On Thursday, Alkem Laboratories announced that the USFDA had issued Form 483. They issued two observations after the approval inspection of its St Louis facility. USA inspection by USFDA between 6 September to 14 September 2022. The pharmaceutical company was issued a Form 483 with two observations by US drug regulators. As per the data integrity, the drug maker stated none of the observations. The USFDA has added that pre-approval inspection is part of that routine business operation. It shall submit a detailed response to close out the said observations to USFDA within the stipulated timeline.
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Global operation Alkem Laboratories is a leading Indian pharmaceutical company engaged in developing, manufacturing and selling pharmaceutical and nutraceutical products. The company produces branded generic drugs, nutraceuticals, and active pharmaceutical ingredients (APIs), which it markets in India and International markets.
On a consolidated basis, the net profit of Alkem Laboratories jumped 55.2 per cent to Rs 107.58 crore on 13.3 per cent. Increase in net sales to Rs 2,483.86 crore in the fourth quarter of FY22 over FY21. Alkem Laboratories’ shares were down 0.81 per cent to Rs 3,189.95 on the Bombay Stock Exchange (BSE).
