DR. REDDY’S LABORATORIES LTD. UNIT I PLOT NO.137, 138, 145 & 146, S.V. CO-OPERATIVE INDUSTRIAL ESTATE, IDA BOLLARAM, MANDAL, ,

PRE-FEASIBILITY REPORT

DR. REDDY’S LABORATORIES LTD. Regd. Office : 8-2-337, Road No.3, , – 500 034. Phone: 040 4900 2900 Fax: 040 4900 2999 E-mail: [email protected], [email protected]

SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE GOVERNMENT OF INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI Unit I Pre-Feasibility Report

Pre – Feasibility Report

Dr. Reddy’s Laboratories Ltd, Unit I Plot. Nos. 137,138,145 & 146, S.V. Cooperative Industrial Estate, Bollaram IDA, Jinnaram Mandal, Sangareddy District, Telangana

1. Executive Summary M/s. Dr. Reddy’s Laboratories Ltd, Unit - I proposed to increase the manufacturing from 490 kg/day to 735 kg/day located at Plot. Nos. 137,138,145 & 146, S.V. Cooperative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana. The expansion entails a capital cost of Rs. 10 crores. Expansion utility proposed and enhancement of ZLD system. The company has about 19.75 acres of land at Plot. Nos. 137,138,145 & 146, S.V. Cooperative Industrial Estate, IDA Bollaram.

The site is having a longitude 78020’43.67’’ (E) and latitude 17032’32.65’’ (N). The plant is surrounded by road in north & east direction, Plot No. 147 in west direction and M/s. Premier Oxygen in south direction. The nearest human settlement from the site is Bollaram village located at distance of 1.1 km from the site in Northeast direction. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site.

2. Introduction of the Project / Background Information:

2.1 Identification of Project and Project Proponent:

The objective of this pre-feasibility study is to provide information for the manufacturing of Active Pharmaceuticals Ingredients unit with production capacity of 735 kg/day with a proposal to manufacture 31 products, R&D products at Plot. Nos. 137,138,145 & 146 S.V. Cooperative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana in an area of about 19.75 acres.

The project proponent Mr. Sandip Benerijee, Sr.Director, having 25 years’ experience.

2.2 Brief Description of Nature of the Project: The synthetic organic chemicals manufacturing will involve series of chemical reactions to get the final Product. The products of reaction are purified, filtered and dried before 1 | Page

Unit I Pre-Feasibility Report

packing the final product. The Chemical reactions require various supporting services like Heating, Cooling and Agitation etc.

2.3 Need for the project and its importance to the country and or region: World population is growing at an alarming rate. In the Indian sub continent population growth is more than that of developed countries. To meet the needs and comforts of ever-growing population industrialization became inevitable. For the growing population the needs of health care substitutes are also increasing.

2.4 Demands-Supply Gap: The project is envisaged to meet the demand supply gap in both domestic market and export market, as API demand is increasing day by day.

2.5 Imports Vs. Indigenous Production: Since the site is already got US FDA, Australian TGA, WHO GMP, NAMMD – Romania, EDQM – Europe & ISO 9001 Certifications and supplying the products to cater the needs of national and international markets. The project shall reduce imports in some of the intermediate & finished products and also enhance the foreign exchange reserves in view of the proposed exports of few products to regulatory markets.

2.6 Domestic/export Markets: The products shall cater to both domestic and export markets.

2.7 Employment Generation (Direct and Indirect) due to the project: The present project for manufacturing of Synthetic Organic Chemicals requires substantial handling of raw materials, goods in process and finished goods. The proposed expansion shall increase the employment potential.

3. Project Description 3.1 Type of Project including interlinked and interdependent projects, if any: M/s. Dr. Reddy’s Laboratories Ltd, Unit - I proposed to increase the manufacturing from 490 kg/day to 735 kg/day located at Plot. Nos. 137,138,145 & 146, S.V. Cooperative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana. The expansion entails a capital cost of Rs. 10 crores. Expansion utility proposed and enhancement of ZLD system.

