suitable for it. . A double mechanical seal with system it avoid any leakages/splitting. . This equipment fabrication would be as ASME Section – VIII, Div – 1 with 100% radiography with welding factor 1.0 . The motor would be FLP. . The fire Hydrant safety would be provided in the room like, fire Extension, Sprinklers & sand buckets etc. . Process instructions would be displayed at the Hydro generator. . Provision of experienced executed work man on the equipment. . Adequate ventilation would be provided around the Hydro generation room. . Leak preventive Detection system would be provided. . Elimination of the ignition sources near and all around the Hydro Generator area. . Adequate exist and entry would be provided.  During the video conference meeting dated 01/05/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & relevant documents.  Committee noted that the proposal is for expansion. Unit has valid CTE for existing plant for inorganics product granted by GPCB in January 2020. Copy of CTE report is submitted. PP ensured that there were only site levelling and preparation activities were carried out after obtaining CTE. PP ensured that there are no court cases pending and no public complaints against the project. PP submitted details regarding area adequacy. Source of water is Bore well. PP submitted undertaking regarding the CGWA permission for withdrawal of ground water.  PP submitted that after proposed expansion entire effluent generated from process, equipment washing, laboratory, Process RO reject, boiler blow down, cooling tower blow down, floorwashing & scrubber will be treated in in-house ETP-1 having primary treatment. Treated effluent of ETP-1 will be fed into in- house MEE followed by ATFD. MEE condensate shall be treated in ETP-2 having secondary and tertiary treatment followed by RO. RO permeate will be reused within premises while RO reject will be fed into in- house MEE followed by ATFD.  PP submitted that they have proposed two boiler and one DG set. Fuel used will be Briquettes/ Wood chips for Boilers and Diesel for DG set. PP submitted that they will provide adequate APCM with Flue

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gas and Process stack.  PP submitted Hazardous Waste Matrix as per HWR – 2016.  Product profile along with End Use discussed in depth. PP has not addressed specific end use of each products and why as to consider proposed products under B2 category in line with the Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API) satisfactorily.

 After detailed discussion, it was decided to consider the proposal only after submission of the following documents: 1. Submit specific end-uses of proposed product profile. Also submit an undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API). 2. Revise stream segregation and wastewater management based on characteristics of stream. Proposal of ZLD for industrial effluent. Revised ETP sludge and MEE salt quantity based on revised wastewater management. 3. Justification of proposing 5 MT/Month R & D products. Revised project details in this regard.  Project proponent submitted reply of above query via Email on dated 27/05/2020. PP presented in SEAC videoconference for above query on dated 30/05/2020.  PP replied as below : 1. PP submitted the end-uses of proposed product profile and undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API). PP presented that they proposed 28 nos of new product out of which 20 nos are API and remaining are API intermediate. 2. PP submitted the stream wise effluent characteristics and treatability. PP revifchrontensed the effluent treatment scheme by providing solvent stripper to process stream before treated in ETP (Primary treatment). PP also submitted the revised hazardous waste matrix considering revised ETP sludge, MEE salt and spent solvent recovered from solvent stripper. 3. PP submitted revised product profile with R&D quantity 2 MT/month which is approximate 1 % of the proposed expansion.  The case was reconsidered in the Video conference meeting dated 30/05/2020. During the said meeting Committee observed that reply submitted by PP is satisfactory.

 After detailed discussion, it was decided to recommend the project to SEIAA Gujarat for grant of Environmental Clearance.

Conditions with which Environment Clearance is recommended:

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SPECIFIC CONDITIONS: 1. PP shall comply conditions of any subsequent amendment or expansion or change in product mix, after the 30th September 2020, considered as per the provisions in force at that time as mentioned in the Notification vide S.O. 1223 (E) dated 27/03/2020. 2. PP shall not manufacture any products in proposed project/activities (as per the undertaking submitted by PP) which are not qualifying the amended EIA Notification vide S.O. 1223 (E) dated 27/03/2020 and any subsequent amendments. 3. PP shall submit six monthly compliance report of Environmental Clearance without fail and the same shall be critically assessed by the regulatory authority. 4. R & D products shall be of similar chemistry and the pollution load shall remain the same as committed. 5. Project proponent shall not take continuous/commercial production of the R & D products. Necessary approvals shall be obtained from the concern authorities prior to commercial production of R & D products. 6. Project proponent shall provide continuous online flow meter for groundwater withdrawal and shall maintain records of the same thereof. 7. Unit shall obtain the prior permission of CGWA for the withdrawal of ground water through borewell. 8. Close loop solvent recovery system with adequate condenser system shall be provided to recover solvent vapors in such a manner that recovery shall be maximum and recovered solvent shall be reused in the process within premises. 9. Leak Detection and Repair (LDAR) program shall be prepared and implemented as per the CPCB guidelines. LDAR Logbooks shall be maintained. 10. Complete Zero Liquid Discharge [ZLD] status shall be maintained all the time and there shall be no drainage connection from the premises. 11. Unit shall provide adequate treatment to industrial efflunet before feeding it to in-house MEE in order to prevent adverse impact on Human Health and Environment. 12. Safety: a) PP shall obtain PESO permission for the storage and handling of hazardous chemicals. (If applicable) b) Flame proof electrical fittings shall be provided in the plant premises, wherever applicable. c) Unit shall never store drum/barrels/carboys of incompatible material/chemical together. d) Unit shall provide safety valve & rupture disc to the Hydrogenation vessel. 5 SIA/GJ/IND2/151243/2020 M/s. Shivam Petrochem Industries EC – Reconsideration Plot No. 1761/P & 1757, Village: Gothda, Tal: Savli, Dist: Vadodara (Guj.)

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Category of the unit: 5(f) Project status: Expansion

 Project proponent (PP) submitted online application vide no. SIA/GJ/IND2/151243/2020 dated 17/04/2020 for obtaining Environmental Clearance.  Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. QUANTITY SR. CAS NO. / Cl (MT/MONTH) PRODUCTS NO. NO. EXISTING PROPOSED TOTAL PROPOSED 1. DISTILLED SOLVENT -- 600 0 600

SR. GROUP-1 NO. ORGANIC PRODUCT (INTERMEDIATE) 1. HEXA METHYL DI 999-97-3 0 1000 1000 SILAZANE (HMDS) 2. N – BUTYL CHLORIDE 109-69-3 0 200 200 3. OXALYL CHLORIDE 79-37-8 0 50 50 4. CINNAMIC ALDEHYDE 104-55-2 0 250 250 5. CINNAMIC ALCOHOL 104-54-1 0 100 100 SR. GROUP-2 NO. STEROID AND VITAMIN B-12 (PHARMA PRODUCT) 1. HALOBETASOLE 66852-54-8 0 5 5 PROPIONATE 2. CLOBETASOLE 25122-57-0 0 5 5 BUTYRATE 3. CLOBETASOLE 25122-46-7 0 10 10 PROPIONATE 4. DEFLAZACORT 14484-47-0 0 10 10 5. BETAMETHASONE 5593-20-4 DIPROPIONATE 0 15 15 6. BETAMETHASONE 2152-44-5

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VALERATE 7. DUTASTERIDE 164656-23-9 8. MOMETASONEFUREAT 105102-22-5 E 9. BETAMETHASONE 151-73-5 SODIUM PHOSPHATE 10. DEXAMETHASONE 2392-39-4 SODIUMPHOSPHATE 11. BECLOMETHASONE 4419-39-0 DIPROPIONATE 12. METHLYL COBALAMINE 13422-55-4 SR. GROUP - 3 NO. 1. CIFIXIMETRIHYDRATE 79350-37-1 0 50 50 2. CEFUROXIME AXETIL 64544-07-6 3. CEFPODOXIME 87239-81-4 0 5 5 PROXETIL SR. GROUP - 4 NO. 1. BENZYL ACETATE 140-11-4 0 50 50 2. BENZYL ALCOHOL 100-51-6 0 600 600 3. DI BENZYL ETHER 103-50-4 0 250 250 4. BENZYL BENZOATE 120-51-4 0 150 150 5. BENZYL CHLORIDE 100-44-7 0 2500 2500 6. BENZAL CHLORIDE 98-87-3 7. BENZO TRICHLORIDE 98-07-7 0 150 150 8. BENZALDEHYDE 100-52-7 0 600 600 9. SODIUM BENZOATE 532-32-1 0 100 100 10. ORTHO CHLORO 89-98-5 0 500 500 BENZALDEHYDE 11. ORTHO CHLORO 118-91-2 0 200 200 BENZOIC ACID SR. GROUP - 5 NO. ACID CHLORIDES 1. 2 METHOXY ETHYL 627-42-9 0 50 50 CHLORIDE (2 MEC)

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2. 2 ETHYL HEXANOYL 760-67-8 CHLORIDE (2 EHC) 3. 2 PROPOXY ETHYL 42149-74-6 CHLORIDE (2 PEC) 4. 2, 4 , 6 TRI METHYL 480-63-7 BENZOYL CHLORIDE (2, 4, 6 TMBC) 5. 3,5 DI METHYL 413-010-9 BENZOYL CHLORIDE (3, 5 DMBC) 6. 4 - CHLORO BUTYRYL 4635-59-0 CHLORIDE (4 - CBC) 7. ISO BUTYRYL 79-30-1 CHLORIDE (IBC) 8. ISO NONANOYL 764-85-2 CHLORIDE (INC) 9. ISO OCTYL CHLORIDE 204-667-0 (IOCL) 0 1000 1000 10. ISOPHTHALOYL 99-63-8 CHLORIDE (IPC) 11. LAUROYL CHLORIDE 112-16-3 (LC) 12. METHOXY ACETYL 38870-89-2 CHLORIDE (MAC) 13. N - BUTYRYL CHLORIDE 109-69-3 (N -BC) 14. NEO DECANOYL 112-13-0 CHLORIDE (NDC) 15. OCTANOYL CHLORIDE 111-64-8 (OC) 16. PIVALOYL CHLORIDE 3282-30-3 (PC) 17. TEREPHTHALOYL 100-20-9 CHLORIDE (TPC) 18. UN DECANOYL 17746-05-3 CHLORIDE ( UNDC )

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19. VALEROYL CHLORIDE ( 638-29-9 VC ) 20. 2-CHLORO ETHYL 870-24-6 AMINE

21. INDOLILONE 15362-40-0 0 50 50 22. BIS 2 CHLORO ETHYL 821-48-7 0 250 250 AMINE HCL 23. CHLORO ACETYL DI 15308-01-7 0 250 250 PHENYL AMINE 24. 2-FUROYL CHLORIDE 527-69-5 0 250 250 25. TRITYL CHLORIDE 76-83-5 0 250 250 TOTAL 600 8900 9500

INORGANIC CHEMICALS (By Product) 1. Ammonium Chloride 12125-02-9 0 12252 12252

2. SO2 Bottling 7446-09-5 0 3100 3100 Specific End Use for the Intermediate Sr Name of the product CAS Type/ Name of API in CAS Said API is used . No. Category which No. for/End Use of N of Product Intermediate (API) said API o. (API/ Used/ End use Intermedia of said te) Intermediate GROUP-1

1. Hexamethyl di silazane 999- Intermediat Cifadroxil 66592- Antibiotics & (HMDS) 97-3 e 87-8 Antiviral medicine, used to treat a wide variety of bacterial infections (e.g., strep throat, skin and urinary tract infections) 2. N – Butyl Chloride 109- Intermediat Phenylbutazone- used as a raw 69-3 e drugs 50-33-9 material for In the pharmaceutical

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industry & used for for synthetic animal insect repellents 3. Oxalyl Chloride 79-37- Intermediat Dioxane 213967 Used in a penem 8 e Tetraketone -57-8 antibiotic drug 4. Cinnamic Aldehyde 104- Intermediat Citalopram 59729- Used as anti cancer 55-2 e 33-8 agent & also used 5. Cinnamic Alcohol 104- Intermediat to treat depression 54-1 e GROUP-2 STEROID AND VITAMIN B-12 (PHARMA PRODUCT) 1. Halobetasole Propionate 66852 API Halobetasol 66852- This medication -54-8 Propionate 54-8 is used to treat a Ointment variety of skin conditions (such as eczema, dermatitis, psoriasis, rash). Halobetasol reduce s the swelling, itching, and redness that can occur in these types of conditions. 2. Clobetasole Butyrate 25122 API Clobetasole 25122- Topical steroids are -57-0 Butyrate 57-0 used in addition to Ointment moisturisers (emollients) for treating inflammatory skin conditions such as eczema and dermatitis 3. Clobetasole Propionate 25122 API Clobetasole 25122- Clobetasol -46-7 Propionate 46-7 propionate) is a Ointment topical (for the skin) steroid used to treat

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the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. 4. Deflazacort 14484 API 14484- Steroid that reduces -47-0 Deflazacort 47-0 inflammation in the body. Deflazacort is used to treat Duchenne muscular dystrophy in adults and children 5. BetamethasoneDipropio 5593- API Betamethasone 5593- Betamethasone nateI 20-4 DipropionateI 20-4 dipropionate is a Ointment "super high potency" corticosteroid used to treat inflammatory skin conditions such as dermatitis, eczema and psoriasis. It is a synthetic analog of the adrenal corticosteroids. 6. Betamethasone Valerate 2152- API Betamethasone 2152- Inflammatory skin 44-5 44-5 conditions such as severe eczema and dermatitis 7. Dutasteride 164656- API Avodart 164656 Treatment of 239 -23-9 symptomatic benign prostatic hyperplasia (BPH) in men

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8. Mometasone Fureate 10510 API Mometasone 105102 Steroid used as 2-22-5 Fureate -22-5 Mometasone anti Cream fungal 9. Betamethasone Sodium 151- API Betamethasone 151-73- Inflammatory skin Phosphate 73-5 Sodium 5 conditions such as Phosphate severe eczema and dermatitis 10 Dexamethasone Sodium 2392- API Dexamethasone 2392- To treat a number . Phosphate 39-4 Sodium 39-4 of conditions Phosphate including arthritis, blood/hormone/imm une system disorders, allergic reactions. 11 Beclomethasone 4419- API Beclomethasone 4419- The inhaled form is . DipropionateI 39-0 DipropionateI 39-0 used in the long- term management of asthma. The cream may be used for dermatitis and psoriasis. 12 Methlyl Cobalamine 13422 API Methlyl 13422- Methylcobalamin is . -55-4 Cobalamine 55-4 used to treat vitamin B12 deficiency. methylcobalamin is sometimes used in people with pernicious anemia, diabetes, and other conditions GROUP - 3 (API GROUP) 1. Cifiximetrihydrate 79350 API cyanocobalamin 68-19-9 Used to treat -37-1 vitamin B12 deficiency. 2. Cefuroxime Axetil 64544 API cyanocobalamin 68-19-9 Used to treat

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-07-6 vitamin B12 deficiency. 3. Cefpodoxime Proxetil 87239 API cyanocobalamin 68-19-9 Used to treat -81-4 vitamin B12 deficiency. GROUP – 4

1. Benzyl Acetate 140- Intermediat Health care product 11-4 e used as a local Cefoperazone 113826 anesthetic with -44-1 LIDOCAINE injection 2. Benzyl Alcohol 100- Intermediat Ivermectin 70288- An anti parasite 51-6 e 86-7 medication used to treat head lice, and enterobiasis. 3. Di Benzyl Ether 103- Intermediat Sarecycline 103565 Used to treat 50-4 e 4-66-0 moderate to severe & acne vulgaris in 389139 adult & treat a wide -89-3 variety of bacterial infections respectively 4. Benzyl Benzoate 120- Intermediat Permethrin 52645- Used for an 51-4 e 53-1 effective and inexpensive topical treatment for human scabies. 5. Benzyl Chloride 100- Intermediat 300-62- Used as central

44-7 e Amphetamine 9 nervous system 6. Benzal Chloride 98-87- (CNS) in Anti- 3 Biotics Drug 7. Benzo Trichloride 98-07- Intermediat Cefoperazone 113826 Health care product 7 e -44-1 used as a local anesthetic with LIDOCAINE

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injection 8. Benzaledhyde 100- Intermediat cinnamic acid 140-10- Many cinnamic acid 52-7 e 3 derivatives, especially those with the phenolic hydroxyl group, are well- known antioxidants 9. Sodium Benzoate 532- Intermediat Cefoperazone 113826 Health care product 32-1 e -44-1 used as a local anesthetic with LIDOCAINE injection 10 Ortho Chloro 89-98- Intermediat benzylpenicillin 61-33-6 antibiotic with . Benzaldehyde 5 e bactericidal activity 11 Ortho Chloro Benzoic 118- Intermediat sodium salt of p- 74-11-3 Used as a . Acid 91-2 e chlorobenzoic preservative in Anti- acid Biotics Drug

GROUP – 5

1. 2 Methoxyl Ethyl 627- Intermediat Isobutyryl-L- 25518- Used in a penem Chloride (2 MEC) 42-9 e carnitine 49-4 antibiotic drug

2. 2 Ethyl Hexanoyl 760- Intermediat pyrazinamide 98-96-4 Use to treat Chloride (2 EHC) 67-8 e tuberculosis (TB) &

bacterial infection.

3. 2 Propoxy Ethyl Chloride 42149 Intermediat Ethyl chloride 75-00-3 helps to relieve (2 PEC) -74-6 e deep muscle pain when used with muscle stretching techniques 4. 2, 4 , 6 Tri Methyl 480- Intermediat Sarecycline 103565 Used to treat a wide Benzoyl Chloride (2, 4, 6 63-7 e 4-66-0 variety of bacterial TMBC) infections

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respectively 5. 3,5 DI Methyl Benzoyl 413- Intermediat β-cyclodextrin 7585- Use for improving Chloride (3, 5 DMBC) 010-9 e 39-9 the solubility and the stability of drugs by complex formation at the solid state 6. 4 - Chloro utyryl 4635- Intermediat Benzamides 55-21-0 used Chloride (4 - CBC) 59-0 e as neuroleptics and/or antipsychotics drug 7. Iso Butyryl Chloride 79-30- Intermediat atropine 51-55-8 Used in a penem (IBC) 1 e antibiotic drug 8. Iso Nonanoyl Chloride 764- Intermediat Tetracyclines 60-54-8 Used in a penem (INC) 85-2 e antibiotic drug 9. Iso Octyl Chloride 204- Intermediat chrysotrione B 17746- Used in a penem (IOCL) 667-0 e 05-3 antibiotic drug 10 Iso Phthaloyl Chloride 99-63- Intermediat chlorobenzoic 74-11-3 Used as . (IPC) 8 e acid preservative in antibiotic drug 11 Lauroyl Chloride (LC) 112- Intermediat 66734- application to body . 16-3 e Aclometasone 13-2 surfaces such as 0.05% the skin or mucous membranes to treat ailments 12 Methoxyl Acetyl Chloride 38870 Intermediat Benzamides 55-21-0 used . (MAC) -89-2 e as neuroleptics and/or antipsychotics 13 N - Butyryl Chloride (N - 109- Intermediat propylisopropyl 60-35-5 Used in a penem . BC) 69-3 e acetamide antibiotic drug 14 Neo Decanoyl Chloride 112- Intermediat Ascaridole 512-85- Used in a penem . (NDC) 13-0 e 6 antibiotic drug 15 Octanoyl Chloride (OC) 111- Intermediat (R)-2- a therapeutic agent . 64-8 e propyloctanoic 208925 for Alzheimer′s acid disease

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16 Pivaloyl Chloride (PC) 3282- Intermediat 3-(T-Butyl)-4- 121-00- Used in a penem . 30-3 e Methoxyph nol 6 antibiotic drug 17 Terephthaloyl Chl ride 100- Intermediat Isobutyryl- 25518- Used in a penem . (TPC) 20-9 e L carnitine 49-4 antibiotic drug 18 Un Decanoyl Chloride ( 17746 Intermediat chrysotrione B 17746- Antibiotic . UNDC ) -05-3 e 05-3 19 Valeroyl Chloride ( VC ) 638- Intermediat Propylisopropyl 60-35-5 Used in a penem . 29-9 e acetamide antibiotic drug 20 2-Chloro Ethyl Amine 870- Intermediat Ifosfamide 3778- Is a chemotherapy . 24-6 e 73-2 medication used to treat a number of types of cancer 21 Indolilone 15362 API -- -- Used as Vitamin B . -40-0 12 22 Bis 2 Chloro Ethyl Amine 821- Intermediat Aripiprazole 129722 It is primarily used . HCL 48-7 e -12-9 in the treatment of schizophrenia and bipolar disorder 23 Chloro Acetyl Di Phenyl 15308 Intermediat Diphenylamine Diphenylamine is . Amine -01-7 e 122-39- widely used as an 4 industrial antioxidant, dye mordant and reagent and is also employed in agriculture as a fungicide and antihelmintic. 24 2-Furoyl Chloride 527- Intermediat Ceftiofur 103980 Ceftiofur sodium is . 69-5 e -44-5 used in cattle and pigs for treatment and control of infections caused by susceptible pathogens.

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25 Trityl Chloride 76-83- Intermediat Cefotaxime 63527- Cefotaxime is a . 5 e 52-6 cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body. Cefotaxime is used to treat many kinds of bacterial infections, including severe or life-threatening forms.  The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The proposal was considered in the meeting dated 29/04/2020.  Salient features of the project including Water, Air and Hazardous waste management: Sr. Particulars Details no. A Total cost of Proposed Project Existing:5 Crores (Rs. in Crores): Proposed: 25 Crores Break-up of proposed project Cost: Total: 30 Crores  Cost of Machinery & Equipment: 21 Crores  Cost of Construction: 3.0 Crores  Labor Charges: 1.0 Crores Details of Environmental Management Plan (EMP) As below: Brief details of EMP

Component Capital Cost of EMP Recurring Cost Of EMP (Per Month)

Cost Rs. 845 Lakh Rs. 111 Lakh

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2. APCM -- 128 -- 0.04 0.04 3. Hazardous -- 27 90.25 -- 90.25 Waste (Expense) 4. AWH -- 10 0.08 -- 0.08 Monitoring Cost 5. Greenbelt -- 80 -- 0.4 0.4 Total 845 111

Details of CER as per OM dated 01/05/2018 As below: As per OM no. 22-65/2017 on dated 01/05/2018 regarding ―Corporate Environment Responsibility‖ (CER), Brownprojects have to contribute 2% of the Additional Capital Investment, the company will contribute Rs. 2.5 Lakhs as funds for CER activities Component As per Norms Allocation CER Rs. 25.0 Lakh Rs. 25.0 Lakh (1 %) (1 %)

Activities to be carried out under CER: CER Activities Fund (Rs.) Company will provide Vegetables, Dal, Rice, Juvar to the needy 25 people of Gothda & Karachiya village. TOTAL 25,00,000/-

B Total Plot area Existing: 10000 Sq. m. ( sq. meter) Proposed: 30000 Sq. m. Total: 40000 Sq. m.

Green belt area Existing: 3000 Sq. m. ( sq. meter) Proposed: 11000 Sq. m. Total: 14000 Sq. m. C Employment generation Existing: 40 Proposed: 60 Total: 100 D Water i Source of Water Supply Ground Water Supply (GIDC Bore well, Surface water, Tanker supply etc...)

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Status of permission from the concern authority. Application No: 21-4/2001/GJ/IND/2017 Dated: 31/03/2017 ii Water consumption (KLD)

Existing Proposed Total after Remarks KLD (Additional) Expansion KLD KLD (G) Domestic 1.5 13.5 15 (H) Gardening 0 15 15 (I) Industrial

Process 0 416 416 Washing 0 25 25 Boiler 5 165 170 Cooling 15 105 120 Others 0 351 351 Industrial Total 20 1062 1082 Grand Total (A+B+C) 21.5 1090.5 1112.0 Brief Note on worst case scenario for water consumption:  All Products are worst case PRODUCT WATER CONSUMPTION GROUP - 1 5. CINNAMIC ALCOHOL 2.6 GROUP - 2 1. HALOBETASOLE PROPIONATE 17.63 2. CLOBETASOLE BUTYRATE 50.63 3. CLOBETASOLE PROPIONATE 22.06 4. DEFLAZACORT 34.41 12. METHYL COBALAMIN 20 GROUP – 3 2. CEFPODOXIME AXETIL 29.69 3. CEFPODOXIME PROXETIL 4.51 GROUP - 4 1. BENZYL ACETATE 19.39 2. BENZYL ALCOHOL 170 4. BENZYL BENZOATE 36

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8. BENZALDEHYDE 4 10. ORTHO CHLORO BENZALDEHYDE 2.13 11. ORTHO CHLORO BENZOIC ACID 1.53 GROUP - 5 21. INDOLILONE 1.46 TOTAL 415.98 KL/Day

- Summary of water Existing Proposed Total after Remarks requirement KLD (Additional) Expansion KLD KLD

Total water 21.5 1090.5 1112.0 requirement for the project (A) Quantity to be 0 324 324 recycled (B) Total fresh water 21.5 766.5 788 requirement (C)

Ensure Total water requirement = Fresh water + Recycled water i.e. A = B + C

In case of no reuse/recycle of waste water, Give brief note on justification as why no reuse/recycle.  Not Applicable.

iii Waste water generation (KLD)

Category Existing Proposed Total after Remarks KLD (Additional) Expansion KLD KLD  Domestic 0.8 11.2 12.0  Industrial

Process 0 347 347 Washing 0 20 20 Boiler 1.2 8.8 10 Cooling 0 10 10 Others 0 501 501

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Industrial waste water 1.2 886.8 888 Total Waste Water 2.0 898.0 900.0

Brief Note on worst case scenario for waste water generation (Qualitative and Quantitative): All Products are Worst case. PRODUCT WASTE WATER GENERATION GROUP - 1 4. CINNAMIC ALDEHYDE 1.16 5. CINNAMIC ALCOHOL 3.54 GROUP - 2 1. HALOBETASOLE PROPIONATE 26.95 2. CLOBETASOLE BUTYRATE 71.9 3. CLOBETASOLE PROPIONATE 33.68 4. DEFLAZACORT 34.58 12. METHYL COBALAMIN 25.4 GROUP – 3 2. CEFPODOXIME AXETIL 41.05 3. CEFPODOXIME PROXETIL 5.28 GROUP - 4 1. BENZYL ACETATE 9.69 2. BENZYL ALCOHOL 92 4. BENZYL BENZOATE 0 8. BENZALDEHYDE 0 10. ORTHO CHLORO BENZALDEHYDE 0 11. ORTHO CHLORO BENZOIC ACID 0 GROUP - 5 21. INDOLILONE 1.74 TOTAL 346.97 KL/Day

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GROUP - 1 COD BOD TDS pH 4. CINNAMIC ALDEHYDE 3000 1000 4000 5-6 5. CINNAMIC ALCOHOL 3000 1000 4000 5-6 GROUP - 2 1. HALOBETASOLE PROPIONATE 15000 5000 25000 2.5 -5.5 2. CLOBETASOLE BUTYRATE 20000 6000 27000 2.5-5.5 3. CLOBETASOLE PROPIONATE 20000 6000 25000 2.5-5.5 4. DEFLAZACORT 18000 6000 23000 2.5-5.5 12. METHYL COBALAMIN 21000 7000 26000 2.5-5.5 GROUP - 3 2. CEFPODOXIME AXETIL 10000 3500 14000 4.5 -6.5 3. CEFPODOXIME PROXETIL 10000 3500 14000 4.5-6.6 GROUP - 4 1. BENZYL ACETATE 5000 1500 8000 4 -6 2. BENZYL ALCOHOL 6500 2200 8500 4-6 4. BENZYL BENZOATE 4000 1200 5500 4-6 8. BENZALDEHYDE 4000 1200 5500 4-6 10. ORTHO CHLORO BENZALDEHYDE 6000 2000 8000 4-6 11. ORTHO CHLORO BENZOIC ACID 6000 2000 8000 4-6 GROUP - 5 21. INDOLILONE 6000 2000 8000 3 -5

Brief justification in case of no process effluent generation or no industrial effluent generation or no high concentration effluent generation from proposed project (Whichever is applicable). Not Applicable iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), Solvent Stripper etc.  ETP – 347 KL/Day  Solvent Stripper – 347 KL/Day  MEE – 340 KL/Day  RO – 404 KL/Day Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed. Stream I (404 KLD) - 40 KLD + 364 KLD MEE Condensate.

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First all non-toxic and biodegradable stream of wastewater effluent shall be collected in Collection cum Equalization Tanks-01 (CET-01). Pipe grid is provided at bottom of the CETs-01 to keep all suspended solids in suspension and to provide proper mixing. 2 nos. of Air Blowers (1W+1 standby) shall supply air through to pipe grid. Then after, equalized wastewater shall be pumped to Neutralization Tank-1 (NT-01-B) where the continuous addition and stirring of Lime solution is done to maintain neutral pH of wastewater from Lime Dosing Tanks (LDT-01-A/B) as per requirement with help of Lime Dosing Pumps. Then after, neutralized wastewater shall go to Flash Mixer (FM-01) by gravity. Alum shall be dosed from Alum Dosing Tanks (ADT-01-A/B) and then Polyelectrolyte shall be dosed from Polyelectrolyte Dosing Tank-1 (PEDT-01) with help of pumps to carry out flocculation with help of Dosing Pumps. Then coagulated effluent shall be collected in Primary Settling Tank (PST-01) where sludge will be settled at the bottom and clear supernatant shall be collected in Intermediate Sump (IS-01) by gravity. Thereafter, the wastewater shall be passed through Multi Grade Filter (MGF-01) to remove left out TSS and Activated Carbon Filter (ACF-01) for final effluent polishing. After tertiary treatment, effluent shall be collected in Treated Effluent Sump (TES-01) before sent to RO-01 for further treatment. RO-01 permeate water shall be collected in RO Treated Water Tank (ROTWT-01) before reuse in plant. RO-01 reject shall be sent to MEE Feed tank (MFT-01) for further treatment. Sludge settled in PST-01, PCL-02 shall be collected in Sludge Sumps (SSs-01) Then, dewatered sludge shall be stored in in HWSA and then ultimate disposal to TSDF. And backwash from MGF- 01 and ACF-01 shall be collected in Drain Pit and pumped back to CET-01-A/B for further treatment. Stream II (347 KLD Process + 80 RO Reject) All High TDS streams of wastewater shall be collected in Collection cum Equalization Tanks-2 (CETs-02). Pipe grid is provided at bottom of the CET-02 to keep all suspended solids in suspension and to provide proper mixing. Mixer is provided in Tank. Then effluent shall be pumped to Neutralization Tank-2(NT-02) where Lime shall be added from Lime Dosing tank. Then after, effluent shall have sent to Flash Mixer-2 (FM-02) where Alum and poly shall be added from ADT and PDT-01 respectively. Then after, coagulated wastewater shall be settled in Primary Clarifier-2 (PCL-02). Clear effluent from PCL-02 shall be collected in Holding Tank (HT-01) before pumped to strippers (ST-01). Effluent from stripper collected in MEE Feed Tank (MFT-01) where RO reject will be mixed with it. Then effluent shall be sent to Multiple Effect Evaporator (MEE-01) for further treatment followed by Agitated Thin Film Dryer (ATFD-01) for solids dewatering. Condensate from MEE & ATFD shall collect in MEE Condensate Tank (MECT-01) before to ETP plant. Solids from ATFD-01 shall be collected and stored in HWSA for disposal in TSDF.

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DILUTE STREAM Sr. Parameter Before Primary Secondary Treatment Tertiary No. Treatment Treatment Treatment First Second Stage Stage Aeration Aeration 1. pH 3.5-9.0 6.5-8.5 6.5-8.5 6.5-8.5 6.5-8.5

2. COD (mg/L) 3000 2200 1000 500 <250

3. BOD (mg/L) 1000 700 350 170 <80 3

4. TDS (mg/L) 4000 4200 4200 4200 3500

RO STREAM Sr. Parameter Before After RO Treatment No. Treatment RO Permeate RO Reject 1. pH 6.5-8.5 6.5-8.5 6.5-8.5 2. COD (mg/L) 150 50 50 3. BOD (mg/L) 50 10 <10 3 4. TDS (mg/L) 200 100 11000 CONCENTRATION STREAM Sr. Parameter Before Treatment After Solvent Stripper After MEE No.

1. pH 2.5-5.5 6.5-8.5 6.5 -8.5 2. COD (mg/L) 25000 2000 150 3. BOD (mg/L) 8000 500 50 3 4. TDS (mg/L) 35000 35000 200

652nd meeting of SEAC-Gujarat, dated 30.05.2020- VIDEO CONFERENCE (VC) on NIC Page 134 of 296 v Mode of Disposal & Final meeting point(Existing and Proposed) Domestic: (Existing & 12 KL/Day Septic Tank & Soak Pit Proposed) Industrial: (Proposed) 347KL/Day Process effluent shall be sent to ETP giving primary treatment after that it will be sent to solvent stripper, after treatment in solvent stripper 7.0KL/Day Solvent Residue shall be sent to Common Incinerator site. & 340KL/Day effluent shall be sent to In-house MEE. 364KL/Day effluent from MEE Condensate, Boiler and Cooling & Washing shall be sent to ETP having Primary, Secondary & tertiary treatment. After that it will be sent to RO. RO permeates 324KL/Day will be reuse in Boiler, Cooling & Scrubber & RO Reject 80KL/Day will be sent to In- house MEE for further treatment. 19MT/Day Salt generates from ATFD will be disposed to TSDF site. vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF)(For waste water treatment)  Not Applicable Membership of Common facility (CF) (For waste water treatment) vii Simplified water balance diagram with reuse / recycle of waste water Total Proposed:

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Water: 1112KL/Day (Fresh: 788KL/Day + Reuse: 324KL/Day)

Domestic: Gardening: 15 KL/Day 15 Process: 416 Boiler: Cooling: Washing: Scrubber: KL/Day 170 120 25 KL/Day 351 12KL/Day KL/Day KL/Day KL/Day  Septic tank & soak pit Process: 347 Boiler: 10 Cooling: 10 Washing: 20 501 KL/Day KL/Day KL/Day KL/Day KL/Day

Sell to end Solven ETP user & t 347 KL/Day Captive Residu ETP - 40 KL/Day (Boiler + Cooling + Washing) + MEE Condensate 364 consumpti e Solvent Stripper- KL/Day on 347 KL/Day 7 RO RO-404 KL/Day KL/Day Reject: 80  MEE: 340 KL/Day CHWIFMEE KL/Day + RO Concentrate Reject 80 ATFD KL/Day 36 KL/Day RO Permeate: Loss: 20 324KL/Day MEE Salt KL/Day  19 MEE KL/Day  Condensate: TSDF 364KL/Day vii Reuse/Recycle details (KLD) with feasibility. [Source of reuse & application area] Total reuse 324 KLD - Source of waste Application area with Characteristics of Remarks water for reuse quantity in KLD (Where it waste water to be regarding with quantity in is used) reused (COD, BOD, feasibility to KLD (From where and TDS etc.) reuse i.e. it is coming)

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RO Permeate 324 Boiler – 170 KL/Day, Cooling pH – 6.5 – 8.5 -- KL/day – 120 KL/Day, Washing – 25 COD : 50 mg/l KL/Day Scrubber – 9 KL/Day BOD : 10 mg/l TDS : 100 mg/l

E Air i Brief Note on fuel based heat energy requirement and worst case scenario thereof:  For Boiler reaction takes place at 115oC to carry out reaction. Flue gas emission details No. of Boilers/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed Existing Air Pollution Source of Stack Quantity Type of Sr. Type of Control emission Height of Fuel emissions i.e. no. Fuel Measures With Capacity (meter) MT/Day Air Pollutants (APCM) 1 Boiler (5 TPH) 20 Agro waste 3 MT/Day SPM Multi Cyclone

or briquette SO2 Bag filter +

NOx Water Scrubber 2 Thermic Fluid 11 LDO 200 SPM Bag Filter +

Heater Liter/Day SO2 Water

NOx Scrubber Propose Air Pollution Source of Stack Quantity Type of Sr. Type of Control emission Height of Fuel emissions i.e. no. Fuel Measures With Capacity (meter) MT/Day Air Pollutants (APCM) 1 Boiler – 1 30 Coal or 18 MT/Day SPM ESP + Water (10 TPH) Agro waste SO2 Scrubber NO x

2 Boiler – 2 30 Coal or 18 MT/Day SPM ESP + Water (10 TPH) Agro waste SO2 Scrubber NOx 3 Steam Boiler 30 Coal or 6 MT/Day SPM Multi cyclone

(2 TPH) Agro waste SO2 with water

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NOx scrubber

4 Thermic Fluid 30 Coal or 30 MT/Day SPM

Heater Agro waste SO2 ESP + Water (30 Lakh NOx Scrubber Kcal/hr.)

5 Thermic Fluid 30 Coal or 3 MT/Day SPM Multi cyclone

Heater Agro waste SO2 Bag filter +

(4 Lakh Kcal/hr.) NOx Water Scrubber 6 D.G. Set 11 HSD 2000 SPM Adequate

(1000 KVA – Liter/Day SO2 Stack Height

2 Nos.) NOx - Stand By 7 D.G. Set 11 HSD 500 SPM Adequate (500 KVA) Liter/Day SO2 Stack Height - Stand By NOx

ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed - No process gas emission in existing scenario. Specific Source of Stack/Vent Air Pollution Control Sr. emission Type of Height Measures no. (Name of the Product & emission (meter) (APCM) Process) 1 Process Vent -1 HCl 11 Two Stage Water Scrubber

2 Process Vent -2 SO2 11 Two Stage Alkali Scrubber

3 Process Vent -3 NH3 11 Two Stage Water + Alkali Scrubber

Note:  Details of gaseous raw materials used in proposed project – HCl Gas is used

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 Estimation of process gas emission (Product wise and Total) – Group -1 (Product No. – 2 & 3) Group -4 (Product No. – 5, 7, 9, 10 & 11) Group -5 (Product No. – 1, 10, 22, 23 & 24)  Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total) Calculation of Scrubbing Media Assumed Water required Quantity of Quantity of Sr. to scrub Emissions Gaseous % of solution bleed liquors No. pollutants Emissions (KL/Day) (KL/Day) (MT/Day) Dil. HCl 1 HCl 107.5 251.5 359 (25-30%)

2 SO2 42.5 99.5 SBS (30%) 142 Total 351 KL/Day 501 KL/Day  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix. Complied iii Fugitive emission details with its mitigation measures.  Enclosed Processed  Minimum joints/flanges  Auto handling for charging Raw Materials  Pumps with double mechanical seals  Proper Ventilation  PPEs F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and calculations shall be incorporated in EMP details separately.- Attached  Disposal to scrap vendors/vendors/traders is not allowed Existing & Proposed

652nd meeting of SEAC-Gujarat, dated 30.05.2020- VIDEO CONFERENCE (VC) on NIC Page 139 of 296 i Sr. Type/ Category Quantity No Name Of And Source Of Disposal . Hazardou Schedule (MT/Annum) Generation Method s Waste As Per HW Existin Addition Total Rules. g al 1 ETP ETP SCH-I/35.3 0 2040.0 2040. Collection, Sludge 0 Storage, transportatio n and Dispose in TSDF Site. 2 Used Oil Machineries SCH-I/5.1 0 5 5 Collection, Storage, KL/Annu KL/A transportatio m nnum n and Disposal by selling to registered reprocessor. 3 Discarded Raw SCH-I/33.1 150 850 1000 Collection, container/ Materials/ Storage, Products transportatio barrel/liner n and / Disposal by sale to bags authorized vendors. 4 Distillation Solvent SCH-I/20.3 125 1591 1716 Collection, Residue Distillation Storage, transportatio Plant n and Disposal at co- processing, Cement industries or

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Common incinerator by M/s. NECL, Nandesari. 5 Spent Process SCH-I/28.2 0 144 144 Collection, Carbon Storage & (Group - 3, Reactivate Product No. within 2,3) premises. 6 Spent Process SCH-I/28.6 7200 49594 5679 Collections, Solvent 4 Storage, distill and reuse in plant premises. 7 Organic Process SCH-I/28.1 0 2220.0 2220. Collection, Waste 0 Storage, (Group - 2, transportatio Product n and No.1,2) Disposal at Common

incinerator by M/s. NECL, Nandesari. 8 MEE Salt MEE SCH-I/35.3 0 6840.0 6840. Collection, 0 Storage, transportatio n and sell to end user or Dispose in TSDF Site. 9 Dil. HCl Process SCH-I/28.1 0 129240.0 1292 Collection, 40.0 Storage, (25-30%) (Group - 1, transportatio Product No. n and sell to 1,2,3) end user who is having

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(Group - 4, Rule-9 Product No. Permission. 5,7,8,10,11)

(Group - 5, Product No. 1,10,22,23,

24) 10 Sodium Process SCH-I/28.1 0 51120.0 5112 Collection, BiSulfite 0.0 Storage, (30%) (Group - 5, transportatio Product No. n and sell to 1,10,22,24) end user who is having Rule-9 Permission. 11 Organic Process SCH-I/28.1 0 1345.0 1345. Collection, Residue 0 Storage, (Group - 3, transportatio Product No. n and 2,3) Disposal at Common (Group - 5, incinerator by Product No. M/s. NECL, 21,24) Nandesari. 12 Solvent Solvent SCH-I/28.1 0 2520.0 2520. Collection, Residue 0 Storage, Stripper transportatio n and Disposal at Common incinerator by M/s. NECL, Nandesari. 13 Fly Ash Utility SCH-I/37.2 0 360.0 360.0 Sent to Brick

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Manufacturer . 14 Spent Process SCH-I/28.2 0 1800 1800 Collection, Catalyst Storage, transportatio n and Disposal in TSDF - ii Membership details of TSDF, CHWIF etc. Nandesari Environment Control (For HW management) Ltd. iii Details of Non-Hazardous waste & its disposal(MSW and Fly ash will be sent to brick others) manufacturer. G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format) Details of Solvent recovery Atmospheric Distillation of Solvents: Primary Condenser HE-01: Cooling Tower water will be used to condense the solvents and the non condensed vapors will be condensed in a Secondary Condenser. Secondary Condenser HE-02: Chilled water at 6 0C will be used to condense the non condensed vapors in the Secondary Condenser. VOC Trap Condenser HE-03: Chilled Brine at -35 0C will be used to trap any traces of Solvent which is slipped from Secondary condenser.

Vacuum distillation of Solvent: Primary Condenser HE-01: Cooling Tower water or Chilled water will be used to condense the solvents depend on the vapor pressure at its operating conditions and the non condensed vapors will be condensed in a Secondary Condenser. Secondary Condenser HE-02: Chilled Brine at -17 0C will be used to condense the non condensed vapors in the Secondary Condenser. VOC Trap Condenser HE-03: Chilled Brine at -35 0C will be used to trap any traces of Solvent which is slipped from Secondary condenser. 95 % of Spent Solvent will be recovered by In-house distillation of Solvent. Solvent Recovery & LDAR

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Solvent B.P V.P INPUT OUTPUT QTY % OF % OF (°C) LOSS RECOVE LOSS ES RY ES Butanol 117.7 6 mmHg 169 161 8 95.26 4.74 (20 °C) MDC 39.75 46.5 kPa 425 406 19 95.52 4.48 (@ 20°C) Methanol 64.5 12.3 kPa 945 898 47 95.02 4.98 (@ 20°C) Toluene 110.6 3.8 kPa 2539 2416 123 95.15 4.85 (@ 25°C) THF 65 19.3 kPa 166 159 7 95.78 4.22 (@ 20°C) Ethyl Acetate 77 12.4 kPa 909 865.75 43.25 95.24 4.76 (@ 20°C) Butyl Acetate 126.1 1.66 kPa 657 628.5 28.50 95.66 4.34 (@ 24 °C) DMF 154 516 pa 91 86.75 4.25 95.34 4.66

ii Brief Note on LDAR proposed: Leak Detection and Repair (LDAR)  To prevent losses of these solvents in atmosphere, following infrastructure shall be used in addition to LDAR program  Leak Free Pumps for transfer of solvents  MSW Gaskets in solvent pipelines to prevent leakage from flanges  Minimum number of flanges, joints and valves in pipelines.  To eliminate chances of leakages from glands of pumps, mechanical seal will be provided at all solvent pumps.  All the rotating equipments like pumps will be installed with Mechanical Seals to arrest any sort of emissions.  Condenser and scrubber post Reactor with cooling arrangement  Enclosures to chemical storage area, collection of emission from loading of raw materials in particular solvents through hoods and ducts by induced draft, and control by scrubber / dust collector to be ensured.  In case the small spillage or leakage observed, first pour the china clay (vermiculate) on material and collect the contaminated china clay (vermiculate) and send to ETP.  If the spillage is of inflammable liquid, switch off all the power supply in the area to prevent

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Electric Spark  Flanges will be sealed so less loss will be there.

