Addressing concern raised by USFDA on Ankleshwar unit: Wockhardt

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26 Aug, 2025 12:21

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Moneycontrol BureauDrugmaker Wockhardt on Wednesday said the latest USFDA warning letter it received for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat is part of the "same process" of an earlier import alert the company received from the US regulator for the same facility."The company has already initiated required steps to address the concerns raised by US FDA and is putting all its efforts to resolve the same," Wockhardt said in a statement to stock exchanges.Wockhardt's Ankleshwar plant was banned by USFDA from exporting drugs into US in August last year.Typically, an import alert follows a warning letter, but in this case the company got import alert first and then the warning letter.The Ankleshwar plant largely caters to domestic and European markets, with some exports of active pharmaceutical ingredients to Wockhardt’s US plant. The plant is the third Wockhardt facility to have been banned from supplying drugs to the US market. The US contributed about 22 percent of Wockhardt’s revenue of Rs.4,461.4 crore in the year ended March.Wockhardt’s Chikhalthana and Waluj plants in Maharashtra have been banned from shipping products to the US since 2013. Both plants are under remediation work.In January last year, the USFDA also issued observations on the company’s Shendra plant in Maharashtra that exports oral solids and injectables to the US.Wockhardt is serving the US market almost entirely from the manufacturing plant in Chicago it acquired from Morton Grove Pharmaceutical Inc. in 2007.The latest warning letter raised issues such as data integrity concerns and microbial contamination of sterile unit, among others.An analyst who didn’t want to named said the latest USFDA action is already factored in the pricing and the uncertainty over remediation timelines continues to be a major overhang on the stock, he added.Shares of Wockhardt dropped 0.93 percent to close at Rs.659.30 on the BSE.