2 | Page

Unit I Pre-Feasibility Report

3.2 Size or magnitude of operation: List of products and manufacturing capacity

Manufacturing Capacity – After Expansion S.No Name of Product CAS No. Capacity TPM Kg/day 1 Clopidogrel Bisulphate 144077-07-6 5 166.67 2 Fexofenadine Hydrochloride 153439-40-8 2 66.67 3 Ziprasidone Hydrochloride 138982-67-9 0.5 16.67 4 Cetirizine Hydrochloride 83881-52-1 1 33.33 5 Losartan Potassium 124750-99-8 10 333.33 6 Lamotragine 84057-84-1 1 33.33 7 Risperidone 106266-06-2 0.45 15.00 8 Rivastigmine 123441-03-2 0.32 10.67 9 Fluoxetine 54910-89-3 1 33.33 10 Gemcitabine 95058-81-4 0.4 13.33 11 Docetaxel 114977-28-5 0.057 1.90 12 Lomustine 13010-47-4 0.04 1.33 13 Pemetrexed 137281-23-3 0.1 3.33 14 Amsacarine 51264-14-3 0.002 0.07 15 Azacitidine 320-67-2 0.02 0.67 16 Bortezomib 179324-69-7 0.001 0.03 17 Altratemine 645-05-6 0.001 0.03 18 Temozolamide 85622-93-1 0.001 0.03 19 Cabazitaxel 183132-96-2 0.01 0.33 20 Validation , R&D products 0.15 5 Total 22 735

3.3 Process Description with process details (a schematic diagram/flow chart) Typical process description with process details is presented in Annexure I of FORM I Application.

3.4 Raw material required along with estimated quantity likely source, marketing area of final product/s, mode of transport of raw material and finished product. All the raw materials required for manufacturing mostly available in India or from abroad. There are no banned chemicals or products which are proposed to be used.

3.5 Availability of water its source, energy/power requirement and source should be given The total water requirement shall increase from 180 KLD to 418 KLD after expansion out of which 325 KLD shall be drawn from HMWS&SB (Industrial water supply) and balance shall be recycled water. The total water balance is presented table below.

3 | Page

Unit I Pre-Feasibility Report

Total Water requirement – After Expansion (Tentative) Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Process 31 33* Washings 12 12 Scrubber 10 10 R& D 5 5 Boiler Feed 120 102 18 Cooling Tower 70 93 131 32 RO and DM Plant 12 12 Domestic 40 3 37 Gardening 25 25 Gross Total 325 93 261 159 Total 418 420 * Process effluents contain soluble raw materials, byproducts, solvents etc.

3.5.1 Electricity: The requirement of power will be 17500 HP. Further, due to the nature of the reactions and requirement of continuous power, the management proposes to put in place 100% self generation of power by DG sets of 4x1450 KVA capacity. Therefore no delay or difficulty is foreseen on the power front.

3.6 Quantity of wastes to be generated (liquid and solid) and Scheme for their Management/disposal

Quantity of Effluent Generated and Mode of Treatment – After Expansion (Tentative) S.No Description Quantity Treatment/Disposal (KLD) 1 Process Effluent 33 After pretreatment sent to Waste water 2 Washings Effluent 12 recycling facility (WWRF at CTO II) 3 Scrubber Effluent 10 having Multiple Effect Evaporator 4 R & D Effluent 5 followed by ATFD and condensate to biological treatment. RO is provided for tertiary treatment. Total HTDS - I 60 6 Boiler Blow Down 18 Pretreated and sent to Biological 7 Cooling tower Blowdown 32 treatment followed by RO. RO permeate 8 RO/DM Rejects 12 is used for utilities and RO rejects sent to 9 Domestic Effluent 37 WWRF at CTO II Total LTDS - I 99 Grand Total (I+II) 159

4 | Page

Unit I Pre-Feasibility Report

Solid Wastes and Disposal – After Expansion (Tentative) S.No Name of the Units Quantity Disposal Hazardous waste 1 Process Residues TPD 8 TSDF, (V), Rangareddy (Distillation Bottom District for Incineration / residue, including SRS) Authorized cement plants for co - 2 Spent Carbon TPD 0.3 processing. 3 Spent Solvents & Spent KL/Month 570 Recovered within the plant premises Mixed Solvents / Reused / Sold to Authorized third parties / Authorized cement plants for co - processing. 4 Inorganic residue TPD 0.01 TSDF, Dundigal (V), Rangareddy District for land filling / Authorized 5 Evaporation salts TPD 1.1 cement plants for co - processing. 6 ETP Sludge TPD 0.48 7 Chemical Sludge TPD 0.36 8 Catalyst Kg/day 24 Sent to manufacturers for recovery. 9 Ash from Boiler TPD 12.57 Sold to Brick manufactures 10 Detoxified Containers and container liners of Shall be disposed after complete HW & hazardous chemicals detoxification. HDPE Drums no.s/Month 1500 Plastic Bags Kg/Month 1500 Glass Bottles Kg/Month 3000 Carboys no.s/Month 5000 11 Waste oil LPM 3000 Authorized Reprocessors / Recyclers. 12 Used batteries No.s/Year 30 Authorized Reprocessors / Recyclers.

