Ipca Laboratories has received approval for its Anti-malarial finished fixed dose combination formulation - Artemether + Lumefantrine under WHO's Prequalification Programme. IPCA is the 4th Company in the World to have pre-qualification for this product. Ipca's API - Artemether and Lumefantrine are already approved by WHO. IPCA currently manufactures and supplies Artemether and Lumefantrine APIs to many of its customers in several countries across the globe.
With this approval, Ipca is the only company in the world who has WHO pre-qualification for both API as well as formulation. The total market for this combination is around 200mn treatment (each treatment cost US$1 to 1.33). The addressable market is US$200-250mn.
As of now, Novartis (brand name Coartem) is the major supplier to UNICEF and other agencies. Novartis procures the API from Chinese company. Ajanta Pharma of India has recently got approval for this combination and Ipca is supplying them one of the API. With this approval, now Ipca can participate in the UNICEF/ PAHO tender next year (annual tender; tender will be finalized by May-June 2010)
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