The United States Food and Drug Administration (USFDA) commenced inspection from 11 April 2022 to 14 April 2022 at company's Bioequivalence Center situated in the state of Maharashtra and at the end of the inspection, no Form 483 was issued.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator 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 15% rise in net profit to Rs 533.35 crore on a 13% increase in net sales to Rs 2,618 crore in Q3 FY22 over Q3 FY21.
Shares of Alkem Laboratories rose 0.59% to close at Rs 17.15 on BSE yesterday,13 April 2022.
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