U.S. FDA May Withhold Approval Of Pending Applications From Lupin’s Goa Plant
Drugmaker Lupin Ltd. said the U.S. health regulator made two observations after inspecting its Goa plant and cautioned that the facility may be subject to regulatory action, and that it may withhold approval of pending applications in which this facility is listed.
The company has received a communication from the U.S. Food and Drug Administration, classifying the inspection conducted at its Goa facility between Jan. 28 to Feb. 8 as Official Action Indicated, Lupin said in a regulatory filing on Monday.
Based on the U.S. FDA's Concept of Operations program, the company said it understands that the status of the facility is still under review. The Mumbai-based drug maker, however, said it does not believe that the classification would 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 U.S. FDA and is hopeful of a positive outcome, it added.
Earlier, the U.S. FDA had classified the inspection conducted at Pithampur facility and its Somerset (New Jersey) facility in April 2019 and December 2018, respectively, as OAI, which means approvals of pending applications or supplements from the site maybe withheld.
Shares of Lupin were trading 3.17 percent lower at Rs 738.75 apiece on the Bombay Stock Exchange this morning.