Certificates & Approvals
Approval of Facility
Pharmacosmos has been approved according to cGMP (1) by the Danish Medicines Agency (DKMA, Lægemiddelstyrelsen) as Active Pharmaceutical Ingredient manufacturer of Dextran products of various well defined molecular size as well as Iron Dextran complexes of various selected strengths.
Please read the specific Statement on Good Manufacturing Practice for Active Pharmaceutical Ingredients (API):
- GMP Statement on Dextran API (Vet) (Document: PDF, 0.59 MB)
- GMP Statement on Dextran Powder (Human) (Document: PDF, 0.59 MB)
- GMP Statement on Iron Dextran Solution (Vet) (Document: PDF, 0.58 MB)
- GMP Statement on Iron Dextran Powder (Human) (Document: PDF, 0.58 MB)
- GMP Statement on Iron Dextran Powder (Vet) (Document: PDF, 0.60 MB)
Furthermore, the entire facility, equipment, processes, and quality control were rated as acceptable by the US 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.
Approval of Products
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:
- European Directorate for the Quality of MedicinesPharmacosmos EDQM Certificate: Dextran 1 for Injection (Document: PDF, 2 pages, 0.44 MB)
- European Directorate for the Quality of MedicinesPharmacosmos EDQM Certificate: Dextran 40 for Injection (Document: PDF, 2 pages, 0.51 MB)
- European Directorate for the Quality of MedicinesPharmacosmos EDQM Certificate: Dextran 60 for Injection (Document: PDF, 2 pages, 0.47 MB)
- European Directorate for the Quality of MedicinesPharmacosmos EDQM Certificate: Dextran 70 for Injection (Document: PDF, 2 pages, 0.46 MB)
To read the statements and the EDQM Certificates Adobe Acrobat Reader must be installed. Download a free version of Adobe Acrobat Reader here.
- Good Manufacturing Practices for active pharmaceutical ingredient according to The Rules governing Medicinal Products in the European Union, Volume 4, Part II (former Annex 18 (ICH Q7A)).