ADDITIONAL ATTACHMENTS

ANNEXURE I

(List of Products with Quantities)

M/s. Cipla Ltd. Unit-I, Plot No. D-7 & D-8, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune.

• Existing Products – 160 MT/Yr. (27 Nos.)

A. Bulk Drugs

Sr. No. Category

Existing Products

Name of Product Quantity

MT/M MT/Yr. 1. Anti –

Inflammatory

1. Celecoxib 5.7 68.4 2. Fluticasone Propionate 0.11 1.3 3. Meloxicam 0.95 11.3 4 Beclomethasone

Dipropionate 0.04 0.5

5. Mometasone Furate 0.06 0.8 6. Budesonide 0.08 1.0 7. Loteprednol Etabonate 0.04 0.5

2. Anti -Retrovirals/ Anti Bacterial

8. Famciclovir 0.28 3.4 9. Lamivudine 0.71 8.5 10. Fluconazole 1.44 17.3

3. Anti-Diabetic 11. Pioglitazone Hydrochloride 0.06 0.7 12. Nateglinide 0.09 1.2

4. Anti - Psychotic 13. Citalopram Hydrobromide 0.3 3.6 14. Sertraline Hydrochloride 0.18 2.2 15. Olanzapine 0.033 0.4 16. Aripiprazole 0.08 1.0

5. Cardiac 17. Carvedilol 0.42 5.0 18. Losartan Potassium 0.132 1.6 19. Ramipril 0.17 2.1

6. Bronchodialator 20. Salbutamol Sulphate 0.59 7.1 21. Formoterol Fumarate

Dihydrate 0.009 0.1

7. Anti-Emitic 22. Ondansetron Hydrochloride Dihydrate

0.54 6.4

8. Bone Resporption Inhibitor

23. Pamidronate Disodium Pentahydrate

0.04 0.4

9. Anti-Parkinsonian 24. Alendronate Sodium Trihydrate

0.96 11.5

25. Pramipexole Dihydrochloride Monohydrate

0.04 0.5

10. Sedative

26. Zolpidem Tartrate 0.30 3.6 27. Rizatriptan Benzoate 0.03 0.4

Total 13 160

1

B. Formulation Products (Existing Unit)

Sr. No. Name of Product/ By-Product Quantity Remarks

1. Tablets as approved by FDA 2000 Million Nos./Year Equivalent weight of formulation products manufacturing shall not exceed 325 MT/Yr.

2. Capsules as approved by FDA 170 Million Nos./Year 3. Soft Gelatin products as approved by

FDA 21.2 Million Nos./Year

4. Suppositories and Oral Paste as approved by FDA

12 Million Nos./Year

5. Sachets as approved by FDA 85 Lakhs Nos./Year

C. Proposed Expansion Products – 106.6 MT/Yr (53 Nos.)

Sr. No. Category

Proposed Expansion Products

Name of Product Quantity MT/M MT/Yr.

1. Anti – Inflammatory 1. Ciclesonide 0.0375 0.450 2. Anti -Retrovirals 2. Oseltamivir phosphate 0.4131 4.957 3. Anti-Hypertensive 3. Valsartan 0.5520 6.624 4. Anti-Hypertensive 4. Tiotropium Bromide

Monohydrate BP/PH EUR 0.0060 0.072

5. Anti - Retrovirals 5. Valganciclovir hydrochloride

0.2400 2.880

6. Anti-Asthamatics 6. Arformoterol Tartarate 0.0002 0.003 7. Antiemetic 7. Ondansetron Base 0.1926 2.311 8. Bone Resorption

