Feb 28, 2013, 09.36 AM | Source: PTI
Drug firm Jubilant Life Sciences today said 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 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.
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 BSE, down sharp 4.90 percent from its previous close.
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