Merdury BioPharmaceutical Inc* (Stock Code: 6932) has integrated its technology platform into UBI Pharma's (Stock Code: 6562) for the development and manufacturing of Sildenafil Citrate Orally Disintegrating Tablet 50mg (referred to as sildenafil orally disintegrating tablet). The collaboration involves implementing Merdury BioPharmaceuticals 3D powder printing equipment and drug formulation technology into UBI's GMP-certified pharmaceutical factory. This collaboration aims to conduct drug trial production and apply for drug certifications globally, marking the beginning of a long-term, in-depth partnership.
Merdury BioPharmaceutical's 3D powder printing pharmaceutical equipment has been accepted into the U.S. FDA's Emerging Technology Program (ETP), which allows for the application of Investigational New Drug (IND) clinical trials. During the Pre-IND meeting with the U.S. FDA, Merdury BioPharmaceutical received positive feedback and is now introducing its 3D powder printing pharmaceutical equipment and drug formulation technology into UBI's GMP-certified factory. This move is aimed at developing and manufacturing a novel type of sildenafil orally disintegrating tablet and preparing to apply for approval from the U.S. FDA.
3D printing manufacturing is listed as an emerging technology in small molecule pharmaceuticals on the U.S. FDA website and has become a benchmark technology in drug development. Particularly, Merdury BioPharmaceutical's "magnetic-assisted drop-on-powder structure for tablet printing" has obtained a U.S. invention patent, valid until March 18, 2042. During this period, other companies are prohibited from using the same method for drug manufacturing. The combination of Merdury BioPharmaceutical's 3D printing pharmaceutical technology and UBI's CDMO professional services leverages the strengths of both parties.
