Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh PRE-FEASIBILITY REPORT Non Production Activies under modernization of M/s. Divi's Laboratories Limited (Unit-2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh 1. Executive Summary: S.No. Description Details 1. Name of the Project “Non Production Activies Under Modernization” of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh” 2. Name and Address of the Madhu Sudhana Rao Divi, Director (Projects), Applicant: Divi’s Laboratories Limited, 1-72/23(P)/DIVIS/303, Cyber hills, Gachibowli, Hyderabad-500032 3. Location of the Plant The Plant is located at Chippadaand AnnavaramVillages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District. Coordinates of the Plant are 17 55’ 59.38” N 83 28’ 25.90” E 17 55’ 48.47” N 83 28’ 26.32” E 17 55’ 55.92” N 83 28’ 44.17” E 17 55’ 49.98” N 83 28’ 57.73” E 17 56’ 04.93” N 83 28’ 59.89” E 4. Production/Estimated Existing Products as per Existing Production Capacity CFE 14.09.2015 as per CFE 14.09.2015 88 17,197 kg/day 5. Total Plant area a) As per CFE order no: APPCB/VSP/196/CFE/HO/2015 Date: 14.09.2015: 387 acres. b) As per Amendment of CFE order no APPCB/VSP/VSP/196/CFE/HO/2012 Date: 07.01.2016 : 387 + 71.26 acres = 458.26 acres c) Additional acquired land 458.26 +37.33 = 495.59 acres. 6. Total Water requirement & After modernization the total water required and wastewater Page 1 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh S.No. Description Details Source generation will not have any change and the source of water is meet from Gosthani River as mentioned in the EC and CFE. The total water requirement for existing projects is 1866.6 KLD. Source of the water form Gosthani River as per CFE 14.09.2015. (After change in product Mix). 7. Working hours One shift operation with 8 hour per shift. 8. Manpower [Operation] 7826 9. Total Cost of the Project Modernization Cost: Rs 100 Crs. Existing Plant Cost: Rs 600 Crs. Total Plant Cost: Rs 700 Crs. 10. Nearest Railway station, Sea Railway Station :Vizianagarm- 21 KM, NW Port, Airport Airport: Visakhapatnam 35 KM SW. 11. Existence of Public Road, Yes, The proposed modernization plant is adjacent to road Railway Track nearby connecting NH5 (Vizag to Kolkatt) to Annavaram village. 2. Introduction of the project: 2.1. Identification of Project and Project proponent: The Divis Laboratories Limited established in the year 1990, with Research &Development as its prime fundamental, Divis Laboratories focussed on developing new processes for the production of Active Pharma Ingredients (APIs) & Intermediates. The company in a matter of short time expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharmaceutical industry. Divi's Laboratories Limited is proposing for Non production activies under Modernization of Unit-II as a commercial facility for manufacturing of APIs & Intermediates products with a firm commitment to Environmental care. This manufacturing facility as Unit-2 is existing plant located at Chippada Village, Annavaram Post, Bheemunipatnammandal, Visakhapatnam. This manufacturing facility is Non Production Activies under modernization unit to be developed. 2.2. Breif Description of nature of the project: The production and manufacturing process of API’s and Intermediates involves various raw materials, where chemical reactions will take precipitation, substitution, addition, Page 2 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh centrifugation, purifications, solvent recovery etc. The layout of the Non Production Activies under modernization project is shown below 2.3. Need for the project and its importance to the Country and or Region: 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. Demand – Supply Gap: Divi’s Laboratories Limited Unit-2 has intended to develop and manufacture intermediates for many MNC customers by undertaking contract research work for them. 