US FDA Classifies Lupin’s Somerset Facility as Official Action Indicated

Drug major Lupin said it has been cautioned by the US health regulator that its Somerset (New Jersey) 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’s subsidiary Novel Laboratories Inc has received a letter from the US Food and Drug Administration (US FDA) classifying the inspection conducted at its Somerset (New Jersey) facility in December 2018, as Official Action Indicated (OAI), Lupin said in a regulatory filing. ‘Official Action Indicated’ means approvals of pending applications or supplements from this site maybe withheld. The US 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, the company added. Lupin said the company does not believe that this classification will have an impact on 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 US FDA and is hopeful of a positive outcome,” Lupin added. – Business Standard