Drug major Ranbaxy Laboratories today said it has received Indian drug regulator’s approval to market SynriamTM for treating malaria caused by Plasmodium vivax parasite. The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market SynriamTM in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite, Ranbaxy Laboratories Ltd said in a statement. Last year, the Gurgaon-based firm had launched SynriamTM for treatment of uncomplicated Plasmodium falciparum malaria in India.
“Phase III clinical trials for the drug, conducted in India successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine,” the company added. “
The company has also received permission to conduct phase III clinical trials for the paediatric formulation in paediatric patients of uncomplicated Plasmodium falciparum malaria, it said.
“This approval makes SynriamTM one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria,” Ranbaxy CEO and Managing Director Arun Sawhney said.
Ranbaxy is working to make this new treatment available in African, Asian and South American markets where malaria is rampant, he added.
“The company has filed New Drug Applications (NDAs) for marketing SynriamTM in some African countries and will be filing more applications during the year. Once approved, the product will be launched in these markets,” Sawhney said.
According to the World Malaria Report 2012 published by WHO, India witnesses about 13 lakh confirmed cases of malaria each year, about 50 per cent of which are caused by Plasmodium vivax, the second most important species after Plasmodium falciparum.
Shares of Ranbaxy were trading at Rs 402.40 on the BSE in afternoon trade, up 2.93 per cent from its previous close.
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