Manufacturing Facility

Pharmacosmos is approved according to currenct Good Manufacturing Practice1 (Part I) by the Danish Medicines Agency (DKMA) as manufacturer of sterile iron carbohydrate drug products.

Furthermore, Pharmacosmos is approved according to current Good Manufacturing Practice1 (Part II) by the Danish Medicines Agency as active pharmaceutical ingredient (API) manufacturer of Dextran products of various well-defined molecular sizes as well as Iron Dextran complexes of various selected strengths.

Pharmacosmos Dextran and Iron Dextran manufacturing facility.

In September 2005 the US Food & Drug Administration (FDA) rated the entire Pharmacosmos facility, equipment, processes and quality control as acceptable after thorough inspection of the newly constructed 13,000m2 state-of-the-art corporate headquarters and manufacturing facility.

For the specific statements on Good Manufacturing Practice for active pharmaceutical ingredient (API), please see Certificates & Approvals.

  1. Good Manufacturing Practice for medicinal products for human and veterinary use according to The Rules Governing Medicinal Products in the European Union, Volume 4, Part I & II (former Annex 18 (ICH Q7A)).