Ranbaxy Announces Consent Decree with U.S. Food and Drug Administration

Takes Corrective Steps, Commits to Further Measures

GURGAON, India--(BUSINESS WIRE)-- 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.”

* Lipitor® is a registered trademark of Pfizer.

** Caduet® is a registered trademark of Pfizer.

About Ranbaxy Laboratories Limited

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com.


Ranbaxy Laboratories Ltd.
Mr. Raghunandan Kochar, +91-124-4135141 / 4135000
Director, Corporate Communications
[email protected]
Ranbaxy, Inc.
Mr. Lavesh L. Samtani, 609-720-8110
Vice President-Americas
[email protected]

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