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Generic drugmaker Ranbaxy Laboratories has agreed to make broad changes at its plants in the United States and India as part of a long-running US government probe,the countrys Justice Department said on Wednesday. The US said Ranbaxy had 8220;numerous problems8221; at its facilities in the United States and in India,such as not keeping written records and not preventing contamination of sterile drugs.
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.
8220;Today8217;s announcement is the next step in the process of finalising our agreement with the FDA to resolve this legacy issue,8221; said Arun Sawhney,Ranbaxy8217;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,Japan8217;s third-largest drugmaker,owns a majority stake in Ranbaxy,and almost halved its annual profit forecast because of the settlement.
In 2009,the FDA accused the company of falsifying data and test results in applications and halted reviews of drugs made at the company8217;s plant in northern India.
