Fenofibrate

Fenofibrate (CAS 49562-28-9 ) is a fibric acid derivative active pharmaceutical ingredient used primarily in lipid-regulating drug formulations. As a pharmaceutical intermediate and finished API, it enables the production of oral dosage forms.

These forms target dyslipidemia management across global generic and branded drug markets. In pharmaceutical manufacturing, it is processed into tablets, capsules, and nanoparticle formulations where particle size engineering affects bioavailability.

Generic drug manufacturers source it as a key API for cholesterol and triglyceride-lowering products sold across regulated markets including the US, EU, and Asia-Pacific. This ensures high-quality therapeutic options for patients worldwide.

Formulators working on lipid-modifying combination therapies incorporate it alongside statins, requiring consistent purity and polymorphic form control. Contract development organizations also use it as a reference compound in dissolution testing.

This material is essential for formulation development benchmarking and comparative studies. It is supplied as a white to off-white crystalline powder in quantities ranging from research-scale to multi-tonne commercial volumes.

Standard grades include USP , BP , and Ph. Eur. specifications, with purity typically at 99% or above to meet pharmacopoeial requirements. This ensures the highest level of safety and efficacy for pharmaceutical use.

Certificate of Analysis documentation, ICH-compliant impurity profiling, and DMF support are standard expectations when sourcing from established API suppliers. These documents provide the necessary transparency for regulatory submissions.

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