MUMBAI, Sept 19: Pharma Major, Lupin has received a warning letter from the US 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), company said in a filing with BSE.
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.
The company is committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. The company upholds quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities.
(UNI)
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