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Ranbaxy receives CDSCO approval to market Synriam in India

New Delhi: Ranbaxy Laboratories on Monday announced that the company has received approval from the Central Drugs Standard Control Organisation (CDSCO) 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, the company said in a statement.

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.

According to Ranbaxy, the company has also received permission to conduct Phase III clinical trials for the paediatric formulation in paediatric patients of uncomplicated Plasmodium falciparum malaria.

Commenting on the approval, Arun Sawhney, chief executive officer and managing director, Ranbaxy, 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 Synriam one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria.”

Ranbaxy is working to make this new treatment available in African, Asian and 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, according to the company.

Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent. It conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria, said the company.

As the dosage regimen for Synriam is simple, it leads to better compliance. A patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost, according to Ranbaxy.

According to the World Malaria Report 2012 published by WHO, India sees about 1.3 million 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. Worldwide, 40 per cent of total malaria burden globally is due to Plasmodium vivax, which shows the vast potential of Synriam in India and globally.

Traditional drugs are proving ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. Availability of plant based Artemisinin, a primary ingredient in established anti-malarial therapies is finite and unreliable. This leads to price fluctuations and supply constraints, which is not the case with a synthetic drug like Synriam, added the statement by Ranbaxy.

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