The United States Food and Drug Administration (USFDA) had conducted a remote and virtual Bio-Analytical inspection of Alkem Laboratories’ Bioequivalence Center located at Taloja, Maharashtra from July 26, 2021 to July 28, 2021. At the end of the inspection, no Form 483 was issued.
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.