Ranbaxy Laboratories Limited on Monday said it had received the approval of the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Synriam™ for the treatment of uncomplicated malaria in adults caused by the Plasmodium vivax parasite.
Phase III clinical trials of the drug successfully demonstrated the efficacy and tolerability of Synriam™ as comparable to chloroquine.
Last year, Ranbaxy launched Synriam™ for the treatment of uncomplicated Plasmodium falciparum malaria in the country. Since its launch, the drug has successfully treated around one million patients. The company has also received permission to conduct Phase III clinical trials of the paediatric formulation of the drug.
CEO & Managing Director of Ranbaxy Arun Sawhney said, “Synriam™ is a new-age cure for malaria and is fast emerging as the preferred option in the hands of doctors. This approval makes it one of the few therapies in the world that successfully treats both Plasmodium vivax and Plasmodium falciparum malaria. Ranbaxy remains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world.”
Synriam™ provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95%. It conforms to the recommendations of the World Health Organisation for using combination therapy in malaria.