 Two condensers will be installed with cooling water and chilled brine to recover the solvent.  Primary Condenser HE-01: Cooling Tower water or Chilled water (at 50C) will be used to condense the solvents depend on the vapor pressure at its operating conditions and the non- condensed vapors will be condensed in a Secondary Condenser  VOC Trap Condenser HE-02: Chilled Brine at -150C will be used to trap any traces of Solvent which is slipped from Secondary condenser  Monitoring of Solvent Losses  Inwarding, storage and consumption of solvents in various products shall be measured through Level Transmitters and Load cells weighing systems resp. The quantity at each stage shall be reconciled periodically to arrive at Losses.  Periodic monitoring of work area will be carried out to check the fugitive emission.  VOC detectors will be installed at various places to detect leak.  Preventive Maintenance to prevent Leakages  In order to prevent leakage from Pump, Seals, Valves etc, preventive maintenance shall be carried out periodically as per plan. Regular maintenance of valves, pumps, flanges, joints and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs.

Sr. Component Preventive Maintenance No. schedule 1 Pump seals with visible liquid dripping Daily 2 Valves/flanges Quarterly 3 Compressor seals Quarterly 4 Pressure relief devices Yearly 5 Pipeline Thickness Testing Yearly Immediate Repair of devices in case of Leakages A regular preventive maintenance schedule will be in place to replace or rectify all gaskets and

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SOLVENT RECOVERY AFTER LDAR Solvent B.P V.P Input Output Qty % of % of (°C) Losse Recover Losse s y s Butanol 117.7 6 mmHg 169 165 4 97.6 2.4 (20 °C) MDC 39.75 46.5 kPa 425 414 11 97.41 2.59 (@ 20°C)

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Methanol 64.5 12.3 kPa 945 923 22 97.6 2.4 (@ 20°C) Acetone 56.2 24 kPa (@ 972 961 11 98.9 1.1 20°C) Toluene 110.6 3.8 kPa (@ 2539 2501 38 98.7 1.3 25°C) THF 65 19.3 kPa 166 163 3 98.5 1.5 (@ 20°C) Ethyl Acetate 77 12.4 kPa 909 894 15 98.3 1.7 (@ 20°C) Butyl Acetate 126.1 1.66 kPa 657 643 14 97.8 2.2 (@ 24 °C) DMF 154 516 pa 91 89 2 97.4 2.6

Storage tanks (If Methanol, Toluene, Acetone, Dimethyl Formamide, Methylene any) Di Chloride, Sulphuric Acid, Hydrochloric Acid

 Safety details of Hazardous chemicals (To be stored in storage tanks) 1. Adequate dyke wall (with acid proof coating) provided. 2. Level indicator with high level alarm provided on the tank. 3. Water curtain system installed on southern extreme of site in front of tank farm to avoid gas dispersing on general road traffic. 4. Dedicated pumps are provided and located with its close proximity to the respective tank to avoid unintentional mistake of mixing of chemicals. 5. Leakage / Spillage handling kit provided. 6. To avoid chemical exposure, closed handling system is provided.

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7. Fire hydrant system provided including water curtain system.  Applicability of PESO :  Company will apply for PESO after getting EC. Ii Process safety details : (If applicable) 1. Hydrogenation process Not Applicable 2. Nitration process- Not Applicable 3. Chlorination process • FLP type area will be provided. • Total enclosed process system. • Instrument & Plant Air System. • Nitrogen blanketing in Chlorination reactor. • Safety valve and Rupture disc provided on reactor. • Cooling Chilling and power alternative arrangement have been made on reactor. • Chlorine and Nitrogen Cylinder bank away from the auto clave reactor. • PRV station with shut off valve, safety valve provision will be made for chlorination reaction safety. • Flame arrestor will be provided on vent line of reactor and it will be extended up to roof level. • Open well ventilated and fragile roofs will be provided to on reactor. • Safe Catalyst charging method will be adopted. • SOP will be prepared and operators will be trained for the same. 4. Exothermic Reaction- Not Applicable  During the video conference meeting dated 29/04/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & Environment Management Plan.  This proposal is for API/Bulk Drug and Intermediates project at Plot No. 1761/P & 1757, Village: Gothda, Tal: Savli.  Project proponent and their technical expert from Aqua-Air Environmental Engineers Pvt. Ltd. remains present video conference meeting.  Committee noted that unit is located Outside GIDC and also not satisfying the condition of small units i: e: (Water Consumption < 25 KL, Fuel Consumption < 25 TPD and not falling in MAH category) However, as per MoEF&CC‘s Notification issued vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category this criteria is not to be considered.  It is noted that public hearing will be exempted considering project falls under category B2 as per the EIA Notification 2006 and amendment dated 27th March, 2020.  Unit has EC and valid CC&A for existing plant. Copy of EC and CC&A, its self-certified compliance report

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is submitted. PP ensured that there are no court cases pending and no public complaints against the project.  Effluent stream will be segregated. Low COD effluent will be treated in ETP (P+S+T) followed by RO and MEE. High COD effluent will be treated in solvent stripper followed by MEE. RO permeate will be reused for industrial purpose. RO reject will be fed to MEE. MEE concentrate will be fed to ATFD.  ESP + Wet scrubber will be provided with proposed coal fired boilers. Two stage scrubber will be provided with process stacks.  Hazardous waste management including exhausted scrubbing media is submitted.  Committee deliberated on EMP, CER, Green Belt, safety aspects and hazardous waste management.  Committee deliberated on Product profile along with specific end- use of the products. Upon asking, technical expert could not explain specific end use of each products and why as to consider proposed products in line with the Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API).  After detailed discussion, it was decided to consider the proposal only after submission of the following documents: 1. Submit specific end-uses of proposed product profile. Also submit an undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API).  Project proponent submitted reply for the above mentioned query dated 26/05/2020 for the above mentioned points via E-mail.  The project was reconsidered in the SEAC VC meeting dated 30/05/2020. PP as well as their technical expert remained present during video conference meeting.  PP presented replied as below: 1. PP presented Product Profile along with undertaking with Name of API in which Intermediate is used/End-use of said intermediate along with its respective CAS No. of API in the product profile in line with MoEF&CC‘s Notification issued vide S.O. 1223(E) dated 27th March, 2020.  Committee deliberated on the reply submitted by PP and noted that PP has addressed the reply point satisfactorily.  After detailed discussion, Committee unanimously decided to recommend the project to SEIAA, Gujarat for grant of Environment Clearance with following Specific Condition.

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submitted by PP) which are not qualifying the amended EIA Notification vide S.O. 1223 (E) dated 27/03/2020 and any subsequent amendments. 3. PP shall submit six monthly compliance report of Environmental Clearance without fail and the same shall be critically assessed by the regulatory authority. 4. PP shall use natural gas for utilities preferably but in case use of other fuel, PP shall put properly designed APCM with regular, periodic stack monitoring system to ensure that there shall be no increase in pollution load for the compliance of directives of Honorable NGT. 5. Close loop solvent recovery system with adequate condenser system shall be provided to recover solvent vapors in such a manner that recovery shall be maximum and recovered solvent shall be reused in the process within premises. 6. Leak Detection and Repair (LDAR) program shall be prepared and implemented as per the CPCB guidelines. LDAR Logbooks shall be maintained. 7. Complete Zero Liquid Discharge [ZLD] status shall be maintained all the time and there shall be no drainage connection from the premises. 8. Safety: a) PP shall obtain PESO permission for the storage and handling of hazardous chemicals. (If applicable) b) Flame proof electrical fittings shall be provided in the plant premises, wherever applicable. c) Unit shall provide double earthling to solvent storage tanks/ area. d) Unit shall never store drum/barrels/carboys of incompatible material/chemical together. e) Unit shall provide chlorine leakage control emergency kit and FRP hood with scrubber system for chlorine safety. f) Unit shall provide a spare tank with emergency transfer system and bund/ dyke wall to Br2 storage tank. 6 SIA/GJ/IND2/151306/2020 M/s. Chemcon Speciality Chemicals EC – Reconsideration Limited Plot No.355,357,358,359, Manjusar Kunpad Road, Vill: Manjusar, Tal: Savli, Dist: Vadodara (Gujarat) Category of the unit: 5(f) Project status: Expansion

 Project proponent (PP) submitted online application vide no. SIA/GJ/IND2/151306/2020 dated 17/04/2020 for obtaining Environmental Clearance.  Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration

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of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. SR. NAME OF THE PRODUCTS CAS NO. / QUANTITY (MT/MONTH) NO. CI NO. EXISTING PROPOSED TOTAL EXISTING 1 HEXA METHYL DI SILAZANE (HMDS) 999-97-3 500 00 500 2 N – BUTYL CHLORIDE 109-69-3 3 CHLORO METHYL ISOPROPYL 35180-01-9 225 00 225 CARBONATE (CMIC) 4 PYRIDINE HYDRO BROMIDE OR HBR-10035- 50 200 250 HYDRO BROMIC ACID 10-6 5 SODIUM SULPHATE 7757-82-6 62 00 62 6 CALCIUM BROMIDE 7789-41-5 7 SODIUM BROMIDE 7647-15-6 8 ZINC BROMIDE 7699-45-8 1500 00 1500 9 CALCIUM SULPHATE (GYPSUM) 7777-18-9 174 00 174 PROPOSED 10 HEXA METHYL DI SILOXANE (HMDO) 107-46-0 00 250 250 11 4 – NITRO BENZENE BROMIDE 100-11-8 00 250 250 (PNBBR) 12 1,1 CYCLOHEXANE DI ACETIC ACID 4455-11-7 00 200 200 13 1,1 CYCLOHEXANE DI ACETIC ACID 99189-60-3 00 MONOAMIDE 14 BROMOBENZENE 108-86-1 00 200 200 15 OXALYL CHLORIDE 79-37-8 00 250 250 16 CINNAMIC ALDEHYDE 104-55-2 00 250 250 17 CINNAMIC ALCOHOL 104-54-1 00 100 100 18 SODIUM BENZOATE 532-32-1 00 100 100 19 DI BENZYL ETHER 103-50-4 00 100 100 20 1,4 DITHINE 2,5 DIOL (DTH) 40018-26-6 00 100 100 21 BENZYL / BENZAL DERIVATIVES BENZYL ACETATE 140-11-4 BENZYL ALCOHOL 100-51-6 BENZYL BENZOATE 120-51-4

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BENZYL BUTYRATE 103-37-7 BENZYL PROPIONATE 122-63-4 00 1200 1200 BENZYL SALICILATE 118-58-1 BENZYL CHLORIDE/BENZAL 100-44-7 CHLORIDE BENZALDEHYDE 100-52-7 ORTHO CHLOROBANZALDEHYDE 89-98-5 ORTHO CHLORO BENZOIC ACID 118-91-2 22 2 ETHYL HEXANOYL CHLORIDE (2 760-67-8 EHC) 23 2 METHOXY ETHYL CHLORIDE (2 627-42-9 MEC) 24 2 PROPOXY ETHYL CHLORIDE (2 PEC) 42149-74-6 25 2, 4, 6 TRI METHYL BENZOYL 938-18-1 CHLORIDE (2, 4, 6 TMBC) 26 3,5 DI METHYL BENZOYL CHLORIDE 2905-62-6 (3, 5 DMBC) 27 4 - CHLORO BUTYRYL CHLORIDE (4 - 4635-59-0 CBC) 28 ISO BUTYRYL CHLORIDE (IBC) 79-30-1 29 ISO NONANOYL CHLORIDE (INC) 764-85-2 30 ISO OCTYL CHLORIDE (IOCL) 29590-42-9 31 ISOPHTHALOYL CHLORIDE (IPC) 99-63-8 32 LAUROYL CHLORIDE (LC) 112-16-3 00 1500 1500 33 METHOXY ACETYL CHLORIDE(MAC) 38870-89-2 34 N - BUTYRYL CHLORIDE (N -BC) 141-75-3 35 NEO DECANOYL CHLORIDE (NDC) 40292-82-8 36 OCTANOYL CHLORIDE (OC) 111-64-8 37 PIVALOYL CHLORIDE (PC) 3282-30-2 38 TEREPHTHALOYL CHLORIDE (TPC) 100-20-9 39 UN DECANOYL CHLORIDE (UNDC) 17746-05-3 40 VALERYL CHLORIDE 638-29-9 41 2-METHYLTHIO 4,6 PYRIMIDINEDIONE 1979-98-2 00 100 100 42 MALTOL 118-71-8 00 100 100 43 CYTOSINE 71-30-7 00 100 100

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TOTAL 2511 5000 7511 INORGANIC CHEMICALS 44 SO2 BOTTLING 7446-09-5 00 3100 3100 45 AMMONIUM CHLORIDE 12125-02-9 00 6750 6750 Specific End Use for the Intermediate Sr. Name of the CAS No. Type/ Name of API Said API is used for/End No. Product (Product) Category of in which CAS No. Use of said API Product Intermediate (API) (API/ Used/ End Intermediate) use of said Intermediate EXISTING PRODUCT 1 Hexa Methyl Di 999-97-3 Intermediate Cifadroxil 66592- Antibiotics & Antiviral Silazane 87-8 medicine, used to treat a (HMDS) wide variety of bacterial infections (e.g., strep throat, skin and urinary tract infections) 2 N – Butyl 109-69-3 Intermediate Phenylbutazo 50-33-9 used as a raw material for Chloride ne-drugs In the pharmaceutical industry & used for for synthetic animal insect repellents 3 Chloro Methyl 35180-01- Intermediate Tenofovir 147127- Used as HIV infection and Isopropyl 9 20-6 chronic hepatitis B virus Carbonate infection (CMIC) 4 Pyridine Hydro HBr- Intermediate Cephalospori 64485- Cephalosporins are Bromide or 10035-10- n 93-4 antibiotics used to treat a Hydro Bromic 6 wide variety of bacterial acid infections, such as respiratory tract infections, skin infections and urinary tract infections. 5 Sodium 7757-82-6 In-Organic -- -- used as a drying agent

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Sulphate Chemicals 6 Calcium 7789-41-5 -- Used as completion fluid, Bromide -- Gravel Pack, Mining 7 Sodium 7647-15-6 -- -- Bromide 8 Zinc Bromide 7699-45-8 -- -- 9 Calcium 7777-18-9 -- -- Fertilizer, Brick Sulphate Manufacturing (Gypsum) PROPOSE PRODUCT 11 Hexa Methyl Di 107-46-0 Intermediate HMDS 999-97-3 Used to produce antibiotics Siloxane & antiviral Pharma (HMDO) intermediate 12 4 – Nitro 100-11-8 Intermediate Cifadroxil 66592- Antibiotics & Antiviral Benzene 87-8 medicine, used to treat a Bromide wide variety of bacterial (PNBBR) infections (e.g., strep throat, skin and urinary tract infections) 13 1,1 4455-11-7 Intermediate Gabapentine 60142- anti-epileptic drug , used Cyclohexane Di 96-3 in adults to treat acetic acid neuropathic pain (nerve pain ) caused by herpes virus or shingles (herpes zoster) 14 1,1 99189-60- Intermediate Gabapentine 60142- anti-epileptic drug , used Cyclohexane Di 3 96-3 in adults to treat acetic acid neuropathic pain (nerve pain Monoamide ) caused by herpes virus or shingles (herpes zoster) 15 Bromobenzene 108-86-1 Intermediate 4-Methoxy 13139- Use in the denickelation of Phenyl 86-1 porphyrins for Chelation Magnesium Therapy. (To treat heart Bromide disease and stroke) 16 Oxalyl Chloride 79-37-8 Intermediate Dioxane 213967- Used in a penem antibiotic tetraketone 57-8 drug

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17 Cinnamic 104-55-2 Intermediate citalopram 59729- Used as anti cancer agent & Aldehyde 33-8 also used to treat 18 Cinnamic 104-54-1 Intermediate citalopram depression Alcohol 19 Sodium 532-32-1 Intermediate phenylbutyrat 1716-12- used as a treatment for urea

Benzoate e 7 cycle disorders & hyper ammonemia in blood level 20 Di Benzyl ether 103-50-4 Intermediate Sarecycline 1035654- Used to treat moderate to 66-0 severe acne vulgaris in adult & & treat a wide variety of 389139- bacterial infections 89-3 respectively 21 1,4 Dithine 2,5 40018-26- Intermediate Emtricitabine 143491- used to treat human Diol (DTH) 6 57-0 immunodeficiency virus (HIV) infection 22 Benzyl / Benzal Derivatives 22.1 Benzyl Acetate 140-11-4 Intermediate Cefoperazon Health care product used as 113826- e a local anesthetic with 44-1 LIDOCAINE injection 22.2 Benzyl Alcohol 100-51-6 Intermediate Ivermectin 70288- An anti parasite medication 86-7 used to treat head lice, and enterobiasis. 22.3 Benzyl 120-51-4 Intermediate Permethrin 52645- Used for an effective and Benzoate 53-1 inexpensive topical treatment for human scabies. 22.4 Benzyl Butyrate 103-37-7 Intermediate Omadacyclin 389139- Used to treat moderate to e 89-3 severe acne vulgaris in adult & treat a wide variety of bacterial infections respectively 22.5 Benzyl 122-63-4 Intermediate Cefoperazon 113826- Health care product used as Propionate e 44-1 a local anesthetic with LIDOCAINE injection

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22.6 Benzyl 118-58-1 Intermediate Citronellol 106-22-9 Used as fragrance excipient Salicilate in many medicinal antibiotic drug, cosmetic and personal care products 22.7 Benzyl 100-44-7 Intermediate 300-62-9 Used as central nervous

Chloride/Benzal Amphetamin system (CNS) in Anti-Biotics Chloride e Drug

22.8 Benzaldehyde 100-52-7 Intermediate cinnamic acid 140-10-3 Many cinnamic acid derivatives, especially those with the phenolic hydroxyl group, are well- known antioxidants 22.9 Ortho 89-98-5 Intermediate benzylpenicill 61-33-6 antibiotic with bactericidal Chlorobanzalde in activity hyde 22.10 Ortho Chloro 118-91-2 Intermediate sodium salt 74-11-3 Used as a preservative in Benzoic Acid of p-chloro Anti-Biotics Drug benzoic acid 23 2 Ethyl 760-67-8 Intermediate pyrazinamide 98-96-4 Hexanoyl Use to treat tuberculosis Chloride (2 & (TB) & bacterial infection. EHC) 24 2 Methoxy 627-42-9 Intermediate Isobutyryl-L- 25518- Used in a penem antibiotic Ethyl Chloride carnitine 49-4 drug 25 2 Propoxy Ethyl 42149-74- Intermediate Ethyl chloride 75-00-3 helps to relieve deep muscle Chloride 6 pain when used with muscle stretching techniques 26 2, 4, 6 Tri 938-18-1 Intermediate Sarecycline 1035654- Used to treat a wide variety Methyl Benzoyl 66-0 of bacterial infections Chloride respectively 27 3,5 Di methyl 2905-62-6 Intermediate β- 7585-39- Use for improving the Benzoyl cyclodextrin 9 solubility and the stability of Chloride drugs by complex formation at the solid state

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28 4 - Chloro 4635-59-0 Intermediate Benzamides 55-21-0 used as neuroleptics and/or Butyryl Chloride antipsychotics drug 29 Iso Butyryl 79-30-1 Intermediate atropine 51-55-8 Used in a penem antibiotic Chloride (IBC) drug 30 Iso Nonanoyl 764-85-2 Intermediate Tetracyclines 60-54-8 Used in a penem antibiotic Chloride (INC) drug 31 Iso Octyl 29590-42- Intermediate chrysotrione 17746- Used in a penem antibiotic Chloride (IOCL) 9 B 05-3 drug 32 Isophthaloyl 99-63-8 Intermediate chlorobenzoi 74-11-3 Used as preservative in Chloride (IPC) c acid antibiotic drug 33 Lauroyl 112-16-3 Intermediate Aclometaso 66734- application to body surfaces Chloride (LC) ne 0.05% 13-2 such as the skin or mucous membranes to treat ailments 34 Methoxy Acetyl 38870-89- Intermediate Benzamides 55-21-0 used as neuroleptics and/or Chloride(MAC) 2 antipsychotics 35 n - Butyryl 141-75-3 Intermediate propylisoprop 60-35-5 Used in a penem antibiotic Chloride (n - yl acetamide drug BC)

36 Neo Decanoyl 40292-82- Intermediate Ascaridole 512-85-6 Used in a penem antibiotic Chloride (NDC) 8 drug 37 Octanoyl 111-64-8 Intermediate (R)-2- a therapeutic agent for Chloride (OC) propyloctanoi 208925 Alzheimer′s disease c acid 38 Pivaloyl 3282-30-2 Intermediate 3-(T-BUTYL)- 121-00-6 Used in a penem antibiotic Chloride (PC) 4- drug METHOXYP HENOL 39 Terephtha oyl 100-20-9 Intermediate Isobutyryl-L- 25518- Used in a penem antibiotic Chloride (TPC) carnitine 49-4 drug 40 Un Decanoyl 17746-05- Intermediate chrysotrione 17746- Antibiotic Chloride 3 B 05-3 (UnDC) 41 Valeryl chloride 638-29-9 Intermediate Propylisoprop 60-35-5 Used in a penem antibiotic yl acetamide drug

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42 2-Methylthio 1979-98-2 Intermediate Prostaglandin 363-24-6 Used for the treatment of 4,6 inflammatory and cancer Pyrimidinedion disease e 43 Maltol 118-71-8 Intermediate Pantoprazole 138786- To treat certain stomach and Sodium 67-1 esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. 44 Cytosine 71-30-7 Intermediate Acyclovir 59277- Used to 89-3 treat infections caused by certain types of viruses, It treats cold sores around the mouth (caused by herpes simplex), shingles (caused by herpes zoster), and chickenpox. This medication is also used to treat outbreaks of genital herpes.  The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The proposal was considered in the meeting dated 29/04/2020.  Salient features of the project including Water, Air and Hazardous waste management: Sr. Particulars Details no. A Total cost of Proposed Project Existing: 45.51 Crore (Rs. in Crores): Proposed: 50 Crore Break-up of proposed project Cost: Total: 95.51 Crore  Cost of Machinery & Equipment: 44 Crores

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 Cost of Construction: 5.0 Crores  Labor Charges: 1.0 Crores Details of Environmental Management Plan As below: (EMP) Brief details of EMP

Component Capital Cost of EMP Recurring Cost Of EMP (Per Month)

Cost Rs. 601 Lakh Rs. 64.58 Lakh

Bifurcation of EMP Cost Sr. Unit Installed Capital Operating Maintenance Total No Capacity Cost (Rs. Cost (Lacs/ Cost (Lacs/ Recurring (KLD) in Lakhs) Month) Month) Cost (Lacs/ Month) 1 ETP -- 500 11.81 -- 11.81 2. APCM -- 14 -- 0.04 0.04 3. Hazardous -- 27 52.42 -- 52.42 Waste (Expense) 4. AWH -- 10 0.08 -- 0.08 Monitoring Cost 5. Greenbelt -- 50 -- 0.25 0.25 Total 601 64.58

Activities to be carried out under CER: CER Activities Fund (Rs.) Company will provide Vegetables, Dal, Rice, Juvar to the people 25 of nearest village. Provision of Raw Material like Cement & Concrete, SS Roads, 20 Briquettes, etc. for Water Tank for water distribution.

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Land Filling at nearby village School 5 TOTAL 50,00,000/-

B Total Plot area Total: 30226 Sq. m. ( sq. meter)

Green belt area Existing: 4000 Sq. m. ( sq. meter) Proposed: 6000 Sq. m. Total: 10000 Sq. m. C Employment generation Existing: 195 Proposed: 50 Total: 245 D Water i Source of Water Supply Ground Water Supply (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern Application No: 21-4/3602/GJ/IND/2018 authority. Dated: 3/04/2018 ii Water consumption (KLD) Existing Proposed Total after Remarks KLD (Additional Expansion ) KLD KLD (J) Domestic 3.0 7.0 10.0 (K) Gardening 1.5 5.0 6.5 (L) Industrial

Process 66.50 492.0 558.5 Washing 1.0 4.0 5.0 Boiler 17.0 33.0 50.0 Cooling 33.0 75.0 108.0 Others 18.0 5.0 23.0 Industrial Total 135.5 609 744.5 Grand Total 140.0 621.0 761.00

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(A+B+C) Brief Note on worst case scenario for water consumption:  All Products are worst case SR. PRODUCT CONSUMPTION NO. 4 Pyridine Hydro Bromide 7.19 11 PNBBR 1.12 12 1,1 Cyclohexane Di acetic acid 17.09 17 Cinnamic Alcohol 2.6 18 Sodium Benzoate 7.4 19 Di Benzyl ether 28 20 1,4 Dithine 2,5 Diol (DTH) 24 21 Benzyl Alcohol 340 41 2-Methylthio 4,6 Pyrimidinedione 26 42 Maltol 20.83 43 Cytosine 17.77 KL/Day 492

- Summary of water Existing Proposed Total after Remarks requirement KLD (Additional) Expansion KLD KLD Total water 140 621 761 requirement for the project (A) Quantity to be 0 228 228 recycled (B) Total fresh water 140 393 533 requirement (C) Ensure Total water requirement = Fresh water + Recycled water i.e. A = B + C In case of no reuse/recycle of waste water, Give brief note on justification as why no reuse/recycle.  Not Applicable.

iii Waste water generation (KLD)

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Category Existing Proposed Total after Remarks KLD (Additional) Expansion KLD KLD  Domestic 1.0 6.0 7.0  Industrial Process 3.75 265.25 269.00 Washing 1.0 4.00 5.00 Boiler 1.0 3.00 4.00 Cooling 1.4 8.60 10.00 Others 23.4 6.7 30.1 Industrial waste water 30.55 287.55 318.1 Total Waste Water 31.55 293.55 325.1

Brief Note on worst case scenario for waste water generation (Qualitative and Quantitative): Sr. PRODUCT GENERATION No. 16 Cinnamic Aldehyde 1.16 17 Cinnamic Alcohol 3.54 19 Di Benzyl ether 16.35 20 1,4 Dithine 2,5 Diol (DTH) 28 21 Benzyl Alcohol 184 41 2-Methylthio 4,6 Pyrimidinedione 32.2 KL/Day 265.25

Brief justification in case of no process effluent generation or no industrial effluent generation or no high concentration effluent generation from proposed project (Whichever is applicable). Not Applicable iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), Solvent Stripper etc.  ETP – 269 KL/Day  Solvent Stripper – 269 KL/Day  MEE – 321 KL/Day  RO – 285 KL/Day Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed.

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Stream I (285 KLD) First all non-toxic and biodegradable stream of wastewater effluent shall be collected in Collection cum Equalization Tanks-01 (CET-01). Pipe grid is provided at bottom of the CETs- 01 to keep all suspended solids in suspension and to provide proper mixing. 2 nos. of Air Blowers (1W+1 stand-by) shall supply air through to pipe grid. Then after, equalized wastewater shall be pumped to Neutralization Tank-1 (NT-01-B) where the continuous addition and stirring of Lime solution is done to maintain neutral pH of wastewater from Lime Dosing Tanks (LDT-01-A/B) as per requirement with help of Lime Dosing Pumps. Then after, neutralized wastewater shall go to Flash Mixer (FM-01) by gravity. Alum shall be dosed from Alum Dosing Tanks (ADT-01-A/B) and then Polyelectrolyte shall be dosed from Polyelectrolyte Dosing Tank-1 (PEDT-01) with help of pumps to carry out flocculation with help of Dosing Pumps. Then coagulated effluent shall be collected in Primary Settling Tank (PST-01) where sludge will be settled at the bottom and clear supernatant shall be collected in Intermediate Sump (IS-01) by gravity. Thereafter, the wastewater shall be passed through Multi Grade Filter (MGF-01) to remove left out TSS and Activated Carbon Filter (ACF-01) for final effluent polishing. After tertiary treatment, effluent shall be collected in Treated Effluent Sump (TES-01) before sent to RO- 01 for further treatment. RO-01 permeate water shall be collected in RO Treated Water Tank (ROTWT-01) before reuse in plant. RO-01 reject shall be sent to MEE Feed tank (MFT-01) for further treatment. Sludge settled in PST-01, PCL-02 shall be collected in Sludge Sumps (SSs-01) Then, dewatered sludge shall be stored in in HWSA and then ultimate disposal to TSDF. And backwash from MGF-01 and ACF-01 shall be collected in Drain Pit and pumped back to CET-01-A/B for further treatment. Stream II (269 KLD Process + 57 RO Reject) All High TDS streams of wastewater shall be collected in Collection cum Equalization Tanks- 2 (CETs-02). Pipe grid is provided at bottom of the CET-02 to keep all suspended solids in suspension and to provide proper mixing. Mixer is provided in Tank. Then effluent shall be pumped to Neutralization Tank-2(NT-02) where Lime shall be added from Lime Dosing tank. Then after, effluent shall have sent to Flash Mixer-2 (FM-02) where Alum and poly shall be added from ADT and PDT-01 respectively. Then after, coagulated wastewater shall be settled in Primary Clarifier-2 (PCL-02). Clear effluent from PCL-02 shall be collected in Holding Tank (HT-01) before pumped to strippers (ST-01). Effluent from stripper collected in MEE Feed Tank (MFT-01) where RO reject will be mixed with it. Then effluent shall be sent to Multiple Effect Evaporator (MEE-01) for further treatment followed by Agitated Thin Film Dryer (ATFD-01) for solids dewatering.

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Condensate from MEE & ATFD shall collect in ME Condensate Tank (MECT-01) before to ETP plant. Solids from ATFD-01 shall be collected and stored in HWSA for disposal in TSDF. Note: Whenever CETP will accept our additional load, we will discharge treated effluent into CETP. DILUTE STREAM Sr. Parameter Before Primary Secondary Treatment Tertiary No. Treatment Treatment First Second Treatment Stage Stage Aeration Aeration 1. pH 3.5-9.0 6.5-8.5 6.5-8.5 6.5-8.5 6.5-8.5 2. COD (mg/L) 3000 2200 1000 500 <250 3. BOD (mg/L) 1000 700 350 170 <80 3 4. TDS (mg/L) 4000 4200 4200 4200 3500 RO STREAM Sr. Parameter Before After RO Treatment No. Treatment RO Permeate RO Reject 1. pH 6.5-8.5 6.5-8.5 6.5-8.5 2. COD (mg/L) 150 50 50 3. BOD (mg/L) 50 10 <10 3 4. TDS (mg/L) 200 100 11000 CONCENTRATION STREAM Sr. Parameter Before Treatment After Solvent Stripper After MEE No. 1. pH 2.5-5.5 6.5-8.5 6.5 -8.5 2. COD (mg/L) 25000 2000 150 3. BOD (mg/L) 8000 500 50 3 4. TDS (mg/L) 35000 35000 200

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Domestic: (Existing & Proposed) Domestic wastewater 7 KLD will be disposed through septic tank & Soak pit system. Industrial: (Proposed) 269KL/Day Process effluent shall be sent to ETP giving primary treatment after that it will be sent to solvent stripper, after treatment in solvent stripper 5.0KL/Day Solvent Residue shall be sent to Common Incinerator site. & 264KL/Day effluent shall be sent to In-house MEE. 266KL/Day effluent from MEE Condensate, Boiler and Cooling & Washing shall be sent to ETP having Primary, Secondary & tertiary treatment. After that it will be sent to RO. RO permeates 228KL/Day will be reuse for industrial purpose & RO Reject 57KL/Day will be sent to In-house MEE for further treatment. 18MT/Day Salt generates from ATFD will be disposed to TSDF site vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF)(For waste water treatment)  Not Applicable Membership of Common facility (CF) (For waste water treatment) vii Simplified water balance diagram with reuse / recycle of waste water Total Proposed:

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Water: 761 KL/Day (Fresh – 533 KL/Day + Reused -228 KL/Day)

Domestic: Industrial: 744.5 (Fresh – 516.5 KL/Day + Gardening: 10 Reused – 228 KL/Day) 6.5

7.0 Septic tank & soak pit Process: Boiler: Cooling: Washing Scrubb 558.5 50 108 : 5.0 er: 23

Process: 269 Boiler: Cooling: Washing: 30.1 4.0 10.0 5.0 KL/Day

Sell to end ETP-269 user or Captive Consumpti ETP-285 on Solvent Solvent Residue Stripper - 269  5 RO RO-285.0 KL/Day Reject  MEE – 264 - MEECHWIF KL/Day + RO Concentrate Reject – 57 57  ATFD35 KL/Day KL/Day Loss – 20 KL/Day RO Loss Permeate- MEE Salt  – 17 MEE 228 18 KL/Day KL/D Condensate- ay 266 TSDF vii Reuse/Recycle details (KLD) with feasibility. [Source of reuse & application area] Total reuse 228 KLD - Source of waste Application area with Characteristics of Remarks water for reuse quantity in KLD (Where it waste water to be regarding with quantity in is used) reused (COD, BOD, feasibility to KLD (From where and TDS etc.) reuse i.e.

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it is coming)

RO, 285 KL/Day RO Permeate 228 KL/Day RO Permeate -- (Boiler: 4 KL/Day + will be reuse in Boiler, having Cooling: 10 KL/Day Cooling, and Scrubber & COD < 100 mg/L, + Washing: 5 Floor Sweeping. BOD < 30 mg/L & KL/Day TDS < 150 mg/ MEE Condensate: 266 KL/Day) effluent will be treated.

E Air i Brief Note on fuel based heat energy requirement and worst case scenario thereof:  For Boiler reaction takes place at 115oC to carry out reaction. Flue gas emission details No. of Boilers/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed Existing Air Source of Stack Quantity Type of Pollution Sr. Type of emission Height of Fuel emissions i.e. Control no. Fuel With Capacity (meter) MT/Day Air Pollutants Measures (APCM) 1 Boiler – I (3 30 Wood 8 MT/Day SPM Multi

MT) (saw mill SO2 Cyclone

cut) NOx Separator 2 Boiler – II (5 200 SPM with Bag

MT) Liter/Day SO2 Filter +

NOx Water Scrubber 3 DG Set 11 Diesel 54 Lit/Hr SPM Acoustic

(500 KVA) SO2 enclosure

NOx with appropriate stack height Propose

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Air Type of Source of Stack Quantity Pollution Sr. Type of emissions emission Height of Fuel Control no. Fuel i.e. Air With Capacity (meter) MT/Day Measures Pollutants (APCM) 1 Thermic Fluid 30 Briquette 20 SPM Multi

Heater MT/Day SO2 Cyclone

(Capacity - 4.0 NOx Separator Lac Kcal/Hr) along with Bag Filter 2 Boiler-III 30 meter Briquette 80 SPM

(10.0 MT) from MT/Day SO2

3 Boiler-IV Ground NOx (10.0 MT) Level ESP + (Common Water Stack for Scrubber Boiler & Thermic Fluid Heater) 4 D.G. Set 11 Diesel 2000 SPM Acoustic

(910 KVA) Lit/Day SO2 enclosure

NOx with appropriate stack height

ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed Existing Specific Source of Stack/Vent Air Pollution Control Sr. emission Type of Height Measures no. (Name of the Product & emission (meter) (APCM) Process) 1 HCL Storage Tank HCl 11 Two Stage Water Scrubber

2 Reactor No.1 & 2 HCl, Cl2 11 Two stage water 3 Reactor-3 scrubber followed by

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caustic trap

4 Reactor no. 1 to 4 & HBr, Br2 11 Two Stage Alkali Bromine Storage Tanks Scrubber Propose Specific Source of Stack/Vent Air Pollution Control Sr. emission Type of Height Measures no. (Name of the Product & emission (meter) (APCM) Process)

1 Process Stack-1 HCl, Cl2 11 Two Stage water + (1,4 DITHINE 2,5 DIOL Alkali Scrubber (DTH)

2 Process Stack-2 SO2 11 Bottling (2 METHOXY ETHYL CHLORIDE (2 MEC)) 3 Process Stack-3 HCl 11 Two Stage water (OXALYL CHLORIDE) Scrubber

4 Process Stack-4 SO2 11 Bottling (2 METHOXY ETHYL CHLORIDE (2 MEC))

5 Process Stack-5 HBr, Br2 11 Two Stage water + (4 – NITRO BENZENE Alkali Scrubber BROMIDE (PNBBR)) Note:

 Details of gaseous raw materials used in proposed project – HCl, Cl2 Gas is used  Estimation of process gas emission (Product wise and Total) – Product No. 15, 20  Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total) Calculation of Scrubbing Media Assumed Water Quantity of Quantity of required to Sr. bleed Emissions Gaseous scrub % of solution No. liquors Emissions pollutants (KL/Day) (MT/Day) (KL/Day) HCl 1 3.5 16 HCl (30%) 20.9 (Chloro Methyl

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Isopropyl Carbonate(CMIC)) , Oxalyl Chloride & HCl Storage Tank Cl2 Sodium 2 (1,4 DITHINE 2,5 DIOL 0.1 0.5 Hypochlorite 0.7 (DTH) (25%) HCl (1,4 DITHINE 2,5 DIOL 0.8 2.5 HCl (30%) 3.3

(DTH) HBr 4 – NITRO BENZENE BROMIDE (Calcium 3 Bromide, Zinc Bromide, 1.67 4 HBr (20-22%) 5.2 Sodium Bromide) (PNBBR)) & Bromine Storage Tank 30.1 Total 23 KL/Day KL/Day  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix. Complied iii Fugitive emission details with its mitigation measures.  Enclosed Processed  Minimum joints/flanges  Auto handling for charging Raw Materials  Pumps with double mechanical seals  Proper Ventilation  PPEs F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and

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calculations shall be incorporated in EMP details separately.- Attached  Disposal to scrap vendors/vendors/traders is not allowed Existing & Proposed i Sr. Type/Name of Specific Categor Quantity Managemen no. Hazardous Source of y and (MT/Annum) t of HW waste generation Schedul (Name of e as per Existin Proposed Total the HW g Activity, Rules. Product etc.) 1 ETP Sludge ETP SCH- 70.00 1080 1150 Collection, I/35.3 Storage, transportatio n and Disposal in TSDF 2 MEE Salt MEE SCH- 0.00 6480 6480 Collection, I/35.3 Storage, transportatio n and Disposal in TSDF 3 Used Oil Machinerie SCH- 2.00 3.00 5.00 Collection, s I/5.1 Storage, transportatio n and Disposal by selling to registered re- processors 4 Discarded Raw SCH- 18/8 36/16 54/24 Collection, container/ Materials/ I/33.1` Storage, barrel/liner/bag Products transportatio s n and

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Disposal by sale to authorized vendors 5 Distillation Distillation SCH- 900 1120 2020 Collection, Residue I/20.3 Storage, 6 Spent Carbon Process SCH- 0.00 180 180 transportatio I/28.2 n and Disposal at co- processing, Cement industries or Common incinerator 7 Spent Solvent Process SCH- 00 22000 22000 Collections, I/28.6 Storage, distill and reuse in plant premises or for job work outside premises. 8 Organic Waste Process SCH- 70.0 1800.0 1870.0 Collection, I/28.1 0 0 Storage, transportatio n and Disposal at Common incinerator 9 Dil. HCl (30%) Process SCH- 1650 36660 38310 Collection, II/D2 Storage, transportatio n and sell to end user

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10 Spent Sulfuric Process SCH- 9144 9240 18384 Collection, Acid (50%) II/D2 Storage, transportatio n and sell to end user 11 HBr solution Process SCH- 1404 468 1872 Collection, I/28.1 Storage, transportatio n and sell to end user who is having Rule-9 Permission. 12 Floor -- -- 98 00 98 Collection, Sweeping Storage, Waste transportatio n and Disposal in TSDF 13 Fly Ash Utility SCH- 0 360.0 360.0 Sent to Brick I/37.2 Manufacturer . 14 Solvent Solvent SCH- 0 1800.0 1800.0 Collection, Residue Stripper I/28.1 Storage, transportatio n and Disposal at Common incinerator by M/s. NECL, Nandesari. 15 Spent Catalyst Process SCH- -- 1800 1800 Collection, I/28.2 Storage, transportatio n and Disposal in

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TSDF

16 HCl (30%) Scrubber B-15 7020 1692 8712 Collection, Storage, transportatio n and reuse within premises in manufacturin g process. 17 Sodium Hypo Scrubber B-15 -- 252 252 Collection, Chlorite (25%) Storage, transportatio n and sell to end user who is having Rule-9 Permission - ii Membership details of TSDF, CHWIF etc. Nandesari Environment Control Ltd. (For HW management) iii Details of Non-Hazardous waste & its disposal(MSW Fly ash will be sent to brick and others) manufacturer. G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format) Details of Solvent recovery Atmospheric Distillation of Solvents: Primary Condenser HE-01: Cooling Tower water will be used to condense the solvents and the non condensed vapors will be condensed in a Secondary Condenser. Secondary Condenser HE-02: Chilled water at 6 0C will be used to condense the non condensed vapors in the Secondary Condenser. VOC Trap Condenser HE-03: Chilled Brine at -35 0C will be used to trap any traces of Solvent which is slipped from Secondary condenser. Vacuum distillation of Solvent:

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Primary Condenser HE-01: Cooling Tower water or Chilled water will be used to condense the solvents depend on the vapor pressure at its operating conditions and the non condensed vapors will be condensed in a Secondary Condenser. Secondary Condenser HE-02: Chilled Brine at -17 0C will be used to condense the non condensed vapors in the Secondary Condenser. VOC Trap Condenser HE-03: Chilled Brine at -35 0C will be used to trap any traces of Solvent which is slipped from Secondary condenser. 95 % of Spent Solvent will be recovered by In-house distillation of Solvent. Solvent Recovery & LDAR Solvent B.P V.P INPUT OUTPU QTY % OF % OF (°C) T LOSS RECOVE LOSS ES RY ES Butanol 117.7 6 mmHg 169 161 8 95.26 4.74 (20 °C) MDC 39.75 46.5 kPa 425 406 19 95.52 4.48 (@ 20°C) Methanol 64.5 12.3 kPa 945 898 47 95.02 4.98 (@ 20°C) Toluene 110.6 3.8 kPa 2539 2416 123 95.15 4.85 (@ 25°C) THF 65 19.3 kPa 166 159 7 95.78 4.22 (@ 20°C) Ethyl Acetate 77 12.4 kPa 909 865.75 43.25 95.24 4.76 (@ 20°C) Butyl Acetate 126.1 1.66 kPa 657 628.5 28.50 95.66 4.34 (@ 24 °C) DMF 154 516 pa 91 86.75 4.25 95.34 4.66

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at all solvent pumps.  All the rotating equipments like pumps will be installed with Mechanical Seals to arrest any sort of emissions.  Condenser and scrubber post Reactor with cooling arrangement  Enclosures to chemical storage area, collection of emission from loading of raw materials in particular solvents through hoods and ducts by induced draft, and control by scrubber / dust collector to be ensured.  In case the small spillage or leakage observed, first pour the china clay (vermiculate) on material and collect the contaminated china clay (vermiculate) and send to ETP.  If the spillage is of inflammable liquid, switch off all the power supply in the area to prevent Electric Spark  Flanges will be sealed so less loss will be there.

