Угандийская биофармацевтическая компания Dei BioPharma включена в континентальную систему закупок Африки

KAMPALA — Uganda’s biotechnology and pharmaceutical manufacturer, Dei BioPharma Ltd, founded by scientist and innovator Dr. Matthias Magoola, has been formally onboarded as a registered supplier under the African Pooled Procurement Mechanism (APPM), a continental procurement platform coordinated by the Africa Centres for Disease Control and Prevention (Africa CDC). In an August 28 notification, Dr. Mariatou Tala Jallow, Director of the APPM at Africa CDC, indicated that Dei BioPharma had met the technical requirements for participation as a supplier under the pooled procurement arrangement. The development gives Uganda a position within a continental effort intended to reshape how African countries procure essential health products by aggregating demand, improving purchasing power, strengthening supply security and creating more predictable markets for manufacturers on the continent. For Dei BioPharma, the significance of the development extends beyond access to a procurement platform. It comes as the company moves from establishing manufacturing infrastructure to building a growing portfolio of regulated products capable of serving markets beyond Uganda. From manufacturing capacity to product innovation Dei BioPharma has submitted 65 product applications to Uganda’s National Drug Authority (NDA). Of these, 40 have been approved for manufacture and 14 have received approval for sale. The figures provide an indication of the progression of the company’s pharmaceutical development activities from manufacturing infrastructure into product development and regulatory execution. Pharmaceutical innovation requires more than production facilities; products must undergo formulation development, analytical assessment, stability evaluation, quality-system controls, regulatory dossier preparation and other requirements before they can be authorised for manufacture or sale. The expanding portfolio is therefore important in understanding the company’s APPM qualification. It demonstrates an emerging pipeline of products that can potentially respond to different health needs while providing a foundation for participation in regional and continental markets. It also reflects a wider shift taking place in Africa’s pharmaceutical sector, where the strategic objective is increasingly moving from dependence on imported finished products towards building domestic capabilities to develop, manufacture and supply medicines and other health technologies. The African Union has set a target of meeting at least 60% of Africa’s health-product needs through African manufacturing by 2040. Achieving that ambition will require not only factories, but also viable product pipelines, regulatory capacity, quality systems, skilled human capital, investment and markets capable of sustaining manufacturers. APPM is intended to address one of those critical market constraints. Creating a market for African production African pharmaceutical manufacturers have historically faced highly fragmented markets, with procurement largely organised through individual national systems. This can make it difficult for manufacturers to achieve the scale and demand predictability required to justify continued investment in product development and production capacity. Pooled procurement offers a different model by aggregating demand across participating countries. The potential of this approach was demonstrated in Africa CDC’s first APPM tender for essential reproductive, maternal and newborn health medicines. Africa CDC reported that the procurement process achieved prices 30% to 90% below participating Member State benchmarks, while establishing framework arrangements intended to improve supply security. For African manufacturers, the significance is not limited to price. Larger and more predictable demand can create greater incentives to invest in regulatory approvals, technology, manufacturing capacity and product development. Dei BioPharma’s entry into this system therefore comes at a point when its product portfolio is expanding and when the company is positioning itself for markets beyond Uganda. Innovation measured by relevance, not simply volume The value of Dei BioPharma’s growing portfolio is ultimately linked to the health needs it can help address. Two products within the company’s portfolio, HYXUREA and TRENMIC, illustrate the broader principle without reducing the company’s continental ambition to individual medicines. HYXUREA, a hydroxyurea 500 mg tablet, sits within the wider effort to improve access to medicines for sickle-cell disease — a condition that places a particularly heavy burden on sub-Saharan Africa. The World Health Organization estimates that 7.74 million people globally were living with sickle-cell disease in 2021, with approximately 515,000 babies born with the condition that year. Nearly 80% of the global burden occurs in sub-Saharan Africa. WHO’s African Region has estimated that approximately 240,000 children are born with sickle-cell disease in Africa each year. In some settings, mortality before the age of five can reach 80%, particularly where diagnosis and appropriate care are unavailable. The challenge is therefore not only the existence of effective interventions, but whether those interventions are consistently available to the populations that need them. WHO Africa has previously reported hydroxyurea availability in only 11 countries in the region, illustrating the gap between disease burden and access. In this context, the emergence of African manufacturing capacity capable of contributing to the availability of such medicines is part of a much broader public-health objective: ensuring that products addressing diseases with a substantial African burden can be sourced closer to the populations they are intended to serve. The same principle applies to TRENMIC, Dei BioPharma’s tranexamic acid 500 mg tablet, within the wider challenge of access to medicines used in the management of serious bleeding. Maternal mortality illustrates the scale of that challenge. In 2023, approximately 260,000 women died from pregnancy- and childbirth-related causes globally, with sub-Saharan Africa accounting for about 182,000 deaths, or roughly 70% of the global total. WHO identifies obstetric haemorrhage as a major contributor to maternal deaths globally. The challenge is especially significant in health systems where access to essential medicines, timely diagnosis, skilled health personnel and emergency care remains constrained. The significance of products such as these is therefore less about individual commercial brands and more about the capacity to ensure that