Ranbaxy bags CDSCO approval for SynriamTM
The approval is for manufacturing and selling SynriamTM in India.
New Delhi, October 21, 2013: Ranbaxy Laboratories has received an approval from Central Drugs Standard Control Organisation (CDSCO) to market SynriamTM for treating malaria caused by Plasmodium vivax parasite.
The company said in a statement that it has received the approval from the Indian drug regulator to manufacture and market SynriamTM in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite.
It is important to note that the company had launched SynriamTM for the treatment of uncomplicated Plasmodium falciparum malaria in India. The company announced that the phase III clinical trials for the drug were conducted successfully in India as it demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine.
The approval makes SynriamTM one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria, said Arun Sawhney, CEO and Managing Director, Ranbaxy.