Merdury Biopharmaceutical Corporation Partners with UBI Pharma Inc. to Pioneer Sildenafil Orally Disintegrating Tablets for the $4.5 Billion Global ED Drug Market
Original text：https://news.cnyes.com/news/id/5380776
(Merdury Biopharmaceutical Partners with UBI Pharma Inc. to Pioneer Sildenafil Orally Disintegrating Tablets for the $4.5 Billion Global ED Drug Market)
Merdury Biopharmaceutical has forged a strategic collaboration with UBI Pharma Inc. (6562.TW) to co-develop and manufacture Sildenafil Citrate Orally Disintegrating Tablets 50mg, referred to as sildenafil orally disintegrating tablets. This collaboration integrates Merdury Biopharmaceutical's cutting-edge 3D powder printing pharmaceutical equipment and drug formulation technology into UBI Pharma's GMP pharmaceutical factory, initiating drug trial production, facilitating global drug certifications, and establishing a robust, long-term partnership.
As the most widely used medication globally for treating erectile dysfunction (ED), Sildenafil is expected to drive the global ED drug market to a value of $7.57 billion by 2030, with a compound annual growth rate of 7.6%. Merdury Biopharmaceutical is actively preparing for mass production, having already secured distribution partners in domestic and Southeast Asian markets, aiding in local certifications and channel sales, with a keen focus on capturing the vast North American market and the rapidly expanding Asia-Pacific market.
Merdury Biopharmaceutical's 3D powder printing pharmaceutical equipment has received acceptance into the U.S. FDA Emerging Technology Program (ETP), enabling Investigational New Drug (IND) applications for drug development. Following a positive response from the FDA during a Pre-IND meeting, Merdury Biopharmaceutical plans to introduce its 3D powder printing pharmaceutical equipment and drug formulation technology into UBI Pharma's GMP pharmaceutical factory to develop and manufacture a groundbreaking sildenafil orally disintegrating tablet, with intentions to submit an application to the U.S. FDA.
With extensive experience in both large and small molecule drug development, UBI Pharma holds multiple domestic and international drug certifications, standing out as one of the few pharmaceutical factories in Asia to pass inspections by the U.S. FDA and Japan PMDA multiple times. In addition to a seasoned production team, UBI Pharma boasts clinical, regulatory, and professional CMC (Chemistry, Manufacturing, and Controls) talent, offering comprehensive one-stop international Contract Development and Manufacturing Organization (CDMO) manufacturing and drug sales services. Capitalizing on UBI Pharma's manufacturing and certification expertise, Merdury Biopharmaceutical aims to conduct trial production for the new generation sildenafil orally disintegrating tablet and proceed with global drug certification applications and sales.
According to a September 2023 Erectile Dysfunction Treatment Market Analysis by Coherent Market Insights, the global ED drug market is projected to grow from $4.54 billion in 2023 to $7.57 billion by 2030, with a compound annual growth rate of 7.6%. Sildenafil is anticipated to command the highest share among ED drugs. The same source predicts the sildenafil market size to increase from $2.9 billion in 2023 to $4.6 billion by 2030, with a compound annual growth rate of 6.8%. North America is expected to account for over 40% of the market share, while the Asia-Pacific market is poised to be the fastest-growing, with a projected compound annual growth rate exceeding 9% from 2023 to 2030.
Recognized as an emerging technology for small molecule pharmaceuticals on the U.S. FDA website, 3D printing manufacturing has become a benchmark technology in drug development. Merdury Biopharmaceutical's 3D printing pharmaceutical technology, combined with UBI Pharma's CDMO professional services, leverages the strengths of both parties, accelerating drug certifications in the United States and other countries to seize the global pharmaceutical market.