TAIPEI, Taiwan — Merdury BiopharmaceuticalCorporation (TPEX: 6932) announced that its proprietary StackDose®drug-manufacturing technology platform will be implemented at BoraPharmaceuticals’ (TWSE: 6472) PIC/S GMP-certified plant in Zhongli through a ProductionRoom Renovation and Engineering Support Project, to take place in 2026, markinga significant step toward scalable adoption of 3D printing technologies in regulated pharmaceutical manufacturing.
Under this collaboration, Merdury will lead the installation of StackDose® equipment, technology transfer, and process validation, while Bora Pharmaceuticals’ Zhongli site will provide facility renovation, process qualification, and GMP environment support. Together, the teams will complete equipment IQ/OQ validation and establish a fully compliant manufacturing environment to enable future IND clinical production and commercial-scale manufacturing.
“Integrating the StackDose platform into Bora’s PIC/S GMP facility marks a pivotal milestone in Merdury’s development journey and a key step toward international expansion,” said a Merdury spokesperson. “By combining our 3D-printed drug formulation and manufacturing technology with Bora’s world-class quality system, we aim to accelerate scalability and global visibility of this emerging platform.”
Technically, the StackDose®platform integrates 3D powder printing with a proprietary binder formulation technology to precisely control drug-release profiles and absorption sites, improving API bioavailability while reducing side effects. The platform has been accepted into the U.S. FDA’s Emerging Technology Program (ETP) and received positive feedback in a Pre-IND meeting, confirming its feasibility forIND submission.
Bora Pharmaceuticals has long been a leader in the global CDMO sector, with multiple manufacturing sites certified by the U.S. FDA, Japan’s PMDA, and PIC/S GMP. The company maintains a comprehensive global manufacturing and operational network. Taiwan’s oral dosage manufacturing sector is advancing toward more specialized and high-value formulations.
As demand for personalized medicine continues to rise, 3D printing allows on-demand manufacturing of complex dosage forms and customized release designs, improving production efficiency and minimizing material waste. According to Future MarketInsights, the global 3D-printed drug market is projected to reach USD1.015 billion by 2035, growing at a CAGR of 9.8% from 2025 to 2035.
The collaboration between Merdury and Bora not only strengthens Taiwan’s position in pharmaceutical innovation but also establishes a foundation for the global application of3D-printed drug technologies. Both companies aim to jointly expand CDMO service offerings and enhance their technological leadership and competitiveness in the rapidly evolving pharmaceutical manufacturing landscape.
