The certificate of compliance has a five-year term and was issued by the State Food and Drug Administration following a site inspection. The good manufacturing practice (GMP) certification provides for an overall annual production capacity of 20 million doses, with the capability to produce up to 40 million doses through reasonable scheduling of production activities.
This production milestone ensures that Sinovac can fully meet increasing market demand and potential production increases for currently commercialized products, namely Healive, Bilive and Anflu. The filling and packaging production plant also has the capabilities to fill and package Panflu, the company’s pandemic influenza vaccine, in order to support China’s prevention and control strategy against a potential outbreak of pandemic influenza.
Weidong Yin, chairman, president and CEO of Sinovac, said: “The receipt of the GMP certification and the operation of the state-of-the-art filling and packaging facility provide the foundation for the further development of Sinovac. We are well positioned to increase output to meet increasing market demand and ultimately achieve sales growth. More importantly, the expanded production capacity should enable Sinovac to supply greater amount of vaccines, which is in line with our mission to eliminate human diseases.”