U.S Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ API manufacturing facility located at Mandva, Maharashtra. The inspection has been classified as Voluntary Action Indicated (VAI) and was closed accordingly.
Earlier, USFDA had concluded inspection at the company’s 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.
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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