Fenofibrate
Fenofibrate API (CAS 49562-28-9)
High-Purity PPARα Agonist for Lipid Management | GMP-Certified Manufacturer & Supplier — Henan Haitian Biotechnology Co., Ltd.
📦 Request a Quote TodayProduct Overview
Fenofibrate — chemically described as propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate — is a fibric acid derivative that acts as a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It is a first‑line pharmacotherapy for severe hypertriglyceridemia and mixed dyslipidemia, effectively lowering triglyceride levels, raising HDL‑C, and reducing atherogenic small‑dense LDL particles.
Henan Haitian Biotechnology Co., Ltd. manufactures Fenofibrate API under strict USPEPGMP compliance. Every batch undergoes rigorous quality control, and a full Certificate of Analysis (CoA) is provided to ensure reliability for pharmaceutical formulation, research, and clinical development.
Fenofibrate Powder
White to Off-White Crystalline
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 49562-28-9 |
| Molecular Formula | C20H21ClO4 |
| Molecular Weight | 360.83 g/mol |
| Appearance | White or almost white crystalline powder |
| Purity | ≥ 99.0% (HPLC) |
| Melting Point | 79 – 82 °C |
| Solubility | Practically insoluble in water; freely soluble in methylene chloride; slightly soluble in ethanol |
| Storage | Room temperature (15‑30 °C), sealed and protected from light and moisture |
| Quality Standard | USP, EP, BP, CP |
| Typical Packing | 1 kg / 5 kg / 25 kg fiber drums or aluminum foil bags |
Data based on current pharmacopoeia monographs and internal QC specifications. A batch‑specific CoA is available upon request.
Mechanism of Action
Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite fenofibric acid. It selectively activates PPARα, a nuclear receptor expressed predominantly in the liver, heart, kidney, and skeletal muscle. Activation of PPARα promotes:
- Increased lipoprotein lipase activity, enhancing triglyceride‑rich particle clearance.
- Apolipoprotein A‑I and A‑II synthesis, raising HDL cholesterol.
- Reduction of apoC‑III, an inhibitor of triglyceride hydrolysis.
- Modulation of LDL subfractions toward larger, less atherogenic particles