HYDERABAD: Pharmaceuticals firm Lupin Ltd on Monday said one of its plants in Goa may be subject to regulatory action by the US FDA. The Mumbai-based drug's maker added that the drugs controller may withhold approval of pending applications in which the facility is listed. An OAI classification is one where approvals of pending applications or supplements from the site may be withheld.
However, the company said it did not believe that the classification would have an impact on supplies or the existing revenues from operations of the facility. Lupin is also in the process of sending further updates of its corrective actions to the USFDA and was ‘hopeful of a positive outcome.’
“The company has received a communication from the US Food and Drug Administration (USFDA), classifying the inspection conducted at its Goa facility between January 28 and February 8, 2019, as Official Action Indicated (OAI),” Lupin said in a disclosure with exchanges. The inspection at the Goa facility had closed with two observations.
Based on USFDA’s Concept of Operations programme, the company said it understood that the status of the facility was still under review.“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,” the company added in the disclosure.