WHO prequalifies Nigerian manufacturer’s antimalarial tablets

The World Health Organisation (WHO) has prequalified Swiss Pharma Nigeria Limited’s (SWIPHA) sulphadoxine/pyrimethamine antimalarial tablets.

The 500/25mg formulation is used for the prevention of malaria in children and pregnant women.

WHO prequalification of medicines assesses the quality, safety and efficacy of medicinal products.

If the product meets the specified requirements, and the associated manufacturing sites and contract research organisations are compliant with WHO standards, it is added to the WHO list of prequalified medicinal products.

The prequalification status ensures global acceptability of the drug and enhances confidence in the drug’s efficacy among healthcare providers.

On May 2, 2023, the WHO prequalification unit added pediatric zinc Sulphate tablet (20mg dispersible tablet) manufactured by Swiss Pharma, to its list of prequalified medicines.

In a statement on Thursday, the National Agency for Food, Drugs Administration and Control (NAFDAC) said the development is the outcome of meaningful collaboration between the agency and Swiss Pharma Nigeria Limited.

NAFDAC said Swiss Pharma Nigeria is the first indigenous manufacturer in Nigeria to achieve the feat in West and Central Africa.

“Being the first manufacturer to be recognized by the WHO as operating at an acceptable level of compliance to good manufacturing practice (GMP) requirements in West Africa in 2013, the manufacturer is now also the first manufacturer of finished pharmaceutical product to attain prequalification of 2 products in the West Africa and Central Africa Sub-region within the time space of 15months,” the statement reads.

“Our designated GMP inspectors in NAFDAC provided immense technical support prior to WHO’s site inspection by the prequalification inspection team and provided valuable insight into objective review of Corrective and Preventive Actions (CAPA) taken to address the few observed non-conformances recorded during WHO’s inspection.

“This is aside several face-to-face meetings, phone calls and virtual meetings with key personnel of Swiss Pharma Nigeria Limited.

“This additional feat without an iota of doubt has reinforced our believe that with the right attitude, collaboration, synergy and appropriate policies, Nigeria Pharma Industries can become a force to reckon with in the comity of nations.

“With this achievement, Swiss Pharma Nigeria Limited has undoubtedly become the trail blazer, a global supplier of quality essential medicines for public health program and is set to improve its fair share of the Pharma market.

“The top management of NAFDAC hereby encourage other well-meaning local drug manufacturers to emulate this feat through harmonization of collective aspiration and synergy of effort with the NAFDAC’s relevant directorates as we can together as a team achieve more.”