Ranbaxy Preps for FDA at Indian Facility
As Daiichi Sankyo's Ranbaxy unit awaits FDA inspection of its Dewas, India, facility--a step toward resuming the export of drugs from the plant--the parent company's incoming CEO Joji Nakayama says he's confident a ban imposed by U.S. regulators will be lifted.
The ban stretches back to 2008 when GMP violations at Dewas and the company's Paonta Sahib facility were compounded by falsified data, as we've reported . The FDA ultimately blocked 30 of the company's generics from U.S. sales. And the regulator prohibited the drugmaker from introducing to the U.S. new drugs from the Paonta Sahib plant. The FDA has also stopped reviewing drug submissions that involve the plant.
"Ranbaxy is experienced in making medicines at a lower cost and Daiichi Sankyo aims to take full advantage of it after the FDA issue is resolved," Nakayama says in a Bloomberg report.
Nakayama's predecessor, Takashi Shoda, said in March that he expected the FDA import ban to be lifted by 2012. And U.K. and Australian regulators have recently approved drugs from the plant after a joint audit.
June 16, 2010