Ranbaxy receives Japanese authorisation for product development outside Japan

Ranbaxy Laboratories Ltd  has received authorisation from the Japanese ministry of health and labour welfare (MHLW) for marketing the generic version of amlodipine tablets2.5mg and 5mg.

Ranbaxy says amlodipine tablet is the first independent product approval received by Ranbaxy in Japan is the first product developed by any foreign generic pharmaceutical maker outside Japan to be granted MHLW approval.

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.

The government of Japan is encouraging generic substitution, which is expected to grow from 17 per cent by volume in 2007 to 30 per cent in 2012.

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

Ranbaxy markets four products in the Japanese generics market and says that it has a strong portfolio in the pipeline which will be introduced during 2008 and 2009.

Ranbaxy entered the Japanese market in 2002 through a strategic alliance with a mid-sized research pharmaceutical company, Nippon Chemiphar Ltd (NC), whose generic subsidiary Nihon Pharmaceutical Industry Ltd (NPI) is a 50:50 joint venture between Ranbaxy and Nippon Chemiphar.