By Samuel Dike
Following the successful Change Notification (CN) approval from the World Health Organisation (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.
According to a press release made available to Pharmanewsonline, this approval positions Colexa Biosensor Limited as the first African entity to locally package a WHO Prequalified HIV RDT kit, the Standard Q HIV 1/2 Ab 3-Line Test. This development will allow the diagnostic kits to be procured not only in Nigeria but also by international donors, enhancing accessibility and affordability across the continent.
Sammy Ogunjimi, group managing director and CEO of Codix Group, emphasised the broader implications of this achievement. “This approval is a leap forward for Nigeria’s healthcare ecosystem, enhancing access to high-quality In-Vitro Diagnostics (IVDs) and driving local production,” Ogunjimi stated. “It’s not just a win for Nigeria but a monumental stride for the entire African continent.”
He further highlighted the company’s ongoing collaboration with the Federal Ministry of Health, NAFDAC, and PVAC to establish Nigeria as a hub for quality diagnostic products in Africa.
Mary Ogangwu, chief operating officer of Codix Pharma, attributed the success to the combined efforts of international partners and local stakeholders. She commended the support from NAFDAC, PVAC, and the Federal Ministry of Health, noting their invaluable technical assistance. “This achievement is the result of tremendous effort from our organisation and our partners. I also want to acknowledge the dedication of our team, led by GMD Mr Sammy Ogunjimi, whose hard work has been the backbone of our success,” Ogangwu remarked.
The statement also noted thag the approval of the Standard Q HIV 1/2 Ab 3-Line Test for local packaging is a historic first for Africa, showcasing Codix Group’s commitment to enhancing Nigeria’s healthcare value chain.
Since its commissioning in December 2023, Colexa Biosensor has received global recognition from prestigious organisations, including the WHO, Global Fund, UNITAID, FIND, and PEPFAR.
It added that this achievement not only underscores Nigeria’s growing capabilities in the healthcare sector but also aligns with the vision of the President of the Federal Republic of Nigeria to bolster local production and self-sufficiency in essential healthcare products.
 approval from the World Health Organisation (WHO), Colexa Biosensor Limited, a subsidiary of Codix){kind=link}