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.