Jubilant Lifesciences Limited (JLL), an integrated global pharmaceuticals and life sciences company, has been informed by the U.S. Food and Drug Administration (USFDA), in correspondence dated March 13, 2019, received today, that the inspection from December 10-18, 2018 at the Jubilant Generics Limited (JGL) (FEI: 3003144728) API manufacturing facility, in Nanjangud, Mysore, has been classified as "Official Action Indicated" (OAI). The USFDA also stated that the facility might be subject to a cGMP regulatory or enforcement action based on this inspection, and that FDA could withhold approval of any pending applications or supplements in which this facility is listed.
FDA's announcement will not have any impact on the existing revenues from operations of this facility. We believe that this letter has been issued as part of a USFDA initiative to respond to the company within 90 days of the inspection, regarding the facility's status. As per the agency's internal procedures, the company can engage with the agency within 40 days to seek to get the decision downgraded from the OAI classification. In that regard, Jubilant is in the process of sending a further update to USFDA of its corrective actions regarding the agency's inspectional observations from December 2018.
Shares of JUBILANT LIFE SCIENCES LIMITED was last trading in BSE at Rs.775.25 as compared to the previous close of Rs. 843.35. The total number of shares traded during the day was 671974 in over 14410 trades.
The stock hit an intraday high of Rs. 832.3 and intraday low of 771.4. The net turnover during the day was Rs. 530973327.