USFDA conducts inspection at Alkem Laboratories’ API manufacturing facility in Gujarat

08 Apr 2023 Evaluate

U.S Food and Drug Administration (USFDA) has conducted a GMP and Pre-Approval inspection at Alkem Laboratories’ API manufacturing facility located at Ankleshwar, Gujarat from April 3, 2023 to April 7, 2023. At the end of the inspection, no Form 483 was issued.

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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