Divi's Laboratories Ltd is an India based manufacturer of Active Pharmaceutical Ingredients (APIs) and Intermediates. The company is engaged in manufacture of leading generic compounds, Nutraceutical ingredients and custom synthesis of APIs and intermediates for global innovator companies. Divis is among the largest pharmaceutical companies in India with a portfolio of 120 products across diverse therapeutic areas. The company has four manufacturing facilities and market presence across several countries. The first facility is located at village Lingojigudem in Yadadri Bhuvanagiri District near Hyderabad (Telangana) comprises 11 multipurpose production blocks with finished product areas for APIs. The second manufacturing unit is an export oriented unit located at village Chippada, Bheemunipatnam Mandal, about 30 KM from the port city of Visakhapatnam (Andhra Pradesh) on the east coast situated on a 100-acre site. The third facility is located at village Chippda situated on a sprawling 267-acre site and is a Special Economic Zone (SEZ) Unit in Pharma Sector. The fourth facility is located at the company's Pharma SEZ at village Chippada. The company has two subsidiaries M/s. Divis Laboratories (USA) Inc., in the United States of America and M/s. Divi's 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.Divi's Laboratories Ltd was established in the year 1990 as Divis Research Center (DRC) with Research & Development as their prime fundamental. During the year 1991-93, 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 ISO-9002 compliant by SGS-Yarsley 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 OHSAS-18001 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 'DRC-Vizag' 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 (Unit-I) and Chippada (Unit-II) for additional machinery installed at both Unit-I and Unit-II. In the year 2006, the company received letter of approval from Ministry of Commerce, Government of India, for setting up a sector-specific special economic zone (SEZ) for pharmaceutical ingredients at Chippada, Bheemunipatnam in Visakhapatnam with investment of Rs 200 crore. The company's second manufacturing site at Chippada, was converted into Export Oriented Unit (EOU) and started operations as EOU from June 1, 2006.During the year 2006-07, the company developed an SEZ titled 'Divi's Pharma SEZ' on a 250-acre site at Chippada, Visakhapatnam. During the year 2007-08, the company set up new production as well as utility facilities in SEZ and EOU Units, and enhanced existing capacities at Unit-1. They commissioned Nutraceuticals Manufacturing facility at Divi's Pharma SEZ and commenced commercial operations effective June 1, 2008.During the year 2008-09, 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 2009-10, 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 2010-11, 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 2012-13, 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 company's Visakhapatnam Unit-2 for the third time. During the year, fourth US FDA inspection was carried out at the company's Visakhapatnam Unit-2. Also during the year, fifth US FDA inspection was carried out for Unit-1. During the year, COFEPRIS (Mexico) inspected the company's Visakhapatnam Unit-2 for the first time. COFEPRIS (Mexico) also inspected the company's Choutuppal Unit-1 in Telangana for the first time in the year 2014.On 19 February 2016, Divi's Laboratories announced that it has had a successful inspection by the US-FDA for its Unit-2 at Chippada, Bheemunipatnam near Visakhapatnam during February 2016 with no observations.The Board of Directors of Divi's Laboratories at its meeting held on 12 August 2016 approved and ratified one-time ex-gratia of an aggregate amount of Rs 79 crore to the employees and whole-time directors of the company on the occasion of completion of 25 years of formation of the company. On 8 April 2017, Divi's Laboratories announced that the US-FDA has exempted some more products manufactured at the company's Unit-II at Visakhapatnam from import alert issued under clauses 66-40 and 99-32 of the FDA regulations. On 22 April 2017, Divi's Laboratories announced that the US-FDA has issued a warning letter for the company's Unit-II at Visakhapatnam. On 4 August 2017, Divi's Laboratories announced that the inspection of the Unit-2 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, Divi's Laboratories announced that the US-FDA has lifted/removed import alert 66-40 imposed on the company's Unit-II at Visakhapatnam.On 18 November 2017, Divi's Laboratories announced that the company has received an Establishment Inspection Report (EIR) from US-FDA for Unit-II at Visakhapatnam, as closure of audit by FDA. Earlier, the company had informed the stock exchanged that its Unit-II at Visakhapatnam was inspected by US-FDA in September 2017 wherein a Form-483 was issued with 6 observations. On 16 May 2018, Divi's Laboratories announced that its Unit-I at Choutuppal, Telangana has had an inspection by the US-FDA 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.