You are here: Home » Companies » News
Business Standard

USFDA recommends regulatory action on Jubilant Life's Roorkee plant

The FDA has classified the inspection of the Roorkee plant as 'Official Action Indicated'

Press Trust of India  |  New Delhi 

USFDA recommends regulatory action on Jubilant Life's Roorkee plant

The US health regulator has recommended a regulatory or administrative action after the inspection of manufacturing facility of drug firm Jubilant Life Sciences, according to a regulatory filing.

The has classified the inspection of the plant as 'Action Indicated', which means approvals of pending applications or supplements from this site maybe withheld, the company said in a BSE filing Saturday.

According to the FDA, Action Indicated means regulatory and/or administrative actions will be recommended against a facility after an inspection.

In response to the USFDA inspection conducted at the facility of solid dosage formulations during August 2018, "the agency has informed to classify the inspection as OAI and that approvals of pending applications or supplements from this site maybe withheld," Jubilant Life said.

However, this will not have any impact on the existing revenues from operations from this facility, it added.

"We believe that this letter has been issued as part of USFDA initiative to respond to the company within 90 days of the inspection, regarding the status," it said.

As per the guidelines, the company can engage within 40 days to get the agency's decision downgraded from classifying as OAI, it added.

The company "is in the process of sending further update of its corrective actions and remains hopeful of a positive outcome, " it said.

First Published: Sat, December 08 2018. 16:40 IST
RECOMMENDED FOR YOU