Lupin: USFDA classifies Pithampur 2 facility as OAI
The company has received a letter from the USFDA classifying the inspection conducted at its Pithampur (Indore) Unit-2 facility in January 2019 as Official Action Indicated (OAI). The USFDA has stated that this facility may be subject to regulatory or administrative action and it may withhold approval of any pending applications or supplements in which this facility is listed.
The company does not expect the classification will have an impact on the disruption of supplies or the existing revenues from the facility's operations. The company is in the process of sending further updates of its corrective actions to the USFDA.
The USFDA had classified the inspection conducted in its Somerset (New Jersey) facility in December 2018 as OAI earlier. This means that approvals of pending applications or supplements from the site may be withheld.
On Wednesday, the stock of Lupin was trading at Rs. 852.65 per share, 1.72 per cent on the BSE. The stock made a 52-week high of Rs. 986.10 per share and a 52-week low of Rs. 722.3 per share on the BSE.