Kampala — Ugandan pharmaceutical manufacturer Dei Biopharma led by scientist Dr. Matthias Magoola has received a significant boost in its bid to enter the highly regulated United States drug market after the U.S. Food and Drug Administration (FDA) accepted its application for a generic osteoporosis drug for substantive review just three days after submission.
The FDA accepted DEI Biopharma’s Abbreviated New Drug Application (ANDA) for teriparatide injection, a generic version of the originator product Forteo®, clearing the way for a full scientific and regulatory assessment. Industry analysts say such rapid acceptance is uncommon and signals strong confidence in the quality and completeness of the company’s submission.
The development marks an important milestone in DEI’s strategy to penetrate the U.S. generics market, particularly for complex injectable medicines that are often expensive and vulnerable to supply shortages. With the review process underway, the company says it is now preparing its commercial, supply chain and market access plans to ensure stable and affordable supply once regulatory approval is granted.
DEI Biopharma chief executive officer Matthias Magoola said the FDA’s swift response reflects the robustness of the company’s regulatory and scientific processes.
“This level of FDA responsiveness is exceptional and reflects the scientific rigor, completeness and clarity of our submission,” Dr Magoola said, adding that the decision validates DEI’s approach to developing complex injectable generics and positions the company for entry into the U.S. market.
Teriparatide, used in the treatment of osteoporosis, remains largely inaccessible in many African markets due to high costs, complicated supply chains and regulatory barriers. DEI says FDA approval would not only open the U.S. market but also help ease access challenges in lower-income regions by enabling more efficient global supply.
The teriparatide application is part of a broader and expanding U.S. pipeline at DEI Biopharma, which includes several other ANDAs at various stages of development. The company says its focus is on medicines with high public health impact, particularly where shortages and high prices persist.
DEI’s progress follows years of engagement with the FDA, including a pre-ANDA product development meeting for teriparatide that aligned the company with U.S. regulatory expectations on analytical comparability and product development. This, the company says, has helped shorten timelines without compromising scientific standards.
Beyond the U.S. market, DEI Biopharma is investing heavily in local manufacturing capacity. The company is developing a multi-billion-dollar drug and vaccine production facility in Matugga, Wakiso District, aimed at supporting large-scale pharmaceutical production for both domestic and export markets.
Its research portfolio spans diseases of major public health concern, including HIV/AIDS, malaria, tuberculosis, sickle cell disease, diabetes and Alzheimer’s disease. The company says it has filed more than 100 patents with the United States Patent and Trademark Office, including for a CAR-T cell immunotherapy for cancer that it claims could dramatically reduce treatment costs.
In April 2025, President Museveni met DEI Biopharma’s management and pledged government support to fast-track licensing of locally produced vaccines for global use. He also reiterated the commitment to expedite the National Drug and Health Products Act, a move seen as critical to enabling the National Drug Authority to attain World Health Organization Maturity Level 3 status, which would allow international recognition of Ugandan-made pharmaceutical products.
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