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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 global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.
The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.
SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.
Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines,recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.
With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.
For more information, please see the Company’s website at www.sinovac.com.