Inhibitor 8. Zoledronic Acid 0.003 0.034 9. Ibandronate Sodium

Monohydrate 0.010 0.125

10. Atazanavir Sulphate 0.2 2.4 11. Risedronate Sodium

Hemipentahydrate USP 0.20 2.400

9. Hyperpara thyrodism 12. Cinacalcet hydrochloride 1.20 14.400 10. Anti Viral 13. Entecavir monohydrate 0.004 0.043

14. Dabigatran etexilate mesylate

0.107 1.288

15. Raloxifene Hydrochloride 0.7400 8.880 16. Indacaterol maleate 0.0060 0.072 17. Selexipag 0.0003 0.003 18. Eluxadoline 0.0006 0.008 19. Bictegravir 0.0060 0.072 20. Bethanechol Chloride 0.388 4.650 21. Sacubitril 1.3 15.60

11. Anthelmintic 22. Mebendazole 0.4200 5.040 23. Alosetron Hydrochloride 0.005 0.055

2

Sr. No. Category

Proposed Expansion Products

Name of Product Quantity MT/M MT/Yr.

24. Albendazole 0.2700 3.240 12. Anti -Depressant 25. Vanlafaxine 2.0000 24.000 13. Oncology 26. Ibrutinib 0.0020 0.024

27. Sorafenib Tosylate III 0.0040 0.048 28. Palbociclib 0.0014 0.017 29. Everolimus Premix 0.0010 0.012 30. Osimertinib Mesylate 0.0003 0.004 31. Lenvatinib Mesylate 0.00002 0.0002 32. Pomalidomide 0.0003 0.004 33. Pazopanib HCl 0.0050 0.060 34. Axitinib 0.0050 0.060 35. Abiraterone Acetate 0.0050 0.060 36. Dasatinib 0.0027 0.032 37. Carfilzomib 0.0003 0.004 38. Estramustine 0.1663 1.995 39. Everolimus 0.0010 0.012 40. Exemestane Stage-I 0.0173 0.207 41. Nilotinib Hydrochloride 0.0028 0.034 42. Pemetrexed hepta hydrate 0.0020 0.024 43. Regorafenib 0.0018 0.022 44. Ruxolitinib phosphate 0.0020 0.024 45. Tegafur 0.0020 0.024 46. Vinblastine sulphate 0.0020 0.024

47. Vincristine Sulfate 0.002 0.024 48. Etoposide 0.002 0.024 49. Capecitabine 0.002 0.024 50. Cisplatin 0.001 0.012 51. Carboplatin 0.002 0.024 52. Oxaliplatin 0.002 0.024 53. R &D Product 0.2 2.4 Total 8.88 106.6

Total – 27 (Existing) + 53 (Expansion) = 80 Nos. of Products

Description Manufacturing Capacity Products Existing Manufacturing Capacity 160 MT/Yr. 27 Proposed Manufacturing Capacity 106.6 MT/Yr. 53 Total Manufacturing Capacity (After Expansion)

266.6 MT/Yr. 80

3

ANNEXURE II

(Plot Layout)

ANNEXURE III

(Registration Certificate)

ANNEXURE IV

(MIDC Plot Letter)

ANNEXURE V

(Consent to Operate Order

& Previous EC Letter)

ANNEXURE VI

(Manufacturing Process)

ANNEXURE VII

(Details of Solid Wastes)

M/s. Cipla Ltd.

Unit-I, Plot No. D-7 & D-8, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune.

Details of Solid Waste

Sr. No

Description Quantity Mode of Disposal Existing Expansion

1. Plastic Scrap, Glass scrap, wooden scrap, metal scrap

250 MT/Yr 150 MT/Yr Sale to authorized party

2. Ash 8.3 MT/D 1 MT/D Sold to brick manufacturers/ land

ANNEXURE VIII

(ETP Process & Flow Diagram)

KurkumbhSCHEMATIC FLOW DIAGRAM OF ETP

Primary Treatment Secondary Treatment

OilCatch

Neutralisation FlashEq.

