The US Food and Drug Administration (USFDA) has completed inspection at Alkem Laboratories’ manufacturing facility located at Daman. The agency had conducted inspection from August 26, 2019 to August 30, 2019. At the end of the inspection, the company has received a Form 483 with two observations.
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.