Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted
China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers of hepatitis B vaccine in China have suspended production, reports the state news agency Xinhua.
BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharm failed to meet the 2010 Good Manufacturing Practice (GMP) code for all pharmaceutical manufacturers by the deadline at the end of 2013. Those who did not reach the new standards must suspend production in 2014. The statement by the CDFA says that companies may resume production after certification.
Over the first 11 months last year, hepatitis B vaccines produced by the three suppliers accounted for about 80% of total output. Hepatitis B vaccines sold in China are produced by seven companies, including the UK’s GlaxoSmithKline. Only two have passed the new GMP certification, responsible for no more than 10% of sales.
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