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Ranbaxy Laboratories receives CDSCO approval to market Synriam in India

21 Oct 2013 Evaluate

Ranbaxy Laboratories has received approval from the Central Drugs Standard Control Organisation (CDSCO), Government of India to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite.

Phase III clinical trials for the drug conducted in India, successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine.

Last year on World Malaria Day, April 25, Ranbaxy had launched India's first new drug, Synriam for the treatment of uncomplicated Plasmodium falciparum malaria in India. Since its launch, Synriam has successfully treated around one million patients. The company has also received permission to conduct Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria.

Ranbaxy is working to make this new treatment available in African, Asian arid South American markets where malaria is rampant. The company has filed New Drug Applications (NDAs) for marketing Synriam in some African countries and will be filing more applications during the year. Once approved, the product will be launched in these markets.

Ranbaxy Laboratories, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

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