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CEP Certified APIs, or Certificate of Suitability APIs, are active pharmaceutical ingredients that have been certified by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to meet specific quality standards for pharmaceutical use. These APIs are produced in compliance with Good Manufacturing Practice (GMP) and are intended for use in the formulation of medicinal products. The certification ensures that the APIs are suitable for use in European markets and adhere to stringent regulatory requirements.
| Certification | CEP (Certificate of Suitability) |
| Compliance Standards | GMP (Good Manufacturing Practice) |
| Purity Levels | Typically ≥ 98% purity |
| Formulation Types | Solid, liquid, or semi-solid forms |
| Packaging | Standardized pharmaceutical packaging |
When selecting CEP Certified APIs, buyers should consider the specific therapeutic application and any relevant regulatory requirements. It is important to specify the required purity levels, formulation types, and any necessary documentation such as the Drug Master File (DMF) references. Additionally, buyers should inquire about batch sizes and lead times for delivery to ensure alignment with production schedules.
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CEP certification indicates that the API meets European quality standards for pharmaceutical use.
Yes, CEP Certified APIs are produced in compliance with Good Manufacturing Practice.
Typically, CEP Certified APIs have a purity level of ≥ 98%.
Yes, they are commonly used in the production of generic pharmaceuticals.
They are available in solid, liquid, and semi-solid forms.
Specify the required purity levels, formulation types, and any necessary documentation.