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 In order to prevent leakage from Pump, Seals, Valves etc, preventive maintenance shall be carried out periodically as per plan. Regular maintenance of valves, pumps, flanges, joints and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs. Sr. Component Preventive Maintenance No. schedule 1 Pump seals with visible liquid dripping Daily 2 Valves/flanges Quarterly 3 Compressor seals Quarterly 4 Pressure relief devices Yearly 5 Pipeline Thickness Testing Yearly Immediate Repair of devices in case of Leakages A regular preventive maintenance schedule will be in place to replace or rectify all gaskets and joints to ensure no fugitive emissions shall take place. Plant shall also maintain adequate number of spares and consumables required to repair the leaking device Plant shall also have competent contractor team to handle Leakages and can repair the same immediately Standby equipments like Pumps, valves etc shall be kept basis the criticality and usage Plant shall also have access equipments like Boom lift to handle leakages at height immediately  Leak Detection and Repair (LDAR) for Methanol

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Condenser losses – 0.05 % Carb Secondary on Condenser Towe (Brine Chilling) r Primary Condenser Transfer losses – (Cooling tower) 0.1 %

Reactor Recovere d Solvent Drum

Solve nt Stora ge Drum Losses to effluent – 0.8 %

Distillation Residue – 1.45 %

SOLVENT RECOVERY AFTER LDAR SOLVENT B.P V.P INPUT OUTPU QTY % OF % OF (°C) T LOSS RECOVE LOSS ES RY ES Butanol 117.7 6 mmHg 169 165 4 97.6 2.4 (20 °C) MDC 39.75 46.5 kPa 425 414 11 97.41 2.59 (@ 20°C) Methanol 64.5 12.3 kPa 945 923 22 97.6 2.4 (@ 20°C) Toluene 110.6 3.8 kPa 2539 2501 38 98.7 1.3

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(@ 25°C) THF 65 19.3 kPa 166 163 3 98.5 1.5 (@ 20°C) Ethyl Acetate 77 12.4 kPa 909 894 15 98.3 1.7 (@ 20°C) Butyl Acetate 126.1 1.66 kPa 657 643 14 97.8 2.2 (@ 24 °C) DMF 154 516 pa 91 89 2 97.4 2.6

iii VOC emission sources and its mitigation measures  Enclosed Processed  Minimum joints/flanges  Auto handling for charging Raw Materials  Pumps with double mechanical seals  Proper Ventilation  PPEs H SAFETY details i  Details regarding storage of Hazardous chemicals (For tank storages only) Storage Name of major Hazardous chemicals Remark details s Storage Methanol, Toluene, Dimethyl Formamide, tanks (If Methylene Di Chloride, Sulphuric Acid, any) Hydrochloric Acid, Bromine Tonner Chlorine Storage Try Ethyl Amine, Pyridine, Liquor Ammonia, Drums Phenol, Chloroform, Formaldehyde, Ethylene Glycol, Butanol, Acetaldehyde, Cyclohexanone, Benzene, Sodium Hydroxide, Xylene  Safety details of Hazardous chemicals (To be stored in storage tanks) 1. Adequate dyke wall (with acid proof coating) provided. 2. Level indicator with high level alarm provided on the tank. 3. Water curtain system installed on southern extreme of site in front of tank farm to avoid gas dispersing on general road traffic. 4. Dedicated pumps are provided and located with its close proximity to the respective tank to avoid unintentional mistake of mixing of chemicals. 5. Leakage / Spillage handling kit provided. 6. To avoid chemical exposure, closed handling system is provided.

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7. Fire hydrant system provided including water curtain system.  Applicability of PESO :  Company will apply for PESO after getting EC. Ii Process safety details : (If applicable) 1. Hydrogenation process Not Applicable 2. Nitration process- Not Applicable 3. Chlorination process • FLP type area will be provided. • Total enclosed process system. • Instrument & Plant Air System. • Nitrogen blanketing in Chlorination reactor. • Safety valve and Rupture disc provided on reactor. • Cooling Chilling and power alternative arrangement have been made on reactor. • Chlorine and Nitrogen Cylinder bank away from the auto clave reactor. • PRV station with shut off valve, safety valve provision will be made for chlorination reaction safety. • Flame arrestor will be provided on vent line of reactor and it will be extended up to roof level. • Open well ventilated and fragile roofs will be provided to on reactor. • Safe Catalyst charging method will be adopted. • SOP will be prepared and operators will be trained for the same. 4. Exothermic Reaction- Not Applicable  During the video conference meeting dated 29/04/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & Environment Management Plan.  Project proponent and their technical expert from Aqua-Air Environmental Engineers Pvt. Ltd. remains present video conference meeting.  This proposal is for API/Bulk Drug and Intermediates project at Plot No.355,357,358,359, Manjusar Kunpad Road, Vill: Manjusar, Tal: Savli, Dist: Vadodara (Gujarat).  Committee noted that unit is located Outside GIDC and also not satisfying the condition of small units i: e: (Water Consumption < 25 KL, Fuel Consumption < 25 TPD and not falling in MAH category) However, as per MoEF&CC‘s Notification issued vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category this criteria is not to be considered.  It is noted that public hearing will be exempted considering project falls under category B2 as per the EIA Notification 2006 and amendment dated 27th March, 2020.  Unit has EC and valid CC&A for existing plant. Copy of EC and CC&A, its self-certified compliance report

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is submitted. PP ensured that there are no court cases pending and no public complaints against the project.  Effluent stream will be segregated. Low COD effluent will be treated in ETP (P+S+T) followed by RO and MEE. High COD effluent will be treated in solvent stripper followed by MEE. RO permeate will be reused for industrial purpose. RO reject will be fed to MEE. MEE concentrate will be fed to ATFD.  ESP + Wet scrubber will be provided with proposed coal fired boilers. Two stage scrubber will be provided with process stacks.  Hazardous waste management including exhausted scrubbing media is submitted.  Committee deliberated on EMP, CER, Green Belt, safety aspects and hazardous waste management.  Committee deliberated on Product profile along with specific end- use of the products. Upon asking, technical expert could not explain specific end use of each products and why as to consider proposed products in line with the Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API).  After detailed discussion, it was decided to consider the proposal only after submission of the following documents: 1. Submit specific end-uses of proposed product profile. Also submit an undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API). 2. Revise water consumption and bleed liquor generation considering product profile, quantum of production; type, solubility and temperature of process gas.  Project proponent submitted reply for the above mentioned query dated 26/05/2020 for the above mentioned points via E-mail.  The project was reconsidered in the SEAC VC meeting dated 30/05/2020. PP as well as their technical expert remained present during video conference meeting.  PP presented replied as below: 1. PP presented Product Profile along with undertaking with Name of API in which Intermediate is used/End-use of said intermediate along with its respective CAS No. of API in the product profile in line with MoEF&CC‘s Notification issued vide S.O. 1223(E) dated 27th March, 2020. 2. PP presented revised water consumption and bleed liquor generation considering product profile, quantum of production; type, solubility and temperature of process gas.  Committee deliberated on the reply submitted by PP and noted that PP has addressed the reply point satisfactorily.  After detailed discussion, Committee unanimously decided to recommend the project to SEIAA, Gujarat for grant of Environment Clearance with following Specific Condition.

SPECIFIC CONDITIONS:

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1. PP shall comply conditions of any subsequent amendment or expansion or change in product mix, after the 30th September 2020, considered as per the provisions in force at that time as mentioned in the Notification vide S.O. 1223 (E) dated 27/03/2020. 2. PP shall not manufacture any products in proposed project/activities (as per the undertaking submitted by PP) which are not qualifying the amended EIA Notification vide S.O. 1223 (E) dated 27/03/2020 and any subsequent amendments. 3. PP shall submit six monthly compliance report of Environmental Clearance without fail and the same shall be critically assessed by the regulatory authority. 4. PP shall use natural gas for utilities preferably but in case use of other fuel, PP shall put properly designed APCM with regular, periodic stack monitoring system to ensure that there shall be no increase in pollution load for the compliance of directives of Honorable NGT. 5. Close loop solvent recovery system with adequate condenser system shall be provided to recover solvent vapors in such a manner that recovery shall be maximum and recovered solvent shall be reused in the process within premises. 6. Leak Detection and Repair (LDAR) program shall be prepared and implemented as per the CPCB guidelines. LDAR Logbooks shall be maintained. 7. Unit shall maintain complete ZLD within premises. 8. Complete Zero Liquid Discharge [ZLD] status shall be maintained all the time and there shall be no drainage connection from the premises. 9. Safety: a) PP shall obtain PESO permission for the storage and handling of hazardous chemicals. (If applicable) b) Flame proof electrical fittings shall be provided in the plant premises, wherever applicable. c) Unit shall provide double earthing to solvent storage tanks/ area. d) Unit shall never store drum/barrels/carboys of incompatible material/chemical together. e) Unit shall provide chlorine leakage control emergency kit and FRP hood with scrubber system for chlorine safety. f) Unit shall provide a spare tank with emergency transfer system and bund/ dyke wall to Br2 storage. 7 SIA/GJ/IND2/152599/020 M/s. Chronten Pharmachem Appraisal Plot No. C-228, GIDC Saykha, Tal: Vagra,Dist: Bharuch -392140, Gujarat Category of the unit: 5(f) Project status: New  Project proponent (PP) submitted online application vide SIA/GJ/IND2/152202/2020 dated 09/05/2020 for obtaining Environmental Clearance (EC).

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 Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is a new project for manufacturing of synthetic organic chemicals [API and Its Intermediates] as tabulated below. Sr. CAS no. /CI Quantity End-use of the Name of the Products No. no. MT/Month products API / 1 Duloxetine HCl 136434-34-9 Antidepressant 3-(dimethylamino)-1-(thiophen-2- Duloxetine HCl/ 1.1 5424-47-5 yl)propan-1-one hydrochloride Antidepressant 3-(dimethylamino)-1-(thiophen-2- Duloxetine HCl/ 1.2 13636-01-6 yl)propan-1-ol Antidepressant (s)-3-(dimethylamino)-1-(thiophen-2- Duloxetine HCl/ 1.3 - yl)propan-1-ol L-Mandelate Antidepressant (s)-3-(dimethylamino)-1-(thiophen-2- Duloxetine HCl/ 1.4 132335-44-5 yl)propan-1-ol Antidepressant (s)-N,N-dimethyl-3-(naphthalen-1-yloxy)- Duloxetine HCl/ 1.5 132335-47-8 3(thiophen-2-yl)propan-1-amine Antidepressant (s)-N-methyl-3-(naphthalen-1-yloxy)- Duloxetine HCl/ 1.6 116539-59-4 3(thiophen-2-yl)propan-1-amine Antidepressant API / 2 Levosulpiride 23672-07-3 Schizophrenia Levosulpiride/ 2.1 2-methoxy benzoic acid 579-75-9 Schizophrenia Levosulpiride/ 2.2 2-methoxy-5-sulfamoyl- benzoic acid 33045-52-2 Schizophrenia Levosulpiride/ 2.3 Methyl 2-methoxy-5-sulfamoyl- benzoate 33045-52-2 Schizophrenia 100 Levosulpiride/ 2.4 1-ethyl-2-(nitromethyl)pyrrolidine 265315-52-4 Schizophrenia Levosulpiride/ 2.5 (1-ethylpyrrolidine-2-yl)methanamine 22795-99-9 Schizophrenia 1(1-ethylpyrrolidine-2-yl) methanamine1. Levosulpiride/ 2.6 2(1-ethylpyrrolidine-2-yl)methanamineD-(- 84277-13-4 Schizophrenia )-Tartaric acid Levosulpiride/ 2.7 (s)-(1-ethylpyrrolidine-2-yl)methanamine 22795-99-9 Schizophrenia API / Shrinks 3 Phenylepherine 59-42-7 blood vessels Phenylepherine 3.1 3-acetylphenyl acetate 2454-35-5 HCl/ Shrinks blood vessels Phenylepherine 2-(benzyl(methyl)amino-1-(3- 3.2 71786-67-9 HCl/ Shrinks hydroxyphenyl)ethanone hydrochloride blood vessels Phenylepherine 3.3 3-(1-hydroxy-2-(methylamino)ethyl)phenol 1477-63-0 HCl/ Shrinks blood vessels API / 4 Strontium Renelate 135459-90-4 Osteoporosis

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Strontium 4.1 Diethyl 3-oxopentanedioate 105-50-0 Renelate/ Osteoporosis Strontium ethyl 5-amino-4-cyano-3-(2-ethoxy-2- 4.2 58168-20-0 Renelate/ oxoethyl)thiophene-2-carboxylate Osteoporosis Diethyl 2,2((3-cyno-4-(2-ethoxy-2- Strontium 4.3 oxoethyl)-5-(ethoxycarbonyl)thiophen-2- 58194-26-6 Renelate/ yl)azanedyl)diacetateI compound Osteoporosis 5 Torsemide 56211-40-6 API / Edema Torsemide/ 5.1 4-aminopyridine-3-sulfonic acid 29452-57-1 Edema Torsemide/ 5.2 4-chloropyridine-3-sulfonamide 33263-43-3 Edema Torsemide/ 5.3 4-(m-tolyamino)pyridine-3-sulfonamide 72811-73-5 Edema API / Lipid- 6 Atorvastatin Calcium 134523-00-5 lowering agent Atorvastatin tert-butyl2-((4R,6R)-6-(2-aminoethyl)-2,2- 6.1 122995-13-3 Calcium / Lipid- dimethyl-1,3-dioxan-4-yl)acetate lowering agent tert-butyl2-((4R,6R)-6-(2-2-(4- Atorvastatin fluorophenyl)-5-isopropyl-3-phenyl-4- Calcium / Lipid- 6.2 125971-95-1 (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)- lowering agent 2,2-dimethyl-1,3-dioxan-4-yl)acetate API / relieve allergy symptoms such as watery 7 Fexofenadine Intermediate 2459-09-8 eyes, runny nose, itching eyes/nose, sneezing, hives Fexofenadine/ relieve allergy symptoms such 2-(4-(4-chlorobutanoyl)phenyl)-N,N,2- 7.1 343255-26-5 as watery eyes, trimethylpropanoic acid runny nose, itching eyes/nose, sneezing, hives Fexofenadine/ relieve allergy symptoms such 2-[4-(cyclopropylcarbonyl) phenyl]-2- 7.2 162096-54-0 as watery eyes, methylpropionic acid runny nose, itching eyes/nose, sneezing, hives Fexofenadine/ relieve allergy 2-[4-(cyclopropylcarbonyl) phenyl]-2- symptoms such 1690344-90- 7.3 methylpropionic acid cyclohexyl amine as watery eyes, 1 salt runny nose, itching eyes/nose, sneezing, hives API / treat high 8 Azilsartan Kamedoxomil 863031-24-7 blood pressure

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Ethyl 2-ethoxy-1-((2'-(N'- Azilsartan hydroxycarbamimidoyl)biphenyl-4- Kamedoxomil/ 8.1 147403-65-4 yl)methyl)-1H-benzo[d]imidazole-7- treat high blood carboxylate pressure Ethyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro- Azilsartan 1,2,4-oxadiazol-3-yl)biphenyl-4- Kamedoxomil/ 8.2 147403-52-9 yl)methyl)-1H-benzo[d]imidazole-7- treat high blood carboxylate pressure Azilsartan 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4- Kamedoxomil/ 8.3 oxadiazol-3-yl)biphenyl-4yl)methyl)-1H- 147403-03-0 treat high blood benzo[d]imidazole-7-carboxylic acid pressure (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2- Azilsartan ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4- Kamedoxomil/ 8.4 863031-21-4 oxadiazol-3-yl)biphenyl-4-yl)methyl)-1H- treat high blood benzo[d]imidazole-7-carboxylate pressure API /Alzheimer 9 Benfotiamine 22457-89-2 disease 3-((4-amino-2-methylpyrimidin-5- Benfotiamine 9.1 yl)methyl)-5-(2-(phosphonooxy)ethyl)-4,5- 532-40-1 /Alzheimer dihydrothiazol-3-ium disease Clopidogrel Hydrogen 10 Clopidogrel Hydrogen sulphate 135046-48-9 sulphate/ Antiplatelet medication Clopidogrel Hydrogen Methyl (+)-alpha-(2- thienylethylamino)(2- 10.1 141109-19-5 sulphate/ chlorophenyl) acetate Antiplatelet medication API / Manages 11 Leveteracitam 102767-28-2 seizures Leveteracitam/ 11.1 Levetiracetam Technical 102767-28-2 Manages seizures 12 Fluconazole 86386-73-4 API / Antifungals 1-(2,4-Difluorophenyl)-2(1-H-1,2,4-triazol- Fluconazole/ 12.1 86404-63-9 1-yl)ethanone Antifungals 1-((2-2,4-diflurophenyl)oxiran-2- Fluconazole/ 12.2 86386-77-8 yl)methyl)1H-1,2,4-triazole Antifungals API / Bipolar 13 Quetiapine Fumarate 111974-69-7 disorder Quetiapine 13.1 (2-nitrophenyl)(phenyl)sulfane 4171-83-9 Fumarate/ Bipolar disorder Quetiapine 13.2 2-(phenylthio)aniline 1134-94-7 Fumarate/ Bipolar disorder Quetiapine 13.3 phenyl(2-(phenylthio)phenyl)carbamate 111974-73-3 Fumarate/ Bipolar disorder Quetiapine 13.4 dibenzo[b,f][1,4]thiazepin-11(10H)-one 3159-07-7 Fumarate/

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Bipolar disorder API / Anti- 14 Vildagliptin 3159-07-7 hyperglycemic agent Vildagliptin/ Anti- 14.1 3-Aminoadamantan-1-ol 702-82-9 hyperglycemic agent Vildagliptin/ Anti- (s)-1-(2-chloroacetyl)pyrrolidine-2- 14.2 214398-99-9 hyperglycemic carboxamide agent Vildagliptin/ Anti- (s)-1-(2-chloroacetyl)pyrrolidine-2- 14.3 207557-35-5 hyperglycemic carbonitrile agent Vildagliptin/ Anti- 14.4 Vildagliptin Technical 274901-16 hyperglycemic agent API / 15 Losartan Potassium 124750-99-8 Hypertension Losartan 15.1 Methyl pentanimidate hydrochloride 39739-46-3 Potassium / Hypertension Losartan 15.2 Sodium 2-pentanimidamideacetate 19767-45-4 Potassium / Hypertension Losartan 2-butyl-4-chloro-4,5-dihydro-1H-imi 15.3 83857-96-6 Potassium / dazole-5-carbaldehyde Hypertension Losartan 4'-(bromomethyl)-[1,1'-biphenyl]-2- 15.4 114772-54-2 Potassium / carbonitrile Hypertension 4'-((2-butyl-4-chloro-5-(hydroxymethyl)- Losartan 15.5 1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2- 114772-55-3 Potassium / carbonitrile Hypertension (1-(2,2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]- Losartan 15.6 4-yl)methyl)-2-butyl-4-chloro-1H-imidazol- 114798-26-4 Potassium / 5-yl)methanol Hypertension API / Cox-2 16 Etoricoxib 202409-33-4 inhibitor 3-(6-methylpyridin-3-yl)-2-(4- Etoricoxib/ Cox- 16.1 221615-75-4 (methylthio)phenyl-3-oxopropanenitrile 2 inhibitor 1-(6-methylpyridin)-2-(4- Etoricoxib/ Cox- 16.2 221615-72-1 (methylthio)phenyl)ethanone 2 inhibitor 1-(6-methylpyridin-3-yl)-2-(4- Etoricoxib/ Cox- 16.3 221615-75-4 (methylsulfonyl)phenyl)ethanone 2 inhibitor 2-Chloro-1,3-Bis(Dimethylamino) Etoricoxib/ Cox- 16.4 291756-76-8 trimethynium hexafluro phoshate 2 inhibitor 17 Ketoconazole 65277-42-1 API / Antifungal Ketoconazole/ 17.1 Cis-Bromobenzoate 61397-56-6 Antifungal Ketoconazole/ 17.2 Cis Imidazole alcohol 61397-58-8 Antifungal Ketoconazole/ 17.3 Cis-Tosylate 154003-23-3 Antifungal

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1-(4-(4-hydroxyphenyl)piperazin-1- Ketoconazole/ 17.4 67914-60-7 yl)ethanone Antifungal API / Esophagus 18 Pantoprazole sodium 138786-67-1 problems Pantoprazole sodium / 18.1 3-methoxy-2-methyl-4H-pyran-4-one 4780-14-7 Esophagus problems Pantoprazole sodium / 18.2 3-methoxy-2-methylpyridin-4(1H)-one 76015-11-7 Esophagus problems Pantoprazole sodium / 18.3 4-chloro-3-methoxy-2-methylpyridine 122307-41-9 Esophagus problems Pantoprazole 4-chloro-3-methoxy-2-methylpyridine-N- sodium / 18.4 122307-41-9 oxide Esophagus problems Pantoprazole sodium / 18.5 3,4-dimethoxy-2-methylpyridine-N-oxide 72830-07-0 Esophagus problems Pantoprazole (3,4-dimethoxypyridine-2-yl)methyl sodium / 18.6 102625-99-0 acetate Esophagus problems Pantoprazole sodium / 18.7 (3,4-dimethoxypyridine-2-yl)methanol 72830-08-1 Esophagus problems Pantoprazole 2-(chloromethyl)-3,4-dimethoxypyridine sodium / 18.8 72830-09-2 hydrochloride Esophagus problems Pantoprazole 5-(difluoromethoxy)-2-(((3,4- sodium / 18.9 dimethoxypyridin-2-yl)methyl)thio)-1H- 102625-64-9 Esophagus benzo[d]imidazole problems 19 Glimepiride 93479-97-1 API / Antidiabetic Glimepiride / 19.1 2-Ethylmethyl acetoacetate 609-14-3 Antidiabetic Methyl 2-ethyl-3-hydroxy-3-methyl-4- Glimepiride / 19.2 2985-50-4 nitrobutanoate Antidiabetic Methyl 4-amino—2-ethyl-3-hydroxy-3- Glimepiride / 19.3 - methylbutanoate Antidiabetic Methyl 4-acetamido-2-ethyl-3-hydroxy-3- Glimepiride / 19.4 - methylbutanoate Antidiabetic Glimepiride / 19.5 3-ethyl-4-methyl-1H-pyrrol-2(5H)-one 766-36-9 Antidiabetic 3-ethyl-4-methyl-2-oxo-N-phenethyl-2,5- Glimepiride / 19.6 247098-18-6 dihydro-1-H-pyrrole-1-carboxamide Antidiabetic

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Glimepiride / 3-ethyl-4-methyl-2-oxo-N-(4- Antidiabetic 19.7 sulfamoylphenethyl-2,5-dihydro-1-H- 119018-29-0 pyrrole-1-carboxamide Imatinib/ treat Di methyl Formamide –Di methyl acetyl 20 4637-24-5 certain types of DMF-DMA (Intermediate) cancer Topiramate/ alone or with 2,3,4,5-bis-o-[1-methyl ethyl indene] B- 21 20880-92-6 other medications D-Fructopyranose to prevent and control seizures API / Lowers 22 Rosuvastatin Calcium 147098-20-2 "bad" cholesterol 22.1 Phosphonium, [[4-(4-fluorophenyl)-6-(1- 885477-83-8 Rosuvastatin methylethyl)-2- Calcium / Lowers [methyl(methylsulfonyl)amino]-5- "bad" cholesterol pyrimidinyl]methyl]triphenyl-, bromide 22.2 tert-butyl 2- ((4R,6S)Hydroxymethyl)-2,2- 124655-09-0 Rosuvastatin dimethyl-1,3-dioxan-4yl) acetate Calcium / Lowers "bad" cholesterol 22.3 tert-butyl 2-((4R,6S)--formyl-2,2-dimethyl- 124752-23-4 Rosuvastatin 1,3-dioxan-4yl) acetate Calcium / Lowers "bad" cholesterol API / 23 Valsartan 137862-53-4 Hypertension Valsartan/ 23.1 L-Valine methyl ester 6306-52-1 Hypertension 4‘-(bromomethyl)-[1,1‘-biphenyl]-2- Valsartan/ 23.2 114772-54-2 carbonitrile Hypertension (R)-methyl-2-(((2‘-cyano-[1,1‘-biphenyl]-4- Valsartan/ 23.4 137863-89-9 yl)methyl)amino)-3-methylbutanoate Hypertension (R)-methyl 2-(N-((2‘cyano-[1,1‘-biphenyl]- Valsartan/ 23.5 4-yl)methyl)pentanamido)-3- 137863-90-2 Hypertension methylbutanoate API / 24 Telmisartan 144701-48-4 Hypertension Methyl-3-Amino-4-(butaramido)-5-methyl Telmisartan / 24.1 675882-71-0 benzoate Hypertension 1,7‘-Dimethyl-2‘-propyl-1H-3‘H-2,5‘- 1282554-35- Telmisartan / 24.2 bibenzo[d]-imidazole 1 Hypertension (Intermediate of all sartan products)/ Telmisartan ortho-Tolyl benzonitrile (Intermediate Losartan 25 157366-46-6 of all sartan products) Potassium Valsartan Olmesartan/ Hypertension

API / Anti- 26 Lacosamide 175481-36-4 epileptic drug

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(R)-3-hydroxy-2-pivalamidopropanoic Lacosamide/ 26.1 6368-20-3 acid Anti-epileptic drug (R)-3-methoxy-2-pivalamidopropanoic Lacosamide/ 26.2 55289-06-0 acid Anti-epileptic drug (R)-N-benzyl-3-methoxy-2- Lacosamide/ 26.3 880468-89-3 pivalamidopropanamide Anti-epileptic drug Phenylephirine HCl/ temporary relief of stuffy 1-(3-hydroxyphenyl)-2- nose, sinus, and 27 (methylamino)ethanone sulfate 679394-62-8 ear symptoms MAP sulphate (Intermediate) caused by the common cold, flu, allergies Phenylephirine HCl/ temporary relief of stuffy nose, sinus, and 27.1 3-acetylphenyl benzoate 139-28-6 ear symptoms caused by the common cold, flu, allergies Phenylephirine HCl/ temporary relief of stuffy nose, sinus, and 27.2 3-(2-bromoacetyl)phenyl benzoate 139-27-5 ear symptoms caused by the common cold, flu, allergies API / 28 Bisoprolol Fumarate 66722-44-9 Hypertension 28.1 4-[(2-Isopropoxyethoxy)methyl]phenol 177034-57-0 Bisoprolol Fumarate/ Hypertension 28.2 4-((2- 66722-57-4 Bisoprolol isopropoxyethoxy)methyl)phenoxy)methyl Fumarate/ )oxirane Hypertension 28.3 1 amino 3-( 4-((2- 1215342-36- Bisoprolol isopropoxyethoxy)methyl)phenoxy)propa 1 Fumarate/ n2 –ol Hypertension API / Lowers 29 Simvastatin 79902-63-9 "bad" cholesterol (S)-(1S,3S,7R,8S,8aR)-8-((3R,5R)-7- Simvastatin / (butyl amino)-3,5-dihydroxy-7-oxoheptyl)- Lowers "bad" 29.1 - 3,7-di methyl-1,2,3,7,8,8a-hexahydro cholesterol napthalen-1-yl 2-methylbutanoate (S)-(1S,3S,7R,8S,8aR)-8-((3R,5R)-7- Simvastatin / (butyl amino)-3,5-bis((tert- Lowers "bad" butyldimethylsilyl) oxy)-7-oxoheptyl)-3,7- cholesterol 29.2 - di methyl-1,2,3,7, 8,8a- hexahydronapthalen-1-yl 2-methyl butanoate 29.3 (1S,3S,7R,8S,8aR)-8-((3R,5R)-7-(butyl - Simvastatin /

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amino)-3,5-bis((tert-butyldimethylsilyl) Lowers "bad" oxy)-7-oxoheptyl)-3,7-di methyl-1,2,3,7, cholesterol 8,8a-hexahydronapthalen-1-yl 2,2- dimethylbutanoate 7-((1S,2S,6R,8S)-8-((2,2- Simvastatin / dimethylbutanoyl) oxy)2,6-dimethyl- Lowers "bad" 29.4 1,2,6,7, 8,8a-hexahydronapthalen-1- - cholesterol yl)3,5-dihydroxyheptanoic acid ammonium salt Losartan Potassium Trityl tetrazole bromomethyl biphenyl 30 133051-88-4 & Candesartan/ (TTBB) Intermediate Hypertension

Trityl tetrazole 30.1 Tetrazole methyl biphenyl 120568-11-8 bromomethyl biphenyl Trityl tetrazole 30.2 Trityl Tetrazole methyl biphenyl 124750-53-4 bromomethyl biphenyl 31 Darunavir Ethanolate 635728-49-3 API / AIDS API / Anti 32 Lansoprazole 103577-45-3 ulcerapive Lansoprazole/ 32.1 2,3-Dimethyl-4-nitro-N-Oxide 37699-43-7 Anti ulcerapive (3-methyl-4-(2,2,2-trifluoroethoxy)pyridin- Lansoprazole/ 32.2 103577-66-8 2-yl)methanol hydrochloride Anti ulcerapive API / Bipolar 33 Aripiperazole 129722-12-9 disorder 7-(4-bromobutoxy)-3,4-dihydroquinolin- Aripiperazole/ 33.1 129722-34-5 2(1H)-one Bipolar disorder Aripiperazole/ 33.2 Aripiperazole crude 129722-12-9 Bipolar disorder API /Erectile 34 Sildenafil Citrate 171599-83-0 dysfunction API / Pulmonary 35 Bosentan 147536-97-8 arterial hypertension Bosentan/ Pyrimidine-2-carbox amidine Pulmonary 35.1 138588-40-6 hydrochloride arterial hypertension Bosentan/ 5-(2-Methoxyphenoxy)-2-(pyrimidin-2-yl)- Pulmonary 35.2 329923-15-1 pyrimidine-4,6-diol arterial hypertension API / 36 Olanzapine 132539-06-1 Antipsychotic 2-methyl-10-Piperazine-1-yl-4H-3-thia-4,- Olanzapine/ 36.1 161696-76-0 9-diaza-benzo[f] azulene Antipsychotic Mesalamine 37 2-Chloro-5-nitrobenzoic acid 2516-96-3 /Ulcerative Colitis Etoricoxib /Cox- 38 Methyl-6-methyl-nicotinate 65719-09-7 2 inhibitor

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*R&D 10 KG/Month TOTAL 100 MT/Month API = 33 , Intermediates = 109 End Use of Product Name of API in Type/ which Category of Said API is used Sr. Name of the CAS no. Intermediat CAS No. Product for/End Use of No. Products /CI no. e Used/ End (API) (API/ said API use of said Intermediate) Intermediat e 136434- 1 Duloxetine HCl API - Antidepressant 34-9 3-(dimethylamino)- 1-(thiophen-2- Duloxetine 136434- Duloxetine HCl/ 1.1 5424-47-5 Intermediates yl)propan-1-one HCl 34-9 Antidepressant hydrochloride 3-(dimethylamino)- 13636-01- Duloxetine 136434- Duloxetine HCl/ 1.2 1-(thiophen-2- Intermediates 6 HCl 34-9 Antidepressant yl)propan-1-ol (s)-3- (dimethylamino)-1- Duloxetine 136434- Duloxetine HCl/ 1.3 (thiophen-2- - Intermediates HCl 34-9 Antidepressant yl)propan-1-ol L- Mandelate (s)-3- (dimethylamino)-1- 132335- Duloxetine 136434- Duloxetine HCl/ 1.4 Intermediates (thiophen-2- 44-5 HCl 34-9 Antidepressant yl)propan-1-ol (s)-N,N-dimethyl-3- (naphthalen-1- 132335- Duloxetine 136434- Duloxetine HCl/ 1.5 Intermediates yloxy)-3(thiophen-2- 47-8 HCl 34-9 Antidepressant yl)propan-1-amine (s)-N-methyl-3- (naphthalen-1- 116539- Duloxetine 136434- Duloxetine HCl/ 1.6 Intermediates yloxy)-3(thiophen-2- 59-4 HCl 34-9 Antidepressant yl)propan-1-amine 23672-07- API/ 2 Levosulpiride API - - 3 Schizophrenia 2-methoxy benzoic Levosulpirid 23672- Levosulpiride/ 2.1 579-75-9 Intermediates acid e 07-3 Schizophrenia 2-methoxy-5- 33045-52- Levosulpirid 23672- Levosulpiride/ 2.2 sulfamoyl- benzoic Intermediates 2 e 07-3 Schizophrenia acid Methyl 2-methoxy- 33045-52- Levosulpirid 23672- Levosulpiride/ 2.3 5-sulfamoyl- Intermediates 2 e 07-3 Schizophrenia benzoate 1-ethyl-2- 265315- Levosulpirid 23672- Levosulpiride/ 2.4 (nitromethyl)pyrrolid Intermediates 52-4 e 07-3 Schizophrenia ine (1-ethylpyrrolidine- 22795-99- Levosulpirid 23672- Levosulpiride/ 2.5 Intermediates 2-yl)methanamine 9 e 07-3 Schizophrenia

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1(1-ethylpyrrolidine- 2-yl) methanamine1. 2(1- 84277-13- Levosulpirid 23672- Levosulpiride/ 2.6 Intermediates ethylpyrrolidine-2- 4 e 07-3 Schizophrenia yl)methanamineD-(- )-Tartaric acid (s)-(1- 22795-99- Levosulpirid 23672- Levosulpiride/ 2.7 ethylpyrrolidine-2- Intermediates 9 e 07-3 Schizophrenia yl)methanamine Phenylepherine API/ Shrinks 3 61-76-7 API - - HCl blood vessels Phenylepherine 3-acetylphenyl Phenylepheri 3.1 2454-35-5 Intermediates 61-76-7 HCl/ Shrinks acetate ne HCl blood vessels 2- (benzyl(methyl)ami Phenylepherine 71786-67- Phenylepheri 3.2 no-1-(3- Intermediates 61-76-7 HCl/ Shrinks 9 ne HCl hydroxyphenyl)etha blood vessels none hydrochloride 3-(1-hydroxy-2- Phenylepherine Phenylepheri 3.3 (methylamino)ethyl) 1477-63-0 Intermediates 61-76-7 HCl/ Shrinks ne HCl phenol blood vessels Strontium 135459- API/ 4 API - - Renelate 90-4 Osteoporosis Strontium Diethyl 3- Strontium 135459- 4.1 105-50-0 Intermediates Renelate/ oxopentanedioate Renelate 90-4 Osteoporosis ethyl 5-amino-4- cyano-3-(2-ethoxy- Strontium 58168-20- Strontium 135459- 4.2 2- Intermediates Renelate/ 0 Renelate 90-4 oxoethyl)thiophene- Osteoporosis 2-carboxylate Diethyl 2,2((3-cyno- 4-(2-ethoxy-2- oxoethyl)-5- Strontium 58194-26- Strontium 135459- 4.3 (ethoxycarbonyl)thi Intermediates Renelate/ 6 Renelate 90-4 ophen-2- Osteoporosis yl)azanedyl)diacetat eI compound 56211-40- 5 Torsemide API - - API/ Edema 6 4-aminopyridine-3- 29452-57- 56211- Torsemide/ 5.1 Intermediates Torsemide sulfonic acid 1 40-6 Edema 4-chloropyridine-3- 33263-43- 56211- Torsemide/ 5.2 Intermediates Torsemide sulfonamide 3 40-6 Edema 4-(m- 72811-73- 56211- Torsemide/ 5.3 tolyamino)pyridine- Intermediates Torsemide 5 40-6 Edema 3-sulfonamide Atorvastatin 134523- API/ Lipid- 6 API - - Calcium 00-5 lowering agent tert-butyl2-((4R,6R)- Atorvastatin 6-(2-aminoethyl)- 122995- Atorvastatin 134523- 6.1 Intermediates Calcium / Lipid- 2,2-dimethyl-1,3- 13-3 Calcium 00-5 lowering agent dioxan-4-yl)acetate

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tert-butyl2-((4R,6R)- 6-(2-2-(4- fluorophenyl)-5- isopropyl-3-phenyl- Atorvastatin 4- 125971- Atorvastatin 134523- 6.2 Intermediates Calcium / Lipid- (phenylcarbamoyl)- 95-1 Calcium 00-5 lowering agent 1H-pyrrol-1- yl)ethyl)-2,2- dimethyl-1,3- dioxan-4-yl)acetate API/ relieve allergy symptoms such as watery Fexofenadine 7 2459-09-8 API - - eyes, runny Intermediate nose, itching eyes/nose, sneezing, hives Fexofenadine/ relieve allergy 2-(4-(4- symptoms such chlorobutanoyl)phe Fexofenadin 343255- 2459-09- as watery eyes, 7.1 nyl)-N,N,2- Intermediates e 26-5 8 runny nose, trimethylpropanoic Intermediate itching acid eyes/nose, sneezing, hives Fexofenadine/ relieve allergy 2-[4- symptoms such (cyclopropylcarbony Fexofenadin 162096- 2459-09- as watery eyes, 7.2 l) phenyl]-2- Intermediates e 54-0 8 runny nose, methylpropionic Intermediate itching acid eyes/nose, sneezing, hives Fexofenadine/ 2-[4- relieve allergy (cyclopropylcarbony symptoms such Fexofenadin l) phenyl]-2- 1690344- 2459-09- as watery eyes, 7.3 Intermediates e methylpropionic 90-1 8 runny nose, Intermediate acid cyclohexyl itching amine salt eyes/nose, sneezing, hives Azilsartan 863031- API/ treat high 8 API - - Kamedoxomil 24-7 blood pressure Ethyl 2-ethoxy-1- ((2'-(N'- Azilsartan hydroxycarbamimid Azilsartan 147403- 863031- Kamedoxomil/ 8.1 oyl)biphenyl-4- Intermediates Kamedoxomi 65-4 24-7 treat high blood yl)methyl)-1H- l pressure benzo[d]imidazole- 7-carboxylate Ethyl 2-ethoxy-1- Azilsartan Azilsartan ((2'-(5-oxo-4,5- 147403- 863031- Kamedoxomil/ 8.2 Intermediates Kamedoxomi dihydro-1,2,4- 52-9 24-7 treat high blood l oxadiazol-3- pressure

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yl)biphenyl-4- yl)methyl)-1H- benzo[d]imidazole- 7-carboxylate 2-ethoxy-1-((2'-(5- oxo-4,5-dihydro- Azilsartan 1,2,4-oxadiazol-3- Azilsartan 147403- 863031- Kamedoxomil/ 8.3 yl)biphenyl- Intermediates Kamedoxomi 03-0 24-7 treat high blood 4yl)methyl)-1H- l pressure benzo[d]imidazole- 7-carboxylic acid (5-methyl-2-oxo- 1,3-dioxol-4- yl)methyl 2-ethoxy- 1-((2'-(5-oxo-4,5- Azilsartan Azilsartan dihydro-1,2,4- 863031- 863031- Kamedoxomil/ 8.4 Intermediates Kamedoxomi oxadiazol-3- 21-4 24-7 treat high blood l yl)biphenyl-4- pressure yl)methyl)-1H- benzo[d]imidazole- 7-carboxylate 22457-89- API/Alzheimer 9 Benfotiamine API - - 2 disease 3-((4-amino-2- methylpyrimidin-5- yl)methyl)-5-(2- Benfotiamine 22457- 9.1 (phosphonooxy)eth 532-40-1 Intermediates Benfotiamine /Alzheimer 89-2 yl)-4,5- disease dihydrothiazol-3- ium Clopidogrel 135046- API/ Antiplatelet 10 Hydrogen API - - 48-9 medication sulphate Clopidogrel Methyl (+)-alpha-(2- Clopidogrel Hydrogen thienylethylamino)(2 141109- 135046- 10.1 Intermediates Hydrogen sulphate/ - chlorophenyl) 19-5 48-9 sulphate Antiplatelet acetate medication Leveteracitam/ 102767- 11 Leveteracitam API - - Manages 28-2 seizures Leveteracitam/ Levetiracetam 102767- Leveteracita 102767- 11.1 Intermediates Manages Technical 28-2 m 28-2 seizures 86386-73- 12 Fluconazole API - - API/ Antifungals 4 1-(2,4- Difluorophenyl)-2(1- 86404-63- 86386- Fluconazole/ 12.1 Intermediates Fluconazole H-1,2,4-triazol-1- 9 73-4 Antifungals yl)ethanone 1-((2-2,4- diflurophenyl)oxiran 86386-77- 86386- Fluconazole/ 12.2 Intermediates Fluconazole -2-yl)methyl)1H- 8 73-4 Antifungals 1,2,4-triazole

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Quetiapine 111974- API/ Bipolar 13 API - - Fumarate 69-7 disorder (2- Quetiapine Quetiapine 111974- 13.1 nitrophenyl)(phenyl) 4171-83-9 Intermediates Fumarate/ Fumarate 69-7 sulfane Bipolar disorder Quetiapine 2- Quetiapine 111974- 13.2 1134-94-7 Intermediates Fumarate/ (phenylthio)aniline Fumarate 69-7 Bipolar disorder phenyl(2- Quetiapine 111974- Quetiapine 111974- 13.3 (phenylthio)phenyl) Intermediates Fumarate/ 73-3 Fumarate 69-7 carbamate Bipolar disorder Quetiapine dibenzo[b,f][1,4]thia Quetiapine 111974- 13.4 3159-07-7 Intermediates Fumarate/ zepin-11(10H)-one Fumarate 69-7 Bipolar disorder API/ Anti- 14 Vildagliptin 3159-07-7 API - - hyperglycemic agent Vildagliptin/ 3- 3159-07- Anti- 14.1 Aminoadamantan- 702-82-9 Intermediates Vildagliptin 7 hyperglycemic 1-ol agent Vildagliptin/ (s)-1-(2- 214398- 3159-07- Anti- 14.2 chloroacetyl)pyrrolid Intermediates Vildagliptin 99-9 7 hyperglycemic ine-2-carboxamide agent Vildagliptin/ (s)-1-(2- 207557- 3159-07- Anti- 14.3 chloroacetyl)pyrrolid Intermediates Vildagliptin 35-5 7 hyperglycemic ine-2-carbonitrile agent Vildagliptin/ Vildagliptin 274901- 3159-07- Anti- 14.4 Intermediates Vildagliptin Technical 16 7 hyperglycemic agent Losartan 124750- API/ 15 API - - Potassium 99-8 Hypertension Methyl Losartan 39739-46- Losartan 124750- 15.1 pentanimidate Intermediates Potassium / 3 Potassium 99-8 hydrochloride Hypertension Sodium 2- Losartan 19767-45- Losartan 124750- 15.2 pentanimidamideac Intermediates Potassium / 4 Potassium 99-8 etate Hypertension 2-butyl-4-chloro- Losartan 4,5-dihydro-1H-imi 83857-96- Losartan 124750- 15.3 Intermediates Potassium / dazole-5- 6 Potassium 99-8 Hypertension carbaldehyde 4'-(bromomethyl)- Losartan 114772- Losartan 124750- 15.4 [1,1'-biphenyl]-2- Intermediates Potassium / 54-2 Potassium 99-8 carbonitrile Hypertension 4'-((2-butyl-4- chloro-5- Losartan (hydroxymethyl)- 114772- Losartan 124750- 15.5 Intermediate Potassium / 1H-imidazol-1- 55-3 Potassium 99-8 Hypertension yl)methyl)-[1,1'- biphenyl]-2-

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carbonitrile (1-(2,2'-(1H- tetrazol-5-yl)-[1,1'- Losartan biphenyl]-4- 114798- Losartan 124750- 15.6 Intermediate Potassium / yl)methyl)-2-butyl-4- 26-4 Potassium 99-8 Hypertension chloro-1H-imidazol- 5-yl)methanol 202409- API/ Cox-2 16 Etoricoxib API - - 33-4 inhibitor 3-(6-methylpyridin- 3-yl)-2-(4- 221615- 202409- Etoricoxib/ Cox- 16.1 Intermediate Etoricoxib (methylthio)phenyl- 75-4 33-4 2 inhibitor 3-oxopropanenitrile 1-(6-methylpyridin)- 2-(4- 221615- 202409- Etoricoxib/ Cox- 16.2 Intermediate Etoricoxib (methylthio)phenyl) 72-1 33-4 2 inhibitor ethanone 1-(6-methylpyridin- 3-yl)-2-(4- 221615- 202409- Etoricoxib/ Cox- 16.3 Intermediate Etoricoxib (methylsulfonyl)phe 75-4 33-4 2 inhibitor nyl)ethanone 2-Chloro-1,3- Bis(Dimethylamino) 291756- 202409- Etoricoxib/ Cox- 16.4 Intermediate Etoricoxib trimethynium 76-8 33-4 2 inhibitor hexafluro phoshate 65277-42- 17 Ketoconazole API - - API / Antifungal 1 61397-56- Ketoconazol 65277- Ketoconazole/ 17.1 Cis-Bromobenzoate Intermediate 6 e 42-1 Antifungal Cis Imidazole 61397-58- Ketoconazol 65277- Ketoconazole/ 17.2 Intermediate alcohol 8 e 42-1 Antifungal 154003- Ketoconazol 65277- Ketoconazole/ 17.3 Cis-Tosylate Intermediate 23-3 e 42-1 Antifungal 1-(4-(4- 67914-60- Ketoconazol 65277- Ketoconazole/ 17.4 hydroxyphenyl)pipe Intermediate 7 e 42-1 Antifungal razin-1-yl)ethanone Pantoprazole 138786- API/ Esophagus 18 API - - sodium 67-1 problems Pantoprazole 3-methoxy-2- Pantoprazol 138786- sodium / 18.1 methyl-4H-pyran-4- 4780-14-7 Intermediate e sodium 67-1 Esophagus one problems Pantoprazole 3-methoxy-2- 76015-11- Pantoprazol 138786- sodium / 18.2 methylpyridin- Intermediate 7 e sodium 67-1 Esophagus 4(1H)-one problems Pantoprazole 4-chloro-3-methoxy- 122307- Pantoprazol 138786- sodium / 18.3 Intermediate 2-methylpyridine 41-9 e sodium 67-1 Esophagus problems Pantoprazole 4-chloro-3-methoxy- 122307- Pantoprazol 138786- sodium / 18.4 2-methylpyridine-N- Intermediate 41-9 e sodium 67-1 Esophagus oxide problems

