Press Release
UBI Pharma Inc. Achieves Another Milestone in the US Market: Its Anti-Fungal Injection Generic Product Approved by the US FDA
UBI Pharma Inc. (6562.TW) 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 UBIP’s local sales partner in the US.
UBI Pharma Inc. Expands Southeast Asian Market: Epilepsy Drug Levetiracetam Was Approved in Malaysia
UBI Pharma Inc. (6562.TW) has achieved initial success in developing the Southeast Asian market. Levetiracetam, an epilepsy drug, has been approved by the Malaysian government and will be launched in coordination with distributors to expand the Malaysian market.
Bioequivalence Study is Completed for UBIP’s New Formulation New Drug NDF01, and Will Proceed to NDA Filing Soon
UBI Pharma Inc. (6562.TW) has completed the bioequivalence study and data analysis for its anti-HIV new formulation new drug NDF01. The filing for Taiwan NDA will be proceed soon.
UBI Pharma Inc. passed the TTQS(Talent Quality-management System) assessment and received the bronze medal
UBI Pharma Inc. conducted on-site review of TTQS on November 02, 2022. On November 21, the company received notification passing the evaluation of the TTQS and received the bronze medal certification, affirming the quality and ability of the company’s training.
The Clinical Study Report of the Phase III Clinical Trial of UBIP’s Recombinant Human Erythropoietin Biosimilar Drug UB-851 Has Been Completed
The Clinical Study Report of the phase III clinical trial of the recombinant human erythropoietin biosimilar drug UB-851 of UBI Pharma Inc. (6562.TW) has been completed, and the trial results are accordance with the expectations. The BLA application for marketing and medicine certificate in Taiwan will be submitted in the near future.
The Production Line of UBI Pharma Inc. for Manufacturing Sterile Injectable Drugs Has Been Approved by the U.S. Food and Drug Administration
UBI Pharma Inc. (6562.TW) received a routine GMP inspection combined with a pre-approval inspection for a sterile injectable drug conducted by the U.S. Food and Drug Administration (FDA) from June 10 to June 20, 2019. The company received the Establishment Inspection Report (EIR) issued by the U.S. FDA on August 12, 2019 with a positive conclusion of VAI (voluntary action indicated), which will benefit the future operation of the company.