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Lupin gets OAI letter from USFDA for MP plant

Press Trust of India  |  New Delhi 

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

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

"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 master files (DMF) and Abbreviated Applications (ANDA) pending review or approval from the (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," said.

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

Lupin shares Wednesday ended 4.61 per cent down at Rs 763.90 on the BSE.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, March 13 2019. 22:51 IST