Lupin gets warning letter from USFDA for Tarapur API plant in Maharashtra
Drug firm Lupin on Thursday said it has received a warning letter from the US health regulator for its Tarapur-based manufacturing facility in Maharashtra.
The US Food and Drug Administration (USFDA) inspected the site from March 22, 2022 to April 4, 2022.
The company manufactures both fermentation-based and synthetic APIs (active pharmaceutical ingredients) at the plant.
“The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” the Mumbai-based company said in a regulatory filing.
The drug firm is committed to addressing the concerns raised by the USFDA and will work with the agency to resolve the issues at the earliest, it added.
Lupin did not share details about the issues flagged by the US health regulator.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction.
FDA then checks to ensure that the company’s corrections are adequate.
On Thursday, Lupin shares ended 2.46 per cent lower at Rs 654 apiece on the BSE.
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