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Pantoprazole 3,4-dimethoxy-2- 72830-07- Pantoprazol 138786- sodium / 18.5 methylpyridine-N- Intermediate 0 e sodium 67-1 Esophagus oxide problems Pantoprazole (3,4- 102625- Pantoprazol 138786- sodium / 18.6 dimethoxypyridine- Intermediate 99-0 e sodium 67-1 Esophagus 2-yl)methyl acetate problems Pantoprazole (3,4- 72830-08- Pantoprazol 138786- sodium / 18.7 dimethoxypyridine- Intermediate 1 e sodium 67-1 Esophagus 2-yl)methanol problems 2-(chloromethyl)- Pantoprazole 3,4- 72830-09- Pantoprazol 138786- sodium / 18.8 Intermediate dimethoxypyridine 2 e sodium 67-1 Esophagus hydrochloride problems 5-(difluoromethoxy)- Pantoprazole 2-(((3,4- 102625- Pantoprazol 138786- sodium / 18.9 dimethoxypyridin-2- Intermediate 64-9 e sodium 67-1 Esophagus yl)methyl)thio)-1H- problems benzo[d]imidazole 93479-97- 19 Glimepiride API - - API/ Antidiabetic 1 2-Ethylmethyl 93479- Glimepiride / 19.1 609-14-3 Intermediate Glimepiride acetoacetate 97-1 Antidiabetic Methyl 2-ethyl-3- 93479- Glimepiride / 19.2 hydroxy-3-methyl-4- 2985-50-4 Intermediate Glimepiride 97-1 Antidiabetic nitrobutanoate Methyl 4-amino—2- 93479- Glimepiride / 19.3 ethyl-3-hydroxy-3- - Intermediate Glimepiride 97-1 Antidiabetic methylbutanoate Methyl 4- acetamido-2-ethyl- 93479- Glimepiride / 19.4 - Intermediate Glimepiride 3-hydroxy-3- 97-1 Antidiabetic methylbutanoate 3-ethyl-4-methyl- 93479- Glimepiride / 19.5 766-36-9 Intermediate Glimepiride 1H-pyrrol-2(5H)-one 97-1 Antidiabetic 3-ethyl-4-methyl-2- oxo-N-phenethyl- 247098- 93479- Glimepiride / 19.6 2,5-dihydro-1-H- Intermediate Glimepiride 18-6 97-1 Antidiabetic pyrrole-1- carboxamide 3-ethyl-4-methyl-2- oxo-N-(4- sulfamoylphenethyl- 119018- 93479- Glimepiride / 19.7 Intermediate Glimepiride 2,5-dihydro-1-H- 29-0 97-1 Antidiabetic pyrrole-1- carboxamide Di methyl Formamide –Di Imatinib/ treat 20 methyl acetyl 4637-24-5 API Imatinib - certain types of DMF-DMA cancer (Intermediate) 21 2,3,4,5-bis-o-[1- 20880-92- Intermediate Topiramate 97240- Topiramate/

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methyl ethyl 6 79-4 alone or with indene] B-D- other Fructopyranose medications to prevent and control seizures Rosuvastatin 147098- Rosuvastatin 147098- Lowers "bad" 22 API Calcium 20-2 Calcium 20-2 cholesterol Phosphonium, [[4- (4-fluorophenyl)-6- Rosuvastatin (1-methylethyl)-2- 885477- Rosuvastatin 147098- Calcium / 22.1 [methyl(methylsulfo 83-8 Intermediate Calcium 20-2 Lowers "bad" nyl)amino]-5- cholesterol pyrimidinyl]methyl]tr iphenyl-, bromide tert-butyl 2- Rosuvastatin ((4R,6S)Hydroxyme 124655- Rosuvastatin 147098- Calcium / 22.2 thyl)-2,2-dimethyl- 09-0 Intermediate Calcium 20-2 Lowers "bad" 1,3-dioxan-4yl) cholesterol acetate tert-butyl 2- Rosuvastatin 124752- ((4R,6S)--formyl- Rosuvastatin 147098- Calcium / 22.3 23-4 Intermediate 2,2-dimethyl-1,3- Calcium 20-2 Lowers "bad"

dioxan-4yl) acetate cholesterol 137862- Valsartan/ 23 Valsartan API - - 53-4 Hypertension L-Valine methyl 137862- Valsartan/ 23.1 6306-52-1 Intermediate Valsartan ester 53-4 Hypertension 4‘-(bromomethyl)- 114772- 137862- Valsartan/ 23.2 [1,1‘-biphenyl]-2- Intermediate Valsartan 54-2 53-4 Hypertension carbonitrile (R)-methyl-2-(((2‘- cyano-[1,1‘- 137863- 137862- Valsartan/ 23.4 biphenyl]-4- Intermediate Valsartan 89-9 53-4 Hypertension yl)methyl)amino)-3- methylbutanoate (R)-methyl 2-(N- ((2‘cyano-[1,1‘- biphenyl]-4- 137863- 137862- Valsartan/ 23.5 Intermediate Valsartan yl)methyl)pentanam 90-2 53-4 Hypertension ido)-3- methylbutanoate 144701- Telmisartan / 24 Telmisartan API - - 48-4 Hypertension Methyl-3-Amino-4- 675882- 144701- Telmisartan / 24.1 (butaramido)-5- Intermediate Telmisartan 71-0 48-4 Hypertension methyl benzoate 1,7‘-Dimethyl-2‘- propyl-1H-3‘H-2,5‘- 1282554- 144701- Telmisartan / 24.2 Intermediate Telmisartan bibenzo[d]- 35-1 48-4 Hypertension imidazole Telmisartan (Intermediate of ortho-Tolyl 157366- Losartan all sartan 25 benzonitrile Intermediates - 46-6 Potassium products)Telmis

Valsartan artan

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Olmesatan Losartan (Intermediat Potassium e of all Valsartan sartan Olmesatan/ products) Hypertension

175481- API/ Anti- 26 Lacosamide API - - 36-4 epileptic drug (R)-3-hydroxy-2- Lacosamide/ 175481- 26.1 pivalamidopropanoi 6368-20-3 Intermediate Lacosamide Anti-epileptic 36-4 c acid drug (R)-3-methoxy-2- Lacosamide/ 55289-06- 175481- 26.2 pivalamidopropanoi Intermediate Lacosamide Anti-epileptic 0 36-4 c acid drug (R)-N-benzyl-3- Lacosamide/ methoxy-2- 880468- 175481- 26.3 Intermediate Lacosamide Anti-epileptic pivalamidopropana 89-3 36-4 drug mide Phenylephirine HCl/ temporary 1-(3- relief of stuffy hydroxyphenyl)-2- Phenylephir 679394- nose, sinus, and 27 (methylamino)etha Intermediate ine 61-76-7 62-8 ear symptoms none sulfate HCl caused by the MAP sulphate common cold, flu, allergies 1-(3- hydroxyphen Phenylephirine yl)-2- HCl/ temporary (methylamin relief of stuffy 3-acetylphenyl o)ethanone 679394- nose, sinus, and 27.1 139-28-6 Intermediate benzoate sulfate 62-8 ear symptoms MAP caused by the sulphate common cold, flu, (Intermediat allergies e) 1-(3- hydroxyphen Phenylephirine yl)-2- HCl/ temporary (methylamin relief of stuffy 3-(2- o)ethanone 679394- nose, sinus, and 27.2 bromoacetyl)phenyl 139-27-5 Intermediate sulfate 62-8 ear symptoms benzoate MAP caused by the sulphate common cold, flu, (Intermediat allergies e) Bisoprolol 66722-44- API/ 28 API - - Fumarate 9 Hypertension 4-[(2- Bisoprolol 177034- Bisoprolol 66722- 28.1 Isopropoxyethoxy) Intermediate Fumarate/ 57-0 Fumarate 44-9 methyl]phenol Hypertension 4-((2- Bisoprolol 66722-57- Bisoprolol 66722- 28.2 isopropoxyethoxy)m Intermediate Fumarate/ 4 Fumarate 44-9 ethyl)phenoxy)meth Hypertension

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yl)oxirane 1 amino 3-( 4-((2- Bisoprolol isopropoxyethoxy)m Bisoprolol 66722- 28.3 - Intermediate Fumarate/ ethyl)phenoxy)prop Fumarate 44-9 Hypertension an2 –ol 79902-63- API/ Lowers 29 Simvastatin API - - 9 "bad" cholesterol (S)- (1S,3S,7R,8S,8aR)- 8-((3R,5R)-7-(butyl amino)-3,5- Simvastatin / dihydroxy-7- 79902- 29.1 - Intermediate Simvastatin Lowers "bad" oxoheptyl)-3,7-di 63-9 cholesterol methyl-1,2,3,7,8,8a- hexahydro napthalen-1-yl 2- methylbutanoate (S)- (1S,3S,7R,8S,8aR)- 8-((3R,5R)-7-(butyl amino)-3,5-bis((tert- butyldimethylsilyl) Simvastatin / 79902- 29.2 oxy)-7-oxoheptyl)- - Intermediate Simvastatin Lowers "bad" 63-9 3,7-di methyl- cholesterol 1,2,3,7, 8,8a- hexahydronapthale n-1-yl 2-methyl butanoate (1S,3S,7R,8S,8aR)- 8-((3R,5R)-7-(butyl amino)-3,5-bis((tert- butyldimethylsilyl) Simvastatin / oxy)-7-oxoheptyl)- 79902- 29.3 - Intermediate Simvastatin Lowers "bad" 3,7-di methyl- 63-9 cholesterol 1,2,3,7, 8,8a- hexahydronapthale n-1-yl 2,2- dimethylbutanoate 7-((1S,2S,6R,8S)-8- ((2,2- dimethylbutanoyl) oxy)2,6-dimethyl- Simvastatin / 79902- 29.4 1,2,6,7, 8,8a- - Intermediate Simvastatin Lowers "bad" 63-9 hexahydronapthale cholesterol n-1-yl)3,5- dihydroxyheptanoic acid ammonium salt Losartan Trityl tetrazole Losartan Potassium bromomethyl 133051- Potassium 30 API & biphenyl (TTBB) 88-4 & Candesartan Candesartan Intermediate

Tetrazole methyl 120568- Trityl 133051- Trityl tetrazole 30.1 Intermediate biphenyl 11-8 tetrazole 88-4 bromomethyl

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bromomethyl biphenyl biphenyl (TTBB) Intermediate Trityl tetrazole Trityl tetrazole Trityl Tetrazole 124750- bromomethyl 133051- 30.2 Intermediate bromomethyl methyl biphenyl 53-4 biphenyl 88-4 biphenyl (TTBB) Intermediate Darunavir 635728- Darunavir 635728- 31 API AIDS Ethanolate 49-3 Ethanolate 49-3 103577- Lansoprazole/ 32 Lansoprazole API - - 45-3 Anti ulcerapive 2,3-Dimethyl-4- 37699-43- Lansoprazol 103577- Lansoprazole/ 32.1 Intermediate nitro-N-Oxide 7 e 45-3 Anti ulcerapive (3-methyl-4-(2,2,2- trifluoroethoxy)pyrid 103577- Lansoprazol 103577- Lansoprazole/ 32.2 Intermediate in-2-yl)methanol 66-8 e 45-3 Anti ulcerapive hydrochloride 129722- API/ Bipolar 33 Aripiperazole API -- - 12-9 disorder 7-(4-bromobutoxy)- 129722- 129722- Aripiperazole/ 33.1 3,4-dihydroquinolin- Intermediate Aripiperazole 34-5 12-9 Bipolar disorder 2(1H)-one 129722- 129722- Aripiperazole/ 33.2 Aripiperazole crude Intermediate Aripiperazole 12-9 12-9 Bipolar disorder 171599- API /Erectile 34 Sildenafil Citrate API - - 83-0 dysfunction API/ Pulmonary 147536- 35 Bosentan API - - arterial 97-8 hypertension Bosentan/ Pyrimidine-2-carbox 138588- 147536- Pulmonary 35.1 amidine Intermediate Bosentan 40-6 97-8 arterial hydrochloride hypertension 5-(2- Bosentan/ Methoxyphenoxy)- 329923- 147536- Pulmonary 35.2 Intermediate Bosentan 2-(pyrimidin-2-yl)- 15-1 97-8 arterial pyrimidine-4,6-diol hypertension 132539- API/ 36 Olanzapine API - - 06-1 Antipsychotic 2-methyl-10- Piperazine-1-yl-4H- 161696- 132539- Olanzapine/ 36.1 Intermediate Olanzapine 3-thia-4,-9-diaza- 76-0 06-1 Antipsychotic benzo[f] azulene 2-Chloro-5- Mesalamine 37 2516-96-3 Intermediate Mesalamine 89-57-6 nitrobenzoic acid /Ulcerative Colitis Methyl-6-methyl- 65719-09- 65719- Etoricoxib /Cox- 38 Intermediate Etoricoxib nicotinate 7 09-7 2 inhibitor

 The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006

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and amendment dated 27th March, 2020.  The presentation was considered in the meeting dated 30/05/2020 as per the submission by PP via E- mail dated 22/05/2020.  Salient features of the project including Water, Air and Hazardous waste management:

Sr. Particulars Details No . A A Total cost of Proposed Project 5.238 Crores (Rs. in Crores): Break-up of proposed project Cost:

Approximate Capital Cost Details (Rs. in Lacs) Land 82.0 Building 70.0 Plant & Machinery 190.0 ETP, APCS, LDAR & HWM 177.5 Green Belt Development 1.8 Occupational Health & Training 2.50 Total 523.8

Details of Environmental Management Plan As below: (EMP) Brief details of EMP COMPONENT CAPITAL COST OF EMP RECURRING COST OF EMP (per Month) Cost Rs. 181.8 Lakhs Rs. 53.03 Lakhs

Bifurcation of EMP Cost Sr. Unit Installed Capital Operating Maintenance Total No Capacity Cost Cost Cost Recurring (KLD) (Rs. in (Lacs/Mo (Lacs/Month) Cost Lakhs ) nth) (Lacs/Month) 1 Effluent Stripper: 40 Treatment Plant KLD (Stripper + MEE MEE: 40 KLD 142 35 3.5 38.5 + ETP (Primary ETP:40 KLD & Secondary)) CETP Discharge - 1 4.8 - 4.8 2. APCM + LDAR Water 32.0 0.8 0.4 1.2 Scrubber (01 Nos) + Alkali scrubber (04 Nos) = 05 Nos MCS-2 Nos Bag Filtere-2 Nos 3. Hazardous -- 1.0 8 -- 8

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Waste (Expense) 4. AWH Monitoring -- 1.5 0.1 -- 0.1 Cost 5. OH, Training & -- 2.5 0.10 0.06 0.16 Safety 6. Greenbelt 330 Trees 1.8 0.18 0.09 0.27 Total 181.8 53.03

Details of CER as per OM dated 01/05/2018 As below: As per OM no. 22-65/2017 on dated 01/05/2018 regarding ―Corporate Environment Responsibility‖ (CER), Greenfield projects have to contribute 2% of the Additional Capital Investment, the company will contribute Rs. 0.10 Cr as funds for CER activities Component Project Cost As per Norms Allocation CER 5.23 Cr Rs. 0.10 Cr (2 %) Rs. 0.10 Cr (2 %) (Green field)

Activities to be carried out under CER: Activities Phase Wise Budget 1st 2nd Year TOTAL Year Electrification Including Solar Power– (On basis of Needs 0.01 0.01 0.02 Assessment)  Installation of 10 Nos Solar Street Light @10,000/Light – Village Sutrel  Installation of 1.8 KV Roof Top Solar System @ 1 Lacs for Gam Panchayat Office – Village Wahiyal Solid Waste Management– (On basis of Needs Assessment) 0.02 0.02 0.04  Installation of OWC 500 Kg X 2 Nos @ 2 Lacs/Unit – Tal- Saran & Bhersam Gram Panchayat Plantation / Greenbelt in Community Area– (On basis of Needs Assessment)  Plantation around habitation area with various location areas as – Villages – Saykha, Saran etc: cost of 1 plant – 500/- with maintenance of water. (200 plants) 0.01 0.01 0.02  Installation of green cover as tree guards at the surviving plants & trees, where attached the board ―Pacific Life Science – Villages – Saykha, Saran etc Skill Development – (On basis of Needs Assessment) 0.01 0.01 0.02  Scholarship to Students in ITI @ 20000/Students, Total 5 Students– ITI, Ankleshwar (local student give to first preference)  Contribution @ 1 Lacs at Directorate of Employment & Training / Ministry of Skill Development & Entrepreneurship. Total Cost Approx. INR 0.10 Crore

B Total Plot area ( sq. meter) 3977.83 Sq. m.. Green belt area 1312.74 Sq. m. ( sq. meter) (33 % of total area) C Employment generation Direct = 15 Employees Indirect = 8 Employees D Water I Source of Water Supply GIDC Water supply (GIDC Bore well, Surface water, Tanker supply etc...)

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Status of permission from the concern authority. Yes Obtained. Letter No. GIDC/DEE(WS)/BRH/49 dated:21/01/2020 Ii Water consumption (KLD)

Total Water Remark Consumption (KLD) (M) Domestic 1.00 GIDC Water Supply Authority (N) Gardening 1.50 (O) Industrial Process 28.70 Cis-Bromobenzoate Boiler 5.00 Total water Requirement 48 KLD Total Condensate recovery: 43 Makeup:5 KLD Washing 2.00 Cooling 4.50 Scrubbing 6.65 Industrial Total 46.85 Grand Total (A+B+C) 49.35

1) Total water requirement for the project: 49.35 KLD 2) Quantity to be recycled: 4.0 KLD 3) Total fresh water requirement: 45.35 KLD

Brief Note on worst case scenario for water consumption:  Total Water Requirement of the proposed project will be 49.35 KLD, out of which Water Consumption for Process will be 28.70 KLD.  Worst Case Scenario; SN GRO PRODUCT WATER REQ. (IN TOTAL TOTAL WATER UP KL) FOR 1 TON PRODUCTION REQ. PRODUCTION (MT/MONTH) (KLD) 1 - Cis-Bromobenzoate 8.20 100 27.33

Total Water Consumption – Process 100 27.33 KLD

In case of no reuse/recycle of wastewater, Give brief note on justification as why no reuse/recycle. – In Boiler 43 KLD condensate recovery considered in the recycle, hence makeup reduced to 5.0 KL. We have proposed Reuse / Recycle of 4 KLD in washing & Scrubbing.

Iii Waste water generation (KLD) Waste water Remark Generation (KLD) (A) Domestic 0.80 Sock pit & septic tank (B) Gardening -- (C) Industrial Process 31.4 Worst Case - 2-methoxy-5-sulfamoyl- benzoic acid Washing 2.00 Boiler 0.30 Cooling 0.30

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Scrubbing Solution 1.30

(30% NaCl) Scrubbing Solution 0.70 (10% NaNO2) Scrubbing Solution 3.40 Sold to end user (25-30% NaBr) Scrubbing Solution 1.10 Sold to end user (18% Na2SO3) Scrubbing Solution 0.15 Reuse within premises. (30% Liq. Ammonia) Industrial Total 40.65 Grand Total (A+B+C) 41.45 - Brief Note on worst case scenario for waste water generation (Qualitative and Quantitative): Quantitate & Qualitative:-  Total Waste Water Generation of the proposed project will be 41.45 KLD, out of which Waste Water Generation for Process will be 31.4 KLD.  Worst Case Scenario; TOTAL WASTE WATER TOTAL PRODUC S GEN. (IN KL) WASTE GROUP PRODUCT TION CHARACTERSTICS N FOR 1 TON WATER (MT/MON PRODUCTION (KLD) TH) pH– 6.5 to 7.5 2-methoxy- (neutralization at 5- source) sulfamoyl- 1 - 9.43 100 31.4 benzoic TSS – 220 mg/l, acid TDS – 49648mg/l, BOD – 13744 mg/l, COD – 68500 mg/l Total Waste Water Generation – Process 100 31.4 KLD

Iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc. [In-house ETP (Stripper + Primary + MEE etc).  Hydraulic Load In Stripper – 31.4 KLD  Hydraulic Load In MEE = 30.96  Hydraulic Load In ETP (Primary & Secondary) = 32.46

 Capacity Stripper – 40 KLD  Capacity MEE = 40 KLD  Capacity ETP (Primary & Secondary) = 40 KLD

Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed.  Stream 1: Wastewater from process @ 31.4 KLD will be allowed to Solvent Stripper.  Outlet of Stripper @ 30.96 KLD will be subjected AOP- Fenton Reagent (FeSO4 +H2O2)

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along with primary ETP & followed by MEE.  Condensate from MEE 27.86 KLD will be sent to in-house ETP-Secondary for further treatment.

2-methoxy-5- After AOP After Sr. MEE Parameter Unit sulfamoyl- Solvent (Fenton Primary No. Condensate benzoic acid stripper treatment) Quantity (KLD) 31.4 30.96 30.96 30.96 27.86 6.5-7.5 pH 1 pH (neutralization 6.5-7.5 6.5-7.5 6.5-7.5 6.5-7.5 Unit at source) 2 TSS mg/L 220 220 98 84 38 3 TDS mg/L 49648 50126 50968 52244 1148 4 BOD mg/L 13744 1915 6263 4932 986 5 COD mg/L 68500 27400 14520 10960 2192 Ammo. Nil Nil 6 mg/L Nil Nil Nil Nitrogen

Fenton Treatment:  Stream 2 - : Waste water from Boiler blow down @ 0.3 KLD, Cooling blow down @ 0.3 KLD, washing section @ 2.0 KLD and Scrubbing NaCl So.@ 1.3 KLD & Scrubbing NaNO2 Sol.@ 0.7 KLD = 4.6 KLD will be sent to in-house Primary ETP for further treatment. Stream from utilities Characteristics Combined After Sr. Para Unit Dilute Stream Dilute Primary No. Boiler Cooling Washing Scrubber Stream Treatment Quantity (KLD) 0.3 0.3 2.0 2.0 4.6 4.6 pH 6.5-7.5 1 pH 6-8 6-8 6-8 7-8 6.5-7.5 Unit 2 TSS mg/L 56 87 150 120 127 48 3 TDS mg/L 1500 2100 2500 500 1539 1744 4 BOD mg/L 10 16 800 190 432 259 5 COD mg/L 30 50 2500 524 1320 792 Ammo. Nil 6 mg/L Nil Nil Nil Nil Nil Nitrogen

 Stream 3 (Combined Treated of Stream-1 + Stream-2) -Totally 32.46 KLD (Stream 1 + Stream 2) will be treated in in-house ETP ( Secondary).  Treated effluent form ETP 32.06 KLD. Out of which 28.06 KLD sent to CETP-Saykha for further treatment & Disposal and 4 KLD will be Reuse in Washing & Scrubbing

After Secondary Combine Condens Combined Sr. Treatment Para Unit d Dilute ate From Stream to No. (Reuse / To Stream MEE ETP CETP) Quantity (KLD) 4.6 27.86 32.46 32.46 pH 6.5-7.5 1 pH 6.5-7.5 6.5-7.5 6.5-7.5 Unit 2 TSS mg/L 48 38 39 < 45 3 TDS mg/L 1744 1148 1232 < 2100 4 BOD mg/L 259 986 882 < 90 5 COD mg/L 792 2192 1993 < 250

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Ammo. Nil 6 mg/L Nil Nil Nil Nitrogen

 Stream 4. –  Scrubbing Solution 30% NaCl @ 1.3 KLD sent to effluent for ETP Treatment.  Scrubbing Solution 10% NaNO2 @ 0.7 KLD sent to effluent for ETP Treatment.  Scrubbing Solution 25-30% NaBr @ 3.4 KLD will be sell to end user.  Scrubbing Solution 18% Na2SO3 @ 1.1 KLD will be sell to end user.  Scrubbing Solution 30% Liq. Ammonia @ 0.15 KLD will be reused within premises. Note: (In case of CETP discharge) : Management of wastewater keeping in view direction under section 18 (1) (b) of the Water (Prevention and Control of Pollution) act, 1974 issued by CPCB regarding compliance of CETP.  Treated Effluent 28.06 KLD will be sent to Common CETP, Saykha. Brief note on adequacy of ZLD (In case of Zero Liquid Discharge):  Industrial Effluent will be treated in Primary & Secondary ETP & sent to Common ETP (M/s. GIDC, Saykha) V Mode of Disposal & Final meeting point

Domestic: Domestic Wastewater of 1.0 KL/Day will be disposed through Soak Pit or Septic Tank. Industrial: Treated effluent form ETP 32.06 KLD. Out of 28.06 KLD sent to CETP- Saykha for further treatment & Disposal. Vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE etc. Name of CF  CETP, Saykha Letter No. – GIDC/BRH/DEE/DRG/47 dated:23/01/2020 Membership of Common facility (CF) (For waste water treatment) CETP, Saykha Letter No. – GIDC/BRH/DEE/DRG/47 dated:23/01/2020 Vii Simplified water balance diagram with reuse / recycle of waste water

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Viii Reuse/Recycle details (KLD) with feasibility. Total reuse Nil KLD Source of waste Application Characteristics of Remarks regarding water for reuse with area with waste water to be feasibility to reuse quantity in KLD (From quantity in reused (COD, BOD, i.e. where it is coming) KLD (Where it TDS etc.) is used) (Primary & Secondary) Washing & pH – 6.5 to 7.5 Yes its feasible ETP, 4.0 KLD Scrubbing – TSS - <30 4.0 KLD TDS <2100 COD<250

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BOD<90

E Air I Brief Note on fuel based heat energy requirement and worst case scenario thereof: S Fuel Based Proposed Calorific Value Working Fuel N Heat Fuel (kcal/kg) Hours Consumption in Energy (Worst Case) worst case 1 Boiler 2.0 Bio-coal 3800-4300 kcal/kg 24 Hrs 9 MT/Day TPH Or Natural Gas 7900 – 8500 kcal/kg 24 Hrs 4520 SCM/Day 2 THF Bio-coal 3800-4300 kcal/kg 24 Hrs 7.7 MT/Day (10 Lac Or KCal/Hr) Natural Gas 7900 – 8500 kcal/kg 24 Hrs 3825 SCM/Day

Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc.

Source Air Stack of Quantity Pollution Type of Sr. Height/ emission Type of Fuel of Fuel Control emissions i.e. No. Dia With MT/Day Measures Air Pollutants (meter) Capacity (APCM) 9 MCS + Bag Steam Bio Coal MT/Day Filter & 1 Boiler 12/0.5 OR OR Adequate (2.0 TPH) Natural Gas 4520 Stack Height SCM/Day PM < 150 Thermic 7.7 3 MCS + Bag mg/Nm Fluid Bio Coal MT/Day Filter & SO2 < 100 ppm 2 Heater 11/0.5 OR OR Adequate NOX < 50 ppm (10.0 Lac Natural Gas 3825 Stack Height KCal/Hr.) SCM/Day D.G. Set Adequate 3 (100 11/0.25 Diesel 15 lit/Hr. Stack Height KVA)

-- ii Process gas emission details i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.)

Stack/V Air Pollution Specific Source of emission Sr. ent Type of Control (Name of the Product & Dia No. Height emission Measures Process) (meter) (APCM) Reaction Vessel-1 Two Stage (Bromination) HBr < 20 1 11 0.2 Alkali (Cis-Bromobenzoate & 3-(2- mg/Nm3 Scrubber bromoacetyl)phenyl benzoate) Reaction Vessel-2 Two Stage NOx < 25 2 (Nitration) 11 0.2 Alkali mg/Nm3 Telmisartan Scrubber

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Reaction Vessel-3 (Sulphonation) SO < 40 Two Stage 3 2-(chloromethyl)-3,4-dimethoxy 11 0.2 2 mg/Nm3 Alkali Scrubber pyridine hydrochloride & Lansoprazole) Reaction Vessel-4 (Chlorination) HCl < 20 Two Stage 4 11 0.2 (1-(2,4- Difluoro phenyl)-2(1-H- mg/Nm3 Alkali Scrubber 1,2,4-triazol-1-yl) ethanone) Reaction Vessel-5 Two Stage NH3 < 175 5 (Ammination) 11 0.2 Water mg/Nm3 Simvastatin Scrubber

Note:  Details of gaseous raw materials used in proposed project  Estimation of process gas emission (Product wise and Total)  Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total)  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix.

Require Solutio Total ment of n Proces Emissi Scrubbi / bleed Solubilit Solution / S Gasous Raw s Gas Product on ng liquors y Bleed liquors n Material Emissi (MT/D Media (KLD) (%) (MT/Annum) on ay) (KL Per Day) 2.4 1240 Cis- (Caustic > 90 MT/Annum 1 Bromine HBr 1.02 3.4 Bromobenzoate + (25-30 % Water) NaBr, HBr) 0.6 255 (Caustic > 90 klMT/Annum 3 Telmisartan Nitric acid NOx 0.1 + 0.7 (10-15 % Water) NaNO ) 2 0.77 401.5 (Caustic Thionyl MT/Annum 5 Lansoprazole SO2 0.33 + 1.0 > 90 Chloride (30% Water) Na SO ) 2 3 (1-(2,4-Difluoro 0.91 475 kl phenyl)-2(1-H- Chloroacetyl (Caustic 6 HCl 0.39 1.3 > 90 MT/Annum 1,2,4-triazol-1- chloride + (30% NaCl) yl) ethanone) Water) 0.10 55 kl (Caustic MT/Annum 7 Simvastatin Intermediates NH3 0.05 0.15 > 90 + (30% Liq. Water) Ammonia)

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Iii Fugitive emission details with its mitigation measures: As below:  Whole process will be carried out in close loop.  Pipe line will be having minimum flange.  Pump with double mechanical seals Proper ventilation. F Hazardous wastes (as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and calculations shall be incorporated in EMP details separately.  Disposal to scrap vendors/vendors/traders is not allowed I Categor Specific Source of y and Sr. Type/Name of generation Quantity Schedu no Hazardous (Name of the (MT/ Management of HW le as . waste Activity, Product Annum) per HW etc.) Rules. Collection, Storage, DG/ Compressor/ Transportation & Used Oil/ SCH- 1 Maintenance 0.15 Reused as lubricant or Spent Oil I/5.1 Activities Disposal by selling to Authorised Re-refiners. Collection, Storage, Discarded 100 Transportation, containers/ SCH-I (10000 Decontamination and 2 Barrels/ Raw Material supplier /33.1 Drums, Reuse or Disposal by Liners/plastic 26000 Selling to Authorised Bags Bags) Recyclers having rule 9 permission. Mfg. Process Distillation SCH- 3 (Levetiracetam 828 Residue I/36.1 Technical) Mfg. Process Collection, Storage, (2-butyl-4-chloro- Transportation & given Process Waste SCH-I 4 4,5-dihydro-1H-imi 1092 to pre/co-processing (Organic) /28.1 dazole-5- (cement industries) or carbaldehyde) Disposal at nearest Spent SCH-I CHWIF. 5 Purification 55 Carbon/Hyflow /28.3 SCH-I 6 Spent Catalyst Mfg. 20 /28.3 Collection, Storage, SCH-I Transportation & 7 ETP Sludge ETP 361.5 /35.3 Disposal at nearest TSDF site

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SCH-I 8 MEE Salt From MEE 600.0 /35.3

Mfg. Process Process waste SCH-I 9 (3-methoxy-2-methyl- 948 (Inorganic) /28.1 4H-pyran-4-one) Collection, Storage, Mfg. Process Handling recover & (Levetiracetam *41400 Reused by subjecting to Technical) Distillation assembly 1 SCH-I within the Premises. 0 Spent Solvent /28.6 Collection, Storage,

Transportation & Solvent Stripper 190 send to pre/co processing unit OR send to CHWIF. Mfg. Process Aluminum (1-(2,4- 1 SCH- Chloride Difluorophenyl)-2(1- 6456 KL 1 I/28.1 (30-40%) H-1,2,4-triazol-1- yl)ethanone) Scrubbing Scrubber Solution (Lansoprazole & 2- 1 Sch-I/ Collection, Storage, 30% Sodium (chloromethyl)-3,4- 401.5 KL 2 28.1 Transportation & Sulphite dimethoxypyridine Disposal by Selling to (Na2SO3) hydrochloride) End User having Scrubbing permission Under Rule- Solution 9. 25-30 % Scrubber 1 (3-(2- SCH-I/ Sodium 1240 KL 3 Bromide bromoacetyl)phenyl 28.1 (NaBr)/ benzoate) Hydrogen Bromide (HBr) Collection, Storage & Scrubbing Reuse within premises. 1 Solution Scrubber Sch-I/ (Reused In the Product 55 KL 4 Liq. 30% (Simvastatin) 28.1 like Etoricoxib & its Ammonia intermediates-4320 MT/Year. Scrubbing Scrubber Solution (1-(2,4- 1 Sch-I/ Sodium Difluorophenyl)-2(1- 475 KL Collection, Storage & 5 28.1 Chloride (30% H-1,2,4-triazol-1- Treatment in ETP within NaCl) yl)ethanone) facility & send to Scrubbing common ETP of (M/s. 1 Solution Scrubber Sch-I/ CETP-Saykha) 255 KL 6 Sodium Nitrite (Telmisartan) 28.1 (10-15 %) -

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S r. Product Solvent Fresh Recovery Total n o. ethyl 0.28 6.62 6.9 *Levetiracetam acetate Technical MDC 0.86 27.89 28.75 Total MT/MT 1.14 34.51 35.65 Total MT/Month 114 3451 3565 Total MT/Annum 1368 41400 42768

Ii Membership details of TSDF, CHWIF etc. TSDF & CHWIF site at M/s. BEIL –Dahej. (For HW management) Vide Letter No. BEIL/ANK/2020 dated:01/05/2020. iii Details of Non-Hazardous waste & its disposal No such waste will be generated. (MSW and others)

G Solvent management, VOC emissions etc.

• All the solvents shall be directly distilled from product mixes and; if required shall be purified in packed column with the help of reflux. • The solvent distillation system shall be designed so as to achieve minimum 95.0 % recovery of solvent. • All the pumps shall be mechanical seal type to avoid any leakage of solvent. • All necessary firefighting systems shall be provided with alarm system. Flame proof wiring and flame proof electrical accessories shall be provided to avoid any mishap. • All the distillation column vents are also connected to cooling water/ chilled brine condensers for maximum possible recovery of the solvents. • All the vents will be connected to a common carbon Absorber for removing traces of solvent from vent gases. • Residue generated from the distillation will be incinerated in-house or sent to BEIL incinerator site. • Two condenser will install with cooling water and chilled brine to recover the solvent. • Primary Condenser HE-01: Cooling Tower water or Chilled water at 10 0C -will be used to condense the solvents depend on the vapor pressure at its operating conditions and the non-condensed vapors will be condensed in a Secondary Condenser • VOC Trap Condenser HE-02: Chilled Brine at -05 0C will be used to trap any traces of Solvent which is slipped from Secondary condenser. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format)  solvent Losses in sol Di air ve st To nt ill tal Sol Va Lo at Va Qt Lo ve S po So Sol ss io F. po y Re So ss nt r. B. ur lve ve Su in n Solv P. ur M co lve es Re n Product P. Pr nt nt b (Ef R ent ° de T/ ver nt (A co o °C es Lo Op Tot flu es C ns M y Ha + ver . su ad era al ent id ity T ndl B y re in tio (A) - u ing + % g n stri e C) pp (C ed )

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out ) (B) Ethyl 0.0 0.0 0.0 0.0 0. 0. Duloxetine 8. 8.2 0.0 1 aceta -4 77 10 3 08 12 42 85 21 34 96 HCl 55 1 214 te 6 8 8 5 38 20 3- (dimethyla mino)-1- Isopr 1 (thiophen- 1 0.0 0.0 0.0 0.0 0. 0. pyl 82 2. 1.9 0.0 . 2- 1. 4.4 2 02 03 10 20 05 08 96 alcoh .5 1 2 050 1 yl)propan- 7 0 0 0 0 00 00 ol 1-one hydrochlori de 3- (dimethyla 1 mino)-1- 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 1. 1.4 0.0 . (thiophen- 9 01 02 07 14 03 05 96 anol .5 9 1 47 1 037 2 2- 5 2 4 7 68 88 yl)propan- 1-ol (s)-3- Ethyl 0.0 0.0 0.0 0.0 0. 0. 7. 6.9 0.0 (dimethyla aceta -4 77 10 3 07 10 36 72 18 28 96 24 5 181 mino)-1- te 2 9 2 4 10 96 1 (thiophen- . 2- - 0.0 0.0 0.0 0.0 0. 0. 3 Acet 2. 2.8 0.0 yl)propan- 2 56 24 2 02 04 14 29 04 08 97 one 9 1 073 1-ol L- 0 9 4 5 0 35 70 Mandelate (s)-3- Meth 0.0 0.0 0.0 0.0 0. 0. (dimethyla ylene N 47. 2. 8.7 0.0 40 9 09 13 45 90 13 27 97 1 mino)-1- chlori A 4 9 3 225 0 5 0 0 50 00 . (thiophen- de 4 2- Cyclo - 0.0 0.0 0.0 0.0 0. 0. 10. 2. 1. 1.4 0.0 yl)propan- hexa 8 81 01 02 07 15 03 06 96 3 9 5 4 038 1-ol ne 1 5 3 5 0 75 00 Dime 0.0 0.0 0.0 0.0 0. 0. (s)-N,N- thylfo 5 15 0.4 2. 1. 1.8 0.0 01 02 09 19 06 09 95 dimethyl-3- rma 8 3 9 5 92 2 048 9 9 6 2 72 60 (naphthale mide 1 n-1-yloxy)- 0.0 0.0 0.0 0.0 0. 0. . Tolun 11 3. 2. 2.4 0.0 3(thiophen 4 3.8 02 03 12 25 08 12 95 5 e 1 1 55 2 064 -2- 6 8 8 5 93 75 yl)propan- - 0.0 0.0 0.0 0.0 0. 0. Hexa 1. 1.8 0.0 1-amine 2 69 17 3 01 02 09 19 04 07 96 ne 91 3 048 2 9 9 6 1 78 64 (s)-N- methyl-3- 1 (naphthale 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 6. 6.2 0.0 . n-1-yloxy)- 4 3.8 06 09 32 65 22 32 95 ne 1 1 56 3 164 6 3(thiophen 6 8 8 6 96 80 -2- yl)propan-

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1-amine

Mono ethyl 1 19 0.0 0.0 0.0 0.0 0. 0. Levosulpiri 2. 3. 3.4 0.0 2 ene 1 7. 6.5 03 05 18 36 12 18 95 de 1 6 2 090 Glyc 1 3 6 4 0 0 60 00 ol Methyl 2- 2 0.0 0.0 0.0 0.0 0. 0. methoxy-5- Meth 64 12. 1. 2. 2.6 0.0 . 9 02 04 14 28 07 11 96 sulfamoyl- anol .5 9 1 8 9 070 3 8 2 0 0 00 20 benzoate Meth 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 4. 4.4 0.0 1-ethyl-2- 40 04 06 23 46 06 13 97 2 chlori A 4 9 6 6 115 (nitromethy 6 9 0 0 90 80 . de l)pyrrolidin 4 0.0 0.0 0.0 0.0 0. 0. e Tolue 11 3. 3. 3.1 0.0 4 3.8 03 05 16 33 11 16 95 ne 1 1 3 4 083 3 0 5 0 55 50 (1- 2 ethylpyrroli 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 3.8 0.0 . dine-2- 9 4 04 06 20 40 10 16 96 anol .5 9 1 4 100 5 yl)methana 0 0 0 0 00 00 mine 1(1- ethylpyrroli dine-2-yl) methanami 2 ne1. 2(1- 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 4. 4.6 0.0 . ethylpyrroli 9 04 07 24 48 12 19 96 anol .5 9 1 8 1 120 6 dine-2- 8 2 0 0 00 20 yl)methana mineD-(-)- Tartaric acid (s)-(1- Meth 2 ethylpyrroli 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 6. 6.3 0.0 . dine-2- 40 06 09 32 65 09 19 97 chlori A 4 9 5 1 163 7 yl)methana 5 8 5 0 75 50 de mine Isopr 1 0.0 0.0 0.0 0.0 0. 0. Phenyleph opyl 82 2. 6. 6.1 0.0 3 1. 4.4 06 09 32 64 16 25 96 erine alcoh .5 1 4 4 160 7 4 6 0 0 00 60 ol Aceti 0.0 0.0 0.0 0.0 0. 0. 4 11 2. 0. 0.3 0.0 c 1.5 00 00 02 04 01 02 95 3 3- 0 7 1 4 8 010 acid 4 6 0 0 40 00 . acetylphen 0.0 0.0 0.0 0.0 0. 0. 1 yl acetate Tolue 11 3. 1. 1.0 0.0 4 3.8 01 01 05 11 02 04 96 ne 1 1 1 6 028 1 7 5 0 75 40

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2- (benzyl(me N- thyl)amino- Meth 3 1-(3- 7 18 0.0 0.0 0.0 0.0 0. 0. yl 0. 0. 0.3 0.0 . hydroxyph 7. 0. 0.9 00 00 02 04 01 02 95 benz 93 4 8 010 2 enyl)ethan 8 5 4 6 0 0 40 00 ylami one ne hydrochlori de 3-(1- 3 hydroxy-2- 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 4. 4.3 0.0 . (methylami 9 04 06 22 45 11 18 96 anol .5 9 1 5 2 113 3 no)ethyl)ph 5 8 5 0 25 00 enol 0.0 0.0 0.0 0.0 0. 0. #DI Strontium 0.0 0.0 4 - 00 00 00 00 00 00 V/0 Renelate 0 000 0 0 0 0 00 00 ! Meth 4 Diethyl 3- 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 2.9 0.0 . oxopentan 40 3 03 04 15 30 04 09 97 chlori A 4 9 1 075 1 edioate 0 5 0 0 50 00 de Dysol ethyl 5- - 0.0 0.0 0.0 0.0 0. 0. Cyclo 10. 2. 3.8 0.0 amino-4- 8 81 4 04 06 20 40 10 16 96 hexa 3 9 4 100 cyano-3- 1 0 0 0 0 00 00 ne 4 (2-ethoxy- Cyclo - 0.0 0.0 0.0 0.0 0. 0. . 2- 10. 2. 2. 2.6 0.0 hexa 8 81 02 04 13 27 06 11 96 2 oxoethyl)th 3 9 75 4 069 ne 1 8 1 8 5 88 00 iophene-2- Ethyl 0.0 0.0 0.0 0.0 0. 0. carboxylat 1. 1.0 0.0 aceta -4 77 10 3 01 01 05 11 02 04 96 e 1 6 028 te 1 7 5 0 75 40 Diethyl Dysol - 0.0 0.0 0.0 0.0 0. 0. 2,2((3- Cyclo 10. 2. 3.8 0.0 8 81 4 04 06 20 40 10 16 96 cyno-4-(2- hexa 3 9 4 100 1 0 0 0 0 00 00 ethoxy-2- ne oxoethyl)- 4 5- . (ethoxycar 3 - 0.0 0.0 0.0 0.0 0. 0. bonyl)thiop Acet 3.8 0.0 2 56 24 2 4 04 06 20 40 06 12 97 hen-2- one 8 100 0 0 0 0 0 00 00 yl)azanedy l)diacetateI compound Isopr 1 0.0 0.0 0.0 0.0 0. 0. opyl 82 2. 2. 2.6 0.0 5 Torsemide 1. 4.4 02 04 13 27 06 11 96 alcoh .5 1 76 5 069 7 8 1 8 6 90 04 ol Phos 4- phor 5 chloropyrid 10 0.0 0.0 0.0 0.0 0. 0. us N 5. 1. 1.7 0.0 . ine-3- 5. 5.3 01 02 09 18 06 09 95 oxyc A 3 8 1 045 2 sulfonamid 8 8 7 0 0 30 00 hlorid e e

