DSM's beta-carotene receives CEP approval

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.

The certification is considered important for customers to register products where the ingredients are seen by the authorities as active pharmaceuticals.

To achieve a CEP, the product needs to be found in compliance with the specifications and tests defined by the European Pharmacopoeia.

The manufacturing site producing the product must operate under full good manufacturing practice (GMP) processes and meet Q7 Pharma standards.

The CEPs are considered to enable easier registration of products in EP member states and countries outside of Europe, such as Canada.

DSM says the submission of CEP documentation for beta-carotene to EDQM is in response to customer requests to use the ingredient as an active pharmaceutical ingredient in existing or future products with a formal pharmaceutical registration status.