Rec.Tank Clariflo- Bio

Bio Clarifier-II

Stream E1

Domestic Effluent

Disposal

Tertiary Treatment

Catch

18 m3

n tank

60 m3x 2

Flashmixer

0.7 m3

Eq.tank

745 m3

Tank

90 m3x 2

BioReactor-I

1250 m3

Clariflo-culator

55 m3

RO I & IIFeed tank

BioReactor-II

600 m3

Reactivator

II

65 m3

Sludge for Dewatering

Dewatered

Disposalto

CHW-TSDF

Bio Clarifier- I

65 m3

Sludge for Recirculation

Decanter

UF UF Feed Feed tank

250 m3

PSF

55m3

Reactivator Clarifier

65 m3

Reverse Osmosis plant

400 m3/day

OilCatch

Strippercolumn VTFDM.E.ERec.

TankStream

MEE and VTFD Condensate

DewateredSludge

Eq. Tank

RO Permeate

forUtilities

UFPlant

250 m3

Rejects

UF Feed tank

110m3

Catch

1 8 m3

column

2 m3 / hr

VTFD

550 l/h2.5 m3/hr

Tank

35 m3 x 2

Stream E2

700 m3

Solids sent to disposal at CHWTSDF

Recovered organic solvent sent to authorised

reprocessor.

ETP Process

The wastewater generated from the plant is categorized into two streams namely E-1 and E-2. The stream E-1 contains all the washing of process equipment’s, floor washing, cleaning contains low concentration of BOD and COD. The value of the COD ranges from 2500-6000 mg/l. The stream E-2 contains all the reactions washes, mother liquors and the concentrated solutions having the high BOD and COD. Both the streams of the effluents are collected separately and the method of their treatments is as follows

1. Effluent Treatment System for E-1 Stream :-

The Effluent Treatment System for E-1 Stream consists of following treatment:

Primary Treatment:-

Oil Catcher - To remove oil and floatable material. Bar Screen - To remove coarse material and grit particles. Neutralization Tank - To maintain the pH of the effluent (7.00 to 8.00). Equalization Tank - To mix the effluent and to remove Suspended

Solids.

Secondary Treatment (Biological Treatment):-

Activated Sludge Process

- To convert dissolved organic matter by microorganism into various gases such as CO2 and into cell tissue, which are removed as sludge. Domestic effluent is added intermadiatre.

Tertiary Treatment:-

Pressure Sand Filter - To remove residual Sludge. Reverse Osmosis System

- Reverse Osmosis system is commissioned thereby reducing the COD & BOD levels in the final treated effluent. RO Treated water is used for the Utility (Cooling tower, Boiler).

2. Effluent Treatment System for E-2 Stream:-

The effluent of the E-2 stream is collected separately in the receiving tanks and then feed into the Multiple Effect Evaporator followed by Vertical Thin Film Dryer. The MEE and VTFD condensate sent to CSTR and CSTR outlet goes to E1 treatment. The solids are send to CHWTSDF Ranjangaon, Pune.

ANNEXURE IX

(Water Budget)

Cipla Ltd., Unit –I, Plot No. D-7 & D-8, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune

Water Consumption – Cipla Ltd. (Unit -1)

Sr. No. Description

Water Consumption (M3/Day)

Existing Unit Expansion Unit Total

1. Domestic #74 - #74 2. Canteen #10 - #10 3. Industrial

a. Process #16 #36 #52 b. Boiler Feed #15 #25 #40c. Cooling 400

(#186 + *214) 350

(#244 + *106) 750

(#430 + *320) d. Washing #65 #15 #80 e.WTP Filter backwash

#20 - #20

f. Softener #5 #5 #10 g. Scrubber #12 - #12

4. Industrial Total(a+b+c+d+e+f+g)

533 (#319+ *214)

431 (#325 + *106)

964 (#644 + *320)

5. Gardening #30 #30 #60 • Grand Total

(1+2+4+5) 647

(#433 + *214) 461

(#355 + *106) 1108

(#788 + *320) Note: # fresh Water from MIDC Water Supply Scheme, * Recycled Water

Effluent Generation – Cipla Ltd. (Unit -1)

Sr. No. Description

Effluent Generation (M3/Day) Existing Unit Expansion Unit Total

1. Domestic 70 - 70 2. Canteen 8 - 8 3. Industrial

a. Process 21 50 71 b. Boiler Feed 1.5 2.5 4 c. Cooling 40 35 75 d. Washing 65 15 80 e.WTP Filter backwash

20 - 20

f. RO Reject 25 25 50 g. Softener 5 5 10 h. Scrubber 12 - 12

4. Industrial Total(a+b+c+d+e+f+g+h)

189.5 132.5 322

• Grand Total (1+2+4)

267.5 132.5 400

ANNEXURE X

(Details of Hazardous Wastes)

M/s. Cipla Ltd.

