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The company said that its manufacturing facility at St.Louis, USA was inspected by United States Food and Drug Administration (US FDA) from 6 September 2022 to 14 September 2022.
At the end of the inspection, the pharmaceutical company was issued a Form 483 with 2 observations by the US drug regulator. None of the observations are related to data integrity, the drug maker stated.
The pharma major added that this pre-approval inspection is part of the routine business operations. It shall submit a detailed response to close out the said observations to US FDA within the stipulated timeline.
None of the observations are related to data integrity and management believes that they are addressable, the drug maker stated.
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 down 0.81% to Rs 3,189.95 on the BSE.
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