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. Page 3 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh 2.5. Imports vs. Indigenous production: The project shall meet to reduce the imports in some of the intermediate products and also enhance the foreign exchange reserves in view of the proposed exports of few products. 2.6. Employment Generation (Direct and Indirect) due to the Project. The present project for manufacturing of Synthetic Organic Chemicals – Bulk Drugs &Intermediates requires substantial handling of raw materials, goods in process and finished goods. It is expected that the following employment will be generated by the project: S.No Designation Exisiting 1 Offices 232 2 Superrvisors 3443 3 Ministerial Staff 56 4 Technical Works 378 5 Skilled Workers 3007 6 Unskilled workers 710 Total 7826 Note: No change in manpower after modernization. 3. Project Description: 3.1. Type of the project including interlinked and interdependent projects: The project is an exisiting unit manufacturing of Bulk Drug and Intermediates. Now Proposed for modernization by adding additional land for de congestion of production area by shifting no production activies to new area proposed. No interlinked or Interdependent Project. 3.2. Location: District and State: Visakhapatnam, Andra Pradesh. Mandal: Bheemunipatnam Village: Chippada Village Plot No/Survey/Khasra Existing Modernization no: Page 4 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh Sy No. 52, 134, 138, 139, 140, 159, 160 Sy No. 52, 134, 138, 139, 140, 159, 160 to to 168, 168/1, 183 & 184 of Chippada 168, 168/1, 183 & 184 of Chippada village village and 1, to 4, 6, 45 & 46 of and 1 to 4, 6, 45 & 46 of Annavaram village. Annavaram village. Addiitional survey number : 107, 158, 168, to 172 Area: Existing After Modernization 387 Acres 495.59Acres Modernization of its unit by adding 108.59 acres of land to its existing 387 Acres of land fordecongestion of the production area by shifting non production activities to new area proposed. Ownership/Occupancy: M/S Divi’s Laboratories Limited (Unit-2) Nearest Railway station, Railway Station :Vizianagarm- 27.4 KM, North Airport: Visakhapatnam 35.5 KM South Airport. West. Page 5 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh Figure 3-1 Index Map Showing the Project Site Page 6 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh Figur3-2Map of the Area 5 km around the project site Page 7 of 21 Pre-Feasibility Report for Modernization of M/s. Divi's Laboratories Limited (Unit - 2) -- Bulk Drug Unit at Chippada and Annavaram Villages, Annavaram Taluka, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh 3.3. Details of alternative sites: No Alternative sites are examined as this is an Non Production Activies under modernization project. 3.4. Size or Magnitude of Operation: After modernization of Exisiting unit production capacity remains same. The industry was permitted to produce not more then one scenario and individual capacities of product mentioned therein at any point as presented in Table 3-1. Table 3-1: List of Bulk Drug Existing S.NO PRODUCT NAME Qnty kg/day as per CFE 14.09.2015 1 Dl –naproxen ( intermediate of NAP/SN) ~1960 274 2 Naproxen ( 450 MTA) 5616.4 3 Naproxen (sodium) ( 1600 MTA) 4 SIGMA –I with & ISB ( DEXTROMETHORPHAN HBR INTERMEDITAES) 684.9 5 SIGMA (DEXTROMETHORPHAN HBR INTERMEDITAES) 5.5 6 ATIPA 684.9 7 IMPALA with BAH & 3-HAP 479.5 8 FMOU OSU 1.4 9 CPCCA(KEY) 82.2 10 VERAPAMIL HCL 1.4 11 VENLAFAXINE 41.1 12 SIMVASTATIN 82.2 13 BUPROPION HCL 68.5 14 SITAGLIPTIN PHOSPHATE & KETOAMIDE 411 15 AMINO ALHOCOL 1.4 16 Carbidopa 137 17 Levodopa 547.9 18 Gabapentin 4383.6 19 Triprolidinehcl 5.5 20 (2r)-amino (2,3-dihydro-1h-inden-2yl) ethanoic acid ( classic) 2.7 21 LAMOTRIGINE 191.8 22 CAPECITABINE 54.8 23 VIGADATRINE 13.7 24 RALTEGRAVIER 109.6 25 DCAM 41.1 26 CKE 54.8 Page 8 of 21 Pre-Feasibility Report for Modernization of M/s.