“In response to the US Food & Drug Administration (USFDA) inspection conducted at its Roorkee facility of solid dosage formulations during August 2018, the agency has informed to classify the inspection as “Official Action Indicated” (OAI) and that approvals of pending applications or supplements from this site maybe withheld,” Jubilant Life Sciences said in a regulatory filing on Saturday, December 8, 2018.
However, this will not have any impact on the existing revenues from operations from this facility, it added.
The company said that it believes that this letter has been issued as part of the USFDA's initiative to respond to the company within 90 days of the inspection, regarding the status. As per the guidelines, the company can engage within 40 days to get the agency’s decision downgraded from classifying as OAI. Jubilant is in the process of sending further update of its corrective actions and remains hopeful of a positive outcome.
At 09:26 am; Jubilant Life Sciences was trading 5.6% lower at Rs 746 on the BSE, as compared to 1.44% decline in the S&P BSE Sensex. A combined 106,193 equity shares changed hands on the counter on the BSE and NSE so far.