Expanding production of active pharmaceutical ingredients (APIs) in Africa would increase the availability of essential medicines, reduce supply chain vulnerabilities, and improve health security and economic growth.
Key Takeaways:
- Nigeria is positioning itself as a regional hub for active pharmaceutical ingredient (API) manufacturing to strengthen health security, reduce reliance on imports, and support Africa’s goal of producing 60% of essential medical products by 2040.
- Local API production is critical for combating diseases like malaria and reducing supply chain vulnerabilities, but faces challenges such as high infrastructure costs, limited financing, and gaps in quality control systems.
- Projects like Producing quality APIs in Nigeria and MedSuRe Africa are expanding capacity to produce APIs on the continent to increase availability of essential medicines, reduce supply chain vulnerabilities, and improve health security and economic growth.
Last month, Africa Centres for Diseases Control and Prevention (CDC) announced a new vision for Africa’s health security to include an ambitious goal: By 2040, produce at least 60 percent of essential medical countermeasures, including vaccines, diagnostics, and therapeutics – the most critical products necessary during a public health emergency – directly on the continent.
This announcement, which builds on the New Public Health Order for Africa launched by the African Union and Africa CDC in 2021, expands the continent’s commitment to manufacture more medical products, including critical active pharmaceutical ingredients (APIs).
APIs are essential building blocks of pharmaceutical products, but can be difficult to manufacture, especially in low- and middle-income countries, because they require complex manufacturing processes and expensive key starting materials (KSMs).
Dependence on imported APIs can create vulnerabilities in the supply, decrease availability of quality-assured products, and threaten health security and economic development.
To help create a more resilient and robust supply of APIs, Nigeria is stepping up to expand its capacity for API synthesis, strengthen regulatory oversight, prioritize local procurement, and position itself as an emerging regional hub for API production.
Why manufacturing APIs in Africa matters
Africa faces more health emergencies than any other region and accounts for an outsized burden of tuberculosis, malaria, HIV/AIDS, and maternal mortality. Yet, despite a growing number of regional manufacturers, imports still dominate Africa’s pharmaceutical market by 70 – 90 percent.
However, while many African manufacturers have the capacity to produce finished products and formulations, many lack the resources, skilled workforce, and quality control systems needed for API production. In addition, most companies lack the infrastructure for synthesizing, purifying, and testing APIs on an industrial scale, which requires significant financial investment. High capital expenditure (CAPEX) requirements coupled with limited access to sufficient, long-term financing are critical barriers to expanding pharmaceutical manufacturing on the continent.
API initiatives in Africa
A recent effort to increase API production in Africa kicked off through the Medicines Supply Resilience (MedSuRe) Africa project, led by USP with funding from Unitaid and the European Union, which aims to expand regional production of quality-assured, African-made medicines, including APIs.
MedSuRe activities complement national and regional initiatives, including Nigeria’s Presidential Initiative for Unlocking Healthcare Value Chain (PVAC) initiative, and bolster efforts to advance API manufacturing across the continent.
As a part of the MedSuRe project, USP plans to develop commercially viable API processes to manufacture two APIs for essential medicines and transfer these to African API manufacturers to reduce costs, carbon emissions, and environmental impact. Optimizing API manufacturing processes can significantly improve efficiency, cost-effectiveness, and minimize waste generation potentially leading to innovative, low-cost, carbon-efficient products.
Spotlight on antimalarial APIs in
Nigeria Nigeria has the highest burden of malaria globally, and while some local manufacturers produce quality antimalarial medicines, the country imports all antimalarial APIs from overseas.
A recent project led by PVAC, with the funding from the World Bank, aims to expand Nigeria’s capacity to produce APIs. As part of the project, USP conducted a baseline assessment of Nigeria’s API capabilities to identify opportunities to strengthen local manufacturing, assess key challenges, and propose practical strategies and a roadmap to enhance local API production and market readiness.
Among other findings, our assessment showed a need for significant investment to adapt and upgrade existing quality control systems to enable upstream chemical synthesis, particularly since most plants and facilities across Nigeria have systems designed to produce finished products.
High infrastructure costs compounded by Nigeria’s high energy tariffs, lack of industrial utilities, limited access to finance, policy execution gaps, and insufficient local supply of pharmaceutical-grade solvents and intermediates, make API production very challenging. At the same time, an over reliance on imported APIs makes the industry vulnerable to price fluctuations, shortages, and logistical challenges.
Next steps for API production in Nigeria
Nigeria is at a pivotal moment for jumpstarting API production, with some manufacturers leading the way. Recognizing API manufacturing as a strategic priority, the Nigerian government is addressing challenges around expanding production by developing policies, laws, and regulatory and quality frameworks.
Academic institutions are also participating in workforce capacity initiatives to incorporate pharmaceutical process engineering into curricula to increase the pool of skilled workers. In addition, emerging investment and infrastructure initiatives, including plans to establish industrial parks, are underway that offer shared utilities and analytical laboratories to help reduce operational costs.
Building Nigeria’s API manufacturing capacity will require sustained access to financing, strong regulatory oversight, technology transfer, and other strategic interventions and market-shaping incentives, including gradually increasing procurement of quality-assured, Nigeria-made APIs along with long-term purchase agreements.
Moving forward
Expanding manufacturing of APIs across Nigeria and other parts of Africa would help increase the reliable availability of essential medicines, reduce supply chain vulnerabilities, and improve health security and economic growth.
Strategic investments in quality systems and infrastructure can help countries like Nigeria expand market share, influence, and exports to create competitive regional API manufacturing hubs. USP is proud to support the production of quality assured medicines in Nigeria and in many other countries across Africa by improving GMP, facilitating technology transfers, and advancing sustainable API manufacturing that meets global standards. In addition, our technical approach prioritizes effective regulatory oversight and policy alignment, improving quality systems and analytical methods, supporting greater access to financing through blended finance initiatives, and helping to achieve swift product approvals to create an enabling environment for API production.
Developing a more resilient supply chain for APIs in Nigeria and elsewhere will ultimately bring lifesaving medicines closer to the patients who need them most.
Producing quality APIs in Nigeria
Expanding manufacturing to combat malaria in West Africa.
Learn more about the project
Medicines Supply Resilience (MedSuRe) Africa
Manufacturing more quality-assured, African-made medicines.
Learn more about the project
Manufacturing medical products closer to patients
Increasing the supply of medicines improves resiliency, self-reliance, and security.
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