M/s. Hetero Labs Limited Unit-III obtained Environmental Clearance from Ministry of Environment and Forests (MoEF) vide letter no. F. No. J-11011/396/2011-IA II (I) dated: 10.09.2012. at Sy. No. 119, 120, 125(Part), 126, 138(Part), N.Narsapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh & other unit M/s. Hetero Drugs Limited Unit-VI obtained Environmental Clearance from Ministry of Environment and Forests (MoEF) vide letter no. F. No. J-11011/398/2010-IA II (I) dated: 10.09.2012. at Sy.nos. 150(part),151/1,151/2(part),158/1, Nallamattipalem, Buchurajupeta Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh It is proposed to Combining two units existing EC.

Manufacturing Capacity as per Existing EC – Before Combining (For Hetero Labs Limited Unit-III)

REGULAR PRODUCTS

S.No. Product Name No. of Stages

Production (TPM)

Production (TPD)

1 Abacavir Sulphate 2 20 0.66 2 Efavirenz 3 60 1.97 3 Escitalopram Oxalate 2 20 0.66 4 Fosamprevavir 1 30 0.99 5 Hydralazine HCL 2 50 1.64 6 Indinavir 2 50 1.64 7 Irbesartan 2 20 0.66 8 Lamivudine 3 50 1.64 9 Leviteracetam 2 25 0.82 10 Losartan Potassium 3 40 1.32 11 Maraviroc 1 20 0.66 12 Nevirapine 2 40 1.32 13 Pioglitazone HCL 3 20 0.66 14 Quetiapine Fumerate 2 40 1.32 15 Raltagravir 1 30 0.99 16 Stavudine 2 60 1.97 17 Telmisartan 2 40 1.32 18 Tenofovir Disproxil Fumerate 2 20 0.66 19 Terbinafine HCL 2 20 0.66 20 Zidovudine 2 60 1.97

Worst case scenario- Production (A) 490 16.33 10 products wil be manufactured at any point of time out of total 20 Regular products CAMPAIGN PRODUCTS

S. No. Product Name No. of

Stages Production

(TPM) Production

(TPD) 1 Alendronate Sodium 1 0.1 0.00 2 Aliskiren Hemifumarate 1 0.2 0.01 3 Aripiprazole 1 0.1 0.00 4 Atazanavir Sulphate 1 1 0.03

            

5 Atomoxetine HCL 1 0.1 0.00 6 Benezapril HCl 1 0.1 0.00 7 Butenafine HCl 1 0.02 0.00 8 Candesartan cilexetil 2 0.5 0.02 9 Cilazapril Monohydrate 2 0.1 0.00 10 Cilostazol 1 0.75 0.02 11 Darunavir 1 0.75 0.02 12 Deflazcort 1 0.05 0.00 13 Desloratadine 1 0.05 0.00 14 Didanosine 1 1 0.03 15 Emtricitabine 1 1 0.03 16 Eplerenone 1 0.05 0.00 17 Ezetimibe 1 1 0.03 18 Feropenem Sodium 1 0.1 0.00 19 Fluticasone 1 0.01 0.00 20 Lopinavir 1 1 0.03 21 Loratidine 1 0.2 0.01 22 Maliniciparm HCl 1 0.05 0.00 23 Mifepristone 1 0.1 0.00 24 Miglitol 1 0.05 0.00 25 Moxatidine 1 1 0.03 26 Nadifloxacin 1 0.02 0.00 27 Nelfinavir 1 1 0.03 28 Oseltamivir Phosphate 1 0.75 0.02 29 Ozagrel HCl 1 0.1 0.003 30 Pamidronate Sodium 1 0.1 0.003 31 Posaconazole 1 1 0.03 32 Ramipril 1 1 0.03 33 Rasagiline Mesylate 1 0.1 0.003 34 Residronate Sodium 1 0.1 0.003 35 Rufinamide 1 0.1 0.003 36 Rupatadine Fumarate 1 0.1 0.003 37 Sequinavir Mesylate 1 0.8 0.03 38 Simvastatin 1 0.8 0.03 39 Sumatriptan Succinate 1 0.1 0.003 40 Tazarotane 1 0.05 0.002 41 Tegaserod Maleate 1 0.05 0.002 42 Tiagabine 1 1 0.03 43 Ticonazole 1 0.8 0.03 44 Torsemide 1 0.25 0.01 45 Valsartan 2 1 0.03 46 Voricanazole 1 1 0.03 47 Zonisamide 1 0.2 0.01 Worst case scenario- Production (A) 10 0.33

10 products wil be manufactured at any point of time out of total 47 Compaign products Worst case scenario - Total Production : (A + B) 500 16.66

            

Manufacturing Capacity as per Existing EC – Before Combining (For Hetero Drugs Limited Unit-VI)

REGULAR PRODUCTS S.

