Ranbaxy receives Japanese approval for marketing Amlodipine

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Mumbai, Apr 8 (UNI) Ranbaxy Laboratories Ltd has received authorisation from Ministry of Health and Labour Welfare (MHLW-Japan) for marketing the generic version of Amlodipine tablets.

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), the company informed the BSE today.

Amlodipine tablets has a market size of around USD two billion (Jan-Dec'2007-IMS-Japan). The product was 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 was 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 CEO&Managing Director Malvinder Mohan Singh 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 seven products in Japan and all of them had received approvals. Today Ranbaxy had a total of four 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 had entered the Japanese market in 2002 through a strategic alliance with a mid-sized research pharmaceutical Company Nippon Chemiphar Ltd (NC) of Japan. At present its generic subsidiary Nihon Pharmaceutical Industry Ltd (NPI) is a 50:50 joint venture between Ranbaxy and Nippon Chemiphar.


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