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The United States Food and Drug Administration (USFDA) has made eleven observations following a recent inspection of Ipca Laboratories’ active pharmaceutical ingredients (API) manufacturing facility in Ratlam (Madhya Pradesh).
The USFDA inspection was held from June 5 to 13, 2023, it said. “At the conclusion of the inspection, the USFDA issued a Form 483 with 11 (eleven) observations.” The company will submit a “comprehensive response” on these observations to the USFDA in the stipulated time and shall work closely with the agency to resolve the issues at the earliest, it told the stock exchange.
Earlier this month, Ipca said the Income Tax Department had conducted survey proceedings at its Mumbai offices and manufacturing plants in Sikkim, between May 30, 2023, and June 3, 2023.
Ipca recently acquired a 33 per cent stake in Unichem for ₹1,034 crore, a buy that drew sharp observations from some sections of the analyst community. The company has also been dealing with multiple manufacturing-linked issues involving the United States regulatory authority.
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