Divis Laboratories Ltd

Divis Laboratories Ltd. is one of the leading pharmaceutical companies in the world, manufacturing Active Pharmaceutical Ingredients (APIs), Intermediates and Nutraceuticals. The Company is one of the worlds largest API companies, with two manufacturing units and a market presence across 100 countries. It is engaged in the manufacture of Active Pharmaceutical ingredients (APIs), Intermediates and Nutraceutical ingredients with predominance in exports. In addition to generic business, the Company, through its custom synthesis business, supports innovator pharma companies for their patented products business right from gram scale requirements for clinical trials to launch as well as late life cycle management. It is among the largest pharmaceutical companies in India with a portfolio of approx. 160 products across diverse therapeutic areas. Presently, it has 6 manufacturing facilities and market presence across several countries. The company has two subsidiaries M/s. Divis Laboratories (USA) Inc., in the United States of America and M/s. Divis Laboratories Europe AG in Switzerland for marketing its Nutra products and to provide a greater reach to customers within these regions. The company has Research Centers at Sanathnagar, Hyderabad and at the manufacturing sites. Research Centre at Sanathnagar primarily focuses on custom synthesis, contract research for MNC companies as also future generics involving processes like route design, route selection, establishing gram scale process and structural confirmation.Divis Laboratories Ltd was established in the year 1990 as Divis Research Center (DRC) with Research Development as their prime fundamental. During the year 199193, the company successfully developed several commercial processes for intermediates and bulk actives and supplies to manufacturing majors. In the year 1994, they changed their name to Divis Laboratories Ltd to reflect their growing area of operations.In the year 1995, the company started operations in their manufacturing facility (Unit I) at Choutuppal near Hyderabad. In the year 1997, the company was certified as ISO9002 compliant by SGSYarsley of U.K. In the year 1999, European Directorate gave a Certificate of Suitability (CoS) for Naproxen produced by the company. In the year 2001, the company received OHSAS18001 Certification from BVQI of London for their Occupational Health and Safety Management Systems.In the year 2002, the company commenced setting up of their second manufacturing facility (Unit II) at Chippada near Visakhapatnam. In the year 2003, they opened a new research center christened DRCVizag for fundamental research in selected niche business core segments. The company went for initial public offering (IPO) and their shares were listed on Bombay Stock Exchange and National Stock Exchange.In the year 2004, the company invested an amount of Rs 3035.21 lakh towards capital expenditure at their manufacturing facilities at Choutuppal (UnitI) and Chippada (UnitII) for additional machinery installed at both UnitI and UnitII. In the year 2006, the company received letter of approval from Ministry of Commerce, Government of India, for setting up a sectorspecific special economic zone (SEZ) for pharmaceutical ingredients at Chippada, Bheemunipatnam in Visakhapatnam with investment of Rs 200 crore. The companys second manufacturing site at Chippada, was converted into Export Oriented Unit (EOU) and started operations as EOU from June 1, 2006.During the year 200607, the company developed an SEZ titled Divis Pharma SEZ on a 250acre site at Chippada, Visakhapatnam. During the year 200708, the company set up new production as well as utility facilities in SEZ and EOU Units, and enhanced existing capacities at Unit1. They commissioned Nutraceuticals Manufacturing facility at Divis Pharma SEZ and commenced commercial operations effective June 1, 2008.During the year 200809, the company added 9 products to their product portfolio of which 4 are generic APIs and intermediates and 5 are custom synthesis APIs and intermediates. During the year 200910, they added 7 products to their product portfolio of which 2 are generic APIs and intermediates and 5 are custom synthesis APIs and intermediates.During the year 201011, the company added 21 products to their product portfolio of which 8 are generic APIs and intermediates and 13 are custom synthesis APIs and intermediates. The company set up a new facility called DSN SEZ Unit at Chippada in Visakhapatnam at an estimated cost of Rs 200 crore for creating additional capacities for the new opportunities in generic as well as custom synthesis segment. The DSN SEZ Unit commenced commercial operations from June 1, 2011.During the year 201213, the company added 9 products to its product portfolio of which 3 are generic APIs and intermediates and 6 are custom synthesis APIs and intermediates.In 2014, the Korean Food and Drug Administration (KFDA) carried out inspection of the companys Visakhapatnam Unit2 for the third time. During the year, fourth US FDA inspection was carried out at the companys Visakhapatnam Unit2. Also during the year, fifth US FDA inspection was carried out for Unit1. During the year, COFEPRIS (Mexico) inspected the companys Visakhapatnam Unit2 for the first time. COFEPRIS (Mexico) also inspected the companys Choutuppal Unit1 in Telangana for the first time in the