Nigerian pharmaceutical manufacturer Swipha has received prequalification from the World Health Organization (WHO) for their sulfadoxine-pyrimethamine (SP), a key medication used to prevent malaria in pregnant women.
This marks a major achievement in Africa’s fight against malaria, particularly in Nigeria, which bears the highest malaria burden globally.
The company underwent a rigorous process to submit a detailed dossier to WHO, demonstrating the quality, safety, and efficacy of their SP 500/25mg tablet.
This effort, which began with extensive research and development followed by a bioequivalence study, was supported by technical assistance from Medicines for Malaria Venture (MMV) and funding from Unitaid. Together, these organizations have been working to increase the global supply of quality malaria medicines.
The WHO prequalification programme ensures that medicines meet international standards, a crucial step in expanding access to reliable treatments. The prequalification of Swipha’s SP tablet is part of a larger initiative aimed at strengthening regional manufacturing capacity and reducing Africa’s reliance on imported medications—a vulnerability exposed during the COVID-19 pandemic.
“We are honoured by the WHO prequalification of our sulfadoxine-pyrimethamine drug, a testament to Swipha’s dedication to improving public health,” said Abbas Sambo, Business Development & Licensing Director of Swipha. “This achievement reflects our commitment to producing high-quality medicines and contributing to the ongoing fight against malaria.”
Nigeria, where one in four malaria cases and one in three malaria-related deaths occur globally, relies solely on domestically manufactured SP. The Nigerian National Malaria Elimination Programme has long sought the ability to produce quality-assured malaria medicines locally. Swipha’s prequalification represents a major step forward.
“The Nigerian National Malaria Elimination Programme is elated about Swipha’s attainment of WHO prequalification… This is a major milestone that Nigeria has been striving to achieve,” said Dr. Godwin Ntadom, Coordinator of the programme. He emphasized that the milestone would not only increase the availability of quality medicines but also strengthen national manufacturing capacity and position Nigeria as a global competitor in the pharmaceutical industry.
Dr. Philippe Duneton, Executive Director of Unitaid, echoed these sentiments: “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.”
Swipha is now the second manufacturer in Africa to receive WHO prequalification for SP, with a third manufacturer expected to follow suit soon, also based in Nigeria.
George Jagoe, Executive Vice President of Access and Product Management at MMV, hailed the achievement: “Swipha’s WHO prequalification for sulfadoxine-pyrimethamine is a significant stride in the global fight against malaria… This underscores the power of equitable partnership and local leadership in creating impactful solutions.”
This milestone demonstrates the importance of collaboration between local pharmaceutical companies, global health organizations, and governments in the ongoing efforts to eliminate malaria across Africa.