Jubilant gets USFDA rap for 'violations' in Canada
“As required by USFDA, JHS will respond to this warning letter on or before March 15, 2013,” Jubilant said in a statement. “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 reoccurrence of the items found to be objectionable to the FDA.” Reacting to the news, Jubilant’s share fell close to 5% on the BSE to close at R176.45 on Wednesday.
For the third quarter of this fiscal, Jubilant’s revenues from the US market stood at R539 crore, up 26% year-on-year, contributing over 41% to revenue mix.
Jubilant joins a list of other Indian pharma companies like Ranbaxy Laboratories and Sun Pharma who have come under the USFDA scanner of late, leading to a stoppage of drug production from erring facilities.
In 2008, the USFDA banned Daiichi Sankyo-controlled Ranbaxy from exporting 30 drugs from its facilities in Dewas, Madhya Pradesh, and Paonta Sahib, Himachal Pradesh, and also stopped marketing approvals for new ones following quality control and data reporting issues.
Later, the company said it has committed to strengthen procedures and policies to ensure data integrity and comply with cGMP practices, the global benchmark in drug manufacturing. It also
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