EuBiologics wins WHO PQ for second oral cholera vaccine plant

EuBiologics said Tuesday that it has received World Health Organization (WHO) prequalification (PQ) approval for the finished product manufacturing line of its oral cholera vaccine Euvichol-S at its second plant in Chuncheon, Gangwon Province.

The approval follows a WHO PQ certification granted in April 2024 for the same facility’s bulk drug substance production line.

With the latest WHO nod, EuBiologics can fully operate bulk and finished product production lines at its second facility, independently of its first plant, for global supply through the United Nations procurement system. The company said the expanded capacity positions it to exceed its original 2025 target of supplying 72 million doses of Euvichol-S to UNICEF and other international agencies.

The second facility, completed in 2019 and GMP-certified in 2022, received Korean Ministry of Food and Drug Safety (MFDS) approval in February 2025 for Euvichol-S finished product manufacturing. The WHO PQ enables global distribution of vaccine doses produced at the site, a key milestone for the company’s international vaccine business.

“Receiving WHO PQ for the second plant’s finished product line means we can mass-produce and export Euvichol-S from both sites,” a EuBiologics official said. “That also brings us closer to establishing a full-capacity operation for various vaccines under development.”

In addition to oral cholera vaccines, the Chuncheon facility is being used to produce typhoid conjugate vaccines and meningococcal conjugate vaccine drug substances currently in development. It also serves as a contract manufacturing site for pertussis vaccine antigens for LG Chem, leveraging the site’s surplus capacity.