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Lupin gets warning letter from US FDA for Mandideep facility

Lupin said there are no drug master file and abbreviated new drug applications (ANDA) 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"

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Drug major Lupin said it has received a warning letter from the US health regulator for its Mandideep facility in Madhya Pradesh. This is subsequent to an earlier intimation received from the United States Food and Drug Administration (US FDA) in March 2019 wherein the agency had classified its inspection conducted at the said facility in December 2018 as “official action indicated”, Lupin said in a regulatory filing.

Lupin said there are no drug master file and abbreviated new drug applications (ANDA) 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”. “We are committed to addressing the concerns raised by the US FDA and will work with the regulator to resolve these issues at the earliest,” the company added.

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