June 29, 2011

DSM's Beta-Carotene gets Certificate of Suitability

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has granted DSM a Certificate of Suitability (CEP) that their Beta-Carotene is manufactured in line with the European Pharmacopoeia (EP) standards.

Such CEPs are very important for customers to register products where the ingredients are seen by the authorities as active pharmaceuticals. To achieve a CEP it is a pre-requisite that the product is in compliance with the specifications and tests defined by the European Pharmacopoeia, the manufacturing site operates under full GMP and that all Q7 Pharma standards are implemented. CEP's are not only relevant for EP member states* because more and more countries outside of Europe, e.g. Canada acknowledge the CEPs as part of an easier registration process.

With the submission of CEP documentation for Beta-Carotene to EDQM, DSM has responded to specific customer requests to use Beta-Carotene as active pharmaceutical ingredient in existing or future products with a formal Pharma registration status.

Dr Theodor Graser, Vice-President Marketing DSM Nutritional Products Europe comments, "DSM has CEPs for all its vitamins selling on the market. The new CEP for Beta-Carotene will help to extend DSM's position as supplier of high quality ingredients that are used for various health benefit solutions."