Jubilant Life Sciences lost 3.1% to Rs 751.20 at 15:12 IST on BSE after the USFDA informed that the inspection at API manufacturing facility in Mysore has been classified as Official Action Indicated.
The announcement was made during trading hours today, 22 March 2019.Meanwhile, the S&P BSE Sensex was down 182.34 points, or 0.48% to 38,204.41
On the BSE, 5.56 lakh shares were traded in the counter so far compared with average daily volumes of 2.34 shares in the past two weeks. The stock had hit a high of Rs 769.70 and a low of Rs 750 so far during the day.
Jubilant Life Sciences has been informed by the US Food and Drug Administration (USFDA), in correspondence dated 13 March 2019, received today, that the inspection from December 10-18, 2018 at the Jubilant Generics 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. 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.
Jubilant Life Sciences is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and other businesses including Drug Discovery Solutions and India Branded Pharmaceuticals.
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