Swipha secures WHO prequalification for malaria drug Sulfadoxine-Pyrimethamine

Swipha, a Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organisation (WHO) for its sulfadoxine-pyrimethamine (SP) drug, which is used to prevent malaria infection in pregnant women (1)

Swipha submitted a prequalification dossier to WHO for its SP 500/25mg tablet after conducting extensive research and development, followed by a bioequivalence study to assess the drug’s efficacy and safety. This achievement was supported by Medicines for Malaria Venture (MMV) and funded by Unitaid, as part of a broader initiative to increase the global supply of quality malaria medicines.

The WHO prequalification programme ensures that medicines meet global standards for quality, safety, and efficacy. Swipha’s prequalification is seen as a step toward strengthening regional medicine production and reducing dependence on imported medicines, a reliance that was underscored during the COVID-19 pandemic when global supply chains were disrupted.

“We are honored by the WHO prequalification of our sulfadoxine-pyrimethamine drug, a  testament to Swipha’s dedication to improving public health. This achievement reflects our  commitment to producing high-quality medicines and contributing to the ongoing fight against  malaria,” said Abbas Sambo, Business Development & Licensing Director of Swipha. 

Malaria remains a significant health challenge in Nigeria, which accounts for one in four cases and one in three deaths from the disease globally. The scarcity of WHO-prequalified, African-manufactured medicines has hindered efforts to combat malaria in Nigeria, where programs rely on domestically produced SP.

“The Nigerian National Malaria Elimination Programme is elated about Swipha’s attainment  of WHO prequalification for the production of quality assured sulfadoxine-pyrimethamine with  support from global health organisations MMV and Unitaid. This is a major milestone that  Nigeria has been striving to achieve. It promises to have a tremendous impact on the Nigerian  health system by increasing availability of quality-assured medicines and building national  capacity for sustainable manufacturing and monitoring of quality medicines as well as  positioning Nigeria as a global competitor in the pharmaceutical sector,” said Dr Godwin  Ntadom, Coordinator of the Nigerian National Malaria Elimination Programme.  

“Unitaid is proud to support efforts to increase high-quality production of a vital antimalarial  medicine in Nigeria, the epicentre of the malaria crisis. Growing manufacturing capacity for  malaria drugs in Africa, where nearly all malaria infections occur, is critical to building stronger  health systems and ensuring countries are equipped to respond to the diseases that pose the  greatest threat to their populations,” stated Dr Philippe Duneton, Executive Director of Unitaid. 

Swipha is the second manufacturer in Africa to receive prequalification for SP, with a third African manufacturer expected to secure WHO prequalification soon, also in Nigeria.

“Swipha’s achievement of WHO prequalification for sulfadoxine-pyrimethamine is a significant  stride in the global fight against malaria. The collaborative efforts between Swipha, Unitaid,  and MMV underscore the power of equitable partnership and local leadership in creating  impactful solutions to combat diseases that disproportionately affect vulnerable populations,”  said George Jagoe, Executive Vice President of Access and Product Management at MMV. 

This achievement highlights the importance of partnerships between pharmaceutical entities, global health organisations, and governments in the fight against malaria.

 

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(1) By itself, SP is used to prevent malaria infection in pregnant women and in infants. When combined  with amodiaquine, it is used in seasonal malaria chemoprevention, an intervention which prevents  malaria in children in areas where the disease is highly seasonal.