Alkem Laboratories announced that its API manufacturing facility in Mandva has received establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA), classifying the facility as 'Voluntary Action Indicated' (VAI).
Earlier, on 1 December 2023, the drug maker informed that the US FDA had conducted an inspection at its API manufacturing facility located at Mandva from 27 November 2023 to 1 December 2023. At the end of the inspection, it has received Form 483 with 3 observations. There was no data integrity observation.The facility has now received EIR classifying it as VAI and the inspection was closed accordingly.
Alkem Laboratories is 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.
The pharmaceutical company's consolidated net profit jumped 30.8% to Rs 594.96 crore on 9.3% rise in revenue from operations to Rs 3,323.87 crore in Q3 FY24 over Q3 FY23.
Shares of Alkem Laboratories shed 0.90% to end at Rs 4,991.75 on the BSE.
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