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, Jubilants share fell close to 5% on the BSE to close at R176.45 on Wednesday.
For the third quarter of this fiscal, Jubilants 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 set aside $500 million to cover any potential penalty from an investigation by the US Justice Department.
Similarly, in 2009, USFDA officials had seized 33 drugs manufactured at Sun Pharma arm Caracos Detroit unit and temporarily stopped all manufacturing activities. The regulator had also seized all drugs manufactured by Caraco, including raw materials and active pharmaceutical ingredients. In 2011, Caraco resolved issues raised by the countrys health regulator regarding these violations.
Meanwhile, Jubilant cautioned that the USFDA may withhold approval of new applications or supplements listing JHS as the drug product manufacturer, until all corrections have been completed and that they have confirmed correction of the violations and firm compliance to cGMPs.
We expect that the on-going manufacturing, distribution and sale of products will not be affected by this WL. JHS will work closely with them to resolve this matter, it added.