Afrimedical Manufacturing and Supplies Ltd., located in Ogun State, has reached a significant milestone in West Africa, according to the National Agency for Food and Drug Administration and Control, since the World Health Organization prequalified its Afriject 0.5ml Auto-Disable Syringes.
NAFDAC claims that this accomplishment places Nigeria on the international map for producing high-quality medical devices since it is the first time a Nigerian firm—indeed, any manufacturer in West and Central Africa—has obtained WHO prequalification for syringes.
Prof. Mojisola Adeyeye, the Director General of NAFDAC, referred to the accomplishment as “a landmark achievement for Nigeria’s medical manufacturing industry” during a speech on Wednesday at the NAFDAC Lagos office.
“This is without a doubt the result of significant cooperation between NAFDAC and Afrimedical Manufacturing and Supplies Limited.
“It illustrates how well our regulatory changes are working and how local manufacturers can succeed if they receive the proper assistance.”
She claims that NAFDAC’s dedication to establishing a robust domestic manufacturing sector and lowering an excessive reliance on imports made the milestone feasible.
The goal of NAFDAC is to become a premier regulatory body that guarantees that only safe and high-quality products are made, imported, exported, sold, and used.
“In 2019, we started setting the groundwork for this by implementing regulations like the 5+5 regulatory directive.”
According to the organization, Nigeria’s difficulties during the COVID-19 epidemic, which caused supply chains for imported medical devices to break down, gave local capacity building fresh attention.
Only three of the seven domestic syringe producers were operational at the time, she insisted, and they were producing less than 20% of their 2.5 billion syringe capacity.
NAFDAC announced a number of initiatives to address this, such as technical support to raise local standards, industry involvement, and product quality assessments.
Adeyeye disclosed that although many of the locally made syringes were of high quality, they were having trouble finding a market because of pricing issues and misconceptions.
“Our laboratory assessments showed that some imported syringes were actually of lower quality,” she stated. To guarantee compliance, we carried out GMP inspections and offered advice to the producers on how to enhance their procedures.
Adeyeye revealed that Afrimedical Manufacturing and Supplies Ltd was one of the companies that responded positively, adding that after fulfilling national regulatory requirements, it chose to pursue WHO prequalification, a rigorous international process that examines product safety, quality, and manufacturing practices.
She said, “We are proud to announce that Afriject 0.5ml Auto-Disable Syringes have now been added to the WHO list of prequalified syringes.
“This means they are now eligible for both national and international procurement by organisations such as UNICEF.”
She added that this accomplishment represents “the first time a syringe manufacturer in Nigeria, and indeed in West and Central Africa, has been recognised by WHO as operating at an acceptable level of compliance with global GMP standards.”
The NAFDAC boss also expressed gratitude to the United Nations Children’s Fund for its technical support to Afrimedical during the prequalification process.
“UNICEF has keyed into NAFDAC’s vision and supported the Federal Government’s agenda to produce high-quality health commodities locally,” said Prof. Adeyeye.
She urged other Nigerian manufacturers to emulate Afrimedical’s dedication and work in close synergy with NAFDAC to achieve similar global recognition.
Adeyeye added, “At a time like this in our nation’s history, when the Federal Government is strongly promoting industrialisation and self-sufficiency, we must rally around and encourage local manufacturers.
“NAFDAC is open and ready to support compliant manufacturers on this journey.”
Adeyeye called on government ministries and procurement agencies to prioritise companies like Afrimedical, in line with President Bola Tinubu’s industrialisation policy.
She said, “This achievement is not just Afrimedical’s victory, it is Nigeria’s victory. It proves that when we believe in ourselves and support local innovation, we can compete and thrive on the global stage.”
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