Ranbaxy Secures Usfda Approval For Quinapril+Hctz Tablets

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 19 Mar 2009 - 4:00 PDT

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Ranbaxy Laboratories Limited (Ranbaxy), announced that the company has received an approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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, at New Jersey, USA. The Office of Generic Drugs, USFDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Accuretic Tablets of Pfizer Pharmaceuticals Ltd.

This is the second ANDA approval granted by the USFDA, to Ranbaxy, in the last two months.

Quinapril + HCTZ, is an ACE inhibitor and is used to treat high blood pressure.

Ohm, based in North Brunswick, New Jersey, USA, 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 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 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.

Ranbaxy
http://www.ranbaxy.com

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