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.