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Lupin's Goa facility may face regulatory action, says USFDA

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Press Trust of India New Delhi
Drug maker Lupin Thursday said the US health regulator has cautioned that the firm's Goa facility may be subject to regulatory or administrative action and it may withhold approval of any pending applications or supplements in which this facility is listed.
The company has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Goa facility between January 28 to February 8 as Official Action Indicated (OAI), Lupin said in a regulatory filing.
"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," it added.
The Mumbai-based drug maker, however, said it does not believe that the classification would have an impact on supplies or the existing revenues from operations of this facility.
The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome, it added.
Last month, the USFDA had classified the inspection conducted at the company's Pithampur (Indore) Unit-2 as OAI, which means approvals of pending applications or supplements from the site maybe withheld.
The US health regulator had also classified the inspection conducted at its Somerset (New Jersey) facility in December 2018 as OAI.
Shares of Lupin Thursday ended 1.38 per cent higher at Rs 743.70 apiece on the BSE.

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First Published: May 30 2019 | 9:10 PM IST

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