PQM+ celebrates WHO Prequalification of malaria and NTD medicines

August 30 2024, Rockville, MD - The Promoting the Quality of Medicines Plus (PQM+) program commends the World Health Organization (WHO) for its decision this month to prequalify two groundbreaking medicines: one for malaria developed by Nigeria-based Swiss Pharma Nigeria Limited (Swipha) and another for treating intestinal parasites by India-based Mepro Pharmaceuticals.

The prequalification of both medicines marks a significant milestone in the global fight against infectious diseases. This achievement, supported by PQM+-funded by the United States Agency for International Development (USAID) and implemented by U.S. Pharmacopeia (USP) -will increase the availability of essential medicines for millions affected by malaria and neglected tropical diseases (NTDs).

"The impact of these accomplishments by Swipha and Mepro with support from USAID's PQM+ program is enormous," said Jude Nwokike, USP Vice President and PQM+ Director. "WHO Prequalification of West Africa's first SP from Swipha and the first chewable albendazole from Mepro will not only serve local needs in Nigeria and India respectively, but also open the door for the procurement of these lifesaving, quality-assured medicines by global procurement agencies and international donors and ultimately contribute to the control of malaria and parasitic worm infections."

Swipha recently became the first manufacturer in West Africa to receive WHO Prequalification (PQ) for sulfadoxine-pyrimethamine (SP) 500mg/25mg tablet, an essential medicine that prevents malaria in pregnant women. This milestone marks the second time WHO approved a medicine produced by Swipha in the last 15 months. The first was for zinc sulfate, another essential maternal and child health product.

SP is widely used to prevent malaria in pregnant women. Nigeria accounts for more than a quarter of all malaria cases worldwide, and has more deaths from malaria than any other country. In Nigeria, approximately 40 million women of childbearing age need access to medicines to prevent malaria during pregnancy.

"The WHO Prequalification of Swipha's SP 500mg/25mg tablet will go a long way in reaching tens of millions of pregnant women in Nigeria to prevent malaria, thanks to USAID and USP support," said Mr. Abbas Sambo, Swipha's business development and licensing director.

Mepro Pharmaceuticals also received approval earlier this month for its albendazole 400mg tablet, the first chewable albendazole prequalified by WHO. This medicine treats intestinal parasitic infections in adults and children older than 2 years, helping combat the global burden of neglected tropical diseases (NTDs) that affect more than 1 billion people worldwide. In children and adults, the drug combats tapeworm, hookworm, and other intestinal parasites, which often occur in tropical areas where people have limited access to clean water, quality health care, and proper sanitation.

The Mepro-produced formulation of albendazole, the second WHO-prequalified product (and the first chewable) of its kind, can now reach more of the 3.5 billion people-450 million children-across the globe who develop intestinal parasitic infections.

"The impact of these accomplishments by Swipha and Mepro with support from USAID's PQM+ program is enormous," said Jude Nwokike, USP Vice President and PQM+ Director. "WHO Prequalification of West Africa's first SP from Swipha and the first chewable albendazole from Mepro will not only serve local needs in Nigeria and India respectively, but also open the door for the procurement of these lifesaving, quality-assured medicines by global procurement agencies and international donors and ultimately contribute to the control of malaria and parasitic worm infections."

"Mepro's chewable albendazole tablet is the first of its kind to receive WHO's stamp of approval, ensuring the product meets the highest global standards," said Dipesh Shah, head of business development at Mepro Pharmaceuticals. "This achievement will help millions of children in numerous low- and middle-income countries currently suffering from neglected tropical diseases, and wouldn't have been possible without USAID, PQM+, and USP."

Mepro and Swipha received extensive technical support from PQM+, including improving compliance with good manufacturing practices to ensure the medicines are produced consistently according to quality standards. PQM+ also provided comprehensive technical assistance to the manufacturers to develop the products, manage the necessary studies, develop their dossiers, respond to questions about the dossiers from the WHO PQ team, and prepare for the WHO team's audit, which ultimately led to those products receiving WHO prequalification.

Through PQM+, USP works with 26 manufacturers in 11 countries. To date, 35 medical products have received WHO Prequalification or other stringent regulatory approval.

USAID/Nigeria Mission's announcement
Read more about SWIPHA's first WHO PQ
Explore the NTD dashboard, a centralized source for NTD product information
Learn more about PQM+ in Nigeria

Media contact: [email protected]

About PQM+

The Promoting the Quality of Medicines Plus (PQM+) program is a six-year cooperative agreement between the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP) to sustainably strengthen medical product quality assurance systems in low- and middle-income countries.

About USP

USP is an independent, international, and scientific nonprofit organization focused on building trust in the supply of safe, quality medical products. We strengthen the global supply chain so that the medical products people rely on are available when needed and work as expected. USP has 16 offices across 13 countries and has implemented global health programs in 90+ countries worldwide.

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