USFDA Caution: Lupin Pithampur facility likely to face regulatory action

Lupin, however, said it does not believe that the classification would have an impact on the disruption of supplies or the existing revenues from operations of this facility.

New Delhi: Drug maker Lupin on Tuesday said the US health regulator has cautioned that the firm's Pithampur 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.

The company has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Pithampur (Indore) Unit-2 facility in January 2019 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 drugmaker, however, said it does not believe that the classification would have an impact on the disruption of 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.

Earlier, the USFDA had classified the inspection conducted at its Somerset (New Jersey) facility in December 2018, as OAI, which means approvals of pending applications or supplements from the site may be withheld.