USFDA Caution: Lupin gets OAI letter for MP plant

Lupin has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility in December 2018 as Official Action Indicated' (OAI), Lupin said in a regulatory filing.

New Delhi: Drug firm Lupin said Wednesday it has been cautioned by the US health regulator with possible withholding of approvals of pending applications from its Mandideep facility in Madhya Pradesh, where it is facing manufacturing compliance issues.

The company has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility in December 2018 as Official Action Indicated' (OAI), Lupin said in a regulatory filing.

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"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," it added.

The Mumbai-based company however clarified that there were no new drug master files (DMF) and Abbreviated New Drug Applications (ANDA) pending review or approval from the Mandideep (Unit 1) facility.

"The company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility," Lupin said.

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Lupin is in the process of sending further updates of its corrective actions to the USFDA and remains hopeful of a positive outcome, it added.

In December last year, the USFDA had issued a total of 22 observations after inspecting the Mandideep facility.

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