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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