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medac CDMO is partnering with UroGen Pharma to support the development and supply chain of UGN-103 using its licensed mitomycin formulation and manufacturing services.

Within medac CDMO, we have successfully completed the NaDiNa project, whose main objective was to develop a formulation, establish a manufacturing process, and prepare a prototype of a novel anticancer drug up to the stage enabling its clinical evaluation. The project was carried out in close collaboration with the Faculty of Medicine of Palacký University in Olomouc (UPOL) and was financially supported by the Technology Agency of the Czech Republic (TAČR).

The recent completion of patient enrollment in UroGen Pharma’s Phase 3 UTOPIA trial marks a major step forward in the development of UGN-103 (mitomycin) for intravesical solution under investigation for the treatment of recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). medac CDMO is proud to contribute significantly to this achievement as the development and manufacturing partner for UGN-103....

With over 25 years of aseptic manufacturing experience, medac CDMO enters the global CDMO market under a single, unified brand in 2025. This strategic rebranding brings together two GMP-certified production sites in Germany and the Czech Republic alongside the headquarters in Wedel, aligning capabilities, management and mission.