BWI: Jubilant receives USFDA Approval for Donepezil Hydrochloride Tablets 5mg & 10 mg

Press release from Business Wire India
Source: Jubilant Life Sciences Limited
Friday, June 03, 2011 06:11 PM IST (12:41 PM GMT)
Editors: General: Consumer interest; Business: Advertising, PR & marketing, Business services, Healthcare, biotechnology & pharmaceutical; Healthcare
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Jubilant receives USFDA Approval for Donepezil Hydrochloride Tablets 5mg & 10 mg


Noida, Uttar Pradesh, India, Friday, June 03, 2011 -- (Business Wire India) -- Jubilant Life Sciences Ltd, an integrated Pharma and Life Sciences Company and the largest Custom Research & Manufacturing player out of India announced today that it has received approval from the U.S. Food and Drug Administration (US FDA) for Donepezil Hydrochloride Tablets 5 mg and 10 mg, a generic equivalent of Aricept®.

Donepezil Hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type, in patients with mild, moderate and severe Alzheimer's disease. The total annual market sales for Aricept® 5 mg and 10 mg tablets were $2.6 billion (IMS-MAT: September 2010).

Commenting on the approval, Mr Shyam S Bhartia, Chairman & Managing Director and Mr Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said, "We are pleased to announce the launch of Donepezil, which expands our generic product portfolio in USA. This will be our first product from the Indian dosage form facility set up in Roorkee, Uttarakhand, for the US market and paves the way for further approvals from this facility."

Donepezil Hydrochloride Tablets will be manufactured at Jubilant Life Sciences state of the art dosage form facility at Roorkee in India, with backward integration into the API manufactured at the Company's USFDA approved API facility at Nanjangud in India. The product will be marketed by its US subsidiary Jubilant Cadista Pharmaceuticals Inc. under its label. With this approval Jubilant Cadista will have 15 commercialized products in the US market.

Jubilant along with its subsidiary Cadista, currently holds 17 ANDA approvals and has a pipeline of 19 ANDAs awaiting approvals from the US FDA.

Jubilant's generic formulation of Aricept® will benefit the U.S. healthcare system by providing a more affordable treatment option to patients, which will have a positive impact on escalating U.S. healthcare costs. According to the Alzheimer's Association, 5.3 million Americans of all ages have Alzheimer's disease.

Aricept® is a registered trademark of Eisai Inc.

About Jubilant Life Sciences Ltd

Jubilant Life Sciences Limited, is an integrated Pharma and Life Sciences Company. It is the largest Custom Research and Manufacturing Services (CRAMS) player and a leading Drug Discovery and Development Solution (DDDS) provider out of India. The Company provides Life Sciences products and services across the value chain. With 10 world-class manufacturing facilities and a team of 5700 multicultural people across the globe, the Company is committed to deliver value to its customers in over 70 countries. Jubilant Life Sciences is well recognized as a 'Partner of Choice' by leading life sciences companies worldwide. For more info: www.jubl.com


CONTACT DETAILS
Seema Ahuja, Jubilant Life Sciences Limited, +91 (120) 4361062, seema_ahuja@jubl.com
Nidhi Aggarwal, Jubilant Life Sciences Limited, +91 (120) 4361002, nidhi_aggarwal@jubl.com
Travis Roberts, Cadista Pharmaceuticals Inc., 410-912-3707, travis.roberts@cadista.com

KEYWORDS
CONSUMER, MARKETING, BUSINESS SERVICES, HEALTHCARE, HEALTHCARE

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