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4-(m- 5 tolyamino) mix. 0.0 0.0 0.0 0.0 0. 0. 2 14 3. 2. 2.3 0.0 . pyridine-3- Xylen 0.9 02 03 12 24 06 09 96 7 0 7 4 0 060 3 sulfonamid e 4 6 0 0 00 60 e 0.0 0.0 0.0 0.0 0. 0. Atorvastati Meth 64 12. 1. 3. 3.6 0.0 6 9 03 05 19 38 09 15 96 n Calcium anol .5 9 1 8 5 095 8 7 0 0 50 20 tert-butyl2- ((4R,6R)- 6-(2- 6 aminoethyl 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 3. 3.0 0.0 . )-2,2- 9 03 04 16 32 08 12 96 anol .5 9 1 2 7 080 1 dimethyl- 2 8 0 0 00 80 1,3-dioxan- 4- yl)acetate tert-butyl2- Cyclo - 0.0 0.0 0.0 0.0 0. 0. 10. 2. 3. 3.5 0.0 ((4R,6R)- hexa 8 81 03 05 18 37 09 14 96 3 9 7 5 093 6-(2-2-(4- ne 1 7 6 5 0 25 80 fluorophen yl)-5- isopropyl- 3-phenyl- 6 4- . (phenylcar Isopr 1 0.0 0.0 0.0 0.0 0. 0. 2 bamoyl)- opyl 82 2. 3. 3.0 0.0 1. 4.4 03 04 16 32 08 12 96 1H-pyrrol- alcoh .5 1 2 7 080 7 2 8 0 0 00 80 1-yl)ethyl)- ol 2,2- dimethyl- 1,3-dioxan- 4- yl)acetate 2-[4- (cycloprop ylcarbonyl) 7 0.0 0.0 0.0 0.0 0. 0. phenyl]-2- Tolue 11 3. 1. 1.7 0.0 . 4 3.8 01 02 09 18 06 09 95 methylprop ne 1 1 8 1 045 3 8 7 0 0 30 00 ionic acid cyclohexyl amine salt - Tetra 0.0 0.0 0.0 0.0 0. 0. 1 19. 2. 7. 7.2 0.0 hydro 65 07 11 37 75 18 30 96 4. 3 5 5 0 188 Azilsartan furan 5 3 5 0 75 00 5 8 Kamedoxo - mil 0.0 0.0 0.0 0.1 0. 0. Acet 1 19. 2. 13. 0.0 65 14 14 21 70 40 35 56 96 one 4. 3 5 44 350 0 0 0 0 00 00 5

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3-((4- amino-2- methylpyri midin-5- 9 yl)methyl)- 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 2. 2.7 0.0 . 5-(2- 9 02 04 14 28 07 11 96 anol .5 9 1 88 6 072 1 (phosphon 9 3 4 8 20 52 ooxy)ethyl) -4,5- dihydrothia zol-3-ium 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 2. 2.2 0.0 MDC 40 02 03 11 23 03 06 97 A 4 9 31 4 058 3 5 6 1 47 93 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 0. 0.8 0.0 9 00 01 04 09 02 03 96 Clopidogre anol .5 9 1 92 8 023 1 9 4 6 2 30 68 l Hydrogen 0 ethyl 0.0 0.0 0.0 0.0 0. 0. sulphate 1. 1.4 0.0 aceta -4 77 10 3 01 02 07 15 03 06 96 54 8 039 te 5 3 7 4 85 16 - 0.0 0.0 0.0 0.0 0. 0. Acet 1. 1.1 0.0 2 56 24 2 01 01 06 12 01 03 97 one 23 9 031 0 2 8 2 3 84 69 Methyl (+)- 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 3. 3.1 0.0 1 alpha-(2- MDC 40 03 04 16 32 04 09 97 A 4 9 26 6 082 0 thienylethyl 3 9 3 6 89 78 . amino)(2- ethyl 0.0 0.0 0.0 0.0 0. 0. 1. 1.2 0.0 1 chlorophen aceta -4 77 10 3 01 02 06 13 03 05 96 32 7 033 yl) acetate te 3 0 6 2 30 28 ethyl 0.0 0.0 0.0 0.0 0. 0. 9. 8.8 0.0 aceta -4 77 10 3 09 13 46 92 23 37 96 26 9 232 1 Leveteracit te 3 9 3 6 15 04 1 am 0.0 0.0 0.0 0.1 0. 0. N 47. 2. 9.7 0.0 MDC 40 10 10 15 50 00 15 30 97 A 4 9 0 250 0 0 0 0 00 00 ethyl 0.0 0.0 0.0 0.0 0. 0. 6. 6.6 0.0 1 aceta -4 77 10 3 06 10 34 69 17 27 96 Levetiracet 9 2 173 1 te 9 4 5 0 25 60 am . 28 0.0 0.0 0.1 0.2 0. 0. Technical N 47. 2. 27. 0.0 1 MDC 40 .7 28 43 43 87 43 86 97 A 4 9 89 719 5 8 1 8 5 13 25 0.0 0.0 0.0 0.0 0. 0. 5 15 0.4 2. 6. 6.1 0.0 DMF 06 09 32 65 22 32 95 8 3 9 5 5 8 163 5 8 5 0 75 50 1 Fluconazol Isopr 2 e 1 0.0 0.0 0.0 0.0 0. 0. opyl 82 2. 4. 4.3 0.0 1. 4.4 04 06 22 45 11 18 96 alcoh .5 1 5 2 113 7 5 8 5 0 25 00 ol 1-(2,4- 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 3. 3.0 0.0 1 Difluoroph MDC 40 03 04 15 31 04 09 97 A 4 9 13 4 078 2 enyl)-2(1- 1 7 7 3 70 39 . H-1,2,4- Isopr 1 0.0 0.0 0.0 0.0 0. 0. 82 2. 1. 1.4 0.0 1 triazol-1- opyl 1. 4.4 01 02 07 15 03 06 96 .5 1 5 4 038 yl)ethanon alcoh 7 5 3 5 0 75 00

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e ol ethyl 0.0 0.0 0.0 0.0 0. 0. 1. 1.4 0.0 aceta -4 77 10 3 01 02 07 15 03 06 96 5 4 038 te 5 3 5 0 75 00 Triet - 0.0 0.0 0.0 0.0 0. 0. hyl 88 3. 0. 0.5 0.0 1 7.2 00 00 02 05 01 02 96 amin .8 5 58 6 015 7 6 9 9 8 45 32 e 1-((2-2,4- 1 diflurophen 0.0 0.0 0.0 0.0 0. 0. 2 yl)oxiran-2- Tolue 11 3. 9. 8.9 0.0 4 3.8 09 14 47 94 32 47 95 . yl)methyl)1 ne 1 1 41 4 235 4 1 1 1 94 05 2 H-1,2,4- triazole 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 8. 7.7 0.0 9 08 12 40 80 20 32 96 anol .5 9 1 06 4 202 1 Quetiapine 1 1 3 6 15 24 3 Fumarate 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 5. 4.7 0.0 4 3.8 05 07 25 50 17 25 95 ne 1 1 04 9 126 0 6 2 4 64 20 1 (2- 0.0 0.0 0.0 0.0 0. 0. 3 nitrophenyl Tolue 11 3. 4. 4.2 0.0 4 3.8 04 06 22 45 15 22 95 . )(phenyl)su ne 1 1 5 8 113 5 8 5 0 75 50 1 lfane 1 2- 0.0 0.0 0.0 0.0 0. 0. 3 Meth 64 12. 1. 9. 9.2 0.0 (phenylthio 9 09 14 48 96 24 38 96 . anol .5 9 1 61 3 240 )aniline 6 4 1 1 03 44 2 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 7. 7.2 0.0 9 07 11 37 75 18 30 96 anol .5 9 1 54 4 189 5 3 7 4 85 16 1 phenyl(2- 0.0 0.0 0.0 0.0 0. 0. 3 (phenylthio Tolue 11 3. 3. 3.1 0.0 4 3.8 03 05 16 33 11 16 95 . )phenyl)car ne 1 1 3 4 083 3 0 5 0 55 50 3 bamate - 0.0 0.0 0.0 0.0 0. 0. Pet 10 2. 2.6 0.0 9 31 3 02 04 14 28 09 14 95 ether 0 83 9 071 5 8 2 2 3 91 15 - 0.0 0.0 0.0 0.0 0. 0. dibenzo[b,f Acet 8. 7.9 0.0 1 2 56 24 2 08 12 41 82 12 24 97 ][1,4]thiaze one 24 9 206 3 0 2 4 2 4 36 72 pin- . 0.0 0.0 0.0 0.0 0. 0. 11(10H)- 5 15 0.4 2. 6. 6.2 0.0 4 DMF 06 09 33 65 23 32 95 one 8 3 9 5 59 6 165 6 9 0 9 07 95 0.0 0.0 0.0 0.0 0. 0. 1 N 47. 2. 5. 5.6 0.0 Vildagliptin MDC 40 05 08 29 58 08 17 97 4 A 4 9 8 3 145 8 7 0 0 70 40 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 1. 1.5 0.0 1 3- MDC 40 01 02 07 15 02 04 97 A 4 9 55 0 039 4 Aminoada 6 3 8 5 33 65 . mantan-1- ethyl 0.0 0.0 0.0 0.0 0. 0. 1. 1.6 0.0 1 ol aceta -4 77 10 3 01 02 08 17 04 07 96 75 8 044 te 8 6 8 5 38 00 1 (s)-1-(2- Isopr 1 82 2. 1. 1.5 0.0 0.0 0.0 0.0 0.0 0. 0. 4.4 96 4 chloroacet opyl 1. .5 1 57 1 01 02 039 07 15 03 06

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. yl)pyrrolidi alcoh 7 6 4 9 7 93 28 2 ne-2- ol carboxami cyclo - 0.0 0.0 0.0 0.0 0. 0. 10. 2. 4. 4.2 0.0 de hexa 8 81 04 06 22 44 11 17 96 3 9 41 3 110 ne 1 4 6 1 1 03 64 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 2. 2.8 0.0 (s)-1-(2- MDC 40 02 04 14 29 04 08 97 1 A 4 9 91 2 073 chloroacet 9 4 6 1 36 73 4 yl)pyrrolidi Meth . - 3. 0.0 0.0 0.0 0.0 0. 0. ne-2- y t- 55 2.9 0.0 3 2 27 3 03 03 04 15 30 04 09 97 carbonitrile butyl .2 5 076 8 8 0 6 2 4 56 11 ether Meth 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 5. 5.3 0.0 40 05 08 27 55 08 16 97 1 chlori A 4 9 5 4 138 5 3 5 0 25 50 4 Vildagliptin de . Technical Meth - 0.0 0.0 0.0 0.0 0. 0. 4 y t- 55 4. 4.6 0.0 2 27 3 04 07 24 48 07 14 97 butyl .2 8 6 120 8 8 2 0 0 20 40 ether 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 5.7 0.0 9 6 06 09 30 60 15 24 96 anol .5 9 1 6 150 1 Losartan 0 0 0 0 00 00 5 Potassium - 0.0 0.0 0.0 0.0 0. 0. Acet 4. 4.6 0.0 2 56 24 2 04 07 24 48 07 14 97 one 81 7 120 0 8 2 1 1 22 43 Methyl 1 pentanimid 0.0 0.0 0.0 0.0 0. 0. 5 Meth 64 12. 1. 2. 2.0 0.0 ate 9 02 03 10 21 05 08 96 . anol .5 9 1 15 6 054 hydrochlori 2 2 8 5 37 60 1 de 1 Sodium 2- 0.0 0.0 0.0 0.0 0. 0. 5 pentanimid Meth 64 12. 1. 2.8 0.0 9 3 03 04 15 30 07 12 96 . amideacet anol .5 9 1 8 075 0 5 0 0 50 00 2 ate 2-butyl-4- chloro-4,5- 1 dihydro- 0.0 0.0 0.0 0.0 0. 0. 5 Tolue 11 3. 5. 5.1 0.0 1H-imi 4 3.8 05 08 27 54 19 27 95 . ne 1 1 43 6 136 dazole-5- 4 1 2 3 01 15 3 carbaldehy de Meth 4'- 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 4. 3.9 0.0 1 (bromomet 40 04 06 20 41 06 12 97 chlori A 4 9 1 8 103 5 hyl)-[1,1'- 1 2 5 0 15 30 de . biphenyl]- 0.0 0.0 0.0 0.0 0. 0. 4 2- Meth 64 12. 1. 3. 3.5 0.0 9 03 05 18 37 09 14 96 carbonitrile anol .5 9 1 73 8 093 7 6 7 3 33 92 4'-((2- 0.0 0.0 0.0 0.0 0. 0. 1 Meth 64 12. 1. 1. 1.5 0.0 butyl-4- 9 01 02 08 16 04 06 96 5 anol .5 9 1 64 7 041 chloro-5- 6 5 2 4 10 56 . (hydroxym Tolue 11 3. 2. 1.9 0.0 0.0 0.0 0.0 0.0 0. 0. 5 4 3.8 95 ethyl)-1H- ne 1 1 02 2 02 03 051 10 20 07 10

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imidazol-1- 0 0 1 2 07 10 yl)methyl)- [1,1'- biphenyl]- 2- carbonitrile (1-(2,2'- (1H- tetrazol-5- yl)-[1,1'- 1 biphenyl]- 0.0 0.0 0.0 0.0 0. 0. 5 4- Tolue 11 3. 2. 2.3 0.0 4 3.8 02 03 12 24 08 12 95 . yl)methyl)- ne 1 1 45 3 061 5 7 3 5 58 25 6 2-butyl-4- chloro-1H- imidazol-5- yl)methano l Isopr 1 0.0 0.0 0.0 0.0 0. 0. 1 opyl 82 2. 7. 7.2 0.0 Etoricoxib 1. 4.4 07 11 37 75 18 30 96 6 alcoh .5 1 5 0 188 7 5 3 5 0 75 00 ol 3-(6- 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 2. 2.7 0.0 methylpyri 4 3.8 02 04 14 29 10 14 95 ne 1 1 94 9 074 1 din-3-yl)-2- 9 4 7 4 29 70 6 (4- . (methylthio 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 0. 0.2 0.0 1 )phenyl-3- 9 00 00 01 02 00 01 96 anol .5 9 1 29 8 007 oxopropan 3 4 5 9 73 16 enitrile 1-(6- 1 methylpyri 0.0 0.0 0.0 0.0 0. 0. 6 din)-2-(4- Tolue 11 3. 1. 1.0 0.0 4 3.8 01 01 05 11 03 05 95 . (methylthio ne 1 1 1 5 028 1 7 5 0 85 50 2 )phenyl)eth anone Isopr 1-(6- 1 0.0 0.0 0.0 0.0 0. 0. opyl 82 2. 3. 3.1 0.0 methylpyri 1. 4.4 03 04 16 32 08 12 96 1 alcoh .5 1 23 0 081 din-3-yl)-2- 7 2 8 2 3 08 92 6 ol (4- . Meth (methylsulf 0.0 0.0 0.0 0.0 0. 0. 3 ylene N 47. 2. 5. 5.3 0.0 onyl)pheny 40 05 08 27 54 08 16 97 chlori A 4 9 47 1 137 l)ethanone 5 2 4 7 21 41 de - 0.0 0.0 0.0 0.0 0. 0. Acet 4.8 0.0 2 56 24 2 5 05 07 25 50 07 15 97 one 5 125 0 0 5 0 0 50 00 0.0 0.0 0.0 0.0 0. 0. 1 Ketoconaz Meth 64 12. 1. 2. 2.3 0.0 9 02 03 12 24 06 09 96 7 ole anol .5 9 1 4 0 060 4 6 0 0 00 60 Ethyl 0.0 0.0 0.0 0.0 0. 0. 3. 3.1 0.0 aceta -4 77 10 3 03 05 16 33 08 13 96 3 7 083 te 3 0 5 0 25 20 1 Cis- Meth 9 64 12. 1. 8. 8.2 0.0 0.0 0.0 0.0 0.0 0. 0. 96

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7 Bromoben anol .5 9 1 6 6 08 12 215 43 86 21 34 . zoate 6 9 0 0 50 40 1 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 6. 6.1 0.0 4 3.8 06 09 32 64 22 32 95 ne 1 1 45 3 161 5 7 3 5 58 25 n- 0.0 0.0 0.0 0.0 0. 0. 2 11 0.5 2. 1. 1.0 0.0 Buat 01 01 05 10 02 04 96 9 7 8 6 08 4 027 anol 1 6 4 8 70 32 1 Cis 0.0 0.0 0.0 0.0 0. 0. 7 Meth 64 12. 1. 7. 7.2 0.0 Imidazole 9 07 11 37 75 18 30 96 . anol .5 9 1 58 8 190 alcohol 6 4 9 8 95 32 2 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 7. 7.1 0.0 9 07 11 37 74 18 29 96 anol .5 9 1 4 0 185 4 1 0 0 50 60 Meth 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 7. 7.1 0.0 1 40 07 11 37 74 11 22 97 chlori A 4 9 4 8 185 7 Cis- 4 1 0 0 10 20 de . Tosylate Ethyl 0.0 0.0 0.0 0.0 0. 0. 3 5. 5.0 0.0 aceta -4 77 10 3 05 08 26 53 13 21 96 3 9 133 e 3 0 5 0 25 20 n- - 0.0 0.0 0.0 0.0 0. 0. 5. 5.0 0.0 hexa 2 62 17 3 05 08 26 53 13 21 96 3 9 133 ne 2 3 0 5 0 25 20 1-(4-(4- 1 hydroxyph n- 11 0.0 0.0 0.0 0.1 0. 0. 7 enyl)pipera 2 11 0.5 2. 11. 0.0 Buta .6 11 17 58 16 40 58 95 . zin-1- 9 7 8 6 05 291 nol 3 6 4 2 3 71 15 4 yl)ethanon e - 0.0 0.0 0.0 0.0 0. 0. 1 Pantopraz Acet 3.8 0.0 2 56 24 2 4 04 06 20 40 06 12 97 8 ole sodium one 8 100 0 0 0 0 0 00 00 1 3-methoxy- - 0.0 0.0 0.0 0.0 0. 0. 8 2-methyl- Acet 9. 9.4 0.0 2 56 24 2 09 14 48 97 14 29 97 . 4H-pyran- one 71 2 243 0 7 6 6 1 57 13 1 4-one 3-methoxy- 1 2- 0.0 0.0 0.0 0.0 0. 0. 8 Tolue 11 3. 6. 6.5 0.0 methylpyri 4 3.8 06 10 34 69 24 34 95 . ne 1 1 9 6 173 din-4(1H)- 9 4 5 0 15 50 2 one 1 4-chloro-3- Ethyl 0.0 0.0 0.0 0.0 0. 0. 8 methoxy-2- ene 1 83 3. 4. 4.6 0.0 8.7 04 07 24 48 12 19 96 . methylpyri dichl 3 .4 42 8 1 120 8 2 0 0 00 20 3 dine oride Meth 0.0 0.0 0.0 0.0 0. 0. 4-chloro-3- ylene N 47. 2. 5. 5.6 0.0 1 40 05 08 29 58 08 17 97 methoxy-2- dichl A 4 9 87 9 147 8 9 8 4 7 80 61 methylpyri oride . dine-N- n- - 0.0 0.0 0.0 0.0 0. 0. 4 5. 5.1 0.0 oxide hexa 2 62 17 3 05 08 26 53 13 21 96 33 2 133 ne 2 3 0 7 3 33 32

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3,4- 1 dimethoxy- 0.0 0.0 0.0 0.0 0. 0. 8 2- Meth 64 12. 1. 5. 5.3 0.0 9 05 08 27 55 13 22 96 . methylpyri anol .5 9 1 53 1 138 5 3 7 3 83 12 5 dine-N- oxide (3,4- 1 Aceti dimethoxy 0.0 0.0 0.0 0.0 0. 0. 8 c 4 13 3. 0. 0.3 0.0 pyridine-2- 0.5 00 00 02 04 01 02 95 . anhy 9 9 5 4 8 010 yl)methyl 4 6 0 0 40 00 6 dride acetate (3,4- 1 Meth dimethoxy 0.0 0.0 0.0 0.0 0. 0. 8 ylene N 47. 2. 4.8 0.0 pyridine-2- 40 5 05 07 25 50 07 15 97 . chlori A 4 9 5 125 yl)methano 0 5 0 0 50 00 7 de l 2- 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 5. 5.1 0.0 (chloromet 4 3.8 05 08 26 53 18 26 95 1 ne 1 1 38 1 135 hyl)-3,4- 4 1 9 8 83 90 8 dimethoxy . - 0.0 0.0 0.0 0.0 0. 0. pyridine Acet 2. 2.6 0.0 8 2 56 24 2 02 04 13 26 04 08 97 hydrochlori one 69 1 067 0 7 0 5 9 04 07 de 5- (difluorome thoxy)-2- 1 (((3,4- 0.0 0.0 0.0 0.0 0. 0. 8 dimethoxy Tolue 11 3. 2. 2.2 0.0 4 3.8 02 03 12 24 08 12 95 . pyridin-2- ne 1 1 4 8 060 4 6 0 0 40 00 9 yl)methyl)t hio)-1H- benzo[d]im idazole 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 3. 3.5 0.0 9 03 05 18 36 09 14 96 anol .5 9 1 65 0 091 7 5 3 5 12 60 Diiso - 0.0 0.0 0.0 0.0 0. 0. 1 Glimepirid propy 15. 3. 0. 0.4 0.0 2 69 00 00 02 04 01 01 96 9 e l 9 5 43 1 011 8 4 6 2 3 08 72 ether 0.0 0.0 0.0 0.0 0. 0. 1 11 3. 4. 4.0 0.0 MIBK 2.1 04 06 21 43 15 21 95 4 8 45 3 9 108 3 5 5 0 05 50 2- 1 Ethylmethy - 0.0 0.0 0.0 0.0 0. 0. 9 Acet 3.8 0.0 l 2 56 24 2 4 04 06 20 40 06 12 97 . one 8 100 acetoaceta 0 0 0 0 0 00 00 1 te Methyl 2- Triet - 0.0 0.0 0.0 0.0 0. 0. 1 ethyl-3- hyl 88 3. 0. 0.6 0.0 1 7.2 00 01 03 06 01 02 96 9 hydroxy-3- amin .8 5 65 2 016 7 7 0 3 5 63 60 . methyl-4- e 2 nitrobutano Meth N 47. 2. 3. 3.0 0.0 0.0 0.0 0.0 0.0 0. 0. 40 97 ate ylene A 4 9 18 8 03 04 080 15 31 04 09

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chlori 2 8 9 8 77 54 de Methyl 4- 1 amino—2- 0.0 0.0 0.0 0.0 0. 0. 9 ethyl-3- Meth 64 12. 1. 6. 6.1 0.0 9 06 09 32 64 16 25 96 . hydroxy-3- anol .5 9 1 4 4 160 4 6 0 0 00 60 3 methylbuta noate Methyl 4- 1 acetamido- Aceti 0.0 0.0 0.0 0.0 0. 0. 9 2-ethyl-3- c 4 13 3. 0. 0.5 0.0 0.5 00 00 02 05 01 02 95 . hydroxy-3- anhy 9 9 5 53 0 013 5 8 7 3 86 65 4 methylbuta dride noate 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 6. 6.7 0.0 1 3-ethyl-4- 9 07 10 34 69 17 27 96 anol .5 9 1 98 0 175 9 methyl-1H- 0 5 9 8 45 92 . pyrrol- Cyclo - 0.0 0.0 0.0 0.0 0. 0. 10. 2. 5. 5.1 0.0 5 2(5H)-one hexa 8 81 05 08 26 53 13 21 96 3 9 35 4 134 ne 1 4 0 8 5 38 40 3-ethyl-4- n- - 0.0 0.0 0.0 0.0 0. 0. 5. 5.1 0.0 methyl-2- hexa 2 62 17 3 05 08 26 53 13 21 96 38 6 135 oxo-N- ne 2 4 1 9 8 45 52 1 phenethyl- 9 2,5- . dihydro-1- 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 5. 5.1 0.0 6 H-pyrrole- 9 05 08 26 53 13 21 96 anol .5 9 1 38 6 135 1- 4 1 9 8 45 52 carboxami de 1 - 17 0.0 0.0 0.0 0.1 0. 0. 9 Glimepirid Acet 16. 0.0 2 56 24 2 .2 17 25 86 72 25 51 97 . e (Crude) one 75 432 0 7 3 9 4 7 91 81 8 Sodi um DMF-DMA 0.0 0.0 0.0 0.0 0. 0. 2 meth 3 35 1. 1. 1.8 0.0 (Intermedi 50 02 02 09 19 06 09 95 0 oxide 3 0 1 95 5 049 ate) 0 9 8 5 83 75 (25% Soln) - 0.0 0.0 0.0 0.0 0. 0. Acet 1.9 0.0 Fructopyra 2 56 24 2 2 02 03 10 20 03 06 97 one 4 050 2 nose 0 0 0 0 0 00 00 1 (Intermedi 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 0. 0.5 0.0 ate) 4 3.8 00 00 03 06 02 03 95 ne 1 1 6 7 015 6 9 0 0 10 00 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 1. 1.6 0.0 4 3.8 01 02 08 17 04 06 96 ne 1 1 74 7 044 7 6 7 4 35 96 2 Rosuvastat Ethyl 0.0 0.0 0.0 0.0 0. 0. 1. 1.5 0.0 2 in Calcium aceta -4 77 10 3 01 02 07 15 03 06 96 58 2 040 te 6 4 9 8 95 32 Meth 64 12. 1. 1. 1.5 0.0 0.0 0.0 0.0 0.0 0. 0. 9 96 anol .5 9 1 6 4 01 02 040 08 16 04 06

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6 4 0 0 00 40 Isopr 1 0.0 0.0 0.0 0.0 0. 0. opyl 82 2. 1. 1.5 0.0 1. 4.4 01 02 07 15 03 06 96 alcoh .5 1 57 1 039 7 6 4 9 7 93 28 ol N-[5- - 0.0 0.0 0.0 0.0 0. 0. Acet 1. 0.9 0.0 (bromo 2 56 24 2 01 01 05 10 01 03 97 one 01 8 025 methyl)-4- 0 0 5 1 1 52 03 (4-fluoro 2 phenyl)-6- 2 isopropyl . pyrimidin- 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 2. 2.4 0.0 1 2-yI]-N- 4 3.8 02 03 12 25 08 12 95 ne 1 1 53 0 063 methyl 5 8 7 3 86 65 methane sulfonamid e.TPP 0.0 0.0 0.0 0.0 0. 0. tert-butyl Meth 64 12. 1. 3. 3.3 0.0 9 03 05 17 35 08 14 96 2-((4R,6S)- anol .5 9 1 5 6 088 5 3 5 0 75 00 2 -formyl- 0.0 0.0 0.0 0.0 0. 0. 2 2,2- 1 11 3. 1.9 0.0 MIBK 2.1 2 02 03 10 20 07 10 95 . dimethyl- 4 8 45 0 050 0 0 0 0 00 00 2 1,3-dioxan- 0.0 0.0 0.0 0.0 0. 0. 4yl) Tolue 11 3. 2. 2.0 0.0 4 3.8 02 03 11 22 07 11 95 acetate ne 1 1 2 9 055 2 3 0 0 70 00 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 8. 8.2 0.0 MDC 40 08 12 42 84 12 25 97 A 4 9 46 1 212 5 7 3 6 69 38 Ethyl 0.0 0.0 0.0 0.0 0. 0. 2 2. 2.2 0.0 Valsartan Acet -4 77 10 3 02 03 11 23 05 09 96 3 31 2 058 ate 3 5 6 1 78 24 0.0 0.0 0.0 0.0 0. 0. Xylen 2 14 3. 4. 4.1 0.0 0.9 04 06 22 44 15 22 95 e 7 0 7 41 9 110 4 6 1 1 44 05 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 5. 5.6 0.0 9 05 08 29 59 14 23 96 anol .5 9 1 93 9 148 9 9 7 3 83 72 2 L-Valine 0.0 0.0 0.0 0.0 0. 0. 3 Tolue 11 3. 1. 0.9 0.0 methyl 4 3.8 01 01 05 10 03 05 95 . ne 1 1 04 9 026 ester 0 6 2 4 64 20 1 - 0.0 0.0 0.0 0.0 0. 0. Acet 3. 3.0 0.0 2 56 24 2 03 04 15 31 04 09 97 one 16 7 079 0 2 7 8 6 74 48 4‘- 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 3. 3.8 0.0 2 (bromomet MDC 40 04 05 19 39 05 11 97 A 4 9 96 4 099 3 hyl)-[1,1‘- 0 9 8 6 94 88 . biphenyl]- Ethyl 0.0 0.0 0.0 0.0 0. 0. 1. 1.7 0.0 2 2- Acet -4 77 10 3 01 02 09 18 04 07 96 8 3 045 carbonitrile ate 8 7 0 0 50 20 0.0 0.0 0.0 0.0 0. 0. 2 (R)-methyl- Tolue 11 3. 7. 7.4 0.0 4 3.8 07 11 39 77 27 38 95 3 2-(((2‘- ne 1 1 79 0 195 . cyano- 8 7 0 9 27 95 4 [1,1‘- DMF 5 15 0.4 2. 5. 5.3 0.0 0.0 0.0 0.0 0.0 0. 0. 95

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biphenyl]- 8 3 9 5 66 8 05 08 142 28 56 19 28 4- 7 5 3 6 81 30 yl)methyl)a mino)-3- methylbuta noate (R)-methyl 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 1. 1.4 0.0 2-(N- MDC 40 01 02 07 15 02 04 97 A 4 9 5 6 038 ((2‘cyano- 5 3 5 0 25 50 [1,1‘- 2 biphenyl]- 3 4- . 0.0 0.0 0.0 0.0 0. 0. yl)methyl)p Xylen 2 14 3. 0. 0.7 0.0 5 0.9 00 01 03 07 02 03 95 entanamid e 7 0 7 78 4 020 8 2 9 8 73 90 o)-3- methylbuta noate (Methyl 4‘- Dime [[4-Methyl- thyl 0.0 0.0 0.0 0.0 0. 0. 5 15 0.4 2. 3. 3.5 0.0 6-(1- form 03 05 18 37 12 18 95 8 3 9 5 71 2 093 methyl-1H amid 7 6 6 1 99 55 benzimida e 2 zol-2-yl)-2- 4 propyl-1H- . benzimida 1 - 0.0 0.0 0.0 0.0 0. 0. zole-1-yl] Acet 1. 1.1 0.0 2 56 24 2 01 01 05 11 01 03 97 methyl] one 13 0 028 0 1 7 7 3 70 39 biphenyl-2- carboxylat e) 2 14 0.0 0.0 0.0 0.1 0. 0. 4 Telmisarta Meth 64 12. 1. 14. 0.0 9 .8 14 22 74 48 37 59 96 . n anol .5 9 1 28 372 7 9 3 4 7 18 48 2 - Tetra 0.0 0.0 0.0 0.0 0. 0. ortho-Tolyl 1 19. 2. 2.8 0.0 hydro 65 3 03 04 15 30 07 12 96 benzonitril 4. 3 5 8 075 2 furan 0 5 0 0 50 00 e 5 5 (Intermedi 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 3.8 0.0 ate) 4 3.8 4 04 06 20 40 14 20 95 ne 1 1 0 100 0 0 0 0 00 00 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 1. 1.2 0.0 4 3.8 01 02 06 13 04 06 95 ne 1 1 31 4 033 2 Lacosamid 3 0 6 1 59 55 6 e 0.0 0.0 0.0 0.0 0. 0. D.C. N 47. 2. 3. 3.5 0.0 40 03 05 18 36 05 11 97 M A 4 9 69 8 092 7 5 5 9 54 07 ethyl 0.0 0.0 0.0 0.0 0. 0. (R)-3- 1. 1.4 0.0 2 aceta -4 77 10 3 01 02 07 15 03 06 96 hydroxy-2- 5 4 038 6 te 5 3 5 0 75 00 pivalamido . - 0.0 0.0 0.0 0.0 0. 0. propanoic pet. 10 0. 0.3 0.0 1 9 31 3 00 00 02 03 01 01 95 acid Ether 0 39 7 010 5 4 6 0 9 37 95 2 (R)-3- Tolue 4 11 3.8 3. 0. 0.8 0.0 0.0 0.0 0.0 0.0 0. 0. 95

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6 methoxy-2- ne 1 1 88 4 00 01 022 04 08 03 04 . pivalamido 9 3 4 8 08 40 2 propanoic ethyl 0.0 0.0 0.0 0.0 0. 0. 0. 0.3 0.0 acid aceta -4 77 10 3 00 00 01 03 00 01 96 35 4 009 te 4 5 8 5 88 40 (R)-N- 2 benzyl-3- Ethyl 0.0 0.0 0.0 0.0 0. 0. 6 methoxy-2- 3. 3.4 0.0 aceta -4 77 10 3 03 05 18 36 09 14 96 . pivalamido 62 8 091 te 6 4 1 2 05 48 3 propanami de MAP Isopr 1 0.0 0.0 0.0 0.0 0. 0. 2 sulphate opyl 82 2. 7.6 0.0 1. 4.4 8 08 12 40 80 20 32 96 7 (Intermedi alcoh .5 1 8 200 7 0 0 0 0 00 00 ate) ol Ethyl 0.0 0.0 0.0 0.0 0. 0. 0.9 0.0 2 3- aceta -4 77 10 3 1 01 01 05 10 02 04 96 6 025 7 acetylphen te 0 5 0 0 50 00 . yl 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 0. 0.1 0.0 1 benzoate 9 00 00 00 01 00 00 96 anol .5 9 1 11 1 003 1 2 6 1 28 44 2 3-(2- 0.0 0.0 0.0 0.0 0. 0. 7 bromoacet meth 64 12. 1. 3. 3.0 0.0 9 03 04 15 31 07 12 96 . yl)phenyl anol .5 9 1 17 4 079 2 8 9 7 93 68 2 benzoate - 0.0 0.0 0.0 0.0 0. 0. 2 Bisoprolol Acet 8. 8.3 0.0 2 56 24 2 08 12 43 86 12 25 97 8 Fumarate one 6 4 215 0 6 9 0 0 90 80 Iso 2 4-[(2- prop 14 0.0 0.0 0.0 0.0 0. 0. 8 isopropoxy 4 0.4 3. 0. 0.4 0.0 oxy 4. 00 00 02 05 01 02 95 . ethoxy)met 4 4 6 5 8 013 Etha 5 5 8 5 0 75 50 1 hyl]phenol nol 2- [4-(2- Isopropoxy 2 - 0.0 0.0 0.0 0.0 0. 0. 8 ethoxymet Tolue 11 3. 5. 4.8 0.0 4 3.8 05 07 25 51 17 25 95 . hyl)- ne 1 1 1 5 128 1 7 5 0 85 50 2 phenoxym ethyll- oxirane 2 0.0 0.0 0.0 0.0 0. 0. 8 Meth 64 12. 1. 5. 5.4 0.0 Bisoprolol 9 05 08 28 57 14 22 96 . anol .5 9 1 7 7 143 7 6 5 0 25 80 3 O- 0.0 0.0 0.0 0.0 0. 0. 3. 3.3 0.0 Xylen 03 05 17 35 08 14 96 5 6 088 e 5 3 5 0 75 00 Cyclo - 0.0 0.0 0.0 0.0 0. 0. 2 Simvastati 10. 2. 3.8 0.0 hexa 8 81 4 04 06 20 40 10 16 96 9 n 3 9 4 100 ne 1 0 0 0 0 00 00 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 2.8 0.0 9 3 03 04 15 30 07 12 96 anol .5 9 1 8 075 0 5 0 0 50 00

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(S)- (1S,3S,7R, 8S,8aR)-8- ((3R,5R)- 7-(butyl amino)- 3,5- dihydroxy- 2 7- 0.0 0.0 0.0 0.0 0. 0. 9 Tolue 11 3. 2. 2.1 0.0 oxoheptyl)- 4 3.8 02 03 11 23 08 11 95 . ne 1 1 31 9 058 3,7-di 3 5 6 1 08 55 1 methyl- 1,2,3,7,8,8 a- hexahydro napthalen- 1-yl 2- methylbuta noate (S)- (1S,3S,7R, 8S,8aR)-8- ((3R,5R)- 7-(butyl amino)- 3,5- bis((tert- butyldimet 2 hylsilyl) Cyclo - 0.0 0.0 0.0 0.0 0. 0. 9 10. 2. 1. 1.5 0.0 oxy)-7- hexa 8 81 01 02 08 16 04 06 96 . 3 9 61 5 040 oxoheptyl)- ne 1 6 4 1 1 03 44 2 3,7-di methyl- 1,2,3,7, 8,8a- hexahydro napthalen- 1-yl 2- methyl butanoate (1S,3S,7R, 8S,8aR)-8- ((3R,5R)- 7-(butyl amino)- 2 3,5- - Tetra 0.0 0.0 0.0 0.0 0. 0. 9 bis((tert- 1 19. 2. 1. 1.5 0.0 hydro 65 01 02 08 16 04 06 96 . butyldimet 4. 3 5 63 6 041 furan 6 4 2 3 08 52 3 hylsilyl) 5 oxy)-7- oxoheptyl)- 3,7-di methyl- 1,2,3,7,

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8,8a- hexahydro napthalen- 1-yl 2,2- dimethylbu tanoate

7- 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 1. 1.7 0.0 ((1S,2S,6R 9 01 02 09 17 04 07 96 anol .5 9 1 79 2 045 ,8S)-8- 8 7 0 9 48 16 ((2,2- dimethylbu tanoyl) oxy)2,6- 2 dimethyl- 9 1,2,6,7, . 8,8a- Ethyl 0.0 0.0 0.0 0.0 0. 0. 2. 2.5 0.0 4 hexahydro Acet -4 77 10 3 02 04 13 26 06 10 96 68 7 067 napthalen- ate 7 0 4 8 70 72 1-yl)3,5- dihydroxyh eptanoic acid ammonium salt Meth ylene 0.0 0.0 0.0 0.0 0. 0. Dichl N 47. 2. 0.9 0.0 Trityl 40 1 01 01 05 10 01 03 97 oride A 4 9 7 025 tetrazole 0 5 0 0 50 00 (MD bromomet C) 3 hyl Ethyl 0 biphenyl 0.0 0.0 0.0 0.0 0. 0. Acet 1. 1.3 0.0 (TTBB) -4 77 10 3 01 02 07 14 03 05 96 ate(E 4 4 035 Intermediat 4 1 0 0 50 60 A) e 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 1.9 0.0 4 3.8 2 02 03 10 20 07 10 95 ne 1 1 0 050 0 0 0 0 00 00 3 Tetrazole 0.0 0.0 0.0 0.0 0. 0. 0 Tolue 11 3. 1. 1.3 0.0 methyl 4 3.8 01 02 07 14 05 07 95 . ne 1 1 45 8 036 biphenyl 5 2 3 5 08 25 1 Meth ylene 0.0 0.0 0.0 0.0 0. 0. Dichl N 47. 2. 0. 0.5 0.0 3 Trityl 40 00 00 02 05 00 01 97 oride A 4 9 57 5 014 0 Tetrazole 6 9 9 7 86 71 (MD . ethyl C) 2 biphenyl 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 0. 0.8 0.0 9 00 01 04 08 02 03 96 anol .5 9 1 86 3 022 9 3 3 6 15 44 3 Darunavir Etha 3. 3.3 0.0 0.0 0.0 0.0 0.0 0. 0. 96

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1 Ethanolate nol 51 7 03 05 088 17 35 08 14 5 3 6 1 78 04 Meth ylene 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 2. 2.8 0.0 3 chlori 40 02 04 14 29 04 08 97 A 4 9 94 5 074 1 de(M 9 4 7 4 41 82 Stage-1 . DC) 1 Cyclo - 0.0 0.0 0.0 0.0 0. 0. 10. 2. 2. 2.2 0.0 hexa 8 81 02 03 11 23 05 09 96 3 9 35 6 059 ne 1 4 5 8 5 88 40 Meth 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 1. 1.8 0.0 40 01 02 09 19 02 05 97 Dichl A 4 9 9 4 048 3 Lansopraz 9 9 5 0 85 70 oride 2 ole 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 2. 2.4 0.0 4 3.8 02 03 13 26 09 13 95 ne 1 1 6 7 065 6 9 0 0 10 00 3 2,3- Aceti 0.0 0.0 0.0 0.0 0. 0. 2 Dimethyl- 4 11 2. 0. 0.6 0.0 c 1.5 00 01 03 07 02 03 95 . 4-nitro-N- 0 7 1 71 7 018 acid 7 1 6 1 49 55 1 Oxide 0.0 0.0 0.0 0.0 0. 0. (3-methyl- 1 11 3. 1. 1.3 0.0 MIBK 2.1 01 02 07 14 04 07 95 4-(2,2,2- 4 8 45 4 3 035 4 1 0 0 90 00 trifluoroeth 3 0.0 0.0 0.0 0.0 0. 0. oxy)pyridin Tolue 11 3. 2. 2.3 0.0 2 4 3.8 02 03 12 25 08 12 95 -2- ne 1 1 5 8 063 . 5 8 5 0 75 50 yl)methano 2 Aceti l 0.0 0.0 0.0 0.0 0. 0. c 4 13 3. 1. 1.3 0.0 hydrochlori 0.5 01 02 07 14 04 07 95 Anhy 9 9 5 4 3 035 de 4 1 0 0 90 00 dride Isopr 1 0.0 0.0 0.0 0.0 0. 0. 3 Aripiperaz opyl 82 2. 0. 0.5 0.0 1. 4.4 00 00 03 06 01 02 96 3 ole Alcoh .5 1 6 8 015 7 6 9 0 0 50 40 ol 7-(4- 3 bromobuto 0.0 0.0 0.0 0.0 0. 0. 3 xy)-3,4- Tolue 11 3. 5. 5.4 0.0 4 3.8 05 08 28 56 19 28 95 . dihydroqui ne 1 1 68 0 142 7 5 4 8 88 40 1 nolin- 2(1H)-one 3 0.0 0.0 0.0 0.0 0. 0. 3 Aripiperaz Tolue 11 3. 4. 4.2 0.0 4 3.8 04 06 22 45 15 22 95 . ole crude ne 1 1 5 8 113 5 8 5 0 75 50 2 0.0 0.0 0.0 0.1 0. 0. Meth 64 12. 1. 9.6 0.0 9 10 10 15 50 00 25 40 96 anol .5 9 1 0 250 0 0 0 0 00 00 - 0.0 0.0 0.0 0.0 0. 0. 3 Sildenafil Acet 7.7 0.0 2 56 24 2 8 08 12 40 80 12 24 97 4 Citrate one 6 200 0 0 0 0 0 00 00 Meth 0.0 0.0 0.0 0.0 0. 0. N 47. 2. 4.8 0.0 ylene 40 5 05 07 25 50 07 15 97 A 4 9 5 125 Chlor 0 5 0 0 50 00

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ide 0.0 0.0 0.0 0.0 0. 0. Toule 11 3. 2.8 0.0 4 3.8 3 03 04 15 30 10 15 95 ne 1 1 5 075 0 5 0 0 50 00 3 Tetra Bosentan - 5 hydro 0.0 0.0 0.0 0.0 0. 0. 1 19. 2. 1.9 0.0 furan 65 2 02 03 10 20 05 08 96 4. 3 5 2 050 (THF 0 0 0 0 00 00 5 ) 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 7. 7.6 0.0 9 08 12 39 79 19 31 96 anol .5 9 1 97 5 199 Pyrimidine- 0 0 9 7 93 88 3 2-carbox Cyclo - 0.0 0.0 0.0 0.0 0. 0. 5 10. 2. 6. 6.5 0.0 amidine hexa 8 81 06 10 34 68 17 27 96 . 3 9 83 6 171 hydrochlori ne 1 8 2 2 3 08 32 1 de Isopr 1 0.0 0.0 0.0 0.0 0. 0. 82 2. 6. 6.5 0.0 opan 1. 4.4 06 10 34 68 17 27 96 .5 1 83 6 171 ol 7 8 2 2 3 08 32 5-(2- Methoxyph 3 enoxy)-2- 0.0 0.0 0.0 0.0 0. 0. 5 Meth 64 12. 1. 5.7 0.0 (pyrimidin- 9 6 06 09 30 60 15 24 96 . anol .5 9 1 6 150 2-yl)- 0 0 0 0 00 00 2 pyrimidine- 4,6-diol Dichl 0.0 0.0 0.0 0.0 0. 0. oro N 47. 2. 1.9 0.0 40 2 02 03 10 20 03 06 97 Meth A 4 9 4 050 3 Olanzapin 0 0 0 0 00 00 ane 6 e 0.0 0.0 0.0 0.0 0. 0. Tolue 11 3. 1. 1.6 0.0 4 3.8 01 02 08 17 06 08 95 ne 1 1 75 6 044 8 6 8 5 13 75 2-methyl- 10- 3 Piperazine 0.0 0.0 0.0 0.0 0. 0. 6 -1-yl-4H-3- Tolue 11 3. 1. 1.7 0.0 4 3.8 01 02 09 18 06 09 95 . thia-4,-9- ne 1 1 8 1 045 8 7 0 0 30 00 1 diaza- benzo[f] azulene 0.0 0.0 0.0 0.0 0. 0. Meth 64 12. 1. 1. 1.5 0.0 9 01 02 08 16 04 06 96 2-Chloro- anol .5 9 1 6 4 040 6 4 0 0 00 40 3 5- Meth 7 nitrobenzoi 0.0 0.0 0.0 0.0 0. 0. ylene N 47. 2. 2. 2.2 0.0 c acid 40 02 03 11 23 03 06 97 chlori A 4 9 31 4 058 3 5 6 1 47 93 de Meth Methyl-6- 0.0 0.0 0.0 0.0 0. 0. 3 ylene N 47. 2. 5.8 0.0 methyl- 40 6 06 09 30 60 09 18 97 8 chlori A 4 9 2 150 nicotinate 0 0 0 0 00 00 de ii VOC emission sources and its mitigation measures (Brief note on LDAR)  Sources - Charging Materials  Measures

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- Enclose Process - Minimum flanges & joints - Handled by pump with double mechanical seals - Proper Ventilation - Adequate PPEs - Primary & Secondary Condenser - LDAR H Safety Detail i  Details regarding storage of Hazardous chemicals (For tank storages only) Storage Name of major Hazardous chemicals Remarks details Storage PESO u/g Storage tanks (Methanol 20 KL, Acetone 20 KL, Toluene 20 condition as KL, Ethyl Acetate 10 KL) ATP Non-PESO (HCl 35% 10 KL, Sulfuric acid 10 KL, Nitric acid 10 KL)

 Applicability of PESO : Will Be Applied

 Safety details of Hazardous chemicals (To be stored in storage tanks)

PESO Tank Area Storage & Handling Safety:  The underground vessels shall be placed within concrete or brick masonry pit with a gap of 1.0 meter between the walls of the pit and the vessel as well as in between the vessels.  The underground vessels shall be installed on a firm foundation and firmly secured to the foundation so as to prevent movement of floatation.  Class A Petroleum products will be received through road tanker and stored in u/g storage tank as per PESO Rule.  Tank farm will be constructed as per explosive department requirement and separation distance will be maintained.  The underground vessels covered by earth (Mound) shall be a designed to withstand external pressure due to load of the earth cover.  Provided with external anti-corrosive coating or cathodic protection to prevent corrosion ;  Covered by earth, sand or any other non-corrosive material free from abrasive particles likely to damage the anti-corrosive coating of the vessel-the thickness of the covering material above the top surface of the vessel shall not be less than 0.5 meter;  Having the discharge level of the safety relief valves at least 2 meters above the top surface of the vessel, but in any case not less than 3 meters from the ground level;  Fitted with the necessary piping's, fittings, valves and other mounting on top of vessel in such a manner that they can be operated and maintained without disturbing the earth cover. In case of above ground vessel with earth cover (mound), liquid outlet pipe at the bottom may be allowed provided the control valve and emergency valve of this line is just outside the earth cover for the purpose of operation and maintenance from outside.  Static earthing provision will be made for road tanker as well as storage tank.  Flame arrestor with breather valve will be provided on vent line.  Road tanker unloading procedure will be prepared and implemented.  Fire load calculation will be done and as per fire load hydrant system will be provided as per NFPA std. and fire extinguishers will be provided as per fire load calculation.  Spark arrestor will be provided to all vehicles in side premises  Lightening arrestor will be provided on the top.  Flame proof type equipment and lighting will be provided.  Trained and experience operator will be employed for tank farm area.  NFPA label (hazard identification) capacity and content will be displayed on tanks

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 Solvents will be transferred by pump only in plant area and day tank will be provided. Overflow line will be return to the storage tank or Pump On-Off switch will be provided near day tank in plant.  Jumpers will be provided on solvent handling pipe line flanges & Flexible SS hose will be used for road tanker unloading purpose and other temp. connection  Ensure that the transfer of petroleum takes place only through electrically continuous sound hose having oil tight couplings at both ends.  Couplings of the hose at the discharge ends of the tank trucks as well as at the fill pipe end of the underground tank shall not be leaky.  Unloading operations should not commence without ensuring earthing of the tanker bodto a proper earthing point. For this purpose, a proper earthing point shall be provided near filling points.  Before commencing unloading operations tanker should be parked in the retail outlet in such a manner that it can be taken out of the retail outlet immediately in case of emergency.  Dip pipe of the underground tank shall not be kept open during unloading operations.  The dealer, supervisors and pump attendants shall be trained in all aspects of safety in RO including the provisions of Petroleum Rules, 2002 in Chapter IV on Electric Installation, Rules 117 to 119,122,125 and conditions 6 to 12, 15,16,18 to 21of licence Form XIV for the RO‘s under the said Rules.  Before starting unloading of petroleum, it must be ensured that at least a safe distance of 3 M is kept clear of any kind of movement of other vehicles that come for fuelling and that there is no source of any spark in the area. In case of retail outlets that are in congested areas operations of fuelling automobiles in the retail outlet may be discontinued.  Do not use plastic hose pipes for unloading purposes.  Do not use hose pipe fitted with metallic pipe (bent pipe) at the discharge end.  Do not use Hose pipes not conforming to OISD 135.  Proper tightening of hose connections using screwed/cam lock couplings.  Make sure that there shall be no collection of leaked petroleum through hose pipe connection at tanker discharge faucet end in the plastic bucket kept on the ground below.  Provision of electrical earthing / bonding by means of flexible cable between tanker chassis and earth boss/fill pipe.  Proper training to the retail outlet staff regarding hazards associated with the petroleum road tanker decantation operation in the retail outlets. NON PESO Tank Area Storage & Handling Safety:  Leakage / spillage mitigation plan  Tank shall be rubber lined to prevent the corrosion  Dyke wall shall be provided for containment  Rubber type hand gloves and chemical splash goggles and full-face cartridge type mask and PVC apron shall be used while manual handling  Lime shall be readily available during leak to neutralize the spill material  Safety shower, eye wash with quenching unit will be provided in acid storage area.  Material will be handled in close condition in pipe line.  Double drain valve will provided.  Level gauge will be provided on all storage tanks.  Fire hydrant system with jockey pump as per TAC norms will be installed

Safety measures for Acid storage Tank:  Storage tank will be stored away from the process plant.  Tanker unloading procedure will be prepared and implemented.  Caution note and emergency handling procedure will be displayed at unloading area and trained all operators.  NFPA label will be provided.  Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator.

