Dei Biopharma Uganda gets U.S. FDA’s node for generic Osteoporosis Treatment.

Uganda based pharmaceutical manufacturer Dei Biopharma under the leadership 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.

Dei Biopharma C.E.O Dr. 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,” he said

 Magoola added that the decision validates DEI’s approach to developing complex injectable generics and positions the company for entry into the U.S. market.

Industry experts 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.

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.