USFDA concludes inspection at Alkem Laboratories’ API manufacturing facility in Maharashtra

02 Dec 2023 Evaluate

U.S Food and Drug Administration (USFDA) has concluded inspection at Alkem Laboratories’ API manufacturing facility located at Mandva, Maharashtra. The said inspection conducted from November 27, 2023 to December 01, 2023. At the end of the inspection, the Company has received Form 483 with three observations. 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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