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Sinovac Biotech Ltd. Receives GMP Certificate In Mexico For Seasonal Flu Vaccine And Hepatitis A Vaccine
Sinovac Biotech Ltd. announced that it has obtained the GMP certificate for its seasonal flu vaccine and hepatitis A vaccine from the Mexican regulatory authority, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of Mexico Ministry of Health. Sinovac is the Chinese vaccine manufacturer to be granted GMP certificate by COFEPRIS. The GMP certification follows the onsite inspection by COFEPRIS at Sinovac's Beijing headquarters in September 2010. The GMP certificate is effective for 30 months with an expiration date of January 12, 2014, at which time a new GMP inspection shall be applied for the renewal of GMP certificate. Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company with operations in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in the Mexican market, pursuant to a prior distribution agreement signed in 2005 with its affiliate.
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