No. Product Name No. of Stages

Production (TPM)

Production (TPD)

1 Atorvastatin calcium 3 50 1.64 2 Cefditorine pivoxil 3 50 1.64 3 Cefidenir 2 25 0.82 4 Cefixime 2 30 0.99 5 Ceforoxime Axetil 1 30 0.99 6 Cefoxitin Sodium 2 35 1.15 7 Cefpodoxime proxetil 3 50 1.64 8 Citalopram hydro bromide 2 60 1.97 9 Lamivudine 3 60 1.97 10 Ritanovir 3 50 1.64 11 Rosiglitazone Maleate 3 35 1.15 12 Venlafaxine 2 50 1.64

Worst case scenario- Production (A) 440 14.466

9 products wil be manufactured at any point of time out of total 12 Regular products

Campaign Products S.

No. Product Name No. of Stages

Production (TPM)

Production (TPD)

1 Acyclovir 1 1 0.033 2 Agomelatine 1 0.5 0.016 3 Alfuzosin HCl 1 1 0.033 4 Amlodipine Besylate 1 0.75 0.025 5 Clopidogrel Hydrogen sulfate 2 1 0.033 6 Dapoxetine HCl 1 0.75 0.025 7 Dorzolamide HCl 1 0.15 0.005 8 Duloxitine HCl 1 0.75 0.025 9 Eprosartan Mesylate 1 0.5 0.016 10 Esomeprazole Magnesium 1 1 0.033 11 Famcyclovir 1 1 0.033 12 Fosinopril Sodium 1 1 0.033 13 Glimepiride 1 1 0.033 14 Itraconazole 1 0.75 0.025 15 Lansoprazole 1 1 0.033 16 Leofloxacin 1 0.75 0.025 17 Lisinopril dihydrate 1 1 0.033 18 Montelukast sodium 1 1 0.033 19 Moxifloxacin 1 1 0.033

            

20 Nebivolol HCl 1 0.75 0.025 21 Olanzapine 1 1 0.033 22 Omeprazole 1 1 0.033 23 Pantoprazole Sodium 1 0.75 0.025 24 Rabeprazole Sodium 2 0.75 0.025 25 Ranolazin diHCl 1 0.5 0.016 26 Rufinamide 1 0.5 0.016 27 Sertraline Hcl 1 1 0.033 28 Sildenafil citrate 1 1 0.033 29 Topiramate 1 1 0.033 30 Valacyclovir 2 2 0.066

Worst case scenario- Production (B) 10 0.329

9 products wil be manufactured at any point of time out of total 30 Compaign products

Worst case scenario - Total Production : (A + B) 450 15

            

Manufacturing Capacity for Proposed EC – After combining the two units REGULAR PRODUCTS S.

No. Product Name No. of Stages

Production (TPM)

Production (TPD)

1 Abacavir Sulphate 2 20 0.658 2 Atorvastatin calcium 3 50 1.644 3 Cefditorine pivoxil 3 50 1.644 4 Cefidenir 2 25 0.822 5 Cefixime 2 30 0.986 6 Ceforoxime Axetil 1 30 0.986 7 Cefoxitin Sodium 2 35 1.151 8 Cefpodoxime proxetil 3 50 1.644 9 Citalopram hydro bromide 2 60 1.973 10 Efavirenz 3 60 1.973 11 Escitalopram Oxalate 2 20 0.658 12 Fosamprevavir 1 30 0.986 13 Hydralazine HCL 2 50 1.644 14 Indinavir 2 50 1.644 15 Irbesartan 2 20 0.658 16 Lamivudine 3 110 3.616 17 Leviteracetam 2 25 0.822 18 Losartan Potassium 3 40 1.315 19 Maraviroc 1 20 0.658 20 Nevirapine 2 40 1.315 21 Pioglitazone HCL 3 20 0.658 22 Quetiapine Fumerate 2 40 1.315 23 Raltagravir 1 30 0.986 24 Ritanovir 3 50 1.644 25 Rosiglitazone Maleate 3 35 1.151 26 Stavudine 2 60 1.973 27 Telmisartan 2 40 1.315 28 Tenofovir Disproxil Fumerate 2 20 0.658 29 Terbinafine HCL 2 20 0.658 30 Venlafaxine 2 50 1.644 31 Zidovudine 2 60 1.973