Unit-I, Plot No. D-7 & D-8, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune.

Details of Hazardous Waste

Sr. No Description Category

Quantity Mode of Disposal Existing Expansion Total

1. Used /spent oilCat.:5.1

400 Lit./M 200 Lit./M 600 Lit./M Sale to authorized re-processor

2. DiscardedContainersbarrels/liners

Cat.: 33.1 400

Nos./M 200 Nos./M 600

Nos./M Sale to authorized party

3. Chemical sludgefrom waste watertreatment

Cat.: 35.3 1.5 MT/M 18.5 MT/M 20 MT/M CHWTSDF

4. Sludge from wetscrubber Cat.: 37.1

5 MT/M 3 MT/M 8 MT/M CHWTSDF

5. Sludge from MEECat.: 35.4

30 MT/M 20 MT/M 50 MT/M CHWTSDF

6. Spent solventsCat.: 28.6

150 KL/M 200 KL/M 350 KL/M Sale to authorized re-processor

7. SpentCatalyst/spentcarbon

Cat.: 28.3 500 Kg/M 300 Kg/M 800 Kg/M CHWTSDF

8. Date-expired,discarded and off-specification drugs

Cat.: 28.5 5 MT/M 3 MT/M 8 MT/M CHWTSDF

9. Spent Organic solvents Cat.: 28.6

5 KL/M 3 KL/M 8 KL/M Sale to authorized re-processor

10. Spent Mother Liquor Cat.: 28.1

750 M3/dilution

with water/M

400 M3/dilution

with water/M

1150 M3/dilution with water/M

MEE

ANNEXURE XI

(CHWTSDF Membership

Certificate)

..AHA RAS HTRANVIRD POWER LTD- --- --- --- --·-- --

09001:20081EMS14001: 200410HSAS18001: 2007CertifiedCompanyommon HazardousWaste Treatment, Storage and Disposal Facility)·- --he Corporate Identity Number (CIN). U40105MH2005PLC150780

~SMS

MAHARASHTRAENVIRO PO'WER LTD

This is to certify that: MIS. CIPLALTD.Address: D - 7.MIDC KURKUMBH. TAL - DAUND. DIST- PUNE-413802.is a Valid member of CHWTSDF {As per MOU with MIDC & MPCB), at PlotNo. P-56, Ranjangaon MIDC, Taluka - Shirur, Pune - 412 220.

Membership No.: MEPL/CPC012

Membership Period: 24 Aug 2017 to 23 Aug 2022

For Maharashtra Enviro Power Ltd.

Marketing Coordinator

C-MWT~ni= ·Plot No. P-56, Ranjangaon, Tai. Shirur, Dist. Pune. Pin-412220. Ph: +91-2138-670352, Telefax: +91-2138-670350- • -· •L - ·o•CornerPt:e Office : 301 PentagonP-3,MagarpattaTownship,Hadapsar, MarketingOffice (Abd) : BharatBazarCommercialComplex,I-Wing,znor oor, ""'"" "' , ~

P ne- 411028.(Mah),India Ph. +91-20-66801111Fax: +91-20-66801100 MIDCArea,Chikalthana,Aurangabad- 431210.Ph.: +91-240-2473047Fax: +91-240-2470145E all: infomepl@smsl.co.mWeb: www.smsenvocare.co.in,www.smsl.co.in E-mail: infomepl@smsl.co.inWeb: www.smsl.co.in,www.smsmepl.com

R gd. Office: 267,GaneshPhadnavisBhavan.NearTriangularPark, CorporateOffice: 20. ITPark,Parsodi,Nagpur-440022.D arampeth,NagpurPh.: +91-0712-2551952/53Telefax: +91-0712-6665100 Ph. : +91-0712-6665000Telefax: +91-0712-6665100

ANNEXURE XII

(Details of Scrubbers)

M/s. Cipla Ltd. Unit-I, Plot No. D-7 & D-8, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune.

