Certificates & approvals
Pharmacosmos has been approved according to cGMP1 by
the Danish Medicines Agency (DKMA) as active pharmaceutical
ingredient manufacturer of dextran products of various well-defined
molecular sizes as well as iron dextran complexes of various
selected strengths.
Please read the specific statement on good manufacturing
practice for active pharmaceutical ingredients (API):
Furthermore, the entire facility, equipment, processes, and
quality control were rated as acceptable by the US Food & Drug
Administration (FDA) after thorough inspection in September 2005.
The entire facility is registered under FEI 3002807874 and food
facility number 15765915122 and includes production and control of
dextran and iron complexes.
Dextran EDQM approvals
Pharmacosmos is the only manufacturer holding the certificates
of the European Directorate for the Quality of Medicines (EDQM) for
specific compendial products Dextran 1, Dextran 40, Dextran 60, and
Dextran 70. Please read the official certificates:
To read the statements and the EDQM certificates Adobe Acrobat
Reader must be installed. Download a free version of
Adobe Acrobat Reader here.