Ranbaxy Laboratories announced that the US Food and Drug Administration (US FDA) notified the company that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products.
The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
Subsequent to the Form 483 issued in early January 2014, Ranbaxy voluntarily and proactively suspended shipments of API from this facility to the U.S. market when it received the inspection findings. Ranbaxy is disappointed with the recent FDA action and would like to apologise to all its stakeholders for the inconvenience caused by the suspension of shipment. “This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation,” said Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy.
Ranbaxy is committed to highest standards of patient safety and quality, and shall constantly endeavour to strengthen its systems and processes. Ranbaxy will cooperate with the FDA and shall comply with the consent decree in both letter and spirit.
EP News Bureau – Mumbai