Shares of Laurus Labs Ltd dropped 4% on Wednesday after the United States Food and Drug Administration (USFDA) issued Form 483 with five observations on the manufacturing facility of the company's subsidiary in Andhra Pradesh.
The stock is currently trading 10% lower from its 52-week high of ₹417.85.
The USFDA inspection at its manufacturing facility in Parawada, Anakapalli, near Visakhapatnam in Andhra Pradesh, took place between December 4 and December 12, the Hyderabad-based drug maker revealed in a filing sent to the stock exchanges.
Robert M. Califf, M.D., is Commissioner of Food and Drugs.According to the USFDA website, issuance of a Form 483 by the regulator indicates that the agency has observed conditions or practices during an inspection that may violate the Food, Drug, and Cosmetic Act or related regulations.
The company is expected to address and rectify these issues to ensure compliance with regulatory requirements. Laurus Labs assured its stakeholders that the firm is committed to addressing these observations promptly.
After Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the firm will take to resolve the observations made by the USFDA.
At 11.14 am, shares of Laurus Labs were trading at ₹377.9 apiece on BSE, down 2.62% from the previous close.
ALSO WATCH: 'Ideas For Profit', Money Control com's Anubhav Sahu tells us why Laurus Labs is an interesting stock to bet on
(Edited by : Sriram Iyer)
First Published: Dec 13, 2023 12:13 PM IST
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