All Compliance
GMP-manufactured API with CEP
CEP (Certificate of Suitability – European Pharmacopoeia) development is currently ongoing with EDQM.
The first stage of the regulatory assessment is in progress, with the next evaluation phase targeted for mid 2026.
In the meantime, pharmaceutical registrations can already be supported through DMF / ASMF regulatory documentation, allowing partners to initiate product registrations without delay while the CEP process is ongoing.
Zinc Oxide produced under GMP conditions is already successfully registered and supplied in several regulated pharmaceutical markets within the European Union.
More information on the regulatory framework and API manufacturing standards can be found on our API compliance page.
