| RANBAXY SECURES FINAL FDA APPROVAL FOR QUINAPRIL
HYDROCHLORIDE + HYDROCHLOROTHIAZIDE TABLETS
Princeton, NJ – March 5, 2009 -- Ranbaxy
Pharmaceuticals Inc. (RPI), a wholly owned subsidiary
of Ranbaxy Laboratories Limited (RLL), announced today
that RLL has received approval from the U.S. Food and
Drug Administration to manufacture and market Quinapril
Hydrochloride & Hydrochlorothiazide (Quinapril +
HCTZ) Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg.
The Application for the drug was submitted by Ranbaxy,
from its Ohm Laboratories manufacturing facility located
in North Brunswick, New Jersey. The Office of Generic
Drugs, U.S. Food and Drug Administration, has determined
the Ranbaxy formulations to be bioequivalent and have
the same therapeutic effect as that of the reference
listed drug Accuretic® Tablets of Pfizer Pharmaceuticals
Ltd. Total annual market sales for Quinapril + HCTZ
Tablets were $29 million (IMS – MAT: December
2008).
According to Jim Meehan, Vice President of Sales and
Distribution for RPI, “We are pleased to receive
this final approval for Quinapril + HCTZ, an ACE inhibitor
that is used to treat high blood pressure. This is the
second ANDA approval granted by the FDA, to Ranbaxy,
in the last two months. Product will be made available
to all classes of trade in the near term.”
Ohm, based in North Brunswick, New Jersey, is a wholly
owned subsidiary of Ranbaxy Laboratories Limited. Ohm
is engaged in the sale and distribution of generic and
branded private label, OTC products in the U.S. healthcare
system.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville,
Florida, is a wholly owned subsidiary of Ranbaxy Laboratories
Limited (RLL), India’s largest pharmaceutical
company. RPI is engaged in the sale and distribution
of generic and branded prescription products in the
U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India,
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 markets and significant progress in New Drug
Discovery Research. The Company’s foray into Novel
Drug Delivery Systems has led to proprietary "platform
technologies", resulting in a number of products
under development. The Company is serving its customers
in over 125 countries and has an expanding international
portfolio of affiliates, joint ventures and alliances,
ground operations in 49 countries and manufacturing
operations in 11 countries.
*Accuretic® is a registered trademark of Pfizer
Pharmaceuticals Ltd.
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