Shares of Lupin declined more than 3 percent intraday on September 19 after the company received a warning letter from the USFDA for its Mandideep (Unit- 1) facility.
This is subsequent to an earlier intimation received from the USFDA (United States Food and Drug Administration) in March 2019, wherein the agency had classified its inspection conducted at the said facility in December 2018 as Official Action Indicated (OAI).
There are no DMF and ANDA applications pending review or approval from the Mandideep (Unit-1) facility and the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility, company said in press release.
We are committed to addressing the concerns raised by the USFDA and will work with the US FDA to resolve these issues at the earliest.
We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities, it further added.
At 1020 hrs, Lupin was quoting at Rs 744.45, down Rs 15.05, or 1.98 percent on the BSE. – Money Control