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 Neutralizing agent will be kept ready for tackle any emergency spillage.  Safety shower, eye wash with quenching unit will be provided in acid storage area.  Material will be handled in close condition in pipe line.  Dyke wall will be provided to all storage tanks, collection pit with valve provision.  Double drain valve will provided.  Level gauge will be provided on all storage tanks.  Safety permit for loading unloading of hazardous material will be prepared and implemented. TREM CARD will be provided to all transporters and will be trained for transportation Emergency of Hazardous chemicals.  Fire hydrant system with jockey pump as per TAC norms will be installed.

ii Process safety details : (If applicable) 1. Hydrogenation process  Provisions of safety rupture disk on reactor.  Provisions of auto dumping Vessel.  PLC (Programmable Logical Control base process controls and operation of plant will be installed.  All electrical equipment‗s shall be installed as per Hazardous Area Classification.  Total enclosed process system.  Instrument & Plant Air System.  Nitrogen blanketing in Hydrogenation reactor.  Safety valve and Rupture disc provided on reactor.  Cooling, Chilling and alternate power arrangement have been made on reactor.  Process area and Hydrogen cylinder bank shall be far away as per standards practice.  PRV station ith shut off valve, safety valve provision will be made for hydrogenation reaction safety.  Standard Operating procedure shall be followed during operation of Hydrogen Gas charging in to reactor and after completion of reaction Nitrogen purging will be done.  Flame arrestor will be provided on vent line of reactor and it will be extended above the roof level.  Safe Catalyst charging method will be adopted.  SOP will be prepared and operators will be trained for the same.  Static earthing and electric earthing (Double) will be provided.  Jumpers for static earthing on pipeline flanges of flammable chemical will be provided.  Hydrogen gas detector will be installed for early detection of gas leak.

2. Nitration process  SOP will be displayed for safe charging of Nitric acid for nitration process.  Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator at time of nitric acid charging.  Make sure the absorber unit (two stage Alkali scrubber) will be working and capable of handling vented NO2 fumes.  Neutralizing agent will be kept ready for tackle any emergency spillage.  Safety Shower and eye wash will be provided near process area.  Total close process will be adopted (from storage tank to measured vessel & then to reactor) for Nitric Acid charging.  Caution note and emergency first aid will be displayed and train for the same to all employees.  First Aid Boxes will be available in process area.  Prevention measures for runaway reaction of nitration reaction. • Instrumentation control • Rotameter • Level alarms

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• TIC (Temperature Indictor & Controller) - jacket as well as the reactor • Emergency control measures: • Flushing water (chilled water / ice quenching) to control the runaway reaction. • Provision of Drainage of the contents of the nitrator.

3. Sulphonation / Chlorination (Chlorination is proposed with Thionyl Chloride)  Provisions of safety rupture disk on reactor.  Provisions of auto dumping Vessel.  Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator.  To avoid runaway reaction, TC charging will be done gradually & slowly.  Charging will be done only through closed line and system. Scrubber attached with closed system.  Make sure the absorber unit (two stage Alkali scrubber) is working and capable of handling vented SO2 / HCl fumes.  Neutralizing agent will be kept ready for tackle any emergency spillage.  Safety Shower and eye wash will be provided near process area.  For Thionyl Chloride evacuate area in down wind direction up to 0.3 km ( 300 meter) in small spillage.  Emergency siren and wind sock will be provided.  Tele Communication system and mobile phone will be used in case of emergency situations for communication.  Total close process will be adopted for Thionyl chloride charging.  Caution note and emergency first aid will be displayed and train for the same to all employees.  First Aid Boxes will be available in process area.  Emergency organization and team will be prepared as per On site-Off site emergency planning.  Emergency team will be prepared and trained for scenario base emergency. Like Toxic control team, Fire control team, First aid team, communication and general administration team, Medical team etc.  Do not touch damaged containers or spilled material unless wearing appropriate protective clothing.  Use water spray to reduce vapors; do not put water directly on leak, spill area or inside container. Keep combustibles (wood, paper, oil, etc.) away from spilled material.  Cover with DRY earth, DRY sand or other non-combustible material followed with plastic sheet to minimize spreading or contact with rain.

4. Bromination  All end nozzles in bromine charging hose will be blinded after use.  Charging of bromine will be done when reactor is in vacuum and POP coated funnel will be used during charging.  Excess bromine will be neutralize or discharged by adding Sodium Bisulfite.  Make sure the absorber unit (scrubber) is working and capable of handling vented bromine fumes.  Structure of bromine bottle area will be periodically inspected to ensure stability.  Personnel employed with bromine handling are made aware of potential hazards of bromine and of appropriate first-aid measure.  Exhaust hood connected with alkali scrubber and ventilation system will be available. Exhaust hood has been provided to maintain to concentration of bromine vapor well below PEL.  Work instructions for bromine charging will be displayed in local language/Hindi.  Safety shower and eye-wash fountains will be available nearby handling and charging facility. The location of such item will be inspected and tested at fixed interval to make

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sure that it is in good condition.  Hypo solution, lime water slurry or soda ash solutions will be available so as to pour them over a liquid bromine spill on the floor. The bromine and neutralizer is then washed to the sump with cold water hose.  Personal Hygiene – the following personal protective equipment will be used.  Chemical safety goggles, face shields, SCBA sets, Aprons, rubber gloves, etc.  Only trained employees handled bromine charging. Training will be given to employees for bromine handling and charging.

 During the video conference meeting dated 30/05/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & relevant documents. PP authorized Technical Expert Mr. Shailandra Umarigar to remain present before committee and made presentation. Technical expert remain present during meeting.  Committee noted that the proposal is for new unit and proposed manufacturing of API and Its Intermediates at GIDC Saykha. Total plot area is 3977.83 Sq. m.  Technical expert submitted that industrial effluent generated from process will be segregated into Concentrated and Dilute stream. Concentrated stream will be treated in stripper, AOP and MEE.MEE condensate will be mixed with loq concentration effluent. Low Concentration effluent will be treated in ETP (P+S+T) and then sent to CETP, Saykha for further treatment.  Water balance, wastewater management, treatment philosophy and ETP stage wise characteristics are disused in depth. Committee asked PP regarding removal of refractory organics to which PP replied that AOP will be provided for it.  Two stage scrubber will be provded with each process stacks. MCS + Bag Filter is proposed as APCM with Biocoal fired boiler.  PP submitted Hazardous Waste Matrix. Committee deliberated on the EMP, CER, LDAR, chemical storage & its safety and green belt development plan.  After detailed discussion, it was decided to recommend the project to SEIAA Gujarat for grant of Environmental Clearance.

Conditions with which Environment Clearance is recommended: SPECIFIC CONDITIONS: 1. PP shall comply conditions of any subsequent amendment or expansion or change in product mix, after the 30th September 2020, considered as per the provisions in force at that time as mentioned in the Notification vide S.O. 1223 (E) dated 27/03/2020. 2. PP shall not manufacture any products in proposed project/activities which are not qualifying the amended EIA Notification vide S.O. 1223 (E) dated 27/03/2020 and any subsequent amendments. 3. PP shall submit six monthly compliance report of Environmental Clearance without fail and the same shall be critically assessed by the regulatory authority.

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4. R & D products shall be of similar chemistry and the pollution load shall remain the same as committed. 5. Project proponent shall not take continuous/commercial production of the R & D products. Necessary approvals shall be obtained from the concern authorities prior to commercial production of R & D products. 6. Project proponent shall provide continuous online monitoring system for waste water discharge to Common Facilities (CETP, Common MEE, Common, Spray dryer etc.) as per the prevailing guidelines of SPCB/GPCB and shall maintain records of the same thereof. 7. Treated waste water shall be sent to common facilities (CETP, Common MEE, Spray dryer etc.) only after complying with the inlet norms of common facilities prescribed by GPCB to ensure no adverse impact on Human Health and Environment. 8. PP shall adopt appropriate methods for segregation of waste water streams based on characteristics at source and its sound management keeping in view inlet norms of Common facilities prescribed by GPCB. 9. Close loop solvent recovery system with adequate condenser system shall be provided to recover solvent vapors in such a manner that recovery shall be maximum and recovered solvent shall be reused in the process within premises. 10. Leak Detection and Repair (LDAR) program shall be prepared and implemented as per the CPCB guidelines. LDAR Logbooks shall be maintained. 11. Safety: a) PP shall obtain PESO permission for the storage and handling of hazardous chemicals. (If applicable) b) Flame proof electrical fittings shall be provided in the plant premises, wherever applicable. c) Unit shall provide effective Isolation for Process area and storage of hazardous chemicals. d) Unit shall provide double earthling to solvent storage tanks/ area. e) Unit shall never store drum/barrels/carboys of incompatible material/chemical together. f) Unit shall provide water sprinkler to the ammonia storage cylinder. g) Unit shall provide water sprinkler to the HCl storage cylinder. h) Unit shall Store Bromine Bottle in cool dry separate area, out of direct sunlight. i) Unit shall provide safety valve and rapture disc, as well as auto dump or auto quench/, suppress system for nitration vessel safety. j) Unit shall provide safety valve & rupture disc to the Hydrogenation vessel. 8 SIA/GJ/IND2/152202/2020 M/s. Pacific Life Science Appraisal Plot No. T-57, GIDC- Saykha, Dist: Bharuch. New

Category of the unit: 5(f) Project status: New

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 Project proponent (PP) submitted online application vide SIA/GJ/IND2/152202/2020 dated 09/05/2020 for obtaining Environmental Clearance (EC).  Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is a new project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. SR. Quantity NAME OF PRODUCT CAS No. End Use of Products NO. (MT/ Month) Group - A 1 Lornoxicam 70374-39-9 API /Anti-inflammatory drug 2 Meloxicam 71125-38-7 API / Anti-inflammatory drug 3 Atovaquone 95233-18-4 API / Anti Pneumocystic 187164-19- 4 Luliconazole API / Anti-fungal 8 137234-62- 5 Voriconazole API / Anti-fungal 9 100643-71- 6 Desloratidine API /Anti-Histamine 8 7 Glimepiride 93479-97-1 API / Anti-Diabetes 8 Oxcarbazepine 28721-07-5 API / Anti Convulsants 9 Metoclopramide Hydrochloride 7232-21-5 API / Relieve heartburn 10 2-(2 Chloroethoxy) Ethanol 64-17-5 Quetiapine /antipsychotic

2-N-Butyl-3(4-Hydroxy Benzoyl) 271-89-6 11 Benzofuran /antidepressant Benzofuran

12 Sulphonamide 63-74-1 API / Anti-Bacterial

13 N,N-Diethyl Ethylene Diamine 100-36-7 API / Liquid Chromatograph

14 2 – Chloro Ethyl Ether 111-44-4 API / Gas Chromatograph

15 Mebendazole 31431-39-7 API / Anthelmintic 16 Meta Bromo Nitro Benzene 585-79-5 Tramadol /Pain Killer 160970-54- API / Benign prostatic 17 Silodosin 7 hyperplasia 3-(Trifluoro Methyl) 5, 6, 7, 8-Tetra 762240-92- Pyrazine Hydrochloride /anti- 18 Hydro (4, 3-A) Pyrazine 6 tuberculosis Hydrochloride & It‘s Intermediates Pyrazine Hydrochloride /anti- 19 2,2-dimethyl-1,3-dioxane-4,6-dione 2033-24-1 40 MT/Month tuberculosis Amlodipine Besylate & It‘s 111470-99- 20 API / High Blood Pressure Intermediates 6 Amlodipine Besylate /High 21 Phthalimido ethanol 3891-07-4 Blood Pressure ethyl-4(2-Phthalimido)ethoxy Amlodipine Besylate /High 22 88150-75-8 acetoacetate Blood Pressure

2-(2-Chloro-benzylidene)-4-[2-(1,3- 400024-08- Amlodipine Besylate /High 23 dioxo-1,3-dihyadro-isoindol-2-yl)- 0 Blood Pressure ethoxy]-3-oxo-butyric acid ethyl ester

2-Methyl-isoindole-1,3-dione Amlodipine Besylate /High 24 550-44-7 (Amlodipine Base) Blood Pressure

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111470-99- Amlodipine Besylate /High 25 Amlodipine Besylate Tech 6 Blood Pressure 103577-45- 26 Lansoprazole & It‘s Intermediates API / Intestinal ulcers 3 27 4-nitro-2,3-dimethyl pyridine-N-oxide 37699-43-7 Lansoprazole /Intestinal ulcers 2-Hydroxy methyl-3-methyl pyridine 28 Lansoprazole /Intestinal ulcers hydrochloride 72830-08-1 2-chloromethyl-3-methyl pyridine 153259-31- 29 Lansoprazole /Intestinal ulcers hydrochloride 5 2[4-(2,2,2-Tri fluoro ethoxy)-3-methyl 117977-21- 30 pyridine ]methyl thio-1H- Lansoprazole /Intestinal ulcers 6 Benzimidazole Olmesartan Medoxomil & It‘s 144689-63- 31 API / Hypertension Intermediates 4 144690-92- Olmesartan Medoximil 32 Trityl olmesartan medoximil 6 /Hypertension Lurasidone Hydrochloride & It‘s 367514-88- 33 API/ Anti-Psychotic Intermediates 3 Methanesulfonic acid 2-methane Lurasidone Hydrochloride 34 sulfonyloxymethyl-cyclohexyl methyl 75-75-2 /Anti-Psychotic ester 2-Benzyl Amino-1-6-Fluoro-3-4- 1322622- Lurasidone Hydrochloride 35 Dihydro-2-H-Chromen-2-Yl-Ethanol 97-8 /Anti-Psychotic & It‘s Intermediates

Lurasidone Hydrochloride 36 Phenylme thanamine 100-46-9 /Anti-Psychotic

Trityl Olmesartan Medoxomil & It‘s 144690-92- Lurasidone Hydrochloride 37 Intermediates 6 /Anti-Psychotic 4-(chlorom ethyl)-methyl-1,3-dioxol- Lurasidone Hydrochloride 38 80841-78-7 2-one /Anti-Psychotic And Group - B 202409-33- 39 Etoricoxib & It‘s Intermediates API / Anti-inflammatory drug 4 1-(4-Methanesulfonyl-Phenyl)- 10297-73- Etoricoxib /Anti-inflammatory 40 ethanone 1. drug (4-Methanesulfonyl-Phenyl)-acetic Etoricoxib /Anti-inflammatory 41 64-19-7 acid drug

2-(4-Methanesulfonyl-Phenyl)-1-(6- 221615-75- Etoricoxib /Anti-inflammatory 42 methyl-pyridin-3-yl)-ethanone 4 30 drug MT/Month (2-Chloro-3-dimethylamino- 291756-76- Etoricoxib /Anti-inflammatory 43 allylidene)-dimethyl-ammonium Salt 8 drug of Phosphorus Hexafluoride Atorvastatin Calcium Trihydrate & It‘s 344423- 44 API / Lower "Bad" cholesterol Intermediates 98-9 [6-(2-Amino-ethyl)-2,2-dimethyl- Atorvastatin Calcium 125995-13- 45 [1,3]dioxane-4-yl]-acetic acid tert- Trihydrate /Lower "Bad" 3 butyl ester cholesterol

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(6-{2-[2-(4-Fluro-Phenyl)-5-isopropyl- 3-phenyl-4-phenylcarbamoyl-pyrrol- Atorvastatin Calcium 125971-95- 46 1-yl]-ethyl}-2,2-dimethyl- Trihydrate /Lower "Bad" 1 [1,3]dioxane-4-yl)-acetic acid tert- cholesterol butyl ester 7-[2-(4-Fluoro -phenyl)-5-isopropyl-3- Atorvastatin Calcium phenyl-4-phenylcarbamoyl-pyrrol-1- 433289-84- 47 Trihydrate /Lower "Bad" yl]-3,5-dihydroxy-heptanoic acid tert- 0 cholesterol butyl ester API / Gastroesophageal reflux 48 Omeprazole & It‘s Intermediates 73590-58-6 disease Omeprazole/Gastroesophageal 49 3,5-Dimethyl-4-nitro-pyridine N-oxide 14248-66-9 reflux disease (4-methoxy-3,5-dimethylpyridin-2- Omeprazole/Gastroesophageal 50 67-56-1 yl)methanol reflux disease 2-(chloromethyl)-4-methyoxy-3,5- Omeprazole/Gastroesophageal 51 86604-75-3 dimethylpyridine reflux disease 5-Methoxy-2-(4-methoxy-3,5- Omeprazole/Gastroesophageal 52 dimethyl-pyridine-2- 73590-85-9 reflux disease ylmethylsulfanyl)-1H-benzoimidazole 148553-50- 53 Pregabalin & It‘s Intermediates API / Focal seizures 8 2-(3-Methyl-butylidene)-melonic acid 54 51615-30-6 Pregabalin /Focal seizures diethyl ester 2-(1-cyan0-3-methyl-butyl)-malonic 186038-82- 55 Pregabalin /Focal seizures acid diethyl ester 4 3-aminomethyl 5-methyl hexanoic 148553-50- 56 Pregabalin /Focal seizures acid 8 57 s(+)Pregabalin mandalate salt 4118-51-8 Pregabalin /Focal seizures Fexofenadine Hydrochloride & It‘s 153439-40- 58 API / Antihistamine Intermediates 8 Fexofenadine 59 2-methlprop-2-en-1-yl-acetate 820-71-3 Hydrochloride/Antihistamine Fexofenadine 60 2-Methyl-2-phenylpropyl Acetate 18755-52-7 Hydrochloride/Antihistamine 2-(4-(4-chloro-butyryl)-phenyl)-2- 154477-54- Fexofenadine 61 methyl-propionic acid methyl ester 0 Hydrochloride/Antihistamine 4-(4-Chloro-1-oxo-butyl) 2,2 162096-54- Fexofenadine 62 Dimethylphenyl acetic acid 0 Hydrochloride/Antihistamine

2-[4-(4-Chloro-butyryl)-cyclohexyl]-2- 154477-54- Fexofenadine 63 methyl-propionic acid methyl ester 0 Hydrochloride/Antihistamine

methyl-2-[4-(4- 154477-54- Fexofenadine 64 chlorobutanoyl)phenyl]-2- 0 Hydrochloride/Antihistamine methylpropanoate Fexofenadine 65 Azacyclonol 115-46-8 Hydrochloride/Antihistamine 4-[4-[4-(Hydroxydiphenyl)-1- piperidinyl]-1-oxo-butyl]-alpha,alpha- 154477-55- Fexofenadine 66 dimethylbenzeneacetic acid methyl 1 Hydrochloride/Antihistamine ester

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Benzeneaceticacid,4-[1-hydroxy -4- [4-(hydroxydiphenylmethyl)-1- Fexofenadine 67 83799-24-0 piperidinyl] butyl ], alpha,alpha- Hydrochloride/Antihistamine Dimethy Quetiapine Fumarate & It‘s 111974-72- 68 API / Schizophrenia Intermediates 2

111974-73- Quetiapine 69 Phenyl-2-(phenyl carbamate 3 Fumarate/Schizophrenia

Quetiapine 70 Dibenzo,1,4-thiozepin,1-H-one 3159-07-7 Fumarate/Schizophrenia

11-Piperazin-1-yl-5a,9a,10,11- 111974-74- Quetiapine 71 tetrahydro- 4 Fumarate/Schizophrenia dibenzo(b,f)[1,4]thiazepine 144701-48- 72 Telmisartan & It‘s Intermediates API / High Blood Pressure 4 7-Methyl-2-propyl-3H- 152628-03- Telmisartan /High Blood 73 benzoimidazole-5-carboxylic acid 0 Pressure Methyl-4-methyl-1,1-biphenyl-2- 114772-34- Telmisartan /High Blood 74 carboxylate 8 Pressure

4-(bromomethyl)biphenyl-2- 114772-38- Telmisartan /High Blood 75 carboxylic acid methyl ester 2 Pressure

methyl-4-[[2n-propyl-4-methyl-6-(-1- 152628-02- methylbenzimidazole-2-yl)- Telmisartan /High Blood 76 9 benzimidazole-1-yl]-methyl]biphenyl Pressure

carboxylate 4-[[2n-Propyl-4-methyl-6-(1- methylbenzimibazole-2-yl)- 528560-93- Telmisartan /High Blood 77 benzimibazole-1-yl]metyhlbiphenyl 2 Pressure carboxylic acid 137862-53- 78 Valsartan & It‘s Intermediates API /High Blood Pressure 4

2-Amino-3-methyl-butyric acid 79 56545-22-3 Valsartan /High Blood Pressure methyl ester hydrochlorie

2-[(2-cyano-biphenyl-4-ylmethyl)- 137863-90- 80 amino]-3-methyl-butyric acid methyl Valsartan /High Blood Pressure 2 ester 2-[(2-cyano-biphenyl-4-ylmethyl)- 137863-90- 81 pentanoyl-amino]-3-methyl-butyric Valsartan /High Blood Pressure 2 acid methyl ester Venlafaxine Hydrochloride & It‘s 99300-78- 82 API / Antidepressant Intermediates 4 . 1-[cyano(4- Venlafaxine Hydrochloride 83 93413-76-4 Methoxyphenyl]cyclohexanol /Antidepressant

1-[2-Amino1-(4- 130198-05- Venlafaxine Hydrochloride 84 methoxyphenyl)ethyl]cyclohexanol 9 /Antidepressant Venlafaxine Hydrochloride 85 Venlafaxine Hydrochloride Tech 99300-78-4 /Antidepressant

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175481-36- API / Anti Convulsant or Anti- 86 Lacosamide & It‘s Intermediates 4 Epileptic 2-Butoxycarbonylamino-3-methoxy- Lacosamide /Anti Convulsant or 87 51293-47-1 propionic Acid Anti-Epileptic (1-Benzylcarbamoyl-2-methoxy- 1352305- Lacosamide /Anti Convulsant or 88 ethyl)-carbabamic acid butyl ester 14-6 Anti-Epileptic 2-Amino-N-benzyl-3-methoxy- 196601-69- Lacosamide /Anti Convulsant or 89 propionanide 1 Anti-Epileptic 2-Acetylamino-N-benzyl-3-methoxy- 175481-36- Lacosamide /Anti Convulsant or 90 propionamide(Lacosamide crude) 4 Anti-Epileptic L-(3-Methyl-L-Phenyl-L-Pyrazol-5-Y-) 401566-79- Teneligliptin/ antidiabetic 91 Piperazine Acetate [Intermediate of 8 Teneligliptin] 92 Intermediate-A 1, 3 - Thiazolidine 444-27-9 Teneligliptin/ antidiabetic Intermediate-B [(2s, 4r) – L - [(9h – Fluoren – 9 – YI Methoxy) Carbonyl] 121808-32- 93 Teneligliptin/ antidiabetic – 4 - Hydroxypyrroiidine – 2 - 3 Carboxylic Acid] Intermediate-C [3 - [(2s, 4r) – L – Fluorenyl Methoxy Carbonyl – 4 – 121808-62- 94 Teneligliptin/ antidiabetic Hydroxyl – 2 - Pyrrolidinyl Carbonyl] 6 1, 3 - Thiazolidine] Intermediate-D [9h – Fluoren – 9 – Yl Methyl - (2s) – 4 – Oxo – 2 - (L, 3 401564-36- 95 – Thiazolidin – 3 – Yl Carbonyl) Teneligliptin/ antidiabetic 1 Pyrrolidine – L - Carboxylate (13 When R = Fmoc) Intermediate-E [L - (3 – Methyl – L 401566-79- 96 – Phenyl – L// - Pyrazol – 5 – Y) Teneligliptin/ antidiabetic 8 Piperazine Acetate] Total – Group A + B 40 + 30=70 10 R & D Kg/Month Classification:  API: 28  n-1 Intermediates (Captive consumption/sell): 32  n-2 Intermediates (Captive consumption/sell): 34  The project falls under Category B2 of project activity 5(f) as per the schedule of EIA Notification 2006 and amendment dated 27th March, 2020.  The presentation was considered in the meeting dated 30/05/2020 as per the submission by PP via E- mail dated 22/05/2020.  Salient features of the project including Water, Air and Hazardous waste management:

Sr. Particulars Details no. A A Total cost of Proposed Project 4.12 Crores (Rs. in Crores):

Break-up of proposed project Cost: Details Approximate Capital Cost

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(Rs. in Lacs) Land 52.0 Building 100.0 Plant & Machinery 200.0 ETP, APCS & HWM 57.00 Green Belt Development 0.88 Occupational Health 2.5 Total 412.38

Details of Environmental Management Plan (EMP) COMPONENT CAPITAL COST OF EMP RECURRING COST OF EMP (per Month) Cost Rs. 61.88 Lakhs Rs. 18.8 Lakhs

Bifurcation of EMP Cost Total Capital Operatin Maintena Recurring Sr. Installed Cost g Cost nce Cost Unit Cost No Capacity (KLD) (Rs. in (Lacs/M (Lacs/Mo (Lacs/Mon Lakhs ) onth) nth) th) Effluent Treatment Plant (Primary + 22.5 KLD 29 5.4 0.54 5.94 1 Secondary Treatment facility) CMEE 5.0 KLD 1.0 7.5 0.0 7.5 Scrubber =5 Nos MCS=1 2. APCM+ LDAR 26.0 0.65 0.33 0.98 Bag Filter=1

Hazardous Waste 3. -- 1.0 3.9 0 3.9 (Expense) AWH Monitoring 4. -- 1.5 0.10 0 0.10 Cost 5. OH Safety& Training -- 2.5 0.2 0.05 0.25 6. Greenbelt 160 Trees 0.88 0.09 0.04 0.13 Total 61.88 18.8

Details of CER as per OM dated 01/05/2018 As per OM no. 22-65/2017 on dated 01/05/2018 regarding ―Corporate Environment Responsibility‖ (CER), Greenfield projects have to contribute 2% of the Additional Capital Investment, the company will contribute Rs. 0.10 as funds for CER activities Component Project Cost As per Norms Allocation CER 4.12 Cr Rs. 0.08 Cr (2 %) Rs. 0.10 Cr (2.5 %) (Green field) Activities to be carried out under CER: Activities Phase Wise Budget 1st 2nd TOTAL Year Year Electrification Including Solar Power– (On basis of 0.01 0.01 0.02 Needs Assessment)  Installation of 10 Nos Solar Street Light @10,000/Light – Village Kothia  Installation of 1.8 KV Roof Top Solar System @ 1

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Lacs for Gam Panchayat Office – Village Sutrel Solid Waste Management– (On basis of Needs 0.02 0.02 0.04 Assessment)  Installation of OWC 500 Kg X 2 Nos @ 2 Lacs/Unit – Tal-Bhersam & Vahiyal Gram Panchayat Plantation / Greenbelt in Community Area– (On basis of Needs Assessment)  Plantation around habitation area with various location areas as – Villages – Saykha, Saran etc: cost of 1 plant – 500/- with maintenance of water. 0.01 0.01 0.02 (200 plants)  Installation of green cover as tree guards at the surviving plants & trees, where attached the board ―Pacific Life Science – Villages – Saykha, Saran etc Skill Development – (On basis of Needs Assessment) 0.01 0.01 0.02  Scholarship to Students in ITI @ 20000/Students, Total 5 Students– ITI, Ankleshwar (Local Students Will be Given First Preference)  Contribution @ 1 Lacs at Directorate of Employment & Training / Ministry of Skill Development & Entrepreneurship. Total Cost Approx.INR 0.10 Crore

B Total Plot area ( sq. meter) 2386.13 Sq. m.

Green belt area 787.42 Sq. m. ( sq. meter) (33 % of total area) C Employment generation Direct = 13 Employees Indirect = 10 Employees D Water i Source of Water Supply GIDC Water Supply (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern Permission Obtained Vide Letter – GIDC/DEE(WS)/BRH/874, authority. Dated;20/11/2019

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ii Water consumption (KLD)

Proposed Remark Category (KL/Day) (A) Domestic 1.25 Source: GIDC Water Supply (B) Gardening 1.00 (C) Industrial WC: G-A: Silodosin: 9.0 KLD & Process 12.00 G-B:3,5-Dimethyl-4-nitro-pyridine N-oxide: 3.0 KLD Washing 2.00 Total Consumption=32 KLD Boiler 5.0 Condensate Recovery=27 Make up=5.0 KLD Cooling 3.00 Scrubber 6.00 Total Ind. 28.00 Total (A+B+C) 30.25

4) Total water requirement for the project: 30.25 KLD 5) Quantity to be recycled: Nil KLD 6) Total fresh water requirement: 30.25 KLD Brief Note on worst case scenario for water consumption:  Total Water Requirement of the proposed project will be 30.25, out of which Water Consumption for Process will be 12 KLD.  Worst Case Scenario; SN GROUP PRODUCT WATER REQ. (IN KL) TOTAL TOTAL WATER FOR 1 TON PRODUCTION REQ. PRODUCTION (MT/MONTH) (KLD) 1 A Silodosin 6.96 40 ~ 9.0 2 B 3,5-Dimethyl-4-nitro- 3.00 30 ~ 3.0 pyridine N-oxide

Total Water Consumption – Process 40 + 30 12 KLD

In case of no reuse/recycle of wastewater, Give brief note on justification as why no reuse/recycle. In Boiler 27 KL condensate recovery considered in the recycle, hence makeup reduced to 5.0 KL. iii Waste water generation (KLD) Category Proposed Mode of disposal (KL/Day)  Domestic 1.00 Septic tank & Soak pit (B) Industrial 12.00 12.0 KLD (Low COD) will be sent to (Silodosin) in house ETP (Primary + Secondary) and sent to CETP-Saykha for further Process treatment and disposal. 5.00 5.0 KLD (High COD) will be sent to (3,5-Dimethyl-4-nitro- Common MEE (M/s. BEIL, Dahej). pyridine N-oxide)

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Washing 2.00 6.2 KLD (Low COD) will be sent to Boiler 0.90 inhouse ETP (Primary + Secondary) Cooling 0.30 and sent to CETP-Saykha for further Scrubbing Solution 2.00 treatment and disposal. (30% NaCl) Scrubbing Solution 1.00 (10% NaNO2) Scrubbing Solution 1.00 To End User (25-30% NaBr/HBr) Scrubbing Solution 1.00 (18% Na2SO3) Scrubbing Solution 1.00 Reuse within premises (Liq. Ammonia) Total Ind. 26.20 Total (A+B) 27.20 Note: 1. High COD Stream from Process of Group-B 5 KLD will be sent to CMEE – BEIL, Dahej. 2. Low COD Stream from Process of Group-A, along with dilute stream of utilities @ 18 KLD will be treated in ETP (Primary + Secondary) and sent to CETP-Saykha GIDC for further treatment and disposal. Brief Note on worst case scenario for waste water generation (Qualitative and Quantitative): Quantitate & Qualitative:-  Total Waste Water Generation of the proposed project will be 27.2 KLD, out of which Waste Water Generation for Process will be 17 KLD.  Worst Case Scenario; SN GROUP PRODUCT WASTE WATER TOTAL TOTAL CHARACTERSTICS GEN. (IN KL) FOR PRODUCTION WASTE 1 TON (MT/MONTH) WATER PRODUCTION (KLD) 1 A Silodosin 9.0 40 ~ 12.0 pH – 6.5 to 7.5, (Neutralization at Source) TSS – 220 mg/l, TDS – 24520 mg/l, BOD – 3340 mg/l, COD – 11060 mg/l 2 B 3,5-Dimethyl- 4.9 30 ~ 5.0 pH – 6.5 to 7.5, 4-Nitro- (Neutralization at Pyridine N- Source) Oxide TSS – 230 mg/l, TDS – 24660 mg/l, BOD – 19530 mg/l, COD – 57620 mg/l Total Waste Water Generation – Process 40 + 30 ~ 17 KLD

Brief justification in case of no process effluent generation, no industrial effluent generation, or no high concentration effluent generation from proposed project (If any applicable to proposal). – Not Applicable. There will be effluent generation. The detail has been furnished in water Balance. iv Treatment facility within premises with capacity [In-house ETP (Primary &Secondary), etc.  Hydraulic Load – 18.2 KLD  In-house ETP (Primary + Secondary Treatment) Capacity – 22.5 KLD

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Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed. .  Stream-1:Concentrate stream of 5.0 KLD from process will be sent Common MEE-M/s. BEIL-Dahej. SR. Para Unit Stream-1 High COD (Group – B) No. Omeprazole & Its Intermediates (Specifically - 3,5-Dimethyl-4- nitro-pyridine N-oxide) Inlet To CMEE – BEIL, Dahej (High COD Stream After Neutralization) Quantity (KLD) 4.90 ~ 5.0 5.0 1 pH pH Unit 6.5 TO 7.5 6.0 To 8.0 (Neutralization at source) 2 TSS mg/L 230 <300 3 TDS mg/L 24660 - 4 BOD mg/L 19530 <25000 5 COD mg/L 57620 <75000 6 Ammo.Nitrogen mg/L Nil <50

 Stream-2: Dilute stream for 12.0 KLD from process, 0.3 KLD from Cooling, 0.9 KLD from boiler, 2 KLD from washing and 2 KLD 30% NaCl Scrubbing Solution & 1 KLD NaNO2 Scrubbing Solution = Total 18.2 KLD will be subjected in Primary & Secondary ETP to achieved CETP inlet norms.  Boiler Condensate Recovery @ 27.0 KLD will be directly recycled in boiler

Stream-2 Low COD (Group – A) + Utilities Composite Sr. Stream from other utilities Characteristics Parameter Unit Effluent No. Boiler Cooling Washing Scrubbing

Quantity (KLD) 0.9 0.3 2 3 6.2 1 pH pH Unit 6-8 6-8 6-8 6-8 6-8 2 TSS mg/L 56 87 150 120 120 3 TDS mg/L 1200 2500 4588 542 2037 4 BOD mg/L 10 16 800 211 365 5 COD mg/L 30 50 2500 612 1109 6 Ammo. Nitrogen mg/L Nil Nil Nil Nil Nil Worst Case from Combine Process Sr. Parameter Unit Effluent Sildosin Combine Effluent (ETP Inlet) No. (Utilities) (Low COD Stream) Quantity (KLD) 6.2 12 18.2 6.5 To 7.5 1 pH pH Unit 6-8 (Neutralization at 6.0 to 8.0 source) 2 TSS mg/L 120 220 185 3 TDS mg/L 2037 24520 16860 4 BOD mg/L 365 3340 2326 5 COD mg/L 1109 11060 7416 6 Ammo. Nitrogen mg/L 0 0 0

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 Treated effluent 17.9 KLD will be sent to Common ETP- M/s. CETP, Saykha for further treatment.

Sr Primary ETP Primar ETP ETP . Param Outlet Unit y SCONDARY SCONDARY CETP Inlet N eter (Secondary ETP (First Stage) (Second Stage) o. ETP Inlet) Inlet Quantity (KLD) 18.2 18.1 18 18 17.9 pH 6.5-7.5 6.5-7.5 1 pH 6-8 6.5-7.5 6.0 - 8.0 Unit 2 TSS mg/L 185 40 30 50 <100 3 TDS mg/L 16860 18881 18881 18881 <21000 4 BOD mg/L 2326 1512 454 65 <90 5 COD mg/L 7416 4156 831 180 <250 Ammo. Nil Nil Nil 6 Nitroge mg/L Nil <10 n

 Stream -3: Scrubbing Solutions:  Scrubbing Solution 10-15% NaCl @ 2.0 KLD will be treated in ETP & sent to CETP  Scrubbing Solution 10-15% NaNO2 @ 1.0 KLD will be treated in ETP & sent to CETP  Scrubbing Solution 25-30% NaBr/HBr @ 1.0 KLD will be sent to end user  Scrubbing Solution 25-30% Na2SO3 @ 1.0 KLD will be sell to end user.  Scrubbing Solution 25-30% Liq. Ammonia @ 1.0 KLD will be reused within premises.  High COD range from 45000 mg/L (Etoricoxib & Its Intermediates) to 57620 mg/L (Omeprazole & Its Intermediates)  Low COD range from Boiler Blowdown 100mg/L to Group-A - Silodosin -11060 mg/L.

Note: (In case of CETP discharge) : Management of waste water keeping in view direction under section 18 (1) (b) of the Water (Prevention and Control of Pollution) act, 1974 issued by CPCB regarding compliance of CETP.  Stream-1:Concentrate stream of 5.0 KLD from process will be sent Common MEE-M/s. BEIL-Dahej.  Stream-2: Dilute stream for 12.0 KLD from process, 0.3 KLD from Cooling, 0.9 KLD from boiler, 2 KLD from washing and 2 KLD 30% NaCl Scrubbing Solution & 1 KLD NaNO2 Scrubbing Solution = Total 18.2 KLD will be subjected in Primary & Secondary ETP & send to CETP after achieving inlet norms.  Treated effluent 17.9 KLD will be sent to Common ETP- M/s. CETP, Saykha for further treatment.

Brief note on adequacy of ZLD (In case of Zero Liquid Discharge):  NOT APPLICABLE. V Mode of Disposal & Final meeting point

Domestic: Domestic Wastewater of 1.0 KL/Day will be disposed through Soak Pit or Septic Tank.

Industrial:  Stream-1: Concentrate stream of 5.0 KLD from process will be sent Common MEE-M/s. BEIL-Dahej.  Stream-2: Treated effluent 17.9 KLD will be sent to Common ETP- M/s. CETP, Saykha for further treatment.

Vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE etc. Name of CF  BEIL, Dahej & M/s. CETP Saykha Membership of Common facility (CF) (For waste water treatment)

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Membership obtain for Common MEE (M/s. BEIL, Dahej) vide Letter No. GIDC/DEE/DRG/BRH/666 Dated: 24/11/2019 Vii Simplified water balance diagram with reuse / recycle of waste water

Viii Reuse/Recycle details (KLD) with feasibility. Total reuse…….KLD

Source of waste Application Characteristics of Remarks regarding water for reuse with area with waste water to be feasibility to reuse quantity in KLD (From quantity in reused (COD, BOD, i.e. where it is coming) KLD (Where it TDS etc.) is used) ------

E Air i Brief Note on fuel-based heat energy requirement and worst case scenario thereof: SN Fuel Based Proposed Fuel Calorific Value (kcal/kg) Working Hours Fuel Consumption Heat Energy (Worst Case) in worst case 1 Boiler 2.0 TPH Bio-coal 3800-4300 kcal/kg 16 Hrs 5.0 MT/Day Or Coal 4200-5600 kcal/kg 16 Hrs 4.0 MT/Day Or Natural Gas 7900-8500 kcal/kg 16 Hrs 2500 SCM/Day

Flue gas emission details No. of Boilers/DG sets etc. with capacities viz. , Kcal/hr, MT/hr, KVA etc.

