Alkem Laboratories has announced closure of USFDA inspection of Baddi manufacturing facility. The USFDA had issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at Baddi, India which was inspected from September 11, 2017 to September 15, 2017.
In response to the two Form 483 observations issued by the USFDA, 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 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.
