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

GURGAON, India--(BUSINESS WIRE)-- Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) (“Ranbaxy”) today announced that the consent decree with the U.S. Food and Drug Administration (“FDA”) that was signed on December 20, 2011 has been filed with the United States District Court for the District of Maryland. Under the terms of the consent decree, which is subject to approval by this Court, Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices.

“Today’s announcement is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue,” said Arun Sawhney, Ranbaxy CEO & Managing Director. “We are pleased with the progress we have made in upgrading and enhancing the quality of our business and manufacturing processes and remain committed to ensuring that all of our facilities and products meet the high standards that patients, prescribers and the public have come to expect from Ranbaxy.”

Mr. Sawhney continued, “As one of the premier global generic pharmaceutical companies, all of our efforts are focused on continuing to provide safe, effective and affordable products to consumers around the world.”

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.



CONTACT:

Ranbaxy Laboratories Ltd.
Mr. Raghunandan Kochar, +91-124-4135141 / 4135000
Director, Corporate Communications
[email protected]
or
Mr. Chuck Caprariello, 609-720-5615
Vice President, Corporate Communications
[email protected]

KEYWORDS:   United States  Asia Pacific  North America  New York  India

INDUSTRY KEYWORDS:   Health  Biotechnology  Pharmaceutical  Professional Services  Legal  Research  Other Science  FDA  Science  General Health

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