Alkem Laboratories has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its manufacturing facility located at Amaliya, Daman, India which was inspected from March 19, 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 (CAPA) plan to the regulator within the stipulated timeline. The inspection has now been closed by the USFDA.
Alkem Laboratories is a leading Indian pharmaceutical company with global operations, 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.