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Source of Stack Air Pollution Quantity of Sr. emission Height/ Control Type of emissions Type of Fuel Fuel No. With Dia Measures i.e. Air Pollutants MT/Day Capacity (meter) (APCM) Bio Coal 5.0 MT/Day OR OR MCS + Bag Steam Boiler Coal 4.0 MT/Day Filter & 1 22/0.5 (2.0 TPH) OR OR Adequate Stack PM < 150 mg/Nm3 2500 Height SO2 < 100 ppm Natural Gas SCM/Day NOX < 50 ppm D.G. Set Adequate Stack 2 11/0.25 Diesel 15 lit/Hr. (62.5 KVA) Height

- ii Process gas emission details i.e. Type of pollutant gases (HBr, HCl, SO2,NH3,NOx etc.)

- Air Pollution Stack/Vent Sr. Specific Source of emission Type of Control Height Dia No. (Name of the Product & Process) emission Measures (meter) (APCM) Reaction Vessel-1 HBr < 20 Two Stage Alkali 1 (Bromination- 11 0.2 mg/Nm3 Scrubber Meta Bromo Nitro Benzene) Reaction Vessel-2 (Nitrification- NOx < 25 Two Stage Alkali 2 11 0.2 4-methoxy-3,5-dimethylpyridin-2- mg/Nm3 Scrubber yl)methanol) Reaction Vessel-3 SO < 40 Two Stage 3 11 0.2 2 (Sulphonation- Mebendazole) mg/Nm3 Alkali Scrubber Reaction Vessel-4 (Chlorination-Mebendazole, 2-Chloro-3- HCl < 20 Two Stage 4 dimethylamino-allylidene)-dimethyl- 11 0.2 mg/Nm3 Alkali Scrubber ammonium Salt of Phosphorus Hexafluoride) Reaction Vessel-5 NH3 < 175 Two Stage Water 5 11 0.2 (Amination- Etoricoxib) mg/Nm3 Scrubber

- Note:  Details of gaseous raw materials used in proposed project  Estimation of process gas emission (Product wise and Total)  Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total)  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix.

Total Requirem Proces Gasous Emissi ent of Solubil Solution / Bleed S s Gas Product Raw on Scrubbing ity liquors n Emissi Material (MT/D Media (%) (MT/Annum) on ay) (KL Per

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Day)

0.7 Meta Bromo (Caustic + > 90 365 MT/Annum 1 Nitro Bromine HBr 0.3 Water) (25-30 % NaBr) Benzene

4-methoxy- 3,5- 0.85 365 MT/Annum 2 dimethylpyridi Nitric Acid NOx 0.15 (Caustic + > 90 (10-15 % NaNO ) n-2- Water) 2 yl)methanol 0.7 Thionyl 365 MT/Annum 3 Mebendazole SO 0.3 (Caustic + > 90 Chloride 2 (25-30% Na SO ) Water) 2 3 Mebendazole , 2-Chloro-3- dimethylamin o-allylidene)- 1.8 Thionyl 730 MT/Annum 4 dimethyl- HCl 0.2 (Caustic + > 90 Chloride (10-15 % NaCl) ammonium Water) Salt of Phosphorus Hexafluoride 0.7 365 MT/Annum 5 Etoricoxib NH3 Gas NH 0.3 > 90 3 (Water) (25-30% Liq. NH3)

iii Fugitive emission details with its mitigation measures: As below: Following measures will be adopted to prevent and control fugitive emissions… 1. Airborne dust at all transfers operations/ points will be controlled either by spraying water or providing enclosures. 2. Raw materials loading and unloading will be done in covered area 3. Care will be taken to store construction material properly to prevent fugitive emissions, if any. 4. Regular maintenance of valves, pumps, flanges, joints and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs. 5. Entire process will be carried out in the closed reactors with proper maintenance of pressure and temperature. 6. Periodic monitoring of work area will be carried out to check the fugitive emission. 7. Breather valves will be provided on solvent tanks. 8. To eliminate chances of leakages from glands of pumps, mechanical seal will be provided at all solvent pumps. 9. Close feeding system will be provided for centrifuges. Centrifuge and filtrate tank vents will be connected to vent chillers. 10. Minimum number of flanges, joints and valves in pipelines. 11. Enclosures to chemical storage area, collection of emission from loading of raw materials in particular solvents through hoods and ducts by induced draft, and control by scrubber / dust collector to be ensured. 12. Adequate ventilation will be provided. 13. Periodic monitoring of work area will be carried out to check the fugitive emission as per the norms of Gujarat Factory Rules. F Hazardous wastes (as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell

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out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and calculations shall be incorporated in EMP details separately.  Disposal to scrap vendors/vendors/traders is not allowed i Category Specific Source of Type/Name of and Quantity Sr. generation Hazardous Schedule (MT/ Management of HW no. (Name of the Activity, waste as per HW Annum) Product etc.) Rules. SCH-I 1 ETP Sludge ETP /35.3 144 Collection, Storage, Transportation & Disposal at Mfg. Process TSDF (M/s. BEIL, Dahej) Process waste [GB=Methyl-4-methyl- SCH-I 2 738 (Inorganic) 1,1-biphenyl-2- /28.1 carboxylate] Collection, Storage, DG/ Used Oil/ Spent Transportation & reused as 3 Compressor/Maintenan SCH-I/5.1 0.5 Oil lubricant or Disposal by selling ce Activities to Authorised Re-refiners. Discarded 70 Collection, Storage, containers/ (7300 Transportation, 4 Barrels/ Raw Material supply SCH-I /33.1 Drums, Decontamination and Reuse or Liners/plastic 18000 Sell to Authorised Recyclers Bags Bags) having rule 9 permission. Mfg. Process [GA=Lurasidone Distillation Hydrochloride & SCH- 5 794.4 Residue GB=2-Amino-3-methyl- I/36.1 butyric acid methyl ester hydrochlorie] SCH-I 6 Spent Carbon Purification 54 /28.3 Collection, Storage, Mfg. Process Transportation & given to Process waste SCH-I 7 GB=Dibenzo,1,4- 97.2 pre/co-processing (cement ( Organic) /28.1 thiozepin,1-H-one industries) or disposal at Mfg. Process nearest CHWIF. [GA-Methanesulfonic acid 2-methane sulfonyloxymethyl- SCH-I 8 Spent Catalyst cyclohexyl methyl ester 18.72 /28.2 & GB-1-[2-Amino1-(4- methoxyphenyl)ethyl] Cyclohexanol] Mfg. Process [GA=Lurasidone Collection, Storage, Handling Hydrochloride & SCH-I recover & reused by subjecting 9 Spent Solvent *30165.6 GB=2-Amino-3-methyl- /28.6 to distillation assembly within butyric acid methyl the Premises. ester hydrochlorie]

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Mfg. Process Aluminum [GA=Mebendazole & 10 Chloride GB= 1-(4- SCH-I/28.1 346.8 (30-40%) Methanesulfonyl- Phenyl)-ethanone] Mfg. Process [GA=2-Hydroxy methyl- Collection, Storage, 3-methyl pyridine Transportation Sell to End Sodium Acetate 11 hydrochloride & SCH-I/28.1 314.4 Users having permission under (70%) GB=2-(1-cyan0-3- Rule-9. methyl-butyl)-malonic acid diethyl ester] Potassium Mfg. Process Acetate 12 [GB=3-aminomethyl 5- SCH-I/28.1 280.8 (70%) methyl hexanoic acid]

Mfg. Process [GA=Mebendazole& GB= (2-Chloro-3- HCl dimethylamino- SCH- 13 1452 (25-30%) allylidene)-dimethyl- I/28.1 ammonium Salt of Phosphorus Hexafluoride] Collection, Storage, Spent Nitric Acid Mfg. Process SCH- Transportation & Disposal 14 1133 (50-60%) [GA= Mebendazole] I/28.1 By Selling to Authorize End User Registered Under Rule-9. Mfg. Process 50-60% SCH- 15 [GA= Meta Bromo Nitro 648 H2SO4 I/28.1 Benzene] Scrubbing Solution Scrubber Sch-I/ 16 25-30% Sodium 365 (GA=Mebendazole) Sulphite 28.1 (Na2SO3) Mfg process 25-30 % GB=2-[(2-cyano- SCH-I/ 17 Potassium biphenyl-4-ylmethyl)- 136.8 28.1 Bromide (KBr) amino]-3-methyl-butyric acid methyl ester Collection, Storage, Scrubbing Transportation Sell to End Solution Users having permission under Scrubber Rule-9. (Bromine Recovery) SCH-I/ 18 25-30 % Sodium [GA=Meta Bromo Nitro 365 28.1 Bromide (NaBr)/ Benzene] Hydrogen Bromide (HBr Scrubber Scrubbing (Gr A=3 Collection, Storage & Reuse Solution Trifluromethyle)-5, Sch-I/ within premises. 19 365 Liq.25- 30% 6,7,8- 28.1 Quantity Require=504 Ammonia Tetrahydro)4,3APyrazi MT/Year ne Hydrochloride)

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Scrubber Scrubbing [GA=N,N-Diethyl Solution SCH-II- 20 Ethylene Diamine & 730 Sodium Chloride Class B(15) Collection, Storage, Treatment GB= 2-methlprop-2-en- (10-15 %) in ETP within facility & send to 1-yl-acetate) common ETP of (M/s. CETP- Scrubbing Scrubber Saykha) Solution (4-methoxy-3,5- SCH-II- 21 365 Sodium Nitrite dimethylpyridin-2- Class B(15) (10-15 %) yl)methanol

*Justification for spent solvent generation & Captive reused Fresh Qty. Qty. Used Product Name Solvent Qty. Used Recovered MT/MT MT/MT MT/MT Acetonitrile 0.32 7.68 8.00 Methanol 0.48 11.52 12.00 GA=Lurasidone Acetone 0.36 11.64 12.00 Hydrochloride Toluene 0.40 7.60 8.00 IPA 0.24 5.76 6.00 Total MT/MT 1.8 44.2 46 Total MT/Month 72 1768 1840 Total MT/Year 864 21216 22080 Fresh Qty. Qty. Used Product Name Solvent Qty. Used Recovered MT/MT MT/MT MT/MT GB=2-Amino-3-methyl- Methanol 0.64 15.36 16.00 butyric acid methyl ester Toluene 0.50 9.50 10.00 hydrochlorie Total MT/MT 1.14 24.86 26 Total MT/Month 34.2 745.8 780 Total MT/Year 410.4 8949.6 9360 ii Membership details of TSDF, CHWIF etc. Company has membership of TSDF & Incineration Facility of (For HW management) M/s.BEIL,Dahej dated 20/11/2019. iii Details of Non-Hazardous waste & its disposal No such waste will be generated. (MSW and others)

G Solvent management, VOC emissions etc. i Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format) solv solvent Losses in air ent Tot Qty Los Dis Va al Sol Va . s in till po Qty. Lo ven po Re Sol Sol (Effl ati Sr. F. ur Use Solv ss t Product Solven B.P. ur cov ven ven Sub uen on No P. Pr d ent es Rec Name t °C de ere t t Tot t - Re . °C es MT/ Ope (A ove ns d Loa Han al stri sid su MT rati + ry ity MT/ din dlin (A) ppe ue re on B+ % MT g g d (C) C) out) (B) 1 Lornoxica Tetra - 66 19 2. 0.81 0.7 0.0 0.0 0.00 0.0 0.00 0.0 0.0 96

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m hydro 14 .3 5 8 008 012 20 041 81 20 32 furan .5 3 4 0.0 0.0 Toluen 110. 3. 3. 1.3 0.0 0.0 0.00 0.0 0.01 2 Meloxicam 4 1.4 49 70 95 e 6 8 1 3 014 021 35 070 40 0 0 0.0 0.0 Atovaquon Methan 12 1. 2.0 0.0 0.0 0.00 0.0 0.02 3 9 64.7 2.13 53 85 96 e ol .9 1 4 021 032 53 107 13 2 2 0.0 0.0 Luliconazol Methan 12 1. 1.2 0.0 0.0 0.00 0.0 0.01 4 9 64.7 1.28 32 51 96 e ol .9 1 3 013 019 32 064 28 0 2 0.0 0.0 N 47 2. 0.6 0.0 0.0 0.00 0.0 0.00 MDC 39.6 0.66 09 19 97 A .4 9 4 007 010 17 033 66 Voriconazo 9 8 5 le - 0.0 0.0 19 2. 0.5 0.0 0.0 0.00 0.0 0.00 THF 14 66 0.55 13 22 96 .3 5 3 006 008 14 028 55 .5 8 0 0.0 0.0 Aceton - 1.1 0.0 0.0 0.00 0.0 0.01 56 24 2 1.22 18 36 97 e 20 8 012 018 31 061 22 Glimepirid 3 6 6 e 0.0 0.0 Methan 12 1. 0.5 0.0 0.0 0.00 0.0 0.00 9 64.7 0.56 19 28 95 ol .9 1 3 006 008 14 028 56 6 0 0.0 0.0 Toluen 110. 3. 3. 1.7 0.0 0.0 0.00 0.0 0.01 4 1.81 63 90 95 e 6 8 1 2 018 027 45 091 81 4 5 0.0 0.0 Oxcarbaze Methan 12 1. 0.13 0.1 0.0 0.0 0.00 0.0 0.00 7 9 64.7 03 05 96 pine ol .9 1 1 3 001 002 03 007 13 3 2 0.0 0.0 Acetic 1. 2. 0.2 0.0 0.0 0.00 0.0 0.00 40 118 0.24 08 12 95 Acid 5 1 3 002 004 06 012 24 4 0 Metoclopra 0.0 0.0 mide N 4. 2. 2.1 0.0 0.0 0.00 0.0 0.02 8 IPA 82.5 2.24 56 89 96 Hydrochlor A 4 1 5 022 034 56 112 24 0 6 ide 2-N-Butyl- 3(4- 0.0 0.0 Hydroxy Methan 12 1. 1.1 0.0 0.0 0.00 0.0 0.01 9 9 64.7 1.2 30 48 96 Benzoyl) ol .9 1 5 012 018 30 060 20 0 0 Benzofura n 0.0 0.0 Sulphona Toluen 110. 3. 3. 0.6 0.0 0.0 0.00 0.0 0.00 10 4 0.72 25 36 95 mide e 6 8 1 8 007 011 18 036 72 2 0 N,N- 0.0 0.1 Diethyl Toluen 110. 3. 3. 1.9 0.0 0.0 0.00 0.0 0.02 11 4 2 70 00 95 Ethylene e 6 8 1 0 020 030 50 100 00 0 0 Diamine Ethyl 0.0 0.0 2 – Chloro 1.2 0.0 0.0 0.00 0.0 0.01 12 Acetat -4 77.1 10 3 1.31 32 52 96 Ethyl Ether 6 013 020 33 066 31 e 8 4 Mebendaz Methan 12 1. 0.2 0.0 0.0 0.00 0.0 0.00 0.0 0.0 13 9 64.7 0.28 96 ole ol .9 1 7 003 004 07 014 28 07 11

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0 2 0.0 0.0 Benze - 2. 1.2 0.0 0.0 0.00 0.0 0.01 80 10 1.29 32 51 96 ne 11 7 4 013 019 32 065 29 3 6 Meta 0.0 0.0 Bromo Methan 12 1. 0.1 0.0 0.0 0.00 0.0 0.00 14 9 64.7 0.2 05 08 96 Nitro ol .9 1 9 002 003 05 010 20 0 0 Benzene 0.1 0.2 Methan 12 1. 5.6 0.0 0.0 0.01 0.0 0.05 9 64.7 5.83 45 33 96 ol .9 1 0 058 087 46 292 83 8 2 Ethyl 0.1 0.2 4.8 0.0 0.0 0.01 0.0 0.05 15 Sidosin Acetat -4 77.1 10 3 5 25 00 96 0 050 075 25 250 00 e 0 0 0.1 0.2 18 59 2. 3.9 0.0 0.0 0.01 0.0 0.04 DMSO 189 4.17 46 08 95 .5 .4 7 6 042 063 04 209 17 0 5 3-(Trifluoro 0.0 0.1 N 47 2. 3.3 0.0 0.0 0.00 0.0 0.03 Methyl) 5, MDC 39.6 3.41 51 02 97 A .4 9 1 034 051 85 171 41 6, 7, 8- 2 3 Tetra 0.0 0.1 - 7. 3. 3.1 0.0 0.0 0.00 0.0 0.03 16 Hydro (4, TEA 89 3.24 81 29 96 17 2 5 1 032 049 81 162 24 3-A) 0 6 Pyrazine Ethyl 0.1 0.2 6.0 0.0 0.0 0.01 0.0 0.06 Hydrochlor Acetat -4 77.1 10 3 6.25 56 50 96 0 063 094 56 313 25 ide e 3 0 0.1 0.1 Toluen 110. 3. 3. 2.9 0.0 0.0 0.00 0.0 0.03 4 3.07 07 53 95 e 6 8 1 2 031 046 77 154 07 5 5 0.3 0.4 Toluen 110. 3. 3. 9.3 0.0 0.0 0.02 0.0 0.09 4 9.8 43 90 95 e 6 8 1 1 098 147 45 490 80 0 0 0.1 0.1 Toluen 110. 3. 3. 3.4 0.0 0.0 0.00 0.0 0.03 4 3.62 26 81 95 e 6 8 1 4 036 054 91 181 62 7 0 0.0 0.0 Amlodipine Hexan - 0.9 0.0 0.0 0.00 0.0 0.01 17 68 17 3 1.01 25 40 96 Besylate e 22 7 010 015 25 051 01 3 4 0.0 0.0 Acetic 1. 2. 0.0 0.0 0.0 0.00 0.0 0.00 40 118 0.06 02 03 95 Acid 5 1 6 001 001 02 003 06 1 0 0.0 0.0 Hexan - 0.6 0.0 0.0 0.00 0.0 0.00 68 17 3 0.63 15 25 96 e 22 0 006 009 16 032 63 8 2 Ethyl 0.0 0.1 2.4 0.0 0.0 0.00 0.0 0.02 Acetat -4 77.1 10 3 2.5 62 00 96 0 025 038 63 125 50 e 5 0 0.0 0.0 Acetic 1. 2. 0.5 0.0 0.0 0.00 0.0 0.00 40 118 0.61 21 30 95 Acid 5 1 8 006 009 15 031 61 Lansopraz 4 5 18 ole 0.0 0.0 2. 3. 1.8 0.0 0.0 0.00 0.0 0.01 MIBK 14 116 1.95 68 97 95 1 45 5 020 029 49 098 95 3 5

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0.2 0.2 Toluen 110. 3. 3. 5.4 0.0 0.0 0.01 0.0 0.05 4 5.73 00 86 95 e 6 8 1 4 057 086 43 287 73 6 5 0.0 0.1 Toluen 110. 3. 3. 2.5 0.0 0.0 0.00 0.0 0.02 4 2.67 93 33 95 e 6 8 1 4 027 040 67 134 67 5 5 0.0 0.0 N 47 2. 1.3 0.0 0.0 0.00 0.0 0.01 MDC 39.6 1.34 20 40 97 A .4 9 0 013 020 34 067 34 1 2 0.0 0.0 11 4. 2. 2.1 0.0 0.0 0.00 0.0 0.02 IPA 82.5 2.2 55 88 96 .7 4 1 1 022 033 55 110 20 0 0 0.0 0.0 Aceton - 1.5 0.0 0.0 0.00 0.0 0.01 56 24 2 1.6 24 48 97 e 20 5 016 024 40 080 60 0 0 Ethyl 0.2 0.3 8.0 0.0 0.0 0.02 0.0 0.08 Acetat -4 77.1 10 3 8.33 08 33 96 0 083 125 08 417 33 e 3 2 Olmesarta Ethyl 0.1 0.2 5.7 0.0 0.0 0.01 0.0 0.06 19 n Acetat -4 77.1 10 3 6 50 40 96 6 060 090 50 300 00 Medoximil e 0 0 0.1 0.3 Aceton - 9.7 0.0 0.0 0.02 0.0 0.10 56 24 2 10 50 00 97 e 20 0 100 150 50 500 00 0 0 0.2 0.3 Toluen 110. 3. 3. 6.2 0.0 0.0 0.01 0.0 0.06 4 6.6 31 30 95 e 6 8 1 7 066 099 65 330 60 0 0 Ethyl 0.1 0.2 6.4 0.0 0.0 0.01 0.0 0.06 Acetat -4 77.1 10 3 6.67 66 66 96 0 067 100 67 334 67 e 8 8 0.1 0.2 Methan 12 1. 6.4 0.0 0.0 0.01 0.0 0.06 9 64.7 6.67 66 66 96 Lurasidone ol .9 1 0 067 100 67 334 67 8 8 20 Hydrochlor 0.2 0.3 ide Acetoni 9. 1. 7.6 0.0 0.0 0.02 0.0 0.08 2 82 8 00 20 96 trile 9 42 8 080 120 00 400 00 0 0 0.3 0.4 Methan 12 1. 11. 0.0 0.0 0.03 0.0 0.12 9 64.7 12 00 80 96 ol .9 1 52 120 180 00 600 00 0 0 0.1 0.3 Aceton - 11. 0.0 0.0 0.03 0.0 0.12 56 24 2 12 80 60 97 e 20 64 120 180 00 600 00 0 0 0.5 0.8 2-Benzyl 11 4. 2. 20.7 19. 0.0 0.0 0.05 0.1 0.20 IPA 82.5 19 30 96 Amino-1-6- .7 4 1 7 94 208 312 19 039 77 3 8 Fluoro-3-4- 0.3 0.4 Dihydro-2- Methan 12 1. 12.0 11. 0.0 0.0 0.03 0.0 0.12 21 9 64.7 01 81 96 H- ol .9 1 4 56 120 181 01 602 04 0 6 Chromen- 0.2 0.4 2-Yl- 11 4. 2. 11.2 10. 0.0 0.0 0.02 0.0 0.11 IPA 82.5 80 49 96 Ethanol .7 4 1 3 78 112 168 81 562 23 8 2 Trityl 0.0 0.0 0.6 0.0 0.0 0.00 0.0 0.00 22 Olmesarta EA -4 77.1 10 3 0.72 18 28 96 9 007 011 18 036 72 n 0 8

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Medoximil 0.1 0.3 Aceton - 9.7 0.0 0.0 0.02 0.0 0.10 56 24 2 10 50 00 97 e 20 0 100 150 50 500 00 0 0 0.1 0.2 5.7 0.0 0.0 0.01 0.0 0.06 EA -4 77.1 10 3 6 50 40 96 6 060 090 50 300 00 0 0 0.1 0.1 8. 3. 4.2 0.0 0.0 0.01 0.0 0.04 EDC 13 83 4.46 11 78 96 7 42 8 045 067 12 223 46 5 4 - 0.0 0.1 19 2. 3.5 0.0 0.0 0.00 0.0 0.03 THF 14 66 3.7 92 48 96 .3 5 5 037 056 93 185 70 .5 5 0 - 0.1 0.2 19 2. 6.2 0.0 0.0 0.01 0.0 0.06 THF 14 66 6.49 62 59 96 .3 5 3 065 097 62 325 49 .5 3 6 23 Etoricoxib - 0.1 0.2 19 2. 5.7 0.0 0.0 0.01 0.0 0.06 THF 14 66 6 50 40 96 .3 5 6 060 090 50 300 00 .5 0 0 0.1 0.2 Toluen 110. 3. 3. 4.7 0.0 0.0 0.01 0.0 0.05 4 5 75 50 95 e 6 8 1 5 050 075 25 250 00 0 0 0.0 0.0 Hexan - 1.9 0.0 0.0 0.00 0.0 0.02 68 17 3 2 50 80 96 e 22 2 020 030 50 100 00 0 0 0.0 0.1 Methan 12 1. 3.3 0.0 0.0 0.00 0.0 0.03 9 64.7 3.48 87 39 96 ol .9 1 4 035 052 87 174 48 0 2 0.0 0.0 - 1.7 0.0 0.0 0.00 0.0 0.01 hexane 68 17 3 1.83 45 73 96 22 6 018 027 46 092 83 8 2 0.0 0.0 11 4. 2. 1.7 0.0 0.0 0.00 0.0 0.01 IPA 82.5 1.83 45 73 96 .7 4 1 6 018 027 46 092 83 8 2 Atorvastati 0.0 0.1 Acetoni 9. 1. 2.8 0.0 0.0 0.00 0.0 0.02 24 n Calcium 2 82 2.94 73 17 96 trile 9 42 2 029 044 74 147 94 Trihydrate 5 6 0.0 0.0 11 4. 2. 1.4 0.0 0.0 0.00 0.0 0.01 IPA 82.5 1.47 36 58 96 .7 4 1 1 015 022 37 074 47 8 8 0.0 0.1 Methan 12 1. 2.8 0.0 0.0 0.00 0.0 0.03 9 64.7 3 75 20 96 ol .9 1 8 030 045 75 150 00 0 0 0.0 0.1 Toluen 110. 3. 3. 1.9 0.0 0.0 0.00 0.0 0.02 4 2 70 00 95 e 6 8 1 0 020 030 50 100 00 0 0 0.2 0.4 Methan 12 1. 11.7 11. 0.0 0.0 0.02 0.0 0.11 9 64.7 94 70 96 ol .9 1 6 29 118 176 94 588 76 0 4 0.3 0.4 Omeprazol Toluen 110. 3. 3. 9.0 0.0 0.0 0.02 0.0 0.09 25 4 9.54 33 77 95 e e 6 8 1 6 095 143 39 477 54 9 0 0.1 0.2 Toluen 110. 3. 3. 5.0 0.0 0.0 0.01 0.0 0.05 4 5.32 86 66 95 e 6 8 1 5 053 080 33 266 32 2 0

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0.0 0.1 Methan 12 1. 2.4 0.0 0.0 0.00 0.0 0.02 9 64.7 2.5 62 00 96 ol .9 1 0 025 038 63 125 50 5 0 0.0 0.0 Hexan - 0.6 0.0 0.0 0.00 0.0 0.00 68 17 3 0.7 17 28 96 e 22 7 007 011 18 035 70 5 0 0.0 0.1 Toluen 110. 3. 3. 2.1 0.0 0.0 0.00 0.0 0.02 4 2.22 77 11 95 e 6 8 1 1 022 033 56 111 22 7 0 0.1 0.1 Ethano 5. 1. 3.8 0.0 0.0 0.01 0.0 0.04 12 79 4 00 60 96 l 8 6 4 040 060 00 200 00 0 0 0.0 0.0 Methan 12 1. 1.3 0.0 0.0 0.00 0.0 0.01 9 64.7 1.44 36 57 96 ol .9 1 8 014 022 36 072 44 0 6 0.0 0.0 11 4. 2. 2.2 0.0 0.0 0.00 0.0 0.02 26 Pregabalin IPA 82.5 2.29 57 91 96 .7 4 1 0 023 034 57 115 29 3 6 0.0 0.0 Ethano 5. 1. 0.2 0.0 0.0 0.00 0.0 0.00 12 79 0.29 07 11 96 l 8 6 8 003 004 07 015 29 3 6 0.2 0.3 11 4. 2. 8.3 0.0 0.0 0.02 0.0 0.08 IPA 82.5 8.73 18 49 96 .7 4 1 8 087 131 18 437 73 3 2 - 0.2 0.3 19 2. 7.8 0.0 0.0 0.02 0.0 0.08 THF 14 66 8.18 04 27 96 .3 5 5 082 123 05 409 18 .5 5 2 0.1 0.2 11 4. 2. 4.8 0.0 0.0 0.01 0.0 0.05 IPA 82.5 5.09 27 03 96 .7 4 1 9 051 076 27 255 09 3 6 0.2 0.3 0. 2. 5.9 0.0 0.0 0.01 0.0 0.06 DMF 58 153 6.25 18 12 95 49 5 4 063 094 56 313 25 8 5 0.1 0.1 Toluen 110. 3. 3. 3.1 0.0 0.0 0.00 0.0 0.03 4 3.33 16 66 95 e 6 8 1 6 033 050 83 167 33 6 5 0.0 0.1 N 47 2. 3.8 0.0 0.0 0.01 0.0 0.04 MDC 39.6 4 60 20 97 A .4 9 8 040 060 00 200 00 0 0 0.1 0.2 Methan 12 1. 6.9 0.0 0.0 0.01 0.0 0.07 Fexofenadi 9 64.7 7.21 80 88 96 ol .9 1 2 072 108 80 361 21 ne 3 4 27 Hydrochlor 0.1 0.2 Methan 12 1. 4.8 0.0 0.0 0.01 0.0 0.05 ide 9 64.7 5 25 00 96 ol .9 1 0 050 075 25 250 00 0 0 - 0.1 0.2 19 2. 4.8 0.0 0.0 0.01 0.0 0.05 THF 14 66 5 25 00 96 .3 5 0 050 075 25 250 00 .5 0 0 0.1 0.1 Toluen 110. 3. 3. 3.1 0.0 0.0 0.00 0.0 0.03 4 3.33 16 66 95 e 6 8 1 6 033 050 83 167 33 6 5 0.0 0.0 2. 3. 0.2 0.0 0.0 0.00 0.0 0.00 MIBK 14 116 0.31 10 15 95 1 45 9 003 005 08 016 31 9 5

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Ethyl 0.1 0.2 6.8 0.0 0.0 0.01 0.0 0.07 Acetat -4 77.1 10 3 7.14 78 85 96 5 071 107 79 357 14 e 5 6 0.2 0.3 Methan 12 1. 8.0 0.0 0.0 0.02 0.0 0.08 9 64.7 8.42 10 36 96 ol .9 1 8 084 126 11 421 42 5 8 0.2 0.3 11 4. 2. 7.6 0.0 0.0 0.02 0.0 0.08 IPA 82.5 8 00 20 96 .7 4 1 8 080 120 00 400 00 0 0 0.0 0.1 Toluen 110. 3. 3. 2.3 0.0 0.0 0.00 0.0 0.02 4 2.42 84 21 95 e 6 8 1 0 024 036 61 121 42 7 0 0.0 0.1 Aceton - 3.3 0.0 0.0 0.00 0.0 0.03 56 24 2 3.48 52 04 97 e 20 8 035 052 87 174 48 2 4 0.0 0.1 Quetiapine Toluen 110. 3. 3. 2.3 0.0 0.0 0.00 0.0 0.02 28 4 2.5 87 25 95 Fumarate e 6 8 1 8 025 038 63 125 50 5 0 0.0 0.0 Methan 12 1. 1.9 0.0 0.0 0.00 0.0 0.02 9 64.7 2 50 80 96 ol .9 1 2 020 030 50 100 00 0 0 0.0 0.1 Toluen 110. 3. 3. 1.9 0.0 0.0 0.00 0.0 0.02 4 2 70 00 95 e 6 8 1 0 020 030 50 100 00 0 0 0.3 0.6 Methan 12 1. 15.7 15. 0.0 0.0 0.03 0.0 0.15 9 64.7 93 29 96 ol .9 1 3 10 157 236 93 787 73 3 2 0.1 0.1 Chlorof N 21 4. 4.2 0.0 0.0 0.01 0.0 0.04 62 4.38 09 75 96 orm A 2 2 0 044 066 10 219 38 5 2 0.0 0.0 Hexan - 1.3 0.0 0.0 0.00 0.0 0.01 68 17 3 1.37 34 54 96 e 22 2 014 021 34 069 37 3 8 0.0 0.1 Telmisarta Aceton - 3.5 0.0 0.0 0.00 0.0 0.03 29 56 24 2 3.66 54 09 97 n e 20 5 037 055 92 183 66 9 8 0.1 0.3 N 47 2. 10.4 10. 0.0 0.0 0.02 0.0 0.10 MDC 39.6 56 12 97 A .4 9 3 12 104 156 61 522 43 5 9 0.2 0.3 Methan 12 1. 8.3 0.0 0.0 0.02 0.0 0.08 9 64.7 8.7 17 48 96 ol .9 1 5 087 131 18 435 70 5 0 0.2 0.3 Methan 12 1. 7.9 0.0 0.0 0.02 0.0 0.08 9 64.7 8.3 07 32 96 ol .9 1 7 083 125 08 415 30 5 0 0.4 0.6 Methan 12 1. 15. 0.0 0.0 0.04 0.0 0.16 9 64.7 16 00 40 96 ol .9 1 36 160 240 00 800 00 0 0 0.3 0.5 Toluen 110. 3. 3. 9.5 0.0 0.0 0.02 0.0 0.10 30 Valsartan 4 10 50 00 95 e 6 8 1 0 100 150 50 500 00 0 0 0.2 0.3 Toluen 110. 3. 3. 6.3 0.0 0.0 0.01 0.0 0.06 4 6.67 33 33 95 e 6 8 1 4 067 100 67 334 67 5 5

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0.2 0.3 Toluen 110. 3. 3. 6.6 0.0 0.0 0.01 0.0 0.07 4 7 45 50 95 e 6 8 1 5 070 105 75 350 00 0 0 0.0 0.1 138. 0. 3. 2.2 0.0 0.0 0.00 0.0 0.02 Xylene 27 2.4 84 20 95 4 9 7 8 024 036 60 120 40 0 0 0.2 0.3 Toluen 110. 3. 3. 6.6 0.0 0.0 0.01 0.0 0.07 4 7 45 50 95 e 6 8 1 5 070 105 75 350 00 0 0 0.0 0.1 N 47 2. 4.8 0.0 0.0 0.01 0.0 0.05 MDC 39.6 5 75 50 97 A .4 9 5 050 075 25 250 00 0 0 0.0 0.0 - 1.9 0.0 0.0 0.00 0.0 0.02 hexane 68 17 3 2 50 80 96 22 2 020 030 50 100 00 0 0 0.2 0.3 Toluen 110. 3. 3. 7.1 0.0 0.0 0.01 0.0 0.07 4 7.5 62 75 95 e 6 8 1 3 075 113 88 375 50 5 0 0.2 0.4 Methan 12 1. 10.8 10. 0.0 0.0 0.02 0.0 0.10 9 64.7 70 32 96 ol .9 1 1 38 108 162 70 541 81 3 4 0.0 0.0 1.9 0.0 0.0 0.00 0.0 0.02 EA -4 77.1 10 3 2 50 80 96 2 020 030 50 100 00 0 0 Venlafaxin 0.0 0.0 e 11 4. 2. 1.9 0.0 0.0 0.00 0.0 0.02 31 IPA 82.5 2 50 80 96 Hydrochlor .7 4 1 2 020 030 50 100 00 0 0 ide 0.1 0.2 N 47 2. 7.7 0.0 0.0 0.02 0.0 0.08 MDC 39.6 8 20 40 97 A .4 9 6 080 120 00 400 00 0 0 0.1 0.2 6.7 0.0 0.0 0.01 0.0 0.07 EA -4 77.1 10 3 7 75 80 96 2 070 105 75 350 00 0 0 0.1 0.1 Methan 12 1. 3.8 0.0 0.0 0.01 0.0 0.04 9 64.7 4 00 60 96 ol .9 1 4 040 060 00 200 00 0 0 0.0 0.0 Methan 12 1. 2.1 0.0 0.0 0.00 0.0 0.02 9 64.7 2.22 55 88 96 ol .9 1 3 022 033 56 111 22 5 8 0.1 0.1 Toluen 110. 3. 3. 3.1 0.0 0.0 0.00 0.0 0.03 4 3.33 16 66 95 e 6 8 1 6 033 050 83 167 33 6 5 0.0 0.1 Toluen 110. 3. 3. 2.4 0.0 0.0 0.00 0.0 0.02 4 2.56 89 28 95 e 6 8 1 3 026 038 64 128 56 Lacosamid 6 0 32 e 0.0 0.0 Aceton - 2.3 0.0 0.0 0.00 0.0 0.02 56 24 2 2.4 36 72 97 e 20 3 024 036 60 120 40 0 0 0.0 0.0 N 47 2. 3.1 0.0 0.0 0.00 0.0 0.03 MDC 39.6 3.2 48 96 97 A .4 9 0 032 048 80 160 20 0 0 0.0 0.1 N 47 2. 6.3 0.0 0.0 0.01 0.0 0.06 MDC 39.6 6.52 97 95 97 A .4 9 2 065 098 63 326 52 8 6

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0.1 0.1 11 4. 2. 4.1 0.0 0.0 0.01 0.0 0.04 IPA 82.5 4.35 08 74 96 .7 4 1 8 044 065 09 218 35 8 0 0.0 0.0 Toluen 110. 3. 3. 1.5 0.0 0.0 0.00 0.0 0.01 4 1.67 58 83 95 e 6 8 1 9 017 025 42 084 67 5 5 0.0 0.1 N 47 2. 3.5 0.0 0.0 0.00 0.0 0.03 MDC 39.6 3.64 54 09 97 A .4 9 3 036 055 91 182 64 6 2 0.1 0.1 3.8 0.0 0.0 0.01 0.0 0.04 EA -4 77.1 10 3 4 00 60 96 4 040 060 00 200 00 0 0 0.0 0.0 N 47 2. 1.1 0.0 0.0 0.00 0.0 0.01 MDC 39.6 1.17 17 35 97 A .4 9 3 012 018 29 059 17 6 1 - 0.0 0.0 19 2. 0.6 0.0 0.0 0.00 0.0 0.00 THF 14 66 0.63 15 25 96 .3 5 0 006 009 16 032 63 .5 8 2 0.0 0.0 - 15 3. 0.4 0.0 0.0 0.00 0.0 0.00 DIPE 68 0.47 11 18 96 28 .9 5 5 005 007 12 024 47 8 8 0.0 0.0 N 47 2. 0.4 0.0 0.0 0.00 0.0 0.00 MDC 39.6 0.44 06 13 97 A .4 9 3 004 007 11 022 44 6 2 0.0 0.0 - 15 3. 0.4 0.0 0.0 0.00 0.0 0.00 DIPE 68 0.48 12 19 96 28 .9 5 6 005 007 12 024 48 0 2 Ethyl 0.0 0.0 0.4 0.0 0.0 0.00 0.0 0.00 Acetat -4 77.1 10 3 0.44 11 17 96 2 004 007 11 022 44 e 0 6 L-(3- 0.0 0.0 Methyl-L- 11 4. 2. 0.2 0.0 0.0 0.00 0.0 0.00 IPA 82.5 0.22 05 08 96 Phenyl-L- .7 4 1 1 002 003 06 011 22 5 8 33 Pyrazol-5- 0.0 0.0 Y-) N 47 2. 0.9 0.0 0.0 0.00 0.0 0.00 MDC 39.6 0.93 14 27 97 Piperazine A .4 9 0 009 014 23 047 93 0 9 Acetate 0.0 0.0 Aceton - 0.4 0.0 0.0 0.00 0.0 0.00 56 24 2 0.42 06 12 97 e 20 1 004 006 11 021 42 3 6 0.0 0.0 18 59 2. 0.7 0.0 0.0 0.00 0.0 0.00 DMSO 189 0.82 28 41 95 .5 .4 7 8 008 012 21 041 82 7 0 0.0 0.0 - 7. 3. 0.4 0.0 0.0 0.00 0.0 0.00 TEA 89 0.45 11 18 96 17 2 5 3 005 007 11 023 45 3 0 0.0 0.0 0. 2. 0.7 0.0 0.0 0.00 0.0 0.00 DMF 58 153 0.8 28 40 95 49 5 6 008 012 20 040 80 0 0 0.0 0.0 N 47 2. 0.7 0.0 0.0 0.00 0.0 0.00 MDC 39.6 0.73 11 21 97 A .4 9 1 007 011 18 037 73 0 9 0.0 0.0 Toluen 110. 3. 3. 0.6 0.0 0.0 0.00 0.0 0.00 4 0.7 24 35 95 e 6 8 1 7 007 011 18 035 70 5 0

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ii VOC emission sources and its mitigation measures Sources - Charging Materials Measures - Enclose Process - Minimum flanges & joints - Handled by pump with double mechanical seals - Proper Ventilation - Adequate PPEs

H Safety Detail  Details regarding storage of Hazardous chemicals Storage details Name of major Hazardous chemicals Remarks Storage tanks Methanol (10 KL X1), Acetone (10 KL X1), IPA(10 KL X1),, Hydrochloric Acid, (5 KL X1), Sulphuric Acid, (5 KL X1), Oleum. (5 KL X2),

 Applicability of PESO : Yes Applicable (Will be Obtained)

 Safety details of Hazardous chemicals (To be stored in storage tanks) PESO Tank Area Storage & Handling Safety:  The underground vessels shall be placed within concrete or brick masonry pit with a gap of 1.0 meter between the walls of the pit and the vessel as well as in between the vessels.  The underground vessels shall be installed on a firm foundation and firmly secured to the foundation so as to prevent movement of floatation.  Class A Petroleum products will be received through road tanker and stored in u/g storage tank as per PESO Rule.  Tank farm will be constructed as per explosive department requirement and separation distance will be maintained.  The underground vessels covered by earth (Mound) shall be a designed to withstand external pressure due to load of the earth cover.  Provided with external anti-corrosive coating or cathodic protection to prevent corrosion ;  Covered by earth, sand or any other non-corrosive material free from abrasive particles likely to damage the anti-corrosive coating of the vessel-the thickness of the covering material above the top surface of the vessel shall not be less than 0.5 meter;  Having the discharge level of the safety relief valves at least 2 meters above the top surface of the vessel, but in any case not less than 3 meters from the ground level;  Fitted with the necessary piping's, fittings, valves and other mounting on top of vessel in such a manner that they can be operated and maintained without disturbing the earth cover. In case of above ground vessel with earth cover (mound), liquid outlet pipe at the bottom may be allowed provided the control valve and emergency valve of this line is just outside the earth cover for the purpose of operation and maintenance from outside.  Static earthing provision will be made for road tanker as well as storage tank.  Flame arrestor with breather valve will be provided on vent line.  Road tanker unloading procedure will be prepared and implemented.  Fire load calculation will be done and as per fire load hydrant system will be provided as per NFPA std. and fire extinguishers will be provided as per fire load calculation.  Spark arrestor will be provided to all vehicles in side premises  Lightening arrestor will be provided on the top.  Flame proof type equipment and lighting will be provided.  Trained and experience operator will be employed for tank farm area.

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 NFPA label (hazard identification) capacity and content will be displayed on tanks  Solvents will be transferred by pump only in plant area and day tank will be provided. Overflow line will be return to the storage tank or Pump On-Off switch will be provided near day tank in plant.  Jumpers will be provided on solvent handling pipe line flanges & Flexible SS hose will be used for road tanker unloading purpose and other temp. connection  Ensure that the transfer of petroleum takes place only through electrically continuous sound hose having oil tight couplings at both ends.  Couplings of the hose at the discharge ends of the tank trucks as well as at the fill pipe end of the underground tank shall not be leaky.  Unloading operations should not commence without ensuring earthing of the tanker bodto a proper earthing point. For this purpose, a proper earthing point shall be provided near filling points.  Before commencing unloading operations tanker should be parked in the retail outlet in such a manner that it can be taken out of the retail outlet immediately in case of emergency.  Dip pipe of the underground tank shall not be kept open during unloading operations.  The dealer, supervisors and pump attendants shall be trained in all aspects of safety in RO including the provisions of Petroleum Rules, 2002 in Chapter IV on Electric Installation, Rules 117 to 119,122,125 and conditions 6 to 12, 15,16,18 to 21of licence Form XIV for the RO‘s under the said Rules.  Before starting unloading of petroleum, it must be ensured that at least a safe distance of 3 M is kept clear of any kind of movement of other vehicles that come for fuelling and that there is no source of any spark in the area. In case of retail outlets that are in congested areas operations of fuelling automobiles in the retail outlet may be discontinued.  Do not use plastic hose pipes for unloading purposes.  Do not use hose pipe fitted with metallic pipe (bent pipe) at the discharge end.  Do not use Hose pipes not conforming to OISD 135.  Proper tightening of those connections using screwed/cam lock couplings.  Make sure that there shall be no collection of leaked petroleum through hose pipe connection at tanker discharge faucet end in the plastic bucket kept on the ground below.  Provision of electrical earthing / bonding by means of flexible cable between tanker chassis and earth boss/fill pipe.  Proper training to the retail outlet staff regarding hazards associated with the petroleum road tanker decantation operation in the retail outlets. NON PESO Tank Area Storage & Handling Safety:  Leakage / spillage mitigation plan  Tank shall be rubber lined to prevent the corrosion  Dyke wall shall be provided for containment  Rubber type hand gloves and chemical splash goggles and full-face cartridge type mask and PVC apron shall be used while manual handling  Lime shall be readily available during leak to neutralize the spill material  Safety shower, eye wash with quenching unit will be provided in acid storage area.  Material will be handled in close condition in pipe line.  Double drain valve will provided.  Level gauge will be provided on all storage tanks.  Fire hydrant system with jockey pump as per TAC norms will be installed Safety measures for Acid storage Tank:  Storage tank will be stored away from the process plant.  Tanker unloading procedure will be prepared and implemented.  Caution note and emergency handling procedure will be displayed at unloading area and trained all operators.  NFPA label will be provided.  Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator.  Neutralizing agent will be kept ready for tackle any emergency spillage.  Safety shower, eye wash with quenching unit will be provided in acid storage area.  Material will be handled in close condition in pipe line.

