Fenofibrate API from France Manufacturers & Suppliers

Fenofibrate (CAS 49562-28-9) is a fibric acid derivative within the benzophenone class, authorized for use as adjunctive therapy in adults with primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia. Its clinical role is centered on reducing elevated LDL‑C, total cholesterol, triglycerides, and apolipoprotein B, while increasing HDL‑C in appropriate patient populations. It received FDA approval in 1993 and is used globally in both general and specialist lipid‑management settings.

Fenofibrate exerts its therapeutic activity through activation of peroxisome proliferator activated receptor alpha (PPARα), a nuclear receptor regulating transcription of genes involved in lipid, glucose, and amino acid homeostasis. PPARα activation enhances lipolysis, increases lipoprotein lipase activity, and reduces apoprotein C‑III, promoting clearance of triglyceride‑rich lipoproteins. This process generates peroxisomes that produce hydrogen peroxide and other reactive oxygen species, which contribute to increased lipid turnover but also create hepatic oxidative stress. Rare cases of chronic active hepatitis and cirrhosis have been reported.

Following oral administration, fenofibrate is hydrolyzed to its active metabolite, fenofibric acid. It exhibits a long half‑life of approximately 19 to 27 hours, supporting once‑daily dosing. The drug is primarily eliminated renally, and dose adjustments may be required in patients with impaired renal function. It interacts with several cytochrome P450 pathways and is a substrate for CYP3A4 and UGT1A9, with weak inhibitory effects noted on CYP2C8, CYP2C19, and CYP2A6.

Safety considerations include risks of myopathy, rhabdomyolysis, and cholelithiasis, particularly when used in combination with other lipid‑modifying agents. Hepatic function monitoring is recommended due to the potential for oxidative liver injury.

Common brand contexts include formulations of fenofibrate capsules and tablets used in chronic lipid regulation.

For API procurement, attention should focus on impurity control, polymorphic consistency, and validation of particle size distribution, as these factors significantly affect bioavailability and regulatory acceptability across global markets.