(Reuters) – Indian generic drugmaker Ranbaxy Laboratories Ltd pleaded guilty yesterday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice.
The settlement is its largest-ever with a generic drugmaker over drug safety, according to the U.S. government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.
The settlement has been in the works for some time. In December 2011, Ranbaxy set aside $500 million to resolve the potential criminal and civil liabilities related to the investigation by the government into its manufacturing practices and falsifying data.
The company reached a related settlement agreement with the U.S. Food and Drug Administration in 2011.
“The financial provision Ranbaxy established in December 2011 will be sufficient to cover all material financial obligations under the agreement,” the company said in a news release announcing the conclusion of the U.S. investigation.
Ranbaxy USA pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to four counts of making material false statements.
