Read the Conversation
Conversation highlights:
- Trends in APIs: Africa’s pharmaceutical industry faces hurdles due to its dependence on imported APIs; local and regional manufacturing is critical for building a competitive sector and pandemic resilience.
- The story behind CPT Pharma: Chemical manufacturing knowledge from animal health to human pharmaceuticals, demonstrating robust pilot-scale API production.
- Competitive Technology Strategy: developing home-grown manufacturing technology to maintain control over improvements and competitiveness.
- The importance of regulatory harmonization across Africa for better access to new markets.
- Leadership, Skills, and Legacy: Dr. Malan is building on African self-sufficiency, job creation, and unlocking opportunities for future manufacturers.
EF: What market opportunity did you identify with CPT Pharma?
HM: Chemical Process Technologies (CPT), founded in 2001, began by supporting South Africa’s animal health industry. Animal health relies heavily on imported active ingredients. The founders recognized an opportunity to produce some of these high-value active pharmaceutical ingredients locally, especially those difficult to source in smaller volumes. By developing local chemical manufacturing technologies to replace imports, CPT established a strong foundation for growth and soon expanded into contract manufacturing. The company became one of the leading producers in the animal health sector, specializing in treatments for both internal and external parasites in production animals.
In 2014, CPT applied the same model to human pharmaceuticals, creating CPT Pharma. Both industries faced similar challenges, particularly dependency on imported raw materials from India and China. We identified four active pharmaceutical ingredients (APIs) for development. However, the team soon realized the complexity of meeting Good Manufacturing Practice (GMP) standards and securing regulatory approvals. Through this experience, CPT also identified a broader industry gap—the shortage of specialized API manufacturing skills in Africa, where most facilities focus solely on final product formulation.
CPT Pharma built a GMP-certified pilot plant to test and improve its processes, initially focusing on tuberculosis treatments. The company has since expanded into other therapeutic areas, successfully scaling several processes from laboratory to pilot production while maintaining yield and purity. Our core strength of CPT Pharma lies in its independent technology development.
Since its inception, CPT Pharma has worked on approximately fifteen APIs, often enhancing existing public-domain processes. These improvements have reduced raw material costs by 10 to 30 percent, significantly improving local production viability. The company’s successful scale-up of multiple products from lab to pilot level demonstrates that its model works—and that South Africa is capable of producing world-class pharmaceutical ingredients locally.
EF: How are you managing your success in strengthening local API manufacturing amid global supply delays?
HM: Africa’s pharmaceutical industry is making steady progress toward global competitiveness, even if it is not yet operating at the same level as major international players. The COVID-19 pandemic played an important role in refocusing attention on the need for local manufacturing.
Across Africa, there are roughly 380 pharmaceutical manufacturers. About 75 percent focus on packaging and filling, which are lower-value activities, while around 25 percent formulate medicines but still rely on imported APIs. Only a few facilities, mainly in Egypt, South Africa, and emerging projects in Nigeria, produce APIs locally.
One of the biggest challenges has been convincing investors to support local API manufacturing. Many perceive it as too complex or risky compared to formulation. The chemistry involved is often misunderstood, and there is a persistent misconception that API production cannot be successfully done in Africa. Building API plants requires specialized equipment, long lead times, and rigorous certification, which means traditional funding instruments are often ill-suited to support them. Yet once established, these facilities operate efficiently and sustainably.
Regional manufacturing and regulatory harmonization are essential for the faster growth of local manufacturing of APIs.
EF: How is CPT Pharma perceived in the market, and how can awareness of local competitiveness be increased?
HM: At CPT Pharma, our next major step is to transition from proven pilot-scale success to full commercial production. We are currently raising funds to complete the commercial plant we began constructing in 2021. Our initial plan is to manufacture three tuberculosis-related APIs at our Pretoria facility, utilizing part of the existing pilot plant’s capacity while expanding into full-scale production. With the required funding, we aim to have the facility fully operational within two years. This milestone represents a pivotal moment for CPT Pharma.
Once this stage is complete, the conversation will shift. Governments and industry partners will see tangible proof that local manufacturing is both viable and competitive. It is important for governments to recognize that the necessary skills and capabilities already exist on the continent; they simply need the right development and support. While their caution is understandable, given the number of unfulfilled promises they hear, we believe it is our responsibility to demonstrate what is possible. By completing our plant and successfully producing APIs, we aim not only to validate our model but also to open pathways for other manufacturers across Africa. This project is central to unlocking the continent’s potential in API production.
Our success is pivotal to advancing the industry. Many observers are watching closely to see whether large-scale API manufacturing can become a reality in Africa. Demonstrating our success is important. If we can prove that sustainable, local API production works, we will pave the way for others across the continent who share the same vision.
Building a competitive API manufacturing industry requires sustained commitment and market predictability. These projects demand investments of around 50 million dollars or more, and such decisions cannot be made on short three-year tender cycles. Investors need clear visibility of the market over at least five to seven years, backed by reliable demand, especially since the government remains the largest buyer of TB treatment. Without a stable, long-term framework, it is difficult to justify investment purely on optimism.
EF: How would you like to be remembered as a leader shaping the future of healthcare in your country?
HM: My goal is to be remembered as a member of the team that pioneered active pharmaceutical ingredient manufacturing on the African continent. Africa deserves access to high-quality medicines, yet far too many people still struggle to obtain them. While South Africa offers a stronger starting point due to its infrastructure, our vision extends to the entire continent. We want every country in Africa to have safe, reliable medicines so that no one suffers or dies from contaminated or counterfeit drugs.
We aim to demonstrate that API manufacturing can thrive in Africa, developed and led by Africans. The talent and potential already exist; they only need the right support and opportunities. For us, true success means establishing efficient facilities, collaborating with other manufacturers across the continent, and building a sustainable foundation for local production. It is also about transforming perceptions. Too often, people question whether Africa can meet global standards, yet many of our scientists and professionals trained here have proven their excellence internationally. They left only because local opportunities were limited.
