Tuesday , October 19 2021

Lupin gets warning letter from USFDA for Mandideep (Unit-1) facility

Lupin has received warning letter from the United States Food and Drug Administration (USFDA) for its Mandideep (Unit-1) facility. This is subsequent to an earlier intimation received from the USFDA 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.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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