by Hannes Malan, Gerrit van der Klashorst & Kelly Chibale
There is an urgent need for Africa to develop local manufacturing capabilities for Active Pharmaceutical Ingredients (APIs) so as to reduce reliance on imports, enhance healthcare outcomes, and stimulate economic growth. But innovative technologies and international partnerships can help stimulate African pharma growth, revolutionize API production, and ensure self-sufficiency across the continent in a post-pandemic world.
Africa’s pharmaceutical industry is at a critical crossroads, with significant progress in downstream activities but a gap in upstream manufacturing, particularly in the production of Active Pharmaceutical Ingredients (APIs).
APIs are essential components responsible for the therapeutic effects of medications, and local production is key to achieving self-sufficiency and long-term sustainability in healthcare across the continent. The COVID-19 pandemic underscored Africa’s dependence on imported medicines, exposing a vulnerability in the supply chain and highlighting the urgent need for local pharmaceutical manufacturing infrastructure on the continent.
Building local capacity for API manufacturing will reduce reliance on imports, ensure a more affordable and reliable supply of essential medicines, and contribute to economic growth by creating jobs for highly trained professionals.
For local manufacturers of final pharmaceutical products, this development offers economic advantages, including a shorter supply chain, the ability to order smaller, more frequent API shipments, reduced costs for quality assurance, and a lower risk of substandard products entering the market.
Additionally, a thriving, independent API manufacturing sector is essential for a sustainable pharmaceutical industry in Africa. As long as local manufacturers remain dependent on imported APIs from India and China, the origin for more than 70% of all of Africa’s imported medicines, the continent will struggle to compete with its Asian neighbours and others.
For tuberculosis (TB) and HIV medicines, for instance, Africa imports more than 80% of products used.
Making new strides
Several pharmaceutical companies in Africa are making significant strides in producing local APIs for their manufacturing processes.
For instance, Emzor Pharmaceuticals in Nigeria is actively involved in producing APIs for anti-malaria medications, while API for Africa (APIFA) is working to enhance local pharmaceutical manufacturing capacity across Sub-Saharan Africa.
This commitment to strengthening local capabilities is also exemplified by the Pretoria-based CPT Pharma’s efforts to tackle upstream manufacturing challenges and build a more robust pharmaceutical infrastructure. We are on a mission to revolutionize API production locally. The company develops, optimizes, and commercializes cost-effective technologies for APIs that treat TB, HIV, and non-communicable diseases.
Supported by the Industrial Development Corporation (IDC) and the Technology Innovation Agency (TIA), CPT Pharma established a pilot plant in 2017 which achieved Good Manufacturing Practice (GMP) certification and a license in 2020 from the South African Regulatory Authority (SAHPRA) to manufacture APIs.
It serves as a proof-of-concept hub for new technologies and provides material for regulatory compliance and clinical trials.
Reducing costs and gaining international support
Local API manufacturers must also prioritise reducing costs and promoting sustainability to be successful. Companies can develop more efficient and eco-friendly production processes by leveraging advances in synthesis technologies, catalysts, starting materials, and reactor technologies. Integrating sustainable practices from the development phase, rather than adding them later, allows for cost-effective and environmentally responsible manufacturing. This approach can help position African companies to become leaders in pharma and API manufacturing.
Support from international organizations is also crucial for local pharmaceutical manufacturers to thrive. For example, assistance from the United States Pharmacopeia (USP) helped us ensure API master file compliance and achieve World Health Organization (WHO) Prequalification (WHO-PQ) status, which is critical for global market access and regulatory approval.
Additionally, international initiatives like the German Investment Bank (GIZ), which has funded quality assurance training through its Support towards Industrialization and the Productive Sectors in the SADC region (SIPS) initiative in the Southern African Development Community (SADC), play a vital role in maintaining high production standards.
In 2024, USAID selected CPT Pharma as a local manufacturing partner to adopt an innovative and more cost-effective, ‘continuous flow technology’ for producing APIs such as Rifapentine, a key drug for treating TB—including drug-resistant strains. This illustrates how international collaborations can significantly enhance local API production capacity and contribute to improving public health outcomes.
Funding remains a significant challenge
Funding, however, remains a significant challenge for local API production in Africa. In comparison to “fill and finish” contracts that African manufacturers more commonly receive from pharma companies abroad, expanding API manufacturing capabilities requires substantial financial investment.
In the case of CPT Pharma, this next stage of growth involves planning and construction of a new facility to manufacture Isoniazid, a critical antibiotic for first-line TB treatments.
Without consistent financial support, maintaining and growing API production remains a formidable challenge, not just for CPT Pharma but for similar enterprises across Africa.
By prioritizing local API manufacturing, Africa can significantly improve its healthcare systems and reduce dependence on imports. Beyond improving access to essential medicines, local API production will stimulate economic growth, create high-quality jobs, and position Africa as a global player in pharmaceutical innovation.
More than that, it will contribute to a resilient pharmaceutical industry, one that can respond to future health crises and provide long-term benefits to public health. While the journey to self-sufficiency is long and requires significant investment, the potential rewards—in terms of both health outcomes and economic impact—are undeniable.
Culled from Health Policy Watch
