Swipha bags WHO pre-qualification for Sulfadoxine Plus Pyrimethamine tablet to combat malaria in pregnancy

Pharma Nigeria Limited (Swipha), a leading pharmaceutical company in Nigeria, has recorded another historic first and a significant milestone in its commitment to improving maternal health and combating malaria in Nigeria and beyond with the accomplishment of the World Health Organisation (WHO) prequalification for its Sulfadoxine Plus Pyrimethamine (SP) 500/25mg tablet for the prevention of malaria in pregnancy.

Malaria remains a significant public health challenge in many parts of the world, particularly in sub-Saharan Africa, where pregnant women and children under five years of age are most vulnerable. Malaria in pregnancy poses severe risks to both the mother and the unborn child, including an increased risk of maternal anaemia, low birth weight, preterm birth, and maternal death. Preventive measures, including using SP during antenatal care visits, are essential in reducing these risks and improving maternal and child health outcomes.

Speaking on the milestone, the Managing Director of Swiss Pharma Nigeria Limited, Frederic Lieutaud, disclosed that the achievement of WHO Prequalification for Swipha’s SP 500/25mg tablet underscores the company’s commitment to providing high-quality, life-saving medicines that meet international standards of safety, efficacy, and quality assurance. He noted that the prequalification also represents a significant step forward in the fight against malaria in pregnancy in Nigeria and across Africa.

“We are immensely proud to have received WHO Prequalification for our Sulfadoxine Plus Pyrimethamine Tablet for preventing malaria in pregnancy. This achievement demonstrates our unwavering commitment to improving maternal health and combating malaria, two critical public health challenges in Nigeria and beyond. We believe every woman deserves access to safe and effective preventive measures during pregnancy, and we are dedicated to making this a reality,” said Mr Lieutaud.

Also speaking on the milestone, Swipha’s Business Development & Licensing Director, Abbas Sambo stated that the achievement highlights Swipha’s belief in providing safe and effective medicines for all, particularly maternal and child health. “This certification enables us to offer the SP Tablet to organizations and governments worldwide, contributing to improved maternal and child health outcomes. We are actively seeking partnerships with global entities such as the Global Fund and USAID to tackle critical health challenges like Malaria,” Sambo added.

Mr Sambo further stressed the importance of collaboration in addressing these health issues, reiterating Swipha’s commitment to working with global organizations, governments, and other stakeholders to ensure essential medicines are accessible to all.

“This achievement emphasizes the incredible teamwork and support from its valued partners and supporters. Servier Generic Group, NAFDAC, Unitaid, Medicines for Malaria Venture (MMV), the World Health Organisation (WHO), USAID, United States Pharmacopoeia (USP), and the USP-PQM+ program all played a crucial role in making this milestone possible. Their expertise and dedication were instrumental in this success, reflecting a shared commitment to improving health outcomes and increasing access to essential medicines. We appreciate all these partners for their vital contributions to this achievement and remain committed to innovation and excellence in pharmaceutical manufacturing, and will continue to pursue initiatives to improve public health in Nigeria and beyond”, he said.

In view of this significant achievement, the National Agency for Food and Drug Administration and Control (NAFDAC) commended Swipha for its efforts and commitment to the highest standards in pharmaceutical manufacturing. The WHO prequalification shows the company’s adherence to stringent quality control measures and compliance with Good Manufacturing Practice (GMP) standards. This accomplishment serves as a beacon of excellence for other local drug manufacturers, encouraging them to pursue similar certifications and enhance the overall quality of pharmaceuticals available in Nigeria and the region.