Ranbaxy gets Japanese Health Ministry nod for Amlodipine
Mumbai (PTI): Ranbaxy Laboratories on Tuesday said it has received approval from Japanese Ministry of Health and Labour Welfare (MHLW-Japan) for marketing the generic version of Amlodipine tablets, used in the treatment of high blood pressure, in that country.
Amlodipine tablets has been approved for the strengths 2.5 mg and 5 mg. Amlodipine has a market size of around two billion dollars and is currently the largest molecule which has gone off patent in Japan, the company informed the Bombay Stock Exchange.
The tablet is the first independent product approval received by Ranbaxy in Japan and has the distinction of being the first product developed by any foreign generic pharmaceutical company outside Japan and subsequently being granted approval by MHLW (Japan), it said.
MHLW-Japan is encouraging generic substitution which is reflected in the growing genericisation of medicines to 30 per cent by volume in 2012 from 17 per cent in 2007, it added.
"This is a significant milestone in our Japan initiative as it marks the acceptance of our high quality generic medicines in one of the most discerning markets. It reflects strongly on our long term commitment to Japan," Ranbaxy Labs CEO and Managing Director Malvinder Mohan Singh said.
Since 2004, Ranbaxy has filed seven products in Japan and so far has 100 per cent success rate in getting approvals.
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