Wednesday, January 25, 2012

U.S. settles with drugmaker Ranbaxy over violations | Reuters

(Reuters) - The U.S. Department of Justice said it had reached an agreement with generic drugmaker Ranbaxy Laboratories Ltd (RANB.NS

) to resolve the company's manufacturing violations.

The United States said Ranbaxy had "numerous problems" at its facilities in the United States and in India, such as not keeping written records and not preventing contamination of sterile drugs.

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

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

Ranbaxy originally announced the agreement with the U.S. government in December but did not provide details about its violations. It set aside $500 million for any liabilities related to the case.

Posted via email from Jack's posterous

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