year 2014.On 19 February 2016, Divis Laboratories announced that it has had a successful inspection by the USFDA for its Unit2 at Chippada, Bheemunipatnam near Visakhapatnam during February 2016 with no observations.The Board of Directors of Divis Laboratories at its meeting held on 12 August 2016 approved and ratified onetime exgratia of an aggregate amount of Rs 79 crore to the employees and wholetime directors of the company on the occasion of completion of 25 years of formation of the company. On 8 April 2017, Divis Laboratories announced that the USFDA has exempted some more products manufactured at the companys UnitII at Visakhapatnam from import alert issued under clauses 6640 and 9932 of the FDA regulations. On 22 April 2017, Divis Laboratories announced that the USFDA has issued a warning letter for the companys UnitII at Visakhapatnam. On 4 August 2017, Divis Laboratories announced that the inspection of the Unit2 Visakhapatnam was completed successfully by HPRA (Ireland) and JAZMP (Slovenia). The inspection was focused on follow up on the effectiveness of the CAPA implemented from the last JAZMP inspection and general GMP inspection of the site. On 15 November 2017, Divis Laboratories announced that the USFDA has lifted/removed import alert 6640 imposed on the companys UnitII at Visakhapatnam.On 18 November 2017, Divis Laboratories announced that the company has received an Establishment Inspection Report (EIR) from USFDA for UnitII at Visakhapatnam, as closure of audit by FDA. Earlier, the company had informed the stock exchanged that its UnitII at Visakhapatnam was inspected by USFDA in September 2017 wherein a Form483 was issued with 6 observations. On 16 May 2018, Divis Laboratories announced that its UnitI at Choutuppal, Telangana has had an inspection by the USFDA from 14th May 2018 to 16th May, 2018. This was a general cGMP inspection by the FDA. The inspection has been concluded with no 483 observations.As on 31 March 2018, the company has two overseas subsidiaries M/s. Divis Laboratories (USA) Inc., in the United States of America and M/s. Divis Laboratories Europe AG in Switzerland for marketing its Nutra products.During the year 201718, the company is making capacity additions at the existing manufacturing facilities and in this process we are building 2 additional production blocks at Unit1 at Choutuppal. Capital WIP as at the yearend amounted to Rs 11976 lakhs. Capital expenditure incurred at the existing Units is to enhance capacities as well as upgrading utilities and infrastructure for compliances. As the company has significant accumulation of cash reserves, all capex has been funded with internal accruals. In order to cater to the increasing opportunities in generic and big pharma business, the Company during the FY2019, is taking up following two brownfield projects with an aggregate investment of Rs 1200 crore.a. An SEZ Unit at our UnitII at Visakhapatnam, named as DCV SEZ Unit, with an investment of Rs 600 crore. (revised from the estimate of Rs 400 crore announced at the last General Meeting),b. Another SEZ Project with an investment of Rs 600 crore in the available land at our UnitI in BhuvangiriYadadri (erstwhile Nalgonda) District, Telangana State.The Company has commenced commercial operations from a part of the DCSEZ Unit in February, 2020, and from a part of the DCVSEZ Unit in March 2020. The Company has also taken up debottlenecking programs at UnitI as well as UnitII by investing an aggregate amount of Rs 300 crore which would also create additional capacities for existing products. In addition, the company also taken up augmentation of waste treatment infrastructure at UnitII at an estimated cost of Rs 150 crore. A part of the backward integration, debottlenecking and utility expansion projects have come into utilization this year. The rest of these projects will be completed and come into utilization by end of second half of financial year 202021. The balance works of the brownfield projects of DCSEZ and DCVSEZ are also expected to be completed by second half of financial year 202021. As on 31 March 2020, the company has two overseas subsidiaries M/s. Divis Laboratories (USA) Inc., in the United States of America and M/s. Divis Laboratories Europe AG in Switzerland for marketing its Nutra products.Eventhough there was a nationwide lockdown restrictions due to COVID19 pandemic since March 24, 2020, the Government has exempted manufacturing units of essential goods including drugs and pharmaceuticals, medical devices, their raw materials and intermediates from the lockdown restrictions, amongst others. The Company has been operating in compliance with the various advisories/ guidelines passed by the Government of India, State Governments and statutory institutions.The new brownfield DC and DCV SEZ Units and the debottlenecking / backward integration programs taken up by the company during the last year, have become fully operational during the FY2021. Also Modernization and upgradation of waste water treatment plants at the manufacturing sites has been implemented. During the year 202021, the company also taken up another capex program with an estimated investment of Rs 400 crore for fasttracking a customs synthesis project.During the year 2023, the Company implemented its project of setting up a manufacturing plant (UnitIII) at Kakinada District of Andhra Pradesh.