Ranbaxy Settles With|USA for $500 Million

(CN) - Generic drugmaker Ranbaxy Laboratories will pay $500 million to settle criminal and civil fines of making adulterated drugs in India and distributing them in the United States, federal prosecutors said.

Ranbaxy USA, a subsidiary of the Indian corporate parent, pleaded guilty to seven felonies and agreed to forfeit $150 million and pay $350 to settle False Claims Act and state law violations, the Department of Justice said Monday.

"Ranbaxy USA pleaded guilty to three felony FDCA [Food, Drug and Cosmetic Act] counts, and four felony counts of knowingly making material false statements to the FDA," the Justice Department said in a statement. "The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas, India. Under the plea agreement, the company will pay a criminal fine of $130 million, and forfeit an additional $20 million."

Ranbaxy USA admitted interstate sales of adulterated Sotret, gababentin and ciprofloxacin. Sotret (isotretinoin) is used to treat a severe form of acne; gabapentin to treat epilepsy and nerve pain, and ciprofloxacin is an antibiotic.

Prosecutors said it was the largest drug safety settlement ever with a generic drugmaker.

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit