The UK's MHRA has cleared UBI's COVID-19 vaccine, UB-612, after inspecting its manufacturing facility. UBIP's production base in Taiwan has obtained GMP certification!
Original text：連結
Great news from the pharmaceutical and biotechnology industry! UBI Group's domestically developed COVID-19 vaccine, UB-612, led by the founder and chairman of UBI Biotech Group, Wang Chang-yi, has successfully passed the Good Manufacturing Practice (GMP) inspection conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and obtained the GMP certificate! UBIA Biotech, UBI Pharmaceuticals, and UBI Pharma respectively received formal notifications from the UK MHRA on February 28th, February 27th, and May 2nd regarding the GMP inspection of the UB-612 production facilities and QC laboratories. The final results of the inspection met the UK GMP standards, and GMP certificates were issued.
UBIA Biotech stated that this certification signifies that the production and QC inspection of UB-612 comply with UK GMP standards. It also reflects MHRA's recognition of UBI Biotech Group's consistent adherence to high-quality production standards across its subsidiaries. The outstanding performance of UBI Biotech's production facilities and production lines in pharmaceutical manufacturing and quality control, as well as strict compliance with GMP regulations, were demonstrated during the MHRA inspection.
Wang Chang-yi remarked, "We are honored to have passed the MHRA's GMP inspection in the UK. This is a testament to our long-standing dedication to the relentless pursuit of high-quality production. We will continue to enhance our high-quality production standards."
UB-612 is developed by UBI Biotech, which oversees product development, conducts clinical trials, and is responsible for some QC inspections. The development and production of some active pharmaceutical ingredients are outsourced to UBI Pharmaceuticals, while the filling and packaging of vaccine finished products are entrusted to UBI Pharma.
The MHRA conducted a five-day GMP inspection in Taiwan from November 20th to 24th last year regarding the production and QC inspection of UB-612. This inspection, conducted before the product is granted marketing authorization, will facilitate UB-612's conditional/temporary marketing approval in the UK and serve as an important milestone for UB-612's international market layout!
UBI Biotech emphasized that the product obtained the Ministry of Health and Welfare's approval for an export-only drug license on December 29th last year. After UBI Biotech's UB-612 COVID-19 vaccine product successfully obtains marketing approval from the UK MHRA, it will mark a new milestone for domestically developed COVID-19 vaccines to enter the international market, expand global markets, benefit high-risk groups, and provide a "safer and more effective" vaccine option. UBI Biotech also believes that UB-612 can provide the global population with the best choice in the post-COVID-19 era, making concrete contributions to pandemic prevention and control.
In conclusion, Wang Chang-yi stated, "We will continue to adhere to innovative research and development, lead the UBI Biotech Group, and work with the industry to create miracles in Taiwan's biotechnology industry."