The US government also said Ranbaxy submitted false data in applications to the US Food and Drug Administration (FDA).

Ranbaxy cannot manufacture drugs for the US market at some of its facilities until it resolves the problems, the government said.

The company agreed to hire an outside expert to conduct a thorough internal review at the affected facilities and to audit past drug applications, and hire an outside auditor for future applications, the US Justice Department said.

"Today's announcement is the next step in the process of finalising our agreement with the FDA to resolve this legacy issue," said Arun Sawhney, Ranbaxy's chief executive, in a statement.

The US government filed a consent decree for the case, which must be approved by the federal court in Maryland before it becomes binding.

Ranbaxy originally announced the agreement with

the US government in December but did not provide details about its violations. It set aside $500 million for any liabilities related to the case.

The company launched the first generic version of the cholesterol-lowering drug Lipitor in the United States on December 1. Lipitor is the biggest-selling drug of all time.

Daiichi Sankyo Co, Japan's third-largest drugmaker, owns a majority stake in Ranbaxy, and almost halved its annual profit forecast because of the settlement.