Lupin receives USFDA warning letter for Mandideep facility (unit 1)

Lupin has received warning letter from the U.S. FDA for its Mandideep (Unit-1) facility. This is subsequent to an earlier intimation received from the U.S. FDA in March 2019 wherein the agency had classified its inspection conducted at the said facility in December 2018 as "Official Action Indicated" (0AI).
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.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
More From This Section
Don't miss the most important news and views of the day. Get them on our Telegram channel
First Published: Sep 19 2019 | 11:44 AM IST
