Alkem Laboratories has received Establishment Inspection Report (EIR) from US FDA for its Baddi manufacturing facility, which was inspected in March 2017. The inspection has now been closed by the US FDA.
The USFDA had inspected the Baddi manufacturing facility from March 2 to 10 March 2017 and had issued Form 483 with 3 observations. Post this, the Company has submitted a detailed corrective and preventive action plan to the regulator within stipulated timelines.
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.
