EDQM Grants Certificate of Suitability for Fenofibrate – Process II
EDQM has granted a Certificate of Suitability (CEP) on 24th September 2026 for the API "Fenofibrate – Process II".
- Certificate Type
- Certificate of Suitability (CEP)
- API Name
- Fenofibrate – Process II
- Regulatory Authority
- European Directorate for the Quality of Medicines & HealthCare (EDQM)
- Grant Date
- 24th September 2026
- Purpose
- Supports supply of the product to regulated markets
What was announced
IOL Chemicals and Pharmaceuticals informed the exchanges that the European Directorate for the Quality of Medicines & HealthCare (EDQM) granted a Certificate of Suitability (CEP) on 24th September 2026 for its Active Pharmaceutical Ingredient (API) "Fenofibrate – Process II".
What a CEP means
A CEP is a certificate confirming that an API maker's product and manufacturing process meet the relevant European Pharmacopoeia standard. Customers in Europe and other regulated markets can rely on it when update their own medicine dossiers, which makes supply easier.
Key points from the update
- The new CEP is in addition to the existing valid CEP the company already holds for "Fenofibrate".
- Process II was developed by the company to cater to the specific process and requirements of its customers.
- The company states the approval strengthens its regulatory portfolio and supports its ability to serve regulated markets for Fenofibrate.
- Validity runs from 24 September 2026, subject to continued compliance with EDQM requirements and conditions.
- Withdrawal, cancellation or suspension: not applicable.
How investors may read it
Fenofibrate is a cholesterol/lipid-lowering drug ingredient. Holding a second CEP for an alternative manufacturing route gives the company added flexibility in serving customers who need that specific process. The perception is generally positive for the company's regulated-market API business, though the update itself does not quantify any revenue effect.
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