$500 Million Penalty, A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in penalties and fines for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S.
Federal prosecutors say the guilty plea by Ranbaxy USA Inc. represents
the largest financial penalty against a generic drug company for
violations of the Federal Food, Drug and Cosmetic Act, which prohibits
the sale of impure drugs.
The deal, announced Monday, concludes a years-long federal investigation
into Ranbaxy's manufacturing deficiencies. The Food and Drug
Administration in 2008 barred from Ranbaxy from importing more than 30
different drugs made at factories in India and, two years ago, struck a
deal that required the company to ensure that data on its products is
accurate, undergo extra oversight and review from a third-party and
improve its drug making procedures.
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