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Policy

Ranbaxy To Pay Large Settlement

by Lisa M. Jarvis
May 20, 2013 | APPEARED IN VOLUME 91, ISSUE 20

In the largest-ever fine levied against a generic drug manufacturer, Ranbaxy will pay $500 million to settle criminal and civil claims by the U.S. Department of Justice that it knowingly manufactured substandard drugs. In addition to the fine, Ranbaxy pled guilty to felony counts and to four counts of making false statements to FDA. The company’s entanglement with regulatory authorities began eight years ago when former Ranbaxy executive Dinesh Thakur tipped off FDA that Ranbaxy routinely falsified data and knowingly violated current Good Manufacturing Practices at generic drug plants in Paonta Sahib and Dewas, India. In 2008, FDA found that the firm was not compliant at the sites and barred the company from exporting 30 generic drugs to the U.S. In late 2011, Ranbaxy signed a consent decree—an agreement that laid out steps it would take to rectify its manufacturing deficiencies. With the conclusion last week of DOJ’s investigation, Thakur, the whistle-blower, is expected to receive $49 million of the $500 million settlement.

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