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Ranbaxy and DOJ agree to largest generic drug safety settlement ever

Steven M. Sellers

In the largest drug safety settlement the Department of Justice has ever executed with a generic drug manufacturer, Ranbaxy USA pleaded guilty to seven felony counts and agreed to pay a total of $500 million in fines and forfeitures. The DOJ alleged that Ranbaxy knowingly produced adulterated drugs at two plants in India that were later distributed in the United States and that Ranbaxy officials failed to notify the FDA of tests that showed numerous drugs it produced were out of specification, impure, and did not meet shelf life standards.

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