Drug firm Jubilant Life Sciences today said the US health regulator has issued a warning letter for violation of manufacturing norms at its facility in Canada.
“Jubilant HollisterStier General Partnership (JHS) located at Kirkland, Quebec, Canada has been issued a warning letter (WL) by the US Food and Drug Administration (FDA) identifying significant violations of current good manufacturing practices (cGMP) regulations,” Jubilant Life Sciences said in a filing to the BSE.
As required by FDA, JHS will respond to this letter by March 15, 2013, it added.
“The response will provide details as to what corrective action has already been completed, as well as, additional detail as to how the facility will prevent the re-occurrence of the items found to be objectionable to the FDA,” Jubilant Life Sciences said.
The USFDA had specified in its letter that until all corrections have been completed, it may withhold approval of new applications or supplements listing JHS as the drug product manufacturer.
“We expect that the on-going manufacturing, distribution and sale of products will not be affected by this warning letter. JHS is committed to implementing the necessary corrective actions required to address the FDA concerns, and will work closely with the FDA to bring resolution to this matter,” it added.
Shares of Jubilant Life Sciences today closed at Rs 176.45 per scrip on the BSE, down sharp 4.90 per cent from its previous close.