Regulatory Status

Last Updated on Montag, 15 August 2016 10:33 Written by admin Samstag, 8 Dezember 2012 01:38

  • GMP inspected by national authority since 1992
  • Foreign inspections e.g. by US FDA, ANVISA, KFDA, PMDA, COFEPRIS
  • PMDA Site Accreditation for Japan
  • Our Active Substance Master File are frequently updated, available in eCTD format and relevant for all markets
  • All our Active Substance Master Files are in compliance with regulations such as ICH Q3C, ICH Q11, ICH Q3D implementation is in Progress
  • 25 Certificates of Suitablility to the monographs of the European Pharmacopoeia (CEPs) are also available


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