Ranbaxy settles cGMP issues with U.S. government

FDA had barred importation of drugs made at two Indian plants in 2008

GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

The generic drug maker said it had signed a consent decree with the Food and Drug Administration, subject to the approval of the U.S. District Court for the District of Maryland, with the intent to ensure data integrity and comply with current good manufacturing practices. Ranbaxy, which Japanese drug maker Daiichi Sankyo took control of in 2008, also is paying $500 million to the Department of Justice, which was investigating the matter.

"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy's history," Ranbaxy CEO and managing director Arun Sawhney said. "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."

In September 2008, the FDA barred importation of 30 drugs made in Ranbaxy's plants in Dewas and Paonta Sahib, India, due to cGMP violations found during routine inspections. It was long speculated that the FDA's actions would jeopardize the drug maker's planned launch of a generic version of Pfizer's cholesterol drug Lipitor (atorvastatin calcium), but a resolution of the cGMP problems with the FDA allowed Ranbaxy to launch on Nov. 30, as scheduled.

 


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