The inspection has been classified as voluntary action indicated (VAI) and has been closed accordingly, the firm added.
Earlier on 27 March 2024, the drug maker informed that the US Food and Drug Administration (USFDA) conducted GMP and pre-approval inspection at its Baddi manufacturing facility. The inspection was conducted from 19 March 2024 to 27 March 2024. At the end of the inspection, the company has received Form 483 with 10 observations.
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 stood at Rs 293.56 crore in Q4 FY24, steeply higher than Rs 70.98 crore posted in Q4 FY23. Net sales was at Rs 2,935.82 crore in Q4 FY24, registering a growth of 1.1% YoY.