Alkem Laboratories has successfully cleared the inspection at Daman facility without any '483 observations'. The United States Food and Drug Administration (USFDA) had conducted a Bio-analytical Inspection at the company’s manufacturing facility located at Daman, India from October 24 to October 28, 2016. The inspection has been cleared successfully without any 483 observations. This inspection was based on an ANDA filed by the company.
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.
