The Department of Justice filed a proposed settlement with Ranbaxy, under which the drug company has agreed improve its data integrity and compliance practices in order to resolve allegations that its manufacturing plants in India failed to meet current good manufacturing practices.  Under the consent decree, Ranbaxy will implement new procedures to ensure it meets data integrity requirements for drug applications, will hire a third party expert to audit its processes, facilities, and applications, and will withdraw any applications which contain false statements of facts or data.  Additionally, Ranbaxy has agreed to forfeit the usual 180 day marketing exclusivity period for three of its pending generic drug applications and will forfeit the exclusivity period for additional drugs if it fails to meet certain benchmarks.  The agreement must still be approved by the district court.

Read the entire press release, “Department of Justice files consent decree of permanent injunction against Ranbaxy”