quality-assured medicines relevant to Africa’s major health challenges are available through reliable supply systems. Building beyond conventional medicines The strategic significance of Dei BioPharma’s development extends beyond the current portfolio. Africa’s health-product needs span a wide range of technologies. Alongside conventional pharmaceutical products, the continent requires stronger capacity in vaccines, diagnostics, oncology medicines, hormones, biological products and biosimilars. These areas are increasingly important as African health systems confront both persistent infectious diseases and a growing burden of non-communicable diseases. The company’s manufacturing and development ambitions encompass several of these platforms, including conventional medicines, injectables, oncology products, biological products, biosimilars, diagnostics and vaccines. This diversification is important because Africa’s pharmaceutical security cannot be achieved through one category of products or a single manufacturing model. The continent needs the capability to develop and produce health technologies across different levels of technological complexity. For Dei BioPharma, the long-term objective has similarly been broader than the manufacture of conventional medicines. “Our ambition is global and deliberately long-term: to develop and make biological drugs available to more than 90% of the populations of the world which currently cannot access them,” Dr. Magoola has said. The challenge ahead is to translate that ambition into sustainable product development, regulatory approvals, manufacturing performance and market access across Africa and, ultimately, other underserved markets. From Uganda’s regulatory system to continental markets Dei BioPharma was established in 2014 and operates a pharmaceutical and biotechnology manufacturing complex at Matugga in Wakiso District. The facility forms the physical foundation of the company’s manufacturing ambitions, but the company’s regulatory pipeline increasingly provides a measure of the activity taking place beyond infrastructure development. The 65 product submissions, 40 approvals to manufacture and 14 approvals for sale show an expanding product-development pathway within Uganda’s regulatory framework. The APPM qualification now creates a potential bridge between that domestic regulatory and manufacturing base and a wider continental market. It does not, by itself, guarantee that every Dei product will be procured through APPM. Individual products must still meet applicable regulatory, technical, quality and procurement requirements. But participation provides an important platform from which eligible products can compete for aggregated African demand as the company’s portfolio develops. This distinction is important. The objective is not simply to increase the number of products manufactured in Uganda. It is to develop products that can meet African health needs, satisfy regulatory and quality requirements and compete effectively in markets beyond the country’s borders. A broader test for Africa’s pharmaceutical future Dei BioPharma’s APPM qualification comes against a wider continental challenge. Africa has spent decades relying heavily on external sources for medicines, vaccines, diagnostics and other health technologies. That dependence has exposed countries to international supply disruptions, foreign-exchange pressures and limited control over critical health-product supply chains. The COVID-19 pandemic made those vulnerabilities particularly visible and accelerated the case for strengthening African manufacturing capacity. But building factories alone will not resolve the problem. A sustainable African pharmaceutical industry requires an ecosystem linking scientific innovation, product development, regulatory systems, quality manufacturing, skilled human capital, financing, procurement and predictable markets. APPM is one component of that ecosystem because it addresses the demand side of the equation. When procurement creates predictable demand, manufacturers have greater incentive to invest. When manufacturing capacity grows, product-development opportunities expand. When African companies develop products relevant to African disease burdens, the continent becomes better positioned to respond to its own health needs. That is the strategic significance of Dei BioPharma’s current trajectory. Its growing regulatory portfolio, combined with manufacturing capabilities extending toward vaccines, diagnostics, oncology, hormones, biological products and biosimilars, positions the company to participate in a health-products market that Africa increasingly seeks to supply from within the continent. Uganda’s opportunity For Uganda, the significance extends beyond the fortunes of a single company. A Ugandan manufacturer qualifying for a continental procurement mechanism demonstrates the possibility of moving beyond a model in which African countries primarily serve as markets for products developed and manufactured elsewhere. The emerging model is different: develop locally, manufacture locally, obtain regulatory approval, build quality systems and compete for continental demand. The 65 products submitted to NDA, the 40 approved for manufacture and the 14 approved for sale provide measurable evidence of progress along that pathway. The APPM qualification adds a new dimension by connecting this product-development trajectory to a continental procurement framework. The ultimate measure of success, however, will not be the number of products submitted or factories established. It will be whether African manufacturing can consistently translate scientific capability into available, quality-assured and affordable health products for populations that have historically faced limited access. That includes medicines relevant to sickle-cell disease, maternal health and cancer, as well as vaccines, diagnostics, hormones, biologics and other advanced health technologies. For Dei BioPharma, the next phase is therefore not simply about producing more products. It is about demonstrating that an African manufacturer can build the scientific, regulatory and manufacturing capabilities required to participate credibly in the continent’s health-product supply chain. For Uganda, it is an opportunity to demonstrate that indigenous pharmaceutical and biotechnology capacity can progress from national manufacturing to continental market participation. And for Africa, it is another step in answering a fundamental question: whether the continent can turn its scientific talent, industrial investment and collective purchasing power into a health-industrial ecosystem capable of meeting a substantially greater share of its own needs.