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Ranbaxy Guilty, Settles Federal Charges for $500M


This is a settlement for the Drugs/Medical Devices lawsuit.

Washington, DC: Ranbaxy has pled guilty to federal drug safety violations and will pay $500 million in fines to resolve the claims. The generic drug manufacturer is alleged to have sold subpar drugs and made false statements to the Food and Drug Administration (FDA) about its manufacturing practices at two factories in India.

According to the Justice Department, the settlement is reportedly the largest in history involving a generic drug maker. Part of the settlement involves Ranbaxy pleading guilty to three felony counts of violating the federal drug safety law and four of making false statements to the FDA.

According to a report by the the New York Times, Ranbaxy acknowledged it had failed to conduct proper safety and quality tests of several drugs manufactured at its Indian plants, known as Paonta Sahib and Dewas, including generic versions of many common medicines, such as the epilepsy drug gabapentin, and the antibiotic ciprofloxacin.

In the case of gabapentin, also known as Neurontin, Ranbaxy reportedly admitted that between June and August in 2007, it was aware that certain batches had tested positive for "unknown impurities"and had unreliable shelf lives. Nevertheless, the company didn't report this to the FDA and announce a recall until October of that year. The recall ultimately involved more than 73 million pills.

Further, testing of certain batches of drugs to ensure their effectiveness was reportedly not done for weeks or months after the company had told the FDA the testing had been carried out.

Ranbaxy has set aside $500 million in anticipation of the penalties, which will break down as a $150 million in a criminal fine and forfeiture, and the remainder going to settle civil claims brought by the federal government and all 50 states. A former Ranbaxy executive who alerted the federal government to the problems will receive close to $49 million in compensation for his role as a whistle-blower, the Times reports.

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Published on May-14-13

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