By Joseph Kiggundu
Ugandan biotechnology and pharmaceutical manufacturer Dei BioPharma Ltd has been registered as a supplier under the African Pooled Procurement Mechanism (APPM).
APPM is a continental procurement platform coordinated by the Africa Centres for Disease Control and Prevention (Africa CDC).
In a notification dated August 28, Dr Mariatou Tala Jallow, Director of the APPM at Africa CDC, said Dei BioPharma had met the technical requirements to participate as a supplier under the pooled procurement arrangement.
The development gives the Ugandan manufacturer access to a continental procurement framework designed to aggregate demand for health products, strengthen purchasing power and improve the security and predictability of medical supplies across participating African countries.
For Dei BioPharma, the registration comes as the company expands its product portfolio and seeks to move beyond Uganda’s domestic market.
The company, founded by Ugandan scientist and innovator Dr Matthias Magoola, 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 regulatory figures point to an expanding pipeline as the company moves from establishing manufacturing infrastructure to developing and securing approvals for individual pharmaceutical products.
Pharmaceutical manufacturing requires extensive product development, quality assurance, analytical testing, stability assessment and regulatory review before products can be authorised for manufacture or sale.
The company operates a pharmaceutical and biotechnology manufacturing complex at Matugga in Wakiso District and has ambitions spanning conventional medicines and more advanced health technologies.
Its areas of interest include pharmaceuticals, injectables, oncology products, biological medicines, biosimilars, diagnostics and vaccines.
The APPM registration comes as African governments and institutions seek to strengthen local and regional manufacturing capacity and reduce the continent’s reliance on imported health products.
The African Union has set an ambition of meeting at least 60 percent of Africa’s health-product needs through African manufacturing by 2040. Achieving that target will require investment in production facilities, product development, regulatory systems, skilled personnel and, critically, reliable markets for locally manufactured products.
Pooled procurement is intended to address part of that market challenge by bringing demand from multiple countries together rather than requiring manufacturers to depend solely on fragmented national procurement systems.
Africa CDC’s first APPM tender for essential reproductive, maternal and newborn health medicines demonstrated the potential impact of the model. According to Africa CDC, the procurement process achieved prices between 30 and 90 percent below participating Member State benchmarks and established framework arrangements aimed at improving supply security.
For manufacturers, aggregated demand could provide greater market predictability and strengthen incentives for investment in production capacity, regulatory approvals and new products.
Dei BioPharma’s registration, however, does not mean that all of its products will automatically be procured through APPM. Individual products will still have to meet relevant regulatory, technical, quality and procurement requirements.
Among the products in the company’s portfolio are HYXUREA, a hydroxyurea 500 mg tablet, and TRENMIC, a tranexamic acid 500 mg tablet.
Hydroxyurea is used in the management of sickle-cell disease, a major health challenge in sub-Saharan Africa. The World Health Organization estimates that millions of people globally live with sickle-cell disease, with the overwhelming majority of the disease burden occurring in sub-Saharan Africa.
Tranexamic acid, meanwhile, is used in the management of bleeding and is relevant to efforts to reduce deaths associated with severe haemorrhage, including in maternal health.
The development of locally manufactured medicines targeting diseases with a significant African burden is part of the continent’s broader effort to strengthen health-product security.
Dei BioPharma’s longer-term ambitions extend beyond conventional pharmaceutical products.
Magoola has previously described the company’s objective as developing biological medicines that can become accessible to populations that currently face barriers to such treatments.
The company says its manufacturing and development activities are intended to build capacity across several health-technology areas, including biologics, biosimilars, diagnostics and vaccines.
For Uganda, the APPM registration represents an opportunity to connect domestic pharmaceutical manufacturing and regulatory development with a wider continental market.
The broader challenge, however, will be translating manufacturing capacity into sustained production, regulatory approvals, competitive pricing and actual market access.
As Africa seeks to increase the share of medicines and other health products manufactured on the continent, companies such as Dei BioPharma will be tested not only on their ability to establish production facilities, but also on their capacity to develop quality-assured products that can compete in increasingly integrated regional and continental markets.