Ranbaxy Laboratories Limited has received an import alert from the US FDA on the company's Mohali facility and the company has vowed that it 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 regulator has also advised that the Mohali facility will be subject to certain terms of the Consent Decree signed in January 2012.
The US FDA had conducted inspections at Ranbaxy's Mohali facility in 2012, resulting in certain observations.
Ranbaxy 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.
The company remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the company and stays firmly committed to its philosophy of 'Quality and Patients First'.
