Ranbaxy Laboratories Ltd. (500359.BY) said it has reached a
settlement with the U.S. Food and Drug Administration while setting
aside $500 million to address its potential liability from a
separate U.S. Justice Department investigation.
The new consent decree with the FDA, which is subject to
approval by the U.S. District Court in Maryland, comes after the
regulator banned the company in 2008 from importing more than 30 of
its generic drugs because of violations of manufacturing practices
at two plants -- at Dewas in central India and Paonta Sahib in
northern India.
The FDA also halted review of drug applications from Paonta
Sahib in 2009, alleging Ranbaxy had falsified data.
On Tuesday, Ranbaxy, the Indian unit of Japan's Daiichi Sankyo
Co. (4568.TO), said the agreement with the FDA would strengthen its
procedures on data integrity and comply with current good
manufacturing practices.
The generic drug maker also said its new $500 million reserve
would cover all potential civil and criminal liability.
"While we were disappointed by the conduct that led to the FDA's
investigation, we are proud of the systematic corrective steps we
have taken to upgrade and enhance the quality of our business and
manufacturing processes," Ranbaxy Chief Executive Arun Sawhney
said.
-By Drew FitzGerald, Dow Jones Newswires; 212-416-2909;
Andrew.FitzGerald@dowjones.com
