The stock was quoting at Rs 761.00, down Rs 14.25, or 1.84 percent, on the BSE at 10:49 hours IST.
Jubilant Life Sciences said it has been informed by the US Food and Drug Administration (USFDA) that the inspection at the Jubilant Generics' API manufacturing facility, in Nanjangud, Mysore, has been classified as 'Official Action Indicated' (OAI).
The US health regulator conducted inspection of the same facility during December 10-18, 2018.
Jubilant Life Sciences shares slipped nearly 3 percent after the US Food and Drug Administration classified company's Nanjangud unit as Official Action Indicated.
The USFDA also stated that the facility might be subject to a current good manufacturing practice (cGMP) regulatory or enforcement action based on this inspection.
"FDA could withhold approval of any pending applications or supplements in which this facility is listed," the regulator said.
The company said FDA's announcement will not have any impact on the existing revenues from operations of this facility.
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, Jubilant said.
In that regard, Jubilant said it is in the process of sending a further update to USFDA of its corrective actions regarding the agency’s inspectional observations from December 2018.
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Source: Moneycontrol
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