Uganda's DEI Biopharma moves to make bone disease drug

Local pharmaceutical company DEI Biopharma says it has made a breakthrough in securing a patent to manufacture a drug for osteoporosis treatment.

Osteoporosis is a bone disease, which makes bones weak, porous and prone to fractures, often silent until a break occurs, commonly in the hip, spine, or wrist, resulting from bone mass loss beyond normal ageing.

It says the US Food and Drug Administration (FDA) has accepted DEI Biopharma’s Abbreviated New Drug Application (ANDA) for teriparatide injection within just three days of submission.

The swift acceptance signals confidence in DEI Biopharma’s regulatory preparedness and the quality of its filing, the company said in a press statement.

The application positions DEI Biopharma to enter the US market for teriparatide, a treatment widely used for osteoporosis.

The company says it is now accelerating plans for commercial rollout, supply chain readiness, and market access strategies aimed at ensuring affordability and broad patient availability.

“This level of FDA responsiveness is exceptional and reflects the scientific rigour, completeness, and clarity of our submission,”  DEI Biopharma chief executive officer Dr Matthias Magoola said in early January 2026.

“It validates our platform approach to complex injectable generics and positions DEI to move decisively toward U.S. market entry for teriparatide.”

Currently, access to teriparatide in Africa remains limited due to high costs and regulatory hurdles. DEI Biopharma believes its FDA approval will help dismantle these barriers, paving the way for improved availability across the continent.

What others say

The Minister for Science, Technology and Innovation, Dr Monica Musenero, said the Ugandan government has positioned the pharmaceutical industry as one of the new strategic economies.

“We are, therefore, very excited by this development. The Government is supporting the industry from end to end and right from ideas, through research up to manufacturing and marketing. Our weakest point was the manufacturing capacity, which meets the strict global standards,” she told New Vision when contacted.

The minister emphasised that the Government’s partnership with Dei Biopharma has, therefore, been to intentionally build manufacturing and position it not only to meet local and regional drug needs, but also the global market.

“Therefore, the company strategically works at global levels of accreditation. FDA approval is extremely important because it enables Uganda-manufactured drugs to access global markets. This is Uganda’s strategic positioning—to contribute to the global health agenda,” she said.

“For example, the disease, Osteoporosis, affects over 200 million people globally. Many of them cannot currently access these effective drugs either because they are too expensive or not available in our countries. Uganda’s entry will mean that many can access this life-saving drug affordably,” she added.

Dr Sarah Nambasa, a Kampala-based clinical pharmacologist, hailed the development as “a game-changer for osteoporosis management in Africa.” She noted that teriparatide is often inaccessible to patients in Uganda due to prohibitive costs.

“If DEI can leverage FDA approval to streamline supply chains and reduce prices, it will significantly improve treatment outcomes for thousands of patients.”

Health economist James Okello emphasised the broader implications for regional healthcare systems.

“This move signals that African pharmaceutical companies can compete globally in complex generics. It’s not just about one drug—it’s about building confidence in Africa’s capacity to deliver high-quality medicines.”

The teriparatide programme is part of DEI’s broader US pipeline, which includes multiple ANDAs for complex injectables and other high-impact therapies. The company’s strategy focuses on addressing drug shortages and reducing costs by delivering high-quality generics efficiently.

DEI’s progress builds on earlier engagement with the FDA, including a pre-ANDA product development meeting that aligned expectations on development and analytical comparability. This collaboration has enabled the company to compress timelines without compromising scientific standards.

About DEI

The firm is a global biopharmaceutical company committed to developing affordable, high-quality medicines across generics, biosimilars, and advanced therapeutics.