UBI Pharma Achieves Another Milestone in the US Market: Its Anti-Fungal Injection Generic Product Approved by the US FDA

UBI Pharma (Stock code: 6562) has developed Voriconazole for Injection, 200mg/vial (Single-Dose Vial), a sterile lyophilized powder injection, and obtained approval from the US FDA for its Abbreviated New Drug Application (ANDA211264). The product will be sold through UBI Pharma’s local sales partner in the US.


This product is widely used in the treatment of fungal infections, including invasive aspergillosis, deep-seated candidiasis, and esophageal candidiasis. Due to its wide range of applications and clear effects, it is included in the WHO Model List of Essential Medicines, 22nd list (2021). According to the IQVIA database, the market value of Voriconazole Injection in the US is US$18 million, and the global sales amount to US$360 million.


There are some technical barriers in the development of Voriconazole Injection. The water solubility for the API is poor. It can only be dissolved in water with the addition of solubilizers along with raising the temperature for compounding. Moreover, the administration doses in clinical settings are large, which makes the freeze-drying process challenging. The operational parameters of large-volume lyophilized products, such as temperature control and pressure control, require thorough study. Through the efforts of the R&D team and the production team in product development, trial batch production, process scale-up, and submission batch production, UBI Pharma finally obtained FDA approval.


After obtaining the US license, the product will be planned for generic drug applications in Taiwan and ASEAN countries, to continue expanding the market. UBI Pharma has been working hard to meet the high regulatory threshold of the US market. In addition to the five approved products, one lyophilized product is under review, and a new product application has also been submitted this year (2023). UBI Pharma will continue to develop high-quality injection products to benefit patients.