Ranbaxy signs consent decree with U.S. FDA

Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) ("Ranbaxy") today announced that it has signed a consent decree with the U.S. Food and Drug Administration ("FDA"). Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The consent decree is subject to approval by the United States District Court for the District of Maryland.

Separately, Ranbaxy also announced that it intends to make a provision of $500 million in connection with the investigation by the U.S. Department of Justice, which the company believes will be sufficient to resolve all potential civil and criminal liability.

"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy's history," said Arun Sawhney, Ranbaxy CEO & Managing Director. "While we were disappointed by the conduct that led to the FDA's investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes. Ranbaxy's new management team, and its new majority shareholder, Daiichi Sankyo, are committed to the utmost levels of professionalism and integrity, and to ensuring that all Ranbaxy facilities meet the high standards that patients, prescribers and the public expect from a leading global generic pharmaceutical company. We look forward to continuing to work cooperatively with the FDA to strengthen the public trust in our company."

Mr. Sawhney continued, "With greater clarity around the outlook for our business in the U.S., we look forward to continuing to serve the U.S. market with safe, effective and affordable products, including our recent launches of Atorvastatin (brand Lipitor®) and Atorvastatin-Amlodipine besylate (brand Caduet®). Importantly, these developments bring greater predictability to Ranbaxy's U.S. operations and allow us to focus all of our efforts on bringing high quality products to market for the benefit of consumers."

Source: Ranbaxy Laboratories Ltd.


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