Following the successful Change Notification (CN) approval from the World Health Organization (WHO), Colexa Biosensor Limited, a subsidiary of Codix Group, is now licensed to package a WHO-Prequalified Rapid Diagnostic Test kit at its factory in Nigeria.
This groundbreaking approval enables Colexa Biosensor Limited to locally package the WHO Prequalified HIV Rapid Diagnostic Test (RDT), making it accessible for procurement by Nigeria and international donors and marks a significant milestone in strengthening local production capabilities and advancing Nigeria’s healthcare sector.
Reacting after receiving the approval, Sammy Ogunjimi, group managing director/CEO Codix Group, said this approval is more than just an achievement for the company, it is a leap forward for Nigeria’s healthcare ecosystem, enhancing access to high-quality In-Vitro Diagnostics (IVDs) and driving local production.
According to him, this is not just a big win for Nigeria, but for the entire African continent, as it is the first time a WHO PQ HIV Test Kit would either be manufactured, assembled or packaged in Africa, and available for procurement by the Development Partners.
Ogunjimi said the company will continue to work in collaboration with the Federal Ministry of Health, NAFDAC and PVAC to make Nigeria a hub for quality diagnostic products in Africa.
Mary Ogangwu, chief operating officer of Codix Pharma said the achievement is the result of tremendous effort, not just from the organisation, but also from international partners and local stakeholders.
Ogangwu lauded NAFDAC, PVAC, FMOH, and others, for providing invaluable technical support and encouragement to make this a reality.
“I also want to highlight the exceptional dedication and sacrifice of our team, led by the GMD, Mr. Sammy Ogunjimi. Their hard work and commitment have been the backbone of our success, and we stand strong, driven by their unwavering support and determination,” she said.
Notably, this achievement is a historic first for Africa, as the Standard Q HIV 1/2 Ab 3-Line Test becomes the first WHO Prequalified HIV RDT to secure Change Notification approval for packaging within the continent. This accomplishment underscores the commitment of Codix Group to unlocking Nigeria’s healthcare value chain and contributing to the vision of the President of the Federal Republic of Nigeria.
Since its commissioning in December 2023, Colexa Biosensor has garnered global recognition from esteemed organizations such as World Health Organisation (WHO), Global Fund, UNITAID, FIND, and PEPFAR.
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