USFDA concludes inspection at Alkem Laboratories’ manufacturing facility at Baddi

28 Mar 2024 Evaluate

U.S Food and Drug Administration (USFDA) has concluded inspection at Alkem Laboratories’ manufacturing facility located at Baddi, India. The said inspection conducted from March 19, 2024 to March 27, 2024. 

At the end of the inspection, the company has received Form 483 with ten observations. This was a GMP as well as a Pre-Approval Inspection. There is no data integrity observation.

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.


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