Certifications
Certificate of Suitability (CEP) certification
Our European Pharmacopoeia products are filed with the European Directorate for Quality of Medicines and Health Care. Our CEP certifications (certification of Suitability to the Monographs of the European Pharmacopoeia) allow our customers to easily administer their Marketing Authorization Applications (MAA) for the medicines that they produce. Access to the Borax Français dossier via the CEP and MAA system provides customers with cost management and control.
Good Manufacturing Practices (GMP) certification
Our entire process including manufacturing, laboratory, packaging, storage, and distribution is documented to comply with GMP guidelines. Borax Français has been inspected by the French authorities since 2007. The current GMP certificate covering active pharmaceutical ingredients is valid until 2021. Our certificate number is: 15MPP081HF01