The certificate is granted for the company’s proprietary vaccines, Haidian district bulk production plants, and Changping filing and packaging facility.
Sinovac chairman, president and CEO Dr. Weidong YIN said Sinovac Beijing’s vaccine products, its bulk production plants, and its Changping filling and packaging facility have passed the GMP inspection ahead of the year end 2013 deadline.
Effective from 17 April 2013 for the next five years, the GMP certificate covers Sinovac Beijing’s vaccines commercialized in China and approved for stockpiling.
The vaccines include hepatitis A vaccine (human diploid cell); hepatitis A and B combined vaccine; influenza vaccine; pandemic influenza vaccine (inactivated, adjuvanted); pandemic influenza vaccine (split virion, adjuvanted); H1N1 influenza A vaccine.
Sinovac Beijing’s production plants in Haidian district and the new filling and packaging line in Changping district were inspected by CFDA in December 2012.
In March 2011, China adopted GMP guidelines that are consistent with international standards.