Ranbaxy to pay $500 million in fines

The settlement is one of the largest seen in India, in a case that was initiated by whistleblower Mr Dinesh Thakur, who reported the company's discrepancies in following cGMP standards for manufacturing of drugs

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Ranbaxy to pay $500 mn as fine for felony charges related to drug safety

Ranbaxy has announced that a previously disclosed investigation by the U.S. Department of Justice (DOJ) of data integrity and manufacturing processes at certain Ranbaxy facilities in India has been concluded, with Ranbaxy agreeing to pay $500 million in fines in a settlement with the DOJ.

Under the terms of the final settlement agreement, Ranbaxy and its affiliates have agreed to settle alleged civil violations of the False Claims Act with the US all 50 states and the District of Columbia. Separately, a US subsidiary, Ranbaxy USA, has agreed to plead guilty to a criminal information charging violations of the Food, Drug and Cosmetic Act and other criminal statutes. Ranbaxy's payments related to both the civil and criminal settlements total $500 million in aggregate. The financial provision Ranbaxy established in December 2011 will be sufficient to cover all material financial obligations under the agreement.

Mr Arun Sawhney, CEO and managing director, Ranbaxy, stated that the conclusion of the DOJ investigation does not materially impact our current financial situation or performance. He added, "Today's announcement marks the resolution of this past issue. While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy's stakeholders. Ranbaxy has successfully launched several generic products recently and is well-positioned for future growth in the US and around the world with a robust pipeline of important products as it continues to build a strong global portfolio of branded and generic prescription and OTC pharmaceuticals."

 

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