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USFDA classifies inspection of Lupin's Somerset facility as Official Action Indicated

Capital Market 

Lupin's subsidiary has received a letter from the U. S. classifying the inspection conducted at its Somerset (New Jersey) facility in December 2018 as Action Indicated (OAI).

The U. S. 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.

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.

The Company is in the process of sending further updates of its corrective actions to the U. S. and is hopeful of a positive outcome.

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

First Published: Sat, March 16 2019. 13:21 IST