“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 OAI,” Lupin said in a BSE filing.
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, it said.
Lupin said the inspection at the Goa facility had closed with two observations. Based on US FDA's concept of operations program, the company understands that the status of the facility is still under review.
The company does not believe that this inspection 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 USFDA and is hopeful of a positive outcome, it said.
The company had reported net profit of Rs 290 crore, against an average analysts expected profit of Rs 455 crore for March quarter. Lupin on May 15 said it has received three observations from the US health regulator for its Aurangabad-based manufacturing facility.
At 09:48 am, Lupin was trading 3.4 per cent lower at Rs 737 on the BSE. In comparison, the S&P BSE Sensex was up 0.47 per cent at 39,621 points. A combined 1.34 million shares had changed hands on the counter on the BSE and NSE so far.