4. Site Analysis 4.1 Plant Location M/s. Dr. Reddy’s Laboratories Ltd, Unit - I proposed to increase the manufacturing from 490 kg/day to 735 kg/day located at Plot. Nos. 137,138,145 & 146, S.V. Cooperative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Telangana. The expansion entails a capital cost of Rs. 10 crores. Expansion utility proposed and enhancement of ZLD system. The company has about 19.75 acres of land at Plot. Nos. 137,138,145 & 146, S.V. Cooperative Industrial Estate, IDA Bollaram.

The site is having a longitude 78020’43.67’’ (E) and latitude 17032’32.65’’ (N). The plant is surrounded by road in north & east direction, Plot No. 147 in west direction and M/s. Premier Oxygen in south direction. The nearest human settlement from the site is

5 | Page

Unit I Pre-Feasibility Report

Bollaram village located at distance of 2 km from the site in Northeast direction. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site.

5. Planning Brief: The project is envisaging to be completed by December 2020, and the production shall be initiated thereon. Consultants are identified for preparing the detailed project report.

6. Proposed Infrastructure: 6.1 Power Requirement and Supply/Source The required energy shall be drawn from Transco. Standby DG sets of 4 x 1450 kVA will be used in case of load shutdown period.

6.2 Utilities List of Utilities S.No Utility Permitted Proposed After Expansion 1 Coal Fired Boiler 1 x 8 TPH* -- 1 x 8 TPH 2 Briquette Biomass /Coal Fired 1 x 10 TPH -- 1 x 10 TPH Boiler 3 DG Set** 4 x 1450 KVA 4 x 1450 KVA *Standby, will be in operation after expansion. ** DG sets will be removed

Equipments The basic technology involved in the manufacturing of Bulk drugs is the process Kettles, Heat Exchangers, Centrifuges, and Storage Tanks. To support the process equipment Boilers, Chilling plants, Cooling Towers Etc. are required. All the above equipment can be sourced indigenously and the lead time to supply the equipment will not exceed 20 weeks.

6.3 Waste management Liquid Effluents The main sources of effluent generation from the plant are process, washings, Scrubber, blow downs from utilities like cooling tower, boiler & domestic effluents. The process effluents are segregated on the basis on TDS and COD loads and treated in Effluent treatment system.

6 | Page

Unit I Pre-Feasibility Report

Air Pollution The sources of air pollution in the plant are from the existing 8 TPH Coal fired boiler and 10TPH Briquette Biomass / Coal Fired Boiler. Backup DG sets of 4 x 1450KVA capacity proposed. The proposed air pollution control equipment for coal fired boiler is Bag filters. DG sets shall be provided with stack heights based on the CPCB formula for effective stack height.

Solid waste Solid wastes are generated from the process, solvent distillation, distillate from stripper, salts from ATFD, sledges from ETP (primary & secondary), waste oil from DG sets, used batteries from DG sets. The stripper distillate, process residue and solvent residue are sent to TSDF/cement plants for co-incineration. The evaporation salts are sent to TSDF. Filter media like spent carbon, catalyst and hyflow are sent to TSDF/authorized recyclers. Waste oil and used batteries from the DG sets are sent to authorized recyclers. The sludge from effluent treatment plant is considered hazardous and the same is sent to TSDF. The ash from boiler is sold to brick manufacturers. The other solid wastes expected from the unit are containers, empty drums which are returned to the product seller or sold to authorize buyers after detoxification.

7. Rehabilitation and Resettlement (R&R) Plan Not applicable as the land area is only 19.75 acres already acquired.

8. Project Schedule & Cost Estimates 8.1 Likely date of start of construction and likely date of completion (Time schedule for the project to be given) December 2020

8.2 Estimated project cost along with analysis in terms of economic viability of the project The estimated cost of the project is approximately Rs. 10 Crores.

7 | Page