Sinovac Receives GMP Certification for its New Filling and Packaging Production Facility
Sinovac Receives GMP Certification for its New Filling and Packaging Production Facility
Annual Production Capacity Increased to 20 Million Doses
Monday March 2, 2009, 8:00 am EST
BEIJING, March 2 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Alternext US: SVA), a leading provider of vaccines in China, today announced that it has received the Good Manufacturing Practice (GMP) certification for its recently opened filling and packaging production facility. The certificate of compliance has a five-year term and was issued by the State Food and Drug Administration (SFDA) following a site inspection.
The 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.
Further to existing commercialized products having obtained GMP certifications, the filling and packaging plant successfully obtained the GMP certification, which further recognizes Sinovac's implementation of high quality management of production process.
Mr. Weidong Yin, Chairman, President and CEO, commented, ''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.''
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's commercialized vaccines include Healive® (hepatitis A), Bilive® (combined hepatitis A and B), Anflu® (influenza) and Panflu(TM) (H5N1). Sinovac is currently developing a Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine. Its wholly-owned subsidiary, Tangshan Yian is currently conducting field trials for the first domestically-developed inactivated animal rabies vaccines. Additional information about Sinovac is available on its website, http://www.sinovac.com . To be added to our distribution list, please email: info@sinovac.com.
For more information, please contact:
Helen G. Yang
Sinovac Biotech Ltd.
Tel: +86-10-8289-0088 x871
Fax: +86-10-6296-6910
Email: info@sinovac.com
Investors/Media:
Stephanie Carrington/Janine McCargo
The Ruth Group
Tel: +1-646-536-7017/7033
Email: scarrington@theruthgroup.com
jmccargo@theruthgroup.com
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, and mumps.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.
For more information, please see the Company’s website at www.sinovac.com.
Contact:
Sinovac Biotech Ltd.
PR Team
pr@sinovac.com