Ranbaxy Secures Final FDA Approval for Quinapril Hydrochloride + Hydrochlorothiazide Tablets
Created by News on 3/11/2009 9:33:25 AM

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.


PRINCETON, N.J., March 5 /PRNewswire/ -- 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(R) 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(R) is a registered trademark of Pfizer Pharmaceuticals Ltd.

CONTACTS:  Charles M. Caprariello
               Vice President, Corporate Communications
               Ranbaxy Inc.
               (609) 720-5615

               Edwige Buteau
               RF Binder Partners Inc.
               (212) 994-7517

               Caroline Dickson
               RF Binder Partners Inc.
               (212) 994-7560
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