Get App

Co-Partners

Associate Partners

you are here: HomeNewsBusiness
Last Updated : Apr 23, 2019 08:22 PM IST | Source: PTI

Lupin's Pithampur facility may face regulatory action, says USFDA

The Mumbai-based drugmaker, however, said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility.

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Drug maker Lupin on April 23 said the US health regulator has cautioned that the firm's Pithampur 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 has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Pithampur (Indore) Unit-2 facility in January 2019 as Official Action Indicated (OAI), Lupin 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 drugmaker, however, said it does not believe that the classification would 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 USFDA and is hopeful of a positive outcome, it added.

Earlier, the USFDA had classified the inspection conducted at its Somerset (New Jersey) facility in December 2018, as OAI, which means approvals of pending applications or supplements from the site maybe withheld.

Shares of Lupin ended 3.94 per cent up to Rs 864.30 apiece on the BSE.
First Published on Apr 23, 2019 08:20 pm
More From
Loading...
Sections
Follow us on
Available On
PCI DSS Compliant