Alkem falls 5%; Ankleshwar unit gets 483 observations from USFDA

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26 Aug, 2025 12:21

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Moneycontrol BureauShares of Alkem Laboratories slipped more than 5 percent intraday Monday on regulatory concerns. The US Food and Drug Administration (USFDA) has issued three 483 observations for its Ankleshwar unit in Gujarat. The drug regulator had conducted inspection at the company’s active pharmaceutical ingredient (API) manufacturing facility located at Ankleshwar December 5 to 9, 2016.The company said it will put together a detailed response with adequate corrective and preventive measures to address the USFDA observations and the same is proposed to be filed within the timeline stipulated by USFDA.At 12:27 hrs Alkem Laboratories was quoting at Rs 1,625, down Rs 50.30, or 3 percent on the BSE.Posted by Rakesh Patil