Business

Dr. Reddy’s U.S. plant gets FDA observations


Dr. Reddy’s Laboratories’ API manufacturing plant in Middleburg, New York, has received 3 observations following an U.S. Food and Drug Administration audit. “We have been issued a Form 483 with three observations… will address them comprehensively within the stipulated timeline. Currently, we do not have any sales from this plant,” the company informed the stock exchange on Wednesday. It, however, did not share details of the observations made by the regulator. Shares of the company closed with a gain of 1.15% at ₹4,498.65 apiece. The USFDA through Form 483 notifies the management of the company whose facility is inspected of the objectionable conditions observed by its officials that may constitute violations of the Food Drug and Cosmetic Act and related Acts.

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