Headquartered in Mumbai India Alkem Laboratories Limited is a leading Indian pharmaceutical company with global operations. The company is engaged in the development manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics generic drugs active pharmaceutical ingredients (APIs) and nutraceuticals which it markets in India and international markets. With a portfolio of more than 700 brands in India Alkem is ranked the fifth largest pharmaceutical company in India in terms of domestic sales. The company also has presence in more than 50 international markets with the United States being its key focus market. Alkem Laboratories Ltd was incorporated as a private limited company on August 8 1973 at Patna under the Companies Act 1956 and subsequently became a deemed public limited company under section 43A(2) of Companies Act 1956 on October 26 1988. Pursuant to our Company passing a resolution under section 21 of Companies Act 1956 and upon issuance of a fresh certificate of incorporation consequent on change of name dated August 21 2001 the name of our Company was changed to `Alkem Laboratories Limited' with effect from October 26 1988.In 1978 the company established its first plant at Taloja Maharashtra. In 1992 the company established its manufacturing facility in Mandwa Maharashtra which was later converted into an API facility in 2005. In 2003 the company set up a research and development facility for ANDA development at Taloja Maharashtra.During the year 2006 the company's anti-infective drug Taxim became the first anti-infective drug in the Indian pharmaceutical industry to cross Rs 100 crore in terms of domestic sales in India. In 2007 the company filed its first ANDA in the US for the drug Amlodipine. In 2009 the company received first ANDA approval in US for Amlodipine. Also during the year the company acquired Pharmacor Pty Ltd. a generic pharma company in Australia.In 2010 Alkem Laboratories acquired Ascend Laboratories a generic marketing company in the US. In 2011 the company acquired Enzene a company engaged in the development of biosimilars in India. In 2012 the company acquired an API manufacturing facility in the US.In 2014 the company acquired the Clindac-A brand in India from Galderma S.A. Also during the year Clavam crossed Rs 200 crore mark in terms of domestic sales in India. In 2015 the company acquired a formulation manufacturing facility in the US.On 23 December 2015 Alkem Laboratories successfully completed an Initial Public Offering (IPO) with its equity shares listed on the Bombay Stock Exchange Limited and the National Stock Exchange of India Limited.On 10 May 2016 Alkem Laboratories announced that the Competition Appellate Tribunal (COMPAT) has passed an order dated 10 May2016 setting aside the penalty of Rs 74.63 crore imposed on the company by the Competition Commission of India (CCI) in its order dated 1 December 2015.On 7 June 2016 Alkem Laboratories announced the closure of the inspection by the United Kingdom - The Medicines and Healthcare Products Regulatory Agency (UK-MHRA) for its Bioequivalence facility at Taloja Maharashtra India. The facility stands UK-MHRA compliant. On 11 August 2016 Alkem Laboratories announced that the USFDA inspected the company's Bioequivalence facility at Taloja Maharashtra India from 1 August to 10 August 2016. At the end of the inspection there were no 483s issued by the USFDA. On 28 October 2016 Alkem Laboratories announced that the USFDA conducted a Bio-analytical inspection at the company's manufacturing facility located at Daman India from 24 October to 28 October 2016. The inspection has been cleared successfully without any 483 observations. This inspection was based on an ANDA filed by the company.On 7 February 2017 Alkem Laboratories announced that it has entered into an alliance with Haw Par India Pvt Ltd. a wholly owned subsidiary of Haw Par Healthcare Ltd. Singapore to exclusively market sell and distribute Tiger Balm range of products in India. Tiger Balm products will be promoted by Alkem Healthcare an Over the Counter (OTC) division of Alkem. Tiger Balm range of products is an internationally known remedy for headaches upper respiratory congestions rheumatic or arthritic pains and muscular sprains. Its unique blend of herbal ingredients derived from an ancient Chinese source has been proven effective for nearly 100 years and is trusted by millions of people in more than 100 countries.On 29 March 2017 Alkem Laboratories announced that the USFDA has issued an Establishment Inspection Report (EIR) for its Ankaleshwar API facility which was inspected in December 2016. The inspection has now been closed by the USFDA. The USFDA had inspected the Ankaleshwar API manufacturing facility from 5 to 9 December 2016 and had issued Form 483 with three observations. Post this the company had submitted a detailed corrective and preventive action plan (CAPA) to the regulator within the stipulated timelines. The USFDA has reviewed the CAPA and has found them acceptable. On 10 January 2018 Alkem Laboratories announced the closure of USFDA inspection at its Baddi facility in Himachal Pradesh.On 28 March 2018 Alkem Laboratories informed the stock exchanges that the USFDA conducted an inspection at the company's manufacturing facility located at Amaliya Daman India from 19 March 2018 to 27 March 2018. Post the inspection the company has received a Form 483 with thirteen observations. The company said it will put together a detailed response with adequate corrective and preventive measures to address the USFDA observations within the timeline stipulated by the USFDA. The USFDA also conducted an inspection at the company's manufacturing facility located at St. Louis USA from 12 March 2018 to 16 March 2018. In response to the one Form 483 observation issued by the USFDA the company has submitted a detailed corrective and preventive action plan (CAPA) plan to the regulator within the stipulated timelines.