Process Scrubber Details

Sr. No.

Stack No.

Scrubber Attached to

Process Plant

Type of gas scrubbed

Diameter of

Scrubber (M)

Height of Scrubber

(M)

Packing Material used

in Scrubber

Mode of regeneration of

the packing material

Scrubbing Media used in

Scrubber

Disposal/ Recycle/ Reuse

1. SBR 01

API - I

Acidic / Alkaline / solvent vapours

0.1 2.5 PP Poll rings NA Water/NAOH Send to ETP

2. SBR 02 Acidic / Alkaline / solvent vapours

0.1 2.5 PP Poll rings NA Water/NAOH Send to ETP

3. SBR 03 Acidic / Alkaline / solvent vapours

0.1 10 PP Poll rings NA Water/NAOH Send to ETP

4. SBR 05

API – 2

Acidic / Alkaline / solvent vapours

0.5 11 PP Poll rings NA Water/NAOH Send to ETP

5. SBR 09 Acidic / Alkaline / solvent vapours

0.3 11 PP Poll rings NA Water/NAOH Send to ETP

7. SBR 06

API - 3

Acidic / Alkaline / solvent vapours

0.5 14.5 PP Poll rings NA Water/NAOH Send to ETP

8 SBR -22 Acidic / Alkaline / solvent vapours

0.5 15 PP Poll rings NA Water/NAOH Send to ETP

9 SBR 07

API -4

Acidic / Alkaline / solvent vapours

.5 12 PP Poll rings NA Water Send to ETP

10 SBR 08 Acidic / Alkaline / solvent vapours

0.5 11.3 PP Poll rings NA Water Send to ETP

11 SBR 14 Acidic / Alkaline / solvent vapours

0.5 11.5 PP Poll rings NA Water Send to ETP

12 SBR 15 Acidic / Alkaline / 0.5 11.5 PP Poll rings NA Water Send to

Sr. No.

Stack No.

Scrubber Attached to

Process Plant

Type of gas scrubbed

Diameter of

Scrubber (M)

Height of Scrubber

(M)

Packing Material used

in Scrubber

Mode of regeneration of

the packing material

Scrubbing Media used in

Scrubber

Disposal/ Recycle/ Reuse

solvent vapours ETP 13 SBR 19 API -5 Acidic / Alkaline /

solvent vapours 0.5 10.5 PP Poll rings NA Water/NAOH Send to

ETP 14 SBR 20 Acidic / Alkaline /

solvent vapours 0.5 10.5 PP Poll rings NA Water/NAOH Send to

ETP 15 SBR-21 API-5 Acidic / Alkaline /

solvent vapours 0.5 10.5 PP Poll rings NA Water/NAOH Send to

ETP 16 SBR-17 R & D Acidic / Alkaline /

solvent vapours 0.3 2.5 PP Poll rings NA Water/NAOH Send to

ETP 17 SBR -04 Deactivation

booth of ETP Acidic / Alkaline / solvent vapours

0.3 5.25 PP Poll rings NA Water Send to ETP

18 SBR -10

Pharma –I

Water 0.3 2 PP Poll rings NA Water Send to ETP

19 SBR -11 Water 0.3 3.5 PP Poll rings NA Water Send to ETP

20 SBR -12 Water 0.3 2.2 PP Poll rings NA Water Send to ETP

21 SBR -13 Water 0.3 2.2 PP Poll rings NA Water Send to ETP

22 SBR-23 Water 0.3 2.5 PP Poll rings NA Water Send to ETP

23 SBR-16 Pharma-II Water 0.3 2.2 PP Poll rings NA Water Send to ETP