Shares of Jubilant Life Sciences was down 6% at Rs 131 in late morning trades after the company said that US drug regulator has issued a warning letter with regards to its facility in the US.
The company in a filing to the BSE today said that one of its manufacturing facilities, Jubilant HollisterStier, LLC (JHC) located at Spokane, Washington State, US has been issued a warning letter by US FOod and Drug Administration.
As required by FDA, JHS-Spokane will respond to this warning letter on or before December 12, 2013. The response will identify corrective actions already been completed as well as some pending corrective actions to ensure on-going cGMP compliance, according to the release.
FDA specified in the warning letter that until all corrections have been completed and that they have confirmed correction of the violations and firm compliance to cGMPs, FDA may withold approval of new applications or supplements listing JHS-Spokane as the drug product manufacturer, the release said.
Over 430,000 shares were traded on both the BSE and NSE so far.
