Alkem Laboratories informs about company updates

04 Dec 2018 Evaluate

In furtherance to the intimation captioned ‘US FDA Inspection at Alkems manufacturing facility located at St. Louis, USA’ dated 28th March, 2018, Alkem Laboratories has informed that US FDA has issued an Establishment Inspection Report (EIR) for the Company’s manufacturing facility located at St. Louis, USA which was inspected from 12th March, 2018 to 16th March, 2018. In response to the Form 483 issued by the US FDA containing one observation, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.

The above information is a part of company’s filings submitted to BSE.

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