The Justice Department cited violations of manufacturing standards and problems with submitted data in a consent decree for permanent injunction filed in court against the company.
"This action against Ranbaxy is groundbreaking in its international reach - it requires the company to make fundamental changes to its plants in both the United States and India," said Tony West, Assistant Attorney General for the Justice Department's Civil Division, after it filed the consent decree at the request of the Food and Drug Administration (FDA).
"Our commitment to ensuring that the drugs the American people rely on are safe, effective and manufactured according to the FDA's standards extends beyond our borders," West said.
The consent decree filed yesterday is unprecedented in its scope, and requires Ranbaxy to take a wide range of actions to correct its violations and ensure that they do not happen again, said the Justice Department.
Among other things, the consent decree seeks to prevent Ranbaxy from manufacturing drugs for the US market at certain of its facilities until those facilities can do so according to US standards.
Once the consent decree is approved by the court, it becomes a court order with which Ranbaxy must comply or face contempt.