Ranbaxy Laboratories Ltd has received authorization from Ministry of Health and Labour Welfare (MHLW-Japan) for marketing the generic version of Amlodipine tablets 2.5mg & 5mg.

Amlodipine tablet is the first independent product approval received by Ranbaxy in Japan. It has the unique distinction of being the first product developed by any foreign generic pharmaceutical company outside Japan and subsequently being granted approval by MHLW (Japan).

Amlodipine tablets has a market size of around US $2 billion (Jan-Dec' 2007 - IMS - Japan). The product is currently the largest molecule which has gone off patent in Japan and represents the biggest generic opportunity so far in the Japanese generic market. The Government of Japan is encouraging generic substitution which is reflected in the growing genericization of medicines from 17 per cent by volume in 2007 to 30 per cent by volume in 2012.

Commenting on the approval, Malvinder Mohan Singh, CEO and managing director, said, "This is a significant milestone in our Japan initiative as it marks the acceptance of our high quality, affordable generic medicines in one of the most discerning markets. It also reflects strongly on our long term commitment to Japan".

Since 2004 Ranbaxy has filed 7 products in Japan and so far has 100 per cent success rate in getting approvals. Today Ranbaxy has a total of 4 products being marketed in the Japanese generics market and has a strong portfolio in the pipeline which will be introduced during 2008 and 2009.

Ranbaxy entered the Japanese market in the 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.