Ranbaxy: Will Cooperate With FDA
Gurgaon, India, Sept. 17, 2013 - Ranbaxy Laboratories Limited, said today that during the late hours of September 16, 2013, the Company received communication from the US FDA that the regulator has imposed an import alert on Ranbaxy’s Mohali facility. The US FDA also advised that the Mohali facility will be subject to certain terms of the Consent Decree signed in January 2012.
Ranbaxy will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest.
The US FDA had conducted inspections at Ranbaxy’s Mohali facility in 2012, resulting in certain observations. The Company believes that it has made further improvements at its Mohali facility since the last inspection in 2012, and remains committed to addressing all concerns of the US FDA. Ranbaxy is hopeful of an early resolution of these concerns.
Ranbaxy remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company. Ranbaxy stays firmly committed to its philosophy of ‘Quality and Patients First’.
Posted: September 2013