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In furtherance to the intimation captioned US FDA Inspection at Alkems manufacturing facility located at Amaliya, Daman dated 28th March, 2018, this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Companys manufacturing facility located at Amaliya, Daman, India which was inspected from 19th March, 2018 to 27th March, 2018. In response to the Form 483 issued by the US FDA containing thirteen observations, 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.

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