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International GMP Compliance

API:
  • Passed US FDA site inspection
    8 times ---Latest inspection occurred in Oct. 2013
  • Passed EDQM site inspection
    1 times ---The inspection occurred in Aug. 2002
  • Passed Germany Health Authority site inspection
    2 times ---Latest inspection occurred in Sep. 2012
  • Passed Japan PMDA site inspection
    1 times ---The inspection occurred in Jun. 2009
  • Passed Brazil ANVISA site inspection
    2 times ---Latest inspection occurred in March 2014
FDF:
  • Passed Health Canada Site Inspection (Oral product), Jan. 2011
  • Passed US FDA Site Inspection (Oral product), EIR received in Feb. 2014
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