不良事件/反應(yīng)報(bào)告
https://www.walvax.com/public_information/?type=5&id=1
不良事件/反應(yīng)報(bào)告
A wholly-owned subsidiary of Shanghai Zerun
To achieve its product development goal, Zerun Biotech established its first manufacturing facility in 2016 for its HPV vaccine production. The site named Yuxi Zerun Biotechnology Co., Ltd. (“Yuxi Zerun”) and located in Yuxi City, Yunnan Province, is an innovation-driven biopharmaceutical company focusing on the industrialization, production and operation of new recombinant vaccines for human use. With the support from Bill & Melinda Gates Foundation, Yuxi premise was designed and constructed to meet both current Chinese and WHO prequalification (WHO-PQ) requirements. The premise is a modern four-story building covering an area of over 4,000 square meters (~40,000 sf) and the premise area is about 20,000 square meters (~200,000 sf), with a capacity producing an initial 15 million doses of bivalent HPV vaccine a year. The state-of-art premise is furnished with top international brand manufacturing equipment to ensure production continuity and process stability. In early 2018, Yuxi Zerun was granted a “Drug Manufacturing License” by the provincial branch of CFDA (now the National Medical Products Administration), signifying the readiness of the plant for production.