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certification
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  • SFDA GMP Certification
    Feb. 2004: GMP Certification Jan. 2009: pass the GMP on-site audit by Jiangsu Food and Drug Administration (apply for new GMP Certification). Mar. 2009: GMP Certification (Expiry: five years)
  • EDQM CEP Certification
    In 2006, the EU EDQM CEP certification, 2011 certification review and obtain CEPs.
  • U.S. FDA Aduit
    Aug. 2008: pass the U.S. FDA audit on heparin sodium API production, zero 483 Sep. 2009: pass the U.S. FDA audit on heparin sodium API registration, zero 483 Oct. 2010: pass the U.S. FDA re-audit on heparin sodium API registration, zero 483
  • Germany Health Bureau Certification
    Jan. 2008: pass the audit of the Health Bureau of Germany Sep. 2010: pass the re-audit of the Health Bureau of Germany
  • Japan PMDA Certification
    Jan. 2011: pass the Japan PMDA audit on LMWHs registration
  • Customer Aduit
    Pass the customer audits
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