IOLCP Granted EDQM CEP for Fenofibrate Process II

Date: 25th September 2026

Regulatory Authority: European Directorate for the Quality of Medicines & HealthCare (EDQM)
Approval Type: Certificate of Suitability (CEP)
Product: Fenofibrate - Process II (Active Pharmaceutical Ingredient)
Grant Date: 24th September 2026
Validity: The CEP is valid from 24 September 2026, subject to continued compliance with applicable EDQM requirements and conditions
Relationship to Existing Approvals: This CEP is in addition to the existing valid CEP held by the company for "Fenofibrate"

Process II has been developed by the company to cater to specific process requirements of its customers
The grant strengthens the company's regulatory portfolio
Facilitates supply of Fenofibrate – Process II in regulated markets
Supports the company's ability to serve regulated markets for Fenofibrate