Ranbaxy Receives Tentative Approval To Market Donepezil Hydrochloride Tablets

Main Category: Alzheimer's / Dementia
Article Date: 27 Feb 2005 - 17:00 PDT

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New Delhi - Ranbaxy Laboratories Limited (RLL) announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Donepezil Hydrochloride Tablets, 5 mg and 10 mg. Total annual market sales for Donepezil Hydrochloride Tablets, 5 mg and 10 mg, were $935.3 million (IMS - MAT: December 2004).

Donepezil Hydrochloride Tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

"We are pleased to receive this tentative approval for Donepezil Hydrochloride Tablets. This product represents a future opportunity and Ranbaxy will launch Donepezil Hydrochloride Tablets following final approval from the FDA," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of 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, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.

For further information please contact:

Ramesh L. Adige
Whole-time Director- Corporate Affairs and Global Corporate Communications
Ranbaxy Laboratories Ltd.
No 19, Nehru Place,
New Delhi -110019
Tel: +91-11-26464037
e-mail: ramesh.adige@ranbaxy.com

or

Raghu Kochar
Director-Corporate Communications
No 19, Nehru Place,
New Delhi -110019
Tel: +91-11-26002075
e-mail: raghu.kochar@ranbaxy.com

or

Krishnan Ramalingam
Manager- Corporate Communications
Ranbaxy Laboratories Ltd.
No 19, Nehru Place,
New Delhi -110019
Tel: +91-11-26002075
e-mail: krishnan.ramalingam@ranbaxy.com

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