Alkem Lab facility gets Form 483 with 3 observations from USFDA

The pharma company on Saturday announced that its manufacturing facility located at St. Louis, USA received Form 483 with three observations from the US drug regulator.

The inspection was carried on from 6 June 2022 to 17 June 2022. The company said that it shall submit to U.S. Food and Drug Administration (USFDA) within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.

As per USFDA, an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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 reported a 55.2% decline in net profit to Rs 107.58 crore despite of 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 0.07% at Rs 3,095.65 on the BSE.

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