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.

The company said that this inspection is part of the routine business operations and it shall submit to US FDA within the stipulated timeline, a detailed response to close out the said 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 pharma major's consolidated net profit rose 30.84% to Rs 594.96 crore on 9.31% increase in net sales to Rs 3323.87 crore in Q3 December 2023 over Q3 December 2022.