Worst case scenario- Production (A) 930 30.575 18 products wil be manufactured at any point of time out of total 31 Regular products CAMPAIGN PRODUCTS S.

No. Product Name No. of Stages

Production (TPM)

Production (TPD)

1 Alendronate Sodium 1 0.1 0.003 2 Aliskiren Hemifumarate 1 0.2 0.007 3 Acyclovir 1 1 0.033 4 Agomelatine 1 0.5 0.016 5 Alfuzosin HCl 1 1 0.033

            

6 Amlodipine Besylate 1 0.75 0.025 7 Aripiprazole 1 0.1 0.003 8 Atazanavir Sulphate 1 1 0.033 9 Atomoxetine HCL 1 0.1 0.003 10 Benezapril HCl 1 0.1 0.003 11 Butenafine HCl 1 0.02 0.001 12 Candesartan cilexetil 1 0.5 0.016 13 Cilazapril Monohydrate 1 0.1 0.003 14 Cilostazol 1 0.75 0.025 15 Clopidogrel Hydrogen sulfate 2 1 0.033 16 Dapoxetine HCl 1 0.75 0.025 17 Darunavir 1 0.75 0.025 18 Deflazcort 1 0.05 0.002 19 Desloratadine 1 0.05 0.002 20 Didanosine 1 1 0.033 21 Dorzolamide HCl 1 0.15 0.005 22 Duloxitine HCl 1 0.75 0.025 23 Emtricitabine 1 1 0.033 24 Eplerenone 1 0.05 0.002 25 Eprosartan Mesylate 1 0.5 0.016 26 Esomeprazole Magnesium 1 1 0.033 27 Ezetimibe 1 1 0.033 28 Famcyclovir 1 1 0.033 29 Feropenem Sodium 1 0.1 0.003 30 Fluticasone 1 0.01 0.000 31 Fosinopril Sodium 1 1 0.033 32 Glimepiride 1 1 0.033 33 Itraconazole 1 0.75 0.025 34 Lansoprazole 1 1 0.033 35 Leofloxacin 1 0.75 0.025 36 Lisinopril dihydrate 1 1 0.033 37 Lopinavir 1 1 0.033 38 Loratidine 1 0.2 0.007 39 Maliniciparm HCl 1 0.05 0.002 40 Mifepristone 1 0.1 0.003 41 Miglitol 1 0.05 0.002 42 Montelukast sodium 1 1 0.033 43 Moxatidine 1 1 0.033 44 Moxifloxacin 1 1 0.033 45 Nadifloxacin 1 0.02 0.001 46 Nebivolol HCl 1 0.75 0.025 47 Nelfinavir 1 1 0.033 48 Olanzapine 1 1 0.033 49 Omeprazole 1 1 0.033 50 Oseltamivir Phosphate 1 0.75 0.025 51 Ozagrel HCl 1 0.1 0.003

            

52 Pamidronate Sodium 1 0.1 0.003 53 Pantoprazole Sodium 1 0.75 0.025 54 Posaconazole 1 1 0.033 55 Rabeprazole Sodium 2 0.75 0.025 56 Ramipril 1 1 0.033 57 Ranolazin diHCl 1 0.5 0.016 58 Rasagiline Mesylate 1 0.1 0.003 59 Residronate Sodium 1 0.1 0.003 60 Rufinamide 1 0.6 0.020 61 Rupatadine Fumarate 1 0.1 0.003 62 Sequinavir Mesylate 1 0.8 0.026 63 Sertraline Hcl 1 1 0.033 64 Sildenafil citrate 1 1 0.033 65 Simvastatin 1 0.8 0.026 66 Sumatriptan Succinate 1 0.1 0.003 67 Tazarotane 1 0.05 0.002 68 Tegaserod Maleate 1 0.05 0.002 69 Tiagabine 1 1 0.033 70 Ticonazole 1 0.8 0.026 71 Topiramate 1 1 0.033 72 Torsemide 1 0.25 0.008 73 Valacyclovir 2 2 0.066 74 Valsartan 1 1 0.033 75 Voricanazole 1 1 0.033 76 Zonisamide 1 0.2 0.007 Worst case scenario - Production (B) 20 0.658

