Pharmacosmos Quality

Quality | Safety | Efficacy

On an ongoing basis Pharmacosmos strives to fulfill customers’ expectations and demands of today and tomorrow for Quality, Safety, and Efficacy of the products (bulk, API's, and drug products) we manufacture. This ensures that all products are fit for their intended use.

Production, documentation, control, and quality in all relevant processes are continuously improved and updated.

Pharmacosmos accomplishes the goals by employing and training personnel to be keen and responsible within their individual functions and by strengthening the knowledge of operating according to best practice.

Validation and Qualification of processes, equipment, methods of analyses etc. in all departments is of paramount importance for our ability to provide products of a constant quality, purity, safety, and efficacy with minimum batch variation. 

Quality Management System

Controlled and covered by a very efficient Quality Management System Pharmacosmos manufactures dextran fractions of high quality and unique product purity to customers worldwide. Our facility and systems are regularly inspected by national and international health authorities including the Danish Medicines Agency (Lægemiddelstyrelsen) and the United States Food & Drug Administration (US FDA).

Pharmacopeia Specifications EP, USP and JP
Pharmacosmos is the only dextran manufacturer who has been granted Certificates of Suitability to the monographs of the European Pharmacopoeia (EP) from the European Directorate for the Quality of Medicines (EDQM) for the specific Pharmacopoeia Pharmaceutical Quality Dextran fractions:

• Dextran 1
• Dextran 40
• Dextran 60
• Dextran 70

Pharmacosmos supplies Pharmaceutical Quality Dextran fractions in accordance with the Pharmacopoeia specifications, for example the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP), and/or the Japanese Pharmacopoeia (JP).