Ranbaxy signs FDA Consent Decree

Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359) signed a Consent Decree with FDA more than two years after the agency halted the review of all applications containing data from the company's Paonta Sahib plant in India due to data integrity and manufacturing concerns. Ranbaxy said Wednesday it committed to further strengthen procedures and policies to ensure data integrity and to comply with cGMP. Details of the decree, which is subject to approval by the U.S. District Court for the District of Maryland, were not disclosed (see BioCentury Extra, Feb. 25, 2009).

Ranbaxy also said it will set aside $500 million to resolve all potential civil and criminal liability in connection with an investigation by the U.S. Department of Justice. Ranbaxy said it is continuing to work closely with DoJ to resolve the liabilities, but declined to provide details of the investigation. Ranbaxy was up Rs11.50 to Rs406.05 on Wednesday. ...