Zinc Oxide API CEP GMP-manufactured
CEP (Certificate of Suitability – European Pharmacopoeia) development for zinc oxide is currently in progress in collaboration with EDQM, with initial regulatory evaluation underway.
In the interim, pharmaceutical registrations can already be supported through DMF and ASMF documentation, enabling partners to proceed with product registrations without delay while CEP certification is ongoing.
Zinc oxide is manufactured under GMP conditions and is already supplied to regulated pharmaceutical markets within the European Union, ensuring compliance with strict quality, traceability and documentation requirements.
Full regulatory support, including API documentation and compliance guidance, is available upon request.
- CEP certification in progress with EDQM
- DMF and ASMF documentation available
- GMP-compliant manufacturing processes
- Suitable for EU and international pharmaceutical markets
- Full regulatory support for product registrations
Zinc oxide API with CEP certification in progress, supported by GMP manufacturing and DMF/ASMF regulatory pathways.
