The WHO Prequalification programme has added artesunate 60mg powder for injection, manufactured by Guilin Pharmaceutical Co. Ltd in China, to its prequalified list.
Artesunate for injection is an important option for patients with severe malaria, as they are often unconscious or likely to vomit an orally administered medication. Artesunate has been on the WHO treatment guidelines for severe malaria, but no GMP1 formulation existed. This is another achievement for MMV – we have been working with Guilin to ensure that their manufacturing facilities and processes for artesunate for injection meet WHO prequalification standards.
“This is really exciting,” said Tim Wells, MMV’s chief scientific officer, “It proves that its worth investing the time and energy with the right partnership. We have been approached by several people to fund their production of GMP artesunate – but Guilin have been the only ones who committed to achieve Prequalification at a price that is affordable in Africa.”
This newly prequalified artesunate for injection will be available at the same affordable price as the current non-GMP material.
Conclusive win of artesunate over quinine - MMV applauds the results from the multi-country clinical trial, AQUAMAT, conducted by Prof Nick White and his team, which concludes beyond a doubt that artesunate should be the preferred treatment for severe malaria.
1 Good Manufacturing Practice