19 products will be manufactured at any point of time out of total 76 Compaign products Worst case scenario - Total Production (A+B) 950 31

            

Quantity of Effluent Generated (As per Existing EC) and Mode of Treatment

Description Existing Quantity-Before Combining

(KLD)

Proposed Quantity-

After Combining

(KLD)

Mode of Treatment

HLL-III HDL-VI

HTDS Effluents Process 396.5 381.8 778.3 Stripper followed by MEE, ATFD

and Biological Treatment, guard ponds, marine outfall.

Washings 29.5 28.2 57.7 Scrubber Effluent 38.0 35.0 73.0 Total - I 464.0 445.0 909.0

LTDS Effluents Cooling Tower Blow downs

30 30 60 After primary treatment, sent to guard ponds & marine outfall

RO Reject 182 175 357 Domestic 45 45 90 Treated in Sewage treatment plant

(STP), online irrigation for green belt development

Total - II 257.0 250.0 507.0 Grand Total (I+II) 721.0 695.0 1416.0

            

Total Water Balance (As per Existing EC)

S.No Input Existing Quantity-

Before Combining

(KLD)

Proposed Quantity-

After Combining

(KLD)

Output Existing Quantity-

Before Combining

(KLD)

Proposed Quantity-

After Combining

(KLD) HLL-

III HDL-

VI HLL-

III HDL-

VI 1 Process &

washings 426 410 836 Process & washings

Effluent 426 410 836

3 Boiler 100 100 200 Boiler Blow down-Scrubber effluents

38.0 35.0 73.0

Loss 62 65 127 4 Cooling

Tower 200 200 400 Blow down 30 30 60

loss 170 170 340 5 Domestic 50 50 100 Domestic Effluent 45 45 90

Loss 5 5 10 6 RO 182 175 357 RO Reject 182 175 357

Total 958 935 1893 Total 958.0 935.0 1893.0

Solid Waste Details (As per Existing EC)

S.No Description

Existing Quantity – Before Combining

(Kgs/day)

Proposed total Quantity – After

Combing (Kgs/day)

Mode of Disposal/Treatment

HLL-III HDL-VI Process

1 Organic residue 15939.2 13475.7 29414.9 Sent to Cement Industries/TSDF 2 Spent Carbon 2391.3 2309.2 4700.5

3 Evaporation salts 16145 4039.5 20184.5 Sent to TSDF 4 Process Inorganic 2965.4 3812.5 6777.9 Sent to TSDF

Other Solid waste 5 ETP & STP Sludge (Kgs/day) 500 500 1000 Sent to TSDF

6

Detoxified Containers & Container liners of HW and hazardous chemicals (No.s/Month)

3000 3000 6000 Empty drums After detoxification shall be disposed to out side agencies

7 Used oil/Waste lubricating Oil (L /Month)

300 300 600 Sent to Authorized Recyclers

8

Used Lead acid Batteries (No.s/Year)

60

60

120

To be returned to the manufacturers / dealers on buy back basis

            

Table A-8 Stack Emission Details

S. No

Stack Connected to Stack Ht (m)

Dia of stack at top(m)

Temp. of exhaust

gases (0C)

Exit Velocity (m/sec)

Pollutant Emission Rate (g/sec)

PM SO2 NOx

Boilers 1 20 TPH 40 1.2 468 24.6 0.67 6.88 2.96 2 25 TPH 42 1.25 475 28.7 0.86 8.6 3.76 DG Sets 1 1x320 KVA 4 0.1 440 4.8 0.006 0.43 0.51 2 1x500 KVA 6 0.15 443 7.5 0.01 0.67 0.8 3 3x1010 KVA 9 0.2 454 8.3 0.1 0.28 1.49 4 6x1165 KVA 10 0.2 456 8.5 0.02 1.28 1.51 5 1X1250 KVA 10 0.2 458 8.5 0.02 1.35 1.6