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.
ranbaxy