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 Dyke wall will be provided to all storage tanks, collection pit with valve provision.  Double drain valve will provided.  Level gauge will be provided on all storage tanks.  Safety permit for loading unloading of hazardous material will be prepared and implemented. TREM CARD will be provided to all transporters and will be trained for transportation Emergency of Hazardous chemicals.  Fire hydrant system with jockey pump as per TAC norms will be installed. ii Process safety details : (If applicable) 5. Hydrogenation process  Provisions of safety valve & rupture disk on reactor.  Provisions of auto dumping Vessel.  PLC (Programmable Logical Control base process controls and operation of plant will be installed.  All electrical equipment‗s shall be installed as per Hazardous Area Classification.  Total enclosed process system.  Instrument & Plant Air System.  Nitrogen blanketing in Hydrogenation reactor.  Safety valve and Rupture disc provided on reactor.  Cooling, Chilling and alternate power arrangement have been made on reactor.  Process area and Hydrogen cylinder bank shall be far away as per standards practice.  PRV station ith shut off valve, safety valve provision will be made for hydrogenation reaction safety.  Standard Operating procedure shall be followed during operation of Hydrogen Gas charging in to reactor and after completion of reaction Nitrogen purging will be done.  Flame arrestor will be provided on vent line of reactor and it will be extended above the roof level.  Safe Catalyst charging method will be adopted.  SOP will be prepared and operators will be trained for the same.  Static earthing and electric earthing (Double) will be provided.  Jumpers for static earthing on pipeline flanges of flammable chemical will be provided.  Hydrogen gas detector will be installed for early detection of gas leak.

6. Nitration process  Provisions of safety valve & rupture disk on reactor.  Provisions of auto dumping Vessel.  SOP will be displayed for safe charging of Nitric acid for nitration process.  Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator at time of nitric acid charging.  Make sure the absorber unit (two stage Alkali scrubber) will be working and capable of handling vented NO2 fumes.  Neutralizing agent will be kept ready for tackle any emergency spillage.  Safety Shower and eye wash will be provided near process area.  Total close process will be adopted (from storage tank to measured vessel & then to reactor) for Nitric Acid charging.  Caution note and emergency first aid will be displayed and train for the same to all employees.  First Aid Boxes will be available in process area.  Prevention measures for runaway reaction of nitration reaction. • Instrumentation control • Rotameter • Level alarms • TIC (Temperature Indictor & Controller) - jacket as well as the reactor • Emergency control measures: • Flushing water (chilled water / ice quenching) to control the runaway reaction. • Provision of Drainage of the contents of the nitrator.

7. Sulphonation / Chlorination Process safety measures: (Through Thionyl Chloride)

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 Required PPEs like full body protection PVC apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator.  To avoid runaway reaction, TC charging will be done gradually & slowly.  Charging will be done only through closed line and system. Scrubber attached with closed system.  Make sure the absorber unit (two stage Alkali scrubber) is working and capable of handling vented SO2 / HCl fumes.  Neutralizing agent will be kept ready for tackle any emergency spillage.  Safety Shower and eye wash will be provided near process area.  For Thionyl Chloride evacuate area in down wind direction up to 0.3 km ( 300 meter) in small spillage.  Emergency siren and wind sock will be provided.  Tele Communication system and mobile phone will be used in case of emergency situations for communication.  Total close process will be adopted for Thionyl chloride charging.  Caution note and emergency first aid will be displayed and train for the same to all employees.  First Aid Boxes will be available in process area.  Emergency organization and team will be prepared as per On site-Off site emergency planning.  Emergency team will be prepared and trained for scenario base emergency. Like Toxic control team, Fire control team, First aid team, communication and general administration team, Medical team etc.  Do not touch damaged containers or spilled material unless wearing appropriate protective clothing.  Use water spray to reduce vapors; do not put water directly on leak, spill area or inside container. Keep combustibles (wood, paper, oil, etc.) away from spilled material.  Cover with DRY earth, DRY sand or other non-combustible material followed with plastic sheet to minimize spreading or contact with rain.

8. Bromination  All end nozzles in bromine charging hose will be blinded after use.  Charging of bromine will be done when reactor is in vacuum and POP coated funnel will be used during charging.  Excess bromine will be neutralize or discharged by adding Sodium Bisulfite.  Make sure the absorber unit (scrubber) is working and capable of handling vented bromine fumes.  Structure of bromine bottle area will be periodically inspected to ensure stability.  Personnel employed with bromine handling are made aware of potential hazards of bromine and of appropriate first-aid measure.  Exhaust hood connected with alkali scrubber and ventilation system will be available. Exhaust hood has been provided to maintain to concentration of bromine vapor well below PEL.  Work instructions for bromine charging will be displayed in local language/Hindi.  Safety shower and eye-wash fountains will be available nearby handling and charging facility. The location of such item will be inspected and tested at fixed interval to make sure that it is in good condition.  Hypo solution, lime water slurry or soda ash solutions will be available so as to pour them over a liquid bromine spill on the floor. The bromine and neutralizer is then washed to the sump with cold water hose.  Personal Hygiene – the following personal protective equipment will be used.  Chemical safety goggles, face shields, SCBA sets, Aprons, rubber gloves, etc.  Only trained employees handled bromine charging. Training will be given to employees for bromine handling and charging.

9. Chlorination Process safety measures: (During Chlorine Gas)  Chlorine Emergency Kit will be procured and kept ready at process site.  Chlorine Hood with blower will be provided with scrubbing arrangement.  SCBA sets will be kept ready at site.  Safety Shower and eye wash will be provided in process area.  Chlorine absorption system will be provided. In case of chlorine leakage in chlorine shed it will be suck

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through blower and it will be scrubbed in Caustic scrubber.  Emergency siren and wind sock will be provided.  Tele Communication system and mobile phone will be used in case of emergency situations for communication.  First Aid Boxes and Occupational health centre will be made at site.  Emergency organization and team will be prepared as per On site-Off site emergency planning.  Full body protection suite and other PPEs will be kept ready at site.  Emergency team will be prepared and trained for scenario base emergency. Like Toxic control team, Fire control team, First aid team, Communication and general administration team, Medical team etc. Evacuate the area in down wind direction  For Chlorine evacuate area in down wind direction up to 0.4 km ( 400 meter) in small spillage and in case of large spillage, evacuate the area in down wind direction 3.5 kms (3500 meters).  SOP will be prepared for safe charging of Chlorine tonners.  Tonner handling EOT crane will be installed in Chlorine shed area for safe tonner handling.  Safety Valve will be provided on chlorine header line and it will be connected to caustic scrubber.  Safety valve will be provided on vaporizer header and outlet of safety valve connected to scrubber.  Flow and temperature controllers will be provided on process line.  Chlorine Gas detectors will be provided in process area.

 During the video conference meeting dated 30/05/2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & relevant documents.  Committee noted that the proposal is for new unit and proposed at GIDC Saykha. PP submitted details regarding area adequacy. PP proposed 33% of greenbelt area within premises.  PP submitted that industrial effluent generated from process will be segregated into Concentrated and Dilute stream out of which concentrated stream will be sent to CMEE of M/s. BEIL, Dahej. Dilute stream along with washing, cooling & boiler blow down and spent scrubbing liquor (NaCl & NaNO2 solution) will be treated in-house in ETP(primary & Secondary treatment) and then treated effluent will be discharge into CETP – Saykha for further treatment and disposal. The spent scrubbing liquor, NaBr/HBr & Na2SO3, will be sell to end user having permission under rule 9. The spent scrubbing liquor, Liq. NH3, will be reused within premises. Domestic effluent will be disposed into soak pit via septic tank.  PP submitted that they have proposed one boiler and one DG set. Fuel used will be Bio- coal/Coal/Natural gas for Boiler and Diesel for DG set. PP submitted that they will provide separate MCD followed by bag filter as an APCM with boiler Flue gas stack. PP proposed 5 Nos of process stack and provide two stage scrubber as APCM therewith.  PP submitted Hazardous Waste Matrix as per HWR – 2016.  Committee deliberated on the EMP, CER, chemical storage & its safety and green belt development plan. Committee observed that in plant layout PP has shown the manufacturing and raw material storage side by side. Hence, committee ask PP to provide effective isolation in order to decrease the quantum of fire in case of fire accident.  PP submitted product profile with end use and membership certificate of common facility.  After detailed discussion, it was decided to recommend the project to SEIAA Gujarat for grant of Environmental Clearance.

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Conditions with which Environment Clearance is recommended:

SPECIFIC CONDITIONS: 1. PP shall comply conditions of any subsequent amendment or expansion or change in product mix, after the 30th September 2020, considered as per the provisions in force at that time as mentioned in the Notification vide S.O. 1223 (E) dated 27/03/2020. 2. PP shall not manufacture any products in proposed project/activities which are not qualifying the amended EIA Notification vide S.O. 1223 (E) dated 27/03/2020 and any subsequent amendments. 3. PP shall submit six monthly compliance report of Environmental Clearance without fail and the same shall be critically assessed by the regulatory authority. 4. R & D products shall be of similar chemistry and the pollution load shall remain the same as committed. 5. Project proponent shall not take continuous/commercial production of the R & D products. Necessary approvals shall be obtained from the concern authorities prior to commercial production of R & D products. 6. Project proponent shall provide continuous online monitoring system for waste water discharge to Common Facilities (CETP, Common MEE, Common, Spray dryer etc.) as per the prevailing guidelines of SPCB/GPCB and shall maintain records of the same thereof. 7. Treated waste water shall be sent to common facilities (CETP, Common MEE, Spray dryer etc.) only after complying with the inlet norms of common facilities prescribed by GPCB to ensure no adverse impact on Human Health and Environment. 8. PP shall adopt appropriate methods for segregation of waste water streams based on characteristics at source and its sound management keeping in view inlet norms of Common facilities prescribed by GPCB. 9. Close loop solvent recovery system with adequate condenser system shall be provided to recover solvent vapors in such a manner that recovery shall be maximum and recovered solvent shall be reused in the process within premises. 10. Leak Detection and Repair (LDAR) program shall be prepared and implemented as per the CPCB guidelines. LDAR Logbooks shall be maintained. 11. Safety: a) PP shall obtain PESO permission for the storage and handling of hazardous chemicals. (If applicable) b) Flame proof electrical fittings shall be provided in the plant premises, wherever applicable. c) Unit shall provide effective Isolation for Process area and storage of hazardous chemicals. d) Unit shall provide double earthling to solvent storage tanks/ area. e) Unit shall never store drum/barrels/carboys of incompatible material/chemical together.

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f) Unit shall provide chlorine leakage control emergency kit and FRP hood with scrubber system for chlorine safety. g) Unit shall provide water sprinkler to the ammonia storage cylinder. h) Unit shall Store Bromine Bottle in cool dry separate area, out of direct sunlight. i) Unit shall provide a spare tank with emergency transfer system and bund/ dyke wall to Oleum storage tank. j) Unit shall provide safety valve and rapture disc, as well as auto dump or auto quench/, suppress system for nitration vessel safety. k) Unit shall provide safety valve & rupture disc to the Hydrogenation vessel. 9 SIA/GJ/IND2/151498/2020 M/s. Laurel Life Science Reconsideration Plot No. 6507, GIDC Industrial Estate, Appraisal Ankleshwar – 393002, Dist – Bharuch. [Expansion]

Category of the unit: 5(f) Project status: Expansion  Project proponent (PP) submitted online application vide SIA/GJ/IND2/151498/2020 on dated 17/04/2020 for obtaining Environmental Clearance (EC).  Project proponent has submitted Form – 1, Pre-Feasibility Report & Environment Management Plan as per Notification issued by MoEF&CC vide S.O. 1223(E) dated 27th March, 2020 regarding consideration of proposals or activities in respect of Active Pharmaceuticals Ingredients (API) as B2 category.  This is an expansion project for manufacturing of synthetic organic chemicals [API-Bulk Drug and Drug Intermediates] as tabulated below. Sr. Name of the CAS no. Quantity End-use of the no. Products / MT/Month products CI no. Existing Proposed Total

1 7727-21- # Potassium Sulphate 100 50 Pharma Industry 1 -50 2 7447-40- # Potassium Chloride 100 75 Pharma Industry 7 -25 3 7647-15- Sodium Bromide 50 - 50 Pharma Industry 6 4 Hydrogen Bromide 10035- 20 - 20 Pharma Industry 48% 10-6 5 7778-53- # Potassium Phosphate 20 10 Pharma Industry 2 -10 6 7758-98- Copper Sulphate 20 - 20 Pharma Industry 7 # Total 310 -85 225 GROUP A 7 Pharmaceutical 1-Bromo Hexane 111-25-1 -- 50 50 Intermediate

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8 Pharmaceutical N-Butyl Bromide 109-65-9 -- Intermediate 9 Pharmaceutical 4-Bromo anisole 104-92-7 -- Intermediate GROUP B 10 4- Amino 1, 2, 4 Pharmaceutical 584-13-4 -- Triazole Intermediate 11 4 - (2 – Methoxy 56718- Pharmaceutical -- Ethyl) Phenol 71-9 Intermediate 12 4 - Nitrobenzyl Pharmaceutical 100-11-8 -- Bromide Intermediate 13 2398-37- Pharmaceutical Meta Bromo anisole -- 25 25 0 Intermediate 14 Pharmaceutical Bromobenzene 108-86-1 -- Intermediate 15 Sodium 2-bromo 56985- Pharmaceutical -- propionic acid 74-1 Intermediate GROUP C 16 97240- Topiramate -- API 79-4 17 98418- Metoprolol Succinate -- API 47-4 18 Pharmaceutical 4 - Nitro Benzoic Acid 62-23-7 -- Intermediate 5 5 19 N-Bromo Pharmaceutical 128-08-5 -- Succinamide Intermediate 20 Pharmaceutical 1,3-Dichloroacetone 534-07-6‎ -- Intermediate 21 3-Chlorobenzyl Pharmaceutical 620-20-2 -- chloride Intermediate 22 R & D Products Nitration, Sulphonation, Pharmaceutical -- -- 0.50 0.50 Bromination, Intermediate Chlorination, Amination) Proposed Total -- 80.50 80.50 Total After Expansion 310 -4.50 305.50 Note:  Unit shall continue to manufacture its all existing products and its production capacity will not exceed as mentioned above.  Unit will manufacture any of the products from Group A on either/or basis and total production capacity of Group A will not exceed 50 MT/Month.  Unit will manufacture any of the products from Group B on either/or basis and total production capacity of Group B will not exceed 25 MT/Month.  Unit will manufacture any of the products from Group C on either/or basis and total production capacity of Group C will not exceed 5 MT/Month.  Unit has proposed 0.50 MT/Month of R & D category products.  # After expansion, unit will surrender 85 MT/M of production capacity from its existing facility. Hence, after expansion existing production capacity will be 225 MT/Month.  Production of proposed Pharmaceutical Intermediate/API products will be 80.50 MT/Month.  After expansion, total production capacity for existing inorganic products will be 225 MT/Month while proposed pharma intermediate will be 80.50 MT/Month. Hence, Total 305.50

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MT/Month.

Sr. Particulars Details no. A Total cost of Proposed Project Existing:0.75 (Rs. in Crores): Break-up of proposed project Cost: Proposed:1.725  Total: 2.475

Details of Environmental Management Plan (EMP) Environment Monitoring Plan is as below:

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Details of CER as per OM dated 01/05/2018 As below:

 As project falls under CEPI area, unit will allot additional 1% (Normally Required 1%) fund towards CER activity. Therefore total fund will be allotted 2% of investment, which will be Rs. 3.45Lacs.

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B Total Plot area Existing: 1888.0 Sq. m. ( sq. meter) Proposed: 0.0 Sq. m.

Total: 1888.0 Sq. m.

Brief note on Area adequacy in line to proposed project activities:  Total plot area is 1888.00 m2  At present, production plant area available is 176.87 m2 on ground floor and first floor and 133.97 on second floor. So, total production area is 487.71 m2.  For expansion project, G+2 floor is proposed having floor area 133.97 m2. So, total production area will be 401.91 m2.  Total floor area utilized for production activity is 125.50 m2 and unit will provide 401.91 m2.  Therefore, area available for pharma intermediate production plant is adequate for proposed expansion  Total area required for raw material storage in drum is 68 m2. Provision for storage of raw materials area excluding tank and cylinder storage is 71.14* m2.  Thus, area allotted for storage of raw materials is adequate.  Total area required for drum storage of finished goods is 34.0m2 and unit will provide 90.60 m2.  Thus, area allotted for storage of finished goods is adequate.  Separate 25.00 m2 area is allotted for storage of hazardous/solid waste, which is 50% unused which will be used for proposed expansion.  11.25 m2 area is provided for gas station.  For expansion project, 20.0 m2 area will be provided tank area and 15.0 m2 cylinder storage area will be provided

Green belt area Existing: 152.00 Sq. m. ( sq. meter) Proposed: 388.68 Sq. m. (Within Premises) + 215.00 Sq. m. (outside premises within 05 km radius from project site) Total: 755.68 S q. m. (40.02% of total area) C Employment generation Existing: 15 (Male-13,

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Female-02) Proposed: 26 (Male-25, Female-01) Total: 41 (Male-39, Female-02) D Water i Source of Water Supply GIDC (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern authority. Unit will get permission from GIDC for additional water requirement. ii Water consumption (KLD)

Existing Proposed Total after Remarks KLD (Additional) Expansio KLD n KLD

(D) Domestic 1.00 0.85 1.85 (E) Gardening 0.60 1.55 2.15

(F) Industrial

Process *Maximum water consumption will be from Product No. 9 (4 BROMO ANISOLE) from Group-A, 3.00 5.00* 8.00 Product No. 13 (Meta Bromo Anisole) from Group-B & Product No. 16 (Topiramate) from Group-C

Washing 0.20 1.80 2.00 Boiler 1.00 16.00 17.00 Cooling 0.20 1.50 1.70

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Others -- 0.70 0.70

4.40 25.00 29.40 Industrial Total

Grand Total 6.00 27.40 33.40 (A+B+C)

Brief Note on worst case scenario for water consumption: For calculating worst case scenario, Maximum water consumption will be from Product No. 9 (4 BROMO ANISOLE) from Group-A, Product No. 13 (Meta Bromo Anisole) from Group-B & Product No. 16 (Topiramate) from Group-C is taken into consideration. Said products water consumption is higher in each group products except other products. In addition maximum boiler working hour, washing water requirement per day is also taken into consideration. For inhouse gardening around 4 L/m2 water is considered. For domestic purposed around 45 Li/person/day water is considered. Based on this our maximum water consumption shall not exceed 33.40 KLD. - Summary of Existing Proposed Total after Remarks water KLD (Additional) Expansion requirement KLD KLD

Total water 6.00 27.40 33.40 requirement for the project (A) Quantity to be Nil Nil Nil recycled (B) Total fresh water 6.00 27.40 33.40 requirement (C)

Ensure Total water requirement = Fresh water + Recycled water i.e. A = B + C

In case of no reuse/recycle of waste water, Give brief note on justification as why no reuse/recycle.

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 Treated water will be used for preparation of dosing chemicals and condensate recover will be reused again in boiler makeup water.  As our unit is pharma unit process, washing waste water is not feasible to reuse in any part of the reaction. For boiler blow down it may have high TDS and in cooling waste water slightly high COD may present. Hence, no water reuse feasible.

iii Waste water generation (KLD)

Category Existing Proposed Total after Remarks KLD (Additional) Expansio KLD n KLD  Domestic 0.50 0.50 1.00

 Industrial

Process **Maximum waste water will be generated from Product No. 11. (4–(2–

-- 2.10** 2.10 Methoxy Ethyl) Phenol) from Group-B & Product No. 16 (Topiramate) from Group-C

Washing -- 1.90 1.90 Boiler -- 0.75 0.75 Cooling -- 0.08 0.08 Others -- 0.10 0.10 Total Industrial -- 4.93 4.93 waste water

Brief Note on worst case scenario for waste water generation(Qualitative and Quantitative): Maximum waste water will be generated from Product No. 11. (4–(2– Methoxy Ethyl) Phenol) from Group- B & Product No. 16 (Topiramate) from Group-C. From Group-A product no waste water generated. In

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Quality of Raw Effluent – Existing ZLD Unit

Quality of Raw Effluent - Proposed

Iv Treatment facility within premises with capacity [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc.  ETP: 5.00 m3/day (Primary Treatment). Treatment scheme including segregation at source. (Give Characteristics of each stream i.e. COD, BOD, TDS etc.) In case of stream segregation, Separate ETP (ETP-1, ETP-2….) for each stream shall be proposed.

Quality of Raw Effluent – Existing ZLD Unit

Quality of Raw Effluent - Proposed

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Domestic: Domestic effluent shall be disposed in to Septic tank / Soak pit system. Industrial: Existing - Unit is Zero Liquid

Discharge (ZLD).

Proposed- Industrial wastewater generated from manufacturing process and other ancillary operations will be allowed into in-house ETP for its primary treatment. Primary treated water will be sent to the Common MEE facility of M/s. BEIL vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility (CF)(For waste water treatment)  Common MEE facility – M/s. Bharuch Enviro Infrastructure Limited Membership of Common facility (CF) (For waste water treatment) Common MEE facility – M/s. Bharuch Enviro Infrastructure Limited vii Simplified water balance diagram with reuse / recycle of waste water(Existing and Proposed)

As per CCA

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After Expansion

vii Reuse/Recycle details (KLD) with feasibility. [Source of reuse & application area] Total reuse 0.0 KLD - Source of waste Application Characteristics of Remarks water for reuse area with waste water to be regarding with quantity in quantity in reused (COD, BOD, feasibility KLD (From KLD (Where it TDS etc.) to reuse i.e. where it is is used) coming)

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- - - -

E Air i Brief Note on fuel based heat energy requirement and worst case scenario thereof:  Electric power requirement for existing project is 45 KVA. It is estimated that the additional power requirement for the proposed project will be 105 KVA. Unit will install one nos. steam boiler of capacity 1 TPH and one nos. D. G. Set of capacity 125 KVA, which will use in case of power failure.  At present one Thermopack of capacity 4 Lac kcal/hr.  In worst case steam requirement from boiler will be around 800 kg/hr and heat energy requirement from thermopack will be around 2 Lac Kcal/hr. Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed - Air Source of Quantit Type of Stack Type Pollution Sr. emission y of emissions Height of Control no. With Fuel i.e. Air (meter) Fuel Measures Capacity MT/Day Pollutants (APCM) Existing

Steam 300 Adequate Boiler PM Natura 1 (Capacity: 12.00 SCM/Da SO2 stack height l Gas NO 1 TPH) y X provided D. G. Set Adequate – stand by 300 PM 2 5.5 Diesel SO2 stack height (Capacity: Lit/day NOX is provided 125KVA) Proposed (Additional) Thermopa Adequate ck 300 Natura PM stack height 1. (Capacity: 10.0 l Gas SCM/Da SO 2 will be 4 Lca y NOX provided Kcal/hr) -

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Ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) Existing & Proposed - Specific Source of Stack/V Air Pollution Control Sr. emission Type of ent Measures no. (Name of the Product emission Height (APCM) & Process) (meter)

Existing

Proposed (Additional)

FBD (Fluidized bed 1 PM 10.00 Bag Filter dryer)

Process Vent (Product Two stage Alkali 2 No. 11, 18) Process: NOx 8.00 Scrubber Nitration Process Vent (Product Two stage Alkali 3 No. 13) Process: SO3 8.00 Scrubber Sulphonation Process Vent (Product Water Scrubber followed 4 No. 12, 14) Process: HBr 8.00 by Alkali Scrubber Bromination Process Vent (Product Two Stage Water 5 No. 20, 21) Process: HCl 8.00 Scrubber followed by Friedel Craft reaction Alkali Scrubber Process Vent (Product Two Stage Water 6. no. 16) Process: NH3 8.0 Scrubber Amination

Note:  Estimation of process gas emission (Product wise and Total) Sr. Product Type of emission Max. Max. No. No. Emission Emission (MT/Day) (MT/Year) 2. 11 0.277 120 NOx 3. 18 0.055 4. 13 SO3 0.27 97.2 5. 12 HBr. 0.0356 12.9

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6. 14 0.03 7. 20 0.13 46.8 HCl 8. 21 0.13 9. 16 NH3 0.015 5.4

 Requirement of the scrubbing media (KL per Day) considering solubility (Product wise and Total) Requirement of Sr. Type of Name of Scrubbing Media Scrubbing No. emission media (Kl/Day) NOx (Product No. 1 Two stage Alkali Scrubber 0.78 11, 18) SO 2 3 (Product No. Two stage Alkali Scrubber 0.63 13 Two Stage Water Scrubber 0.12 HBr (Product No. 3 12, 14) Alkali Scrubber 0.08

Two Stage Water Scrubber 0.43 HCl (Product No. 4 20, 21 Alkali Scrubber 0.30 NH (Product no. 5 3 Two Stage Water Scrubber 0.05 16) Total 2.39  Yearly generation of all bleed liquors (MT/KL per Annum) as mentioned above and its sound management in HW matrix. Sr. Type/Name of Specific Quantity Management of HW no Hazardous Source of (MT/Annum) . waste generatio n (Name of the Activity, Product etc.) Collection, Storage, Transportation (through GPS mounted vehicle) and Disposed Sodium 28.1 by selling to authorized users 1 Sulphate Sch. I whom have valid authorization (10 – 25%) under rule 9 permission & having valid CCA from GPCB to receive this waste Liquid Collection, Storage and 100 % 28.1 2 Ammonia 18.0 reuse within premises (Product Sch. I (20-30 %) no. 16)

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Collection, Storage, Transportation (through GPS mounted vehicle) and Disposed Sodium Nitrite 28.1 by selling to authorized users 3 Solution 400.00 Sch. I whom have valid authorization (20 – 35%) under rule 9 permission & having valid CCA from GPCB to receive this waste  Iii Fugitive emission details with its mitigation measures.  F Hazardous waste (As per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. Note:  Priorities for HW Management: Pre-processing, Co-Processing, Reuse/Recycle within premises, Sell out to actual users having Rule-9 permission, TSDF/CHWIH.  Quantification of hazardous waste shall be based on mass balance and calculations shall be incorporated in EMP details separately.  Disposal to scrap vendors/vendors/traders is not allowed

Existing & Proposed I Sr Type/Nam Specific Categor Quantity Manageme . e of Source y and (MT/Annum) nt of HW no Hazardous of Schedul . waste generati e as per Existin Propo Total on HW g sed (Name of Rules. the Activity, Product etc.)

Empty Collection, Barrels/ Storage, Containers Raw Transportati /Liner 33.1 Material on (through 1 1.00 4.00 5.00 contaminat Sch. I s & GPS ed with Product mounted hazardous vehicle) and chemicals Disposal by

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/wastes selling to registered recycler approved by GPCB/ CPCB / reuse within premises Collection, Storage, Transportati on (through GPS Effluent ETP 35.3 mounted 2 Treatme -- 22.00 22.00 Sludge vehicle) & Sch. I nt Plant Disposal at TSDF site for secured landfill at M/s. BEIL Max. quantity will be reuse for lubrication within premises and balance quantity will be D G Set Collected, 5.1 & Storage, 3 Used Oil 0.05 0.90 0.95 Sch. I Thermo- Transportati pack on (through GPS mounted vehicle) and Disposal by selling to Registered Re-refiners approved by GPCB / CPCB Distillatio Collection, n Storage, Process Transportati (Product on (through Distillation 20.3 124.4 No. 7, 8, -- 124.46 GPS 4 Residue Sch. I 6 9, 11, mounted 12, 13, vehicle) and 14, 16, Disposal for 17) Co-

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Solvent Processing Recover y (Product -- 46.00 46.00 No. 11, 12, 13, 15, 16, 17) Collection, storage, Process recovered (Product through in- Spent 28.6 No. 11, 2349. -- 2349.00 house 5 Solvent Sch. I 12, 13, 00 distillation 15, 16, and reuse 17) within premises Collection, Storage & reuse of 869.30 MT/year within premises in product no. 1, 6, 11 & balance quantity Dilute Process 1853.65 Sulphuric 26.3 (Product 1926. MT/Year will -- 1926.10 6 Acid Sch. I No. 7, 8, 10 be Disposal (40 – 70%) 11, 13) by selling to authorized users whom have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Used for the production of Process Sodium consented 28.1 (Product 256.2 Bromide -- 256.20 (existing 7 Sch. I No. 14, 0 (20-25%) product no. 19) 3) product Sodium Bromide Potassium 28.1 Process 230.8 Used for the -- 230.80 8 Sulphate Sch. I (Product 0 production

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(10-12%) No. 13) of consented (existing product no. 1) product potassium Sulphate Collection, Storage & reuse of 240.0 MT/year within premises in product no. 3 and ETP & balance quantity 228.0 Process Caustic Lye 28.1 468.5 MT/Year will (Product -- 468.50 9 (15-20) % Sch. I 0 be Disposal No. 13) by selling to authorized users whom have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Collection, Storage, Transportati on (through GPS Spent Process 28.2 mounted Catalyst (Product -- 19.75 19.75 10 Sch. I vehicle) and (Nickel) No. 11) Disposal by sending to registered recycler for regeneration Collection, Storage, Transportati Process on (through Inorganic 28.1 (Product -- 41.10 41.10 GPS 11 Salt Sch. I No. 16) mounted vehicle) & Disposal at TSDF site

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for secured landfilling at M/s. BEIL Collection, Storage, Transportati

on (through Process Carbon 28.3 GPS (Product -- 0.75 0.75 12 Waste Sch. I mounted No. 16, vehicle) and 17) Disposal for Co- Processing. Collection, Storage, Transportati on (through GPS mounted vehicle) and Disposed by Sodium Scrubbe selling to Nitrite 28.1 r 400.0 authorized -- 400.00 13 Solution Sch. I (Product 0 users whom (20 – 35%) No. 18) have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Process 240.0 1406. (Product -- 1406.80 MT/Year will 80 No. 9) be reused for the production of consented product Hydrogen HBr bromide and 28.1 Scrubbe Solution balance 14 Sch. I r (20- 30 %) 1210.0 (Product -- 43.20 43.20 MT/Year will No. 12, Disposed by 14) selling to authorized users whom have valid authorizatio n under rule 9 permission

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& having valid CCA from GPCB to receive this waste Collection, Storage, Transportati on (through GPS mounted vehicle) and Disposed by selling to Dibromo- Process 28.1 authorized Benzene (Product -- 120 120 15 Sch. I users whom (50-90%) No. 14) have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Collection, Storage, Transportati on (through Process GPS Hyflo 28.3 (Product mounted -- 4.70 4.70 16 Waste Sch. I No. 11, vehicle) & 16, 17) Disposal at TSDF site for secured landfilling at M/s. BEIL Process Collection, 723.6 (Product -- 723.60 Storage, 0 No. 11) Transportati on (through GPS mounted vehicle) and Sodium Disposed by 28.1 Sulphate Scrubbe selling to 17 Sch. I (10 – 25%) r 324.0 authorized -- 324.00 (Product 0 users whom No. 13) have valid authorizatio n under rule 9 permission & having valid CCA

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from GPCB to receive this waste Collection, Storage, Transportati on (through GPS mounted vehicle) and Disposed by 4 - selling to Process Nitrobenzyl 28.1 authorized (Product -- 90.00 90.00 18 dibromide Sch. I users whom No. 12) (50-90 %) have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Collection, Storage, Transportati on (through GPS mounted vehicle) and Disposed by selling to Chromium Process 28.1 516.6 authorized Sulphate (Product -- 516.62 19 Sch. I 2 users whom (10-20)% No. 20) have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Collection, Storage, Transportati Scrubbe on (through Hydrochlori r GPS c Acid 26.3 156.0 (Product -- 156.00 mounted 20 (20 – 30 %) Sch. I 0 No. 20, vehicle) and

21) Disposed by selling to authorized users whom

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have valid authorizatio n under rule 9 permission & having valid CCA from GPCB to receive this waste Collection, Storage and Scrubbe Liquid 100 % reuse 28.1 r Ammonia -- 18.0 18.0 within 21 Sch. I (Product (20-30 %) premises no. 16) (Product no. 16) Collection, Storage, Transportati on (Through Off GPS 28.4 specificatio Process -- 1.50 1.50 mounted 22 Sch. I n products vehicles) Disposal at co- processing facility - ii Membership details of TSDF, CHWIF etc. Unit has got NOC of M/s. BEIL (For HW management) iii Details of Non-Hazardous waste & its disposal(MSW and others)

Sr. Source of Category of Type of Waste Disposal No. Generation Waste 1. Concrete and Bricks Proposed C & D Waste Temporary store, reuse to increase material construction activity plinth level and in road area Steel, glass, wood To be sell local scrap vendor 2. Domestic Waste Employees working MSW Collected in separate bin and (Food waste, Plastic, in the premises disposed to bin of GIDC. Paper etc.)

3. Industrial Waste Steam Pipe & ISW Sell to local scrap vendor (Glass wool Vessels [Insulating Material, Scrap])

4. Industrial Waste From Raw Material ISW Sell to local scrap vender (Wooden pellets) & Product storage area 5. E-waste Entire Plant E-waste Collection, Storage and disposal to GPCB authorized E-Waste Management facility

G Solvent management, VOC emissions etc.

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I Types of solvents, Details of Solvent recovery, % recovery, reuse of recovered Solvents etc. (Details in Table Format)

Input Recovered Recovery Produ Name of the Name of Product Quantity Quantity Efficiency ct no Solvent (MT/Month) (MT/Month) (%) 11 4 – (2 – Methoxy Ethyl) Methanol 164.47 160.77 97.75 Phenol 12 4-Nitrobenzyl Bromide Methanol 50.00 48.88 97.75 13 Meta Bromo Anisole Toluene 61.54 60.24 97.88 15 Sodium 2-bromo Methanol 12.50 12.22 97.75 propionic acid 16 Topiramate Ethyl Acetate 31.25 30.31 97.00 17 Metoprolol Succinate Acetone 14.54 14.21 97.75 ii Brief Note on LDAR proposed:

In addition to LDAR program, following safety measures will be taken to prevent losses of solvent in atmosphere; • To achieve more than 95% recovery, unit will provide vacuum distillation, double condensers with second condenser using chilled water as cooling media. The condensers shall be provided with sufficient Heat Transfer Area and residence time for maximum recovery. • VOC detectors will be installed to detect any solvent leakages during storage and handling. • In warding, storage and consumption of solvents in various products shall be measured through Level Transmitters and Load cells weighing systems resp. The quantity at each stage shall be reconciled periodically to arrive at Losses. • Periodic monitoring of work area will be carried out to check the fugitive emission. iii VOC emission sources and its mitigation measures

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 Source: VOCs generation will be from storage and usage of raw materials.  VOC analysers will be provided to detect any solvent leakages during storage and handling.  Regular maintenance of valves, pumps, flanges, joints and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs.  Entire process will be carried out in the closed reactors with proper maintenance of pressure and temperature.  Ensure minimum number of flanges, joints and valves in pipelines.  Proper preventive maintenance of roofs and seals for tanks  Monitoring and preventive maintenance of valves, flanges, joints, etc.  VOC detectors will be installed to detect any solvent leakages during storage and handling. H SAFETY details i  Details regarding storage of Hazardous chemicals (For tank storages only) Storage details Name of major Remarks Hazardous chemicals Storage tanks Sulphuric Acid, Oleum Drum/Barrel storage Hydrogen Bromide, Phosphoric acid, Acetone, Acetic Acid etc. Safety Precaution during Storage and Handling of Sulphuric Acid:  Sulphuric acid will be stored in MS Tank.  Dyke will be provided to contain leakages. Dyked enclosure will be able to contain the complete contents of the tank in the dyke in case of any emergency.  Tanker unloading procedure will be prepared and implemented.  Trained and experience operator will be employed for tank farm area.  Efficient Level system in tank will be provided to avoid over flow of tank.  Proper and sufficient fire fighting arrangement will be provided in and around the storage.  Safety shower, eye wash with quenching unit will be provided in storage area.  Adequate PPEs like full body protection apron, Hand gloves, gumboot, Respiratory mask etc. will be provided to operator. Safety Precaution during Storage and Handling of Oleum Storage tank:  Dyke with slopped ground floor is required to contain storage tank(s).  Acidproof lining in dyke -is necessary.

 Tank vent is to be connected with a sulphuric acid tank or scrubber with strong H2SO4 to

prevent discharge of fuming SO3. Provision of one standby tank of similar capacity adjacent to storage tank.Dyke well capacity should be more than storage tank capacity.  Ventline of oleum of more than 45% concentration needs steam tracing to prevent freezing

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of SO3.  A roof is required to protect from rain water.  Nearby safety shower and eye washer is necessary for workers to dilute splashes or burns. To contain spillage ample quantity of sand or slaked lime or sodium carbonate should be kept aside.  Water or wood dust should not be sprayed on leaking oleum.  Self-breathing apparatus and acid-proof hand-gloves, aprons and gum boots are necessary. Level indicator and identification of content are also necessary.  Remote control isolation valve at the bottom outlet or no bottom outlet and submersible pump on the top outlet are desirable.  Compressed air (free from oil, moisture and other impurities) is used to unload the tanker.  The tanker outlet valve should be made of SS with Teflon coating and leakproof.  DCP extinguishers are useful on small fires of oleum.  Workers need training to attend emergencies due to oleum leakage.  Applicability of PESO : Not Applicable ii Process safety details : (If applicable) 1. Hydrogenation process  For hydrogenation process, hydrogen gas will be used. Unit will allot separate storage area for hydrogen gas cylinder. Hydrogen is a colorless, odorless, tasteless, flammable nontoxic gas which is flammable over a wide range of concentrations. • Safety Precaution for Hydrogenation plant:  Standard Operating procedure shall be made for before Hydrogen Gas charging into reactor and after completion of reaction Nitrogen flushing will be done.  SOP will be prepared and operators will be trained for the same.  Nitrogen blanketing will be done in Hydrogenation reactor.  Safety valve and Rupture disc will be provided on reactor. 2. Nitration process  Nitration will be done in closed S.S vessels.  Nitric acid will be used for nitration process. Nitric acid is an extremely corrosive acid capable of causing severe chemical burns very rapidly. Because of the hazards posed by nitric acid, it is important to take safety measures whenever handling it.  In our nitration process, exothermic reaction will be controlled by adequate dosing of reaction chemicals in a fixed time (not short duration) having adequate cooling water circulation in jacket of reaction vessels. Thus, any energy generated due to exothermic reaction will be controlled by external cooling circulation and therefore vessels will not be pressurized.

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 The nitration reaction will be controlled by systematic cooling design to withdraw the energy evolved.  Adequate pressure relief valve will be provided for each vessels having pressure release capacity will be kept below -3 kg/cm2than that of reaction vessels. 3. Chlorination process - Not Applicable 4. Exothermic Reaction – Not Applicable  During the video conference meeting dated 01.05.2020, the project was appraised based on the information furnished in Form – 1, Pre-Feasibility Report & relevant documents.  Committee noted that the proposal is for expansion. Unit has valid CC&A (AWH-86622 valid till: 26/04/2022) for existing plant. Copy of CC&A and its self-compliance report is submitted. PP undertaking that there are no court cases pending and no public complaints against the project. There were 2 Closure direction issued by GPCB during last three year. PP submitted details regarding area adequacy. Source of water is GIDC.  PP submitted that after proposed expansion entire effluent generated from process, boiler blow down, cooling tower blow down, washing and scrubber (2nd stage of water scrubber) will be treated in in-house ETP consisting of primary treatment and treated effluent from ETP will be sent to CMEE of M/s. BEIL, Dahej. The industrial effluent generated from scrubber will be partially reused within premises and partially sold to end user having permission under rule 9. The domestic effluent will be disposed into soak pit via septic tank.  PP submitted that they have one steam boiler and DG set for existing and proposed one Thermopack. Fuel used will be natural gas for steam boiler & thermopack and Diesel for DG set. PP submitted that they will provide adequate APCM with Flue gas and Process stack.  PP submitted Hazardous Waste Matrix as per HWR – 2016.  Product profile along with End Use discussed in depth. PP has not addressed specific end use of each products and why as to consider proposed products under B2 category in line with the Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API) satisfactorily.  After detailed discussion, it was decided to consider the proposal only after submission of the following documents: 1. Submit specific end-uses of proposed product profile. Also submit an undertaking ensuring proposed product profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API).  Project proponent submitted reply of above query via Email on dated 18/05/2020. PP presented in SEAC videoconference for above query on dated 30/05/2020.  PP replied as below : 1. PP submitted the end-uses of proposed product profile and undertaking ensuring proposed product

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profile is in line with Amended EIA Notification dated 27/03/2020 regarding B2 Category in respect of Active Pharmaceutical Ingredients (API). PP presented that they proposed 16 nos of product out of which 2 nos are API and remaining are API intermediate.  The case was reconsidered in the Video conference meeting dated 30/05/2020. During the said meeting Committee observed that reply submitted by PP is satisfactory.  After detailed discussion, Committee unanimously decided to recommend the project to SEIAA for grant of Environment Clearance to the project subject to the strict compliance of the following specific condition as well as the standard conditions prescribed as per ‘ANNEXURE A’ for Synthetic Organic chemicals projects falling under project activity no. 5(f) as per the schedule of the EIA Notification 2006. SPECIFIC CONDITIONS: 1. Project Proponent (PP) shall strictly abide by the outcome/decision of Hon‘ble Supreme Court of India in Civil Appeal no. 8478/2020 regarding operation of the Hon‘ble NGT orders dated 10/07/2019 & 14/11/2019. 2. PP shall comply conditions of any subsequent amendment or expansion or change in product mix, after the 30th September 2020, considered as per the provisions in force at that time as mentioned in the Notification vide S.O. 1223 (E) dated 27/03/2020. 3. PP shall not manufacture any products in proposed project/activities which are not qualifying the amended EIA Notification vide S.O. 1223 (E) dated 27/03/2020 and any subsequent amendments. 4. PP shall submit six monthly compliance report of Environmental Clearance without fail and the same shall be critically assessed by the regulatory authority. 5. R & D products shall be of similar chemistry and the pollution load shall remain the same as committed. 6. Project proponent shall not take continuous/commercial production of the R & D products. Necessary approvals shall be obtained from the concern authorities prior to commercial production of R & D products. 7. Project proponent shall provide continuous online monitoring system for waste water discharge to Common MEE as per the prevailing guidelines of SPCB/GPCB and shall maintain records of the same thereof. 8. Treated waste water shall be sent to Common MEE of non-CPA/SPA only after complying with the inlet norms of common facilities prescribed by GPCB to ensure no adverse impact on Human Health and Environment. 9. PP shall use natural gas for utilities preferably but in case use of other fuel, PP shall put properly designed APCM with regular, periodic stack monitoring system to ensure that there shall be no increase in pollution load for the compliance of directives of Honorable NGT. 10. Close loop solvent recovery system with adequate condenser system shall be provided to recover solvent vapors in such a manner that recovery shall be maximum and recovered solvent shall be reused in the process within premises. 11. Leak Detection and Repair (LDAR) program shall be prepared and implemented as per the CPCB

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guidelines. LDAR Logbooks shall be maintained. 12. Safety: a) PP shall obtain PESO permission for the storage and handling of hazardous chemicals. (If applicable) b) Flame proof electrical fittings shall be provided in the plant premises, wherever applicable. c) Unit shall provide double earthling to solvent storage tanks/ area. d) Unit shall never store drum/barrels/carboys of incompatible material/chemical together. e) Unit shall provide chlorine leakage control emergency kit and FRP hood with scrubber system for chlorine safety. f) Unit shall provide water sprinkler to the ammonia storage cylinder. g) Unit shall Store Bromine Bottle in cool dry separate area, out of direct sunlight. h) Unit shall provide a spare tank with emergency transfer system and bund/ dyke wall to Oleum storage tank. i) Unit shall provide safety valve and rapture disc, as well as auto dump or auto quench/, suppress system for nitration vessel safety. j) Unit shall provide safety valve & rupture disc to the Hydrogenation vessel.

The meeting ended with a vote of thanks to the chair. *** Minutes approved by:

1. Dr. Dinesh Misra, Chairman, SEAC

2. Shri S. C. Srivastav, Vice Chairman, SEAC

3. Shri V. N. Patel, Member, SEAC

4. Shri R. J. Shah, Member, SEAC

5. Dr. V.K. Jain, Member, SEAC

6. Shri A. K. Mule, Member, SEAC

7. Shri Rajesh I. Shah, Member, SEAC

8. Shri A. V. Shah, Secretary, SEAC

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