In this case, Thakur receives a whistleblower share of $48.6 million of the $500 million Ranbaxy was willing to pay as a result of the transaction. Generic drug maker Ranbaxy pleaded guilty Monday to federal drug safety violations and will pay $500 million in fines to settle allegations that it sold sub-average drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India , as the company and federal prosecutors announced on Monday. According to the Department of Justice, the comparison is the largest in history involving a generic drug manufacturer and drug safety. Ranbaxy`s U.S. subsidiary pleaded guilty Monday to paying $US 500 million – the largest comparison ever made by a generic drug maker. The U.S. Department of Justice said in a statement: “In the largest drug safety agreement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories, pleaded guilty to charging the manufacture and distribution of certain falsified drugs manufactured at two Ranbaxy plants in India.” Ranbaxy also agreed to pay a fine and forfeiture totalling $150 million, and to settle civil claims under the False Claims Act and related government laws for $350 million. Ranbaxy USA pleaded guilty to three counts under the Federal Food Durg and Cosmetics Act (FDCA) and four counts of knowingly making statements to the Food and Drug Administration (FDA). The disputed generics were manufactured at Ranbaxy`s factories in Paonta Sahib and Dewas in India. As part of the plea, the company will pay a $130 million fine and lose an additional $20 million,” the Justice Department said. As part of the decision, the whistleblower, a former Ranbaxy Dinesh Thakur director, will receive approximately $48.6 million from the federal government in the amount of the transaction. Although we are disappointed by the past conduct that led to this investigation, we firmly believe that the resolution of this case is now in the interest of all Ranbaxy actors; The conclusion of the DOJ investigation has no significant impact on our current financial position or performance,” said Arun Sawhney, Managing Director and Managing Director of Ranbaxy Laboratories. Ranbaxy USA also acknowledged that samples of drugs awaiting testing were stored for unknown periods in a refrigerator that did not fill certain temperature and humidity ranges for an approved stability chamber, and that this had not been disclosed to the FDA. Ranbaxy USA admitted that certain batches of adulterated drugs produced at Paonta Sahib in 2005 and 2006 were used in interstate trade, including sotret, gabapentin and ciprofloxacin.
Sotret is the branded ranbaxy drug for the treatment of severe notolic acne, gabapentin is a drug for the treatment of epilepsy and nerve pain, and ciprofloxacin is a broad-spectrum antibiotic. When companies sell falsified drugs, they undermine the integrity of the FDA`s marketing authorization process and can lead patients to take poor quality, ineffective or dangerous drugs,” said Stuart F Delery, Assistant Attorney General of the Department of Justice`s Civil Division. Ranbaxy USA also admitted false statements, fictitious and fraudulent FDA submitted in annual reports submitted in annual reports submitted in 2006 and 2007 on data on stability tests conducted on certain batches of Cefaclor, Cefadroxil, amoxicillin, and amoxicillin and Clavulat potassium manufactured at the Dewas plant, said the Ministry of Justice.