In furtherance to the intimation captioned Update on US FDA Inspection at Alkems Ankaleshwar API Facility dated 12th December, 2016; Alkem Laboratories has informed that the US FDA has issued an Establishment Inspection Report (EIR) for the Company’s Active Pharmaceutical Ingredient (API) manufacturing facility located at Ankaleshwar, India which was inspected in December 2016. The inspection has now been closed by the US FDA. In response to the Form 483 issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The US FDA has reviewed the CAPA and has found them acceptable.
The above information is a part of company’s filings submitted to BSE.
