At the end of the inspection, the company received Form 483 with one observation with respect to ANDA filed for the products to be manufactured at the said plant. There is no data integrity observation.

This GMP and pre-approval inspection is part of the routine business operations and the company will submit to US FDA within the stipulated timeline, a detailed response to close out the said observation.

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.

On a consolidated basis, the company net profit slumped 55.2% to Rs 107.58 crore on a 13.3% increase in net sales to Rs 2,483.86 crore in Q4 FY22 over Q4 FY21.

Shares of Alkem Laboratories were up 0.13% to Rs 3,108 on the BSE.