Lupin’s Pithampur Facility May Face Regulatory Action, Says U.S. FDA
The U.S FDA also warned that it may withhold approval of any pending applications or supplements in which this facility is listed.
Drugmaker Lupin Ltd. said the U.S. health regulator had 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 U.S. Food and Drug Administration classifying the inspection conducted at its Pithampur (Indore) Unit-2 facility in January 2019 as Official Action Indicated, Lupin said in a regulatory filing.
“The U.S. FDA 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 disruption of supplies or the existing revenue from operations of this facility.
The company is in the process of sending further updates of its corrective actions to the U.S. FDA and is hopeful of a positive outcome, it added.
Earlier, the U.S. FDA 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 maybe withheld.
Shares of Lupin ended 3.94 percent up to Rs 864.30 apiece on the BSE.