Alkem Laboratories Receives EIR for Manufacturing Facility at Amaliya

Alkem Laboratories announced the USFDA has issued an Establishment Inspection Report (EIR) for the Company’s manufacturing facility located at Amaliya, Daman, India which was inspected from 19 March, 2018 to March 27, 2018. In response to the Form 483 issued by the USFDA containing thirteen observations, the Company had submitted a detailed corrective and preventive action (CAP A) plan to the regulator within the stipulated timeline. The inspection has now been closed by the US FDA. – Business Standard