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news.Sinovac Biotech has received GMP certification from the China State Food and Drug Administration (SFDA) for its Dalian mumps vaccine production plant at its Sinovac Dalian facility.
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Following the site inspection and documentation review, the SFDA has stated that the production plant is in compliance with the new 2010 GMP guidelines.
Sinovac, which obtained production license in 2011, anticipates mumps vaccine commercial production to begin in the third quarter 2012.
Sinovac chairman, president and CEO Weidong Yinof said obtaining GMP certification for the facility will advance development pipeline and expand company’s commercialized vaccines portfolio.
”The commercialization of mumps vaccine is a testament to our capabilities to develop additional live attenuated vaccines,” Yinof added.
”Commercial production of the mumps vaccine will commence immediately and we anticipate launching the vaccine either later this year or early next year following the batch release process."
Sinovac said that there are only two domestic manufacturers at present who provide mumps vaccine in the China private market.