US Food and Drug Administration (USFDA) has completed inspections at Alkem Laboratories’ two manufacturing facilities. The agency has conducted inspection at St. Louis, USA from August 16, 2019 to August 22, 2019 and Baddi, India from August 19, 2019 to August 23, 2019.
At the end of the inspection, the company has received a Form 483 with four observations for the facility located at St. Louis and no Form 483 is received for the facility located at Baddi.
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.