Fenofibrate

Fenofibrate (CAS 49562-28-9) is a fibric acid derivative active pharmaceutical ingredient used primarily in lipid-regulating drug formulations.

Where is Fenofibrate used?

• Pharmaceutical manufacturing: processed into tablets, capsules and nanoparticle formulations where particle size engineering affects bioavailability
• Generic drug production: key API for cholesterol and triglyceride-lowering products sold in the US, EU and Asia-Pacific
• Lipid-modifying combination therapies: incorporated alongside statins, requiring consistent purity and polymorphic form control
• Contract development organizations use it as a reference compound in dissolution testing.

Good to know: Standard grades include USP, BP and Ph. Eur. specifications, with purity typically at 99% or above to meet pharmacopoeial requirements. Certificate of Analysis documentation, ICH-compliant impurity profiling and DMF support are standard expectations when sourcing from established API suppliers.

Commercial specifications

• Purity typically 99% or above
• Quantities from research-scale to multi-tonne commercial volumes