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| Ranbaxy Becomes First Foreign Generic Company to Develop a Generic Product
Receives first independent product authorisation for Amlodipine Tablets in Japan | |||
| 7 Apr 2008
, Gurgaon, Haryana, India
: Ranbaxy Laboratories Limited (Ranbaxy) today announced that the Company 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 USD 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% by volume in 2007 to 30% by volume in 2012. Commenting on the approval, Mr. Malvinder Mohan Singh, CEO & 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% 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. Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries. |
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