Products include both IV, IM, oral, and topical administration. These products have typically been used globally including US and Europe. Examples include Dextran use for plasma volume expansion, in numerous eyes drops, and oral products like Spasfon and Opalmon.
For decades Dextran has had the Generally Recognized As Safe (GRAS) label from the US FDA, which was renewed in 2013. [link]
The established use of dextran through decades of human use in numerous products with different administration forms clearly establishes the low risk profile of Dextran.
This is well known to competent authorities around the world, and it is taken into consideration when the regulatory authorities are establishing their toxicological, preclinical and clinical requirements.
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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)
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).