Ranbaxy Announces Conclusion of Previously Disclosed Investigation by U.S. Department of Justice

  Ranbaxy Announces Conclusion of Previously Disclosed Investigation by U.S.
  Department of Justice

Business Wire

GURGAON, India -- May 13, 2013

Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) (“Ranbaxy”), today
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. The investigation related to
conduct which occurred several years ago, and Ranbaxy’s current management
team fully cooperated with the DOJ.

On December 20, 2011, Ranbaxy announced that it had signed a consent decree
with the U.S. Food and Drug Administration (“USFDA”), under which Ranbaxy
committed to further strengthen procedures and policies to ensure data
integrity and to comply with Current Good Manufacturing Practice (“cGMP”). In
anticipation of the settlement agreement with the DOJ announced today, Ranbaxy
announced at that time its intention to make a financial provision of $500
million related to expected costs associated with resolving the DOJ
investigation.

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 U.S., all 50 states and the District of Columbia. Separately, a U.S.
subsidiary, Ranbaxy USA, Inc., 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 & Managing Director, Ranbaxy, stated, “Today’s
announcement marks the resolution of this past issue. We are pleased to
continue bringing safe, effective and quality medicines to market for the
benefit of consumers in the U.S. and other parts of the world. 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; the conclusion of the DOJ investigation does not
materially impact our current financial situation or performance. Ranbaxy has
successfully launched several generic products recently and is well-positioned
for future growth in the U.S. 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. Our conduct is
guided by our philosophy of ‘Quality and Patients First.’”

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 150 countries and has an
expanding international portfolio of affiliates, joint ventures and alliances,
ground operations in 43 countries and manufacturing operations in 8 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.
Chuck Caprariello
Vice President, Communications
Ph: 609-720-5615
Chuck.caprariello@ranbaxy.com
or
Sard Verbinnen & Co
David Reno/Trevor Rees
Ph: (212) 687-8080
Trees@sardverb.com
 
Press spacebar to pause and continue. Press esc to stop.