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Lupin Somerset facility gets OAI letter from USFDA


Lupin Somerset facility gets OAI letter from USFDA

“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,” said Lupin.

New Delhi:  Drug major Lupin Saturday said it has been cautioned by the US health regulator that its Somerset (New Jersey) 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.

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The company’s subsidiary Novel Laboratories Inc has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Somerset (New Jersey) facility in December 2018, as Official Action Indicated (OAI), Lupin said in a regulatory filing.

‘Official Action Indicated’, means approvals of pending applications or supplements from this site may be withheld.

Read Also: USFDA Caution: Lupin gets OAI letter for MP plant

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, the company added.

Lupin said 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.

Read Also: Lupin gets USFDA nod for Atorvastatin Calcium tablets to lower cholesterol

“The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome,” Lupin added.


Source: PTI
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