Ranbaxy’s $500 Million Settlement Includes Criminal Penalties

The generic drug maker’s Ranbaxy USA Inc. subsidiary pleads guilty to seven felony counts brought in connection with a longstanding government investigation into data integrity issues and manufacturing violations at two Indian sites, but while the settlement eliminates some worries for the firm, operations still face the weight of a FDA consent decree.

Ranbaxy Laboratories Ltd.’s $500 million settlement of criminal and civil allegations involving data fraud and drug manufacturing violations lifts a cloud over the Indian generic drug maker, but the firm still faces a host of operational and regulatory hurdles created by an FDA consent decree.

On May 13, the U.S. Justice Department announced that Ranbaxy had agreed to pay $350 million to settle civil claims brought under the federal False Claims Act and related state laws. The company also agreed to pay a criminal fine of $130 million and forfeit an additional $20 million, with its Ranbaxy USA Inc

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