Ranbaxy gets nod for marketing the generic amlodipine tablets in Japan

Ranbaxy Laboratories, India's largest pharmaceutical company, has received authorization from Ministry of Health and Labour Welfare of Japan for marketing the generic version of amlodipine tablets of 2.5mg and 5mg, used in the treatment of high blood pressure.

Amlodipine is the first independent product approval received by company in Japan and also has the distinction of being the first product developed by any foreign generic pharmaceutical company outside Japan and subsequently being granted approval by the Japanese Government.

The product has a market size of around $2 billion (IMS Japan: January-December 2007) and is currently the largest molecule to have gone off-patent in Japan and represents the biggest generic opportunity so far in the Japanese generic market.

Ranbaxy entered the Japanese market in year 2002 through a strategic alliance with a mid sized research pharmaceutical company, Nippon Chemiphar Limited (NC) of Japan. At present its generic subsidiary Nihon Pharmaceutical Industry Limited (NPI) is a 50:50 joint venture between Ranbaxy and Nippon Chemiphar.

Since 2004 Ranbaxy has filed seven products in Japan, all of which have been granted approvals.

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