US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ manufacturing facility located at Daman, India which was inspected from August 26, 2019 to August 30, 2019 and where the Company had received a Form 483 issued from the USFDA containing two observations.
Further, USFDA has also issued EIR for the company's manufacturing facility located at Baddi, India which was inspected from August 19, 2019 to August 21, 2019 where no Form 483 was received and 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.
