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.

Learn more about our Research and Development.

1) Good Manufacturing Practices for active pharmaceutical ingredient (API) according to The Rules Governing Medicinal Products in the European Union, Volume 4, Part II (former Annex 18 (ICH Q7A)).