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Pharmacosmos Documentation

Dextran Documentation

Documentation on Pharmacosmos Dextran comes in 3 Categories

  1. Freely available:
    This includes the (non-authorized) EDQM documents for Pharmacopeia Dextran 1, 40, 60 and 70, the Material Safety Data Sheet and Pharmacosmos’ GMP certificate, which can be found on this homepage under the relevant products.
  2. Available to customers:
    All Dextrans delivered from Pharmacosmos are delivered with a BRC (Batch Release Certificate) equivalent to COA (Certificate of Analysis). Additional statements on non-animal origin, Latex, GMO-free etc. are available to Pharmacosmos’ customers upon request.

  3. Available under combined Sales and Supply Agreement (SSA) and Quality Service Agreement (QSA):
    Please see below.


Pharmacosmos’ combined Sales and Supply Agreement (SSA) and Quality Service Agreement (QSA)
Pharmacosmos’ core business focuses on delivering high-quality dextrans for clinical use to the market. Our dextrans are as standard provided with a Batch Release Certificate (BRC) describing analytical results and specification limits. 

When services to support a client’s application of Pharmacosmos Dextran are needed, Pharmacosmos offers the combined Sales and Supply Agreement (SSA) and Quality Service Agreement (QSA), granting the client access to the following services and assistance from Pharmacosmos: 

Quality Service Agreement:

  • Certificate of Suitability (CEP) (for Dextran 1, 40, 60 and 70 EP)
  • Letter of Access to US Drug Master File (DMF) (for USP / Pharmaceutical Quality Dextrans)
  • Documentation of stability
  • Letter of change notification
  • Quality declarations / statements (BSE, ICH Q3D, etc.)
  • Quality and Supplier Questionnaire
  • Regulatory assistance (e.g. answers to regulatory authorities)
  • Right to access to 3rd party audit report

During the last couple of years, the demand from our customers to provide assistance beyond supplying high-quality clinical product, has intensified. We try to meet our customer’s needs via this standardized SSA/QSA.


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Pharmacosmos is the only dextran manufacturer holding certificates from the US FDA and European Directorate for the Quality of Medicines (EDQM)

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Quality Delivered

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

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Global Service

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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