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:
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).
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Anne-Marie J. Ørkild
Director, International Sales and Business Carbohydrates
Phone: +45 59 48 59 86 (direct)
Pharmacosmos is the only dextran manufacturer holding certificates from the US FDA and European Directorate for the Quality of Medicines (EDQM)
Pharmacosmos delivers a unique dextran quality through a production technology that completely avoids the use of organic solvents and a quality system that meets the strictest cGMP standards for human medicines
Pharmacosmos sells and ships directly to clients everywhere in the World. We deliver Pharmaceutical Quality Dextran of the highest standards, including those of the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP), and the Japanese Pharmacopoeia (JP).
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