The National Agency for Food and Drug Administration and Control (NAFDAC) has announced that a 0.5ml auto-disable syringe produced by Afrimedical Manufacturing and Supplies Ltd has received prequalification from the World Health Organisation (WHO).
NAFDAC Director-General, Prof. Mojisola Adeyeye, disclosed this during a news conference on Wednesday in Lagos, describing the development as a significant milestone for Nigeria and the West and Central Africa region.
According to Adeyeye, Afrimedical, located in Ogun State, is the first indigenous syringe manufacturer in Nigeria—and the entire West and Central Africa—to obtain WHO prequalification for its syringes.
She noted that the achievement followed a rigorous evaluation process, substantial investment, and technical support and regulatory guidance provided by NAFDAC.
“This milestone aligns with the agenda of the President Bola Tinubu-led administration to promote local production of medical products,” she said. “It is with great joy that I announce that, after a rigorous process, the WHO has prequalified Afrimedical’s 0.5ml AD Syringes.
They are now eligible for national and international procurement by relevant agencies and organisations.”
Adeyeye added that Afrimedical is now the first manufacturer in West Africa to be recognised by WHO as operating at an acceptable level of compliance with Good Manufacturing Practice (GMP) standards.
She emphasised that NAFDAC, in its quest to become a world-class regulator, has embraced global best practices in all areas of medical product regulation.
In 2023, only three out of seven indigenous syringe manufacturers in Nigeria were operational, collectively producing at less than 20 percent of their combined installed capacity of 2.5 billion syringes per year, she revealed.
Adeyeye also highlighted NAFDAC’s “5+5” policy, introduced in 2019, which restricts the importation of medicines and medical devices that can be manufactured locally.
“Products with five-year registration validity that can be manufactured in Nigeria will be granted one final five-year renewal, after which importation will no longer be allowed,” she explained.
Following NAFDAC’s attainment of WHO Maturity Level 3 in 2023, the agency began engaging international procurement bodies, such as UNICEF’s supply division in Copenhagen, to promote patronage of locally manufactured medical products, including syringes.
The Director-General urged other indigenous manufacturers to emulate Afrimedical’s achievement by collaborating with NAFDAC and aligning with its regulatory standards.
Also speaking at the event, Afrimedical’s General Manager, Mr. Gabi Al-Aridi, described the WHO prequalification as a major milestone for the company, NAFDAC, and Nigeria.
Al-Aridi praised the federal government’s support for local production and stated that Afrimedical currently produces about 1.8 billion syringes annually.
He reaffirmed the company’s commitment to high-quality, locally made medical products and encouraged Nigerians to embrace them to help boost the national economy.
