Ranbaxy Receives Tentative Approval For Valsartan Tablets

Main Category: Hypertension
Also Included In: Cardiovascular / Cardiology;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 31 Oct 2007 - 0:00 PDT

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Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valsartan Tablets, 40 mg, 80 mg, 160 mg and 320 mg. Total annual market sales for Valsartan Tablets were $1.3 billion (IMS - MAT: June 2007).

Valsartan is indicated for the treatment of hypertension alone or in combination with other anti-hypertensive agents. Valsartan is also indicated for the treatment of heart failure (NYHA class II-IV).

"We are pleased to receive tentative approval for Valsartan Tablets. We believe, we are first to file a substantially complete ANDA and will stand to gain from the 180 day exclusivity available to the first filer. These product formulations have been developed organically within Ranbaxy and will further expand our product portfolio of affordable generic alternatives," said Jim Meehan, Vice President of Sales and Distribution for RPI.

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.

Ranbaxy Pharmaceuticals Inc.
http://www.ranbaxy.com