Ranbaxy Pharmaceuticals Inc.
(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),
announced today that RLL has received tentative approval from the U.S. Food
and Drug Administration to manufacture and market Amlodipine Besylate
Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).
Amlodipine Besylate Tablets are indicated for the treatment of
hypertension and may be used alone or in combination with other
antihypertensive agents. Amlodipine Besylate is also indicated for the
symptomatic treatment of chronic stable angina and may be used alone or in
combination with other antianginal agents. The product is also indicated
for the treatment of confirmed or suspected vasospastic angina and may be
used as monotherapy or in combination with other antianginal drugs.
"We are pleased to receive this tentative approval for Amlodipine
Besylate Tablets. This product represents a future opportunity for Ranbaxy
and will be launched following final approval from the FDA. This product
will further expand our product portfolio of affordable generic
alternatives," said Jim Meehan, Vice President of Sales and Marketing 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.
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