Announcement: Beilu Pharma’s Gadobutrol API Receives CEP Certificate

Recently, Beilu Pharma received the Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for its Gadobutrol Active Pharmaceutical Ingredient (API), issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

Gadobutrol API is used for the production of Gadobutrol Injection. This injection is indicated for use in adults and children of all ages (including full-term neonates) for contrast-enhanced magnetic resonance imaging (MRI) to detect lesions in all parts of the body (including the brain and spinal cord). It offers distinct advantages in dynamic contrast-enhanced magnetic resonance angiography (DCE-MRA) and dynamic contrast-enhanced MRI (DCE-MRI) across all body regions. Currently, Gadobutrol Injection is included in China's National Reimbursement Drug List (NRDL) as a Category B drug.

The acquisition of this CEP certificate marks the official completion of the EU registration for the company’s Gadobutrol API, permitting its sale within the European Union pharmaceutical market. It will also play a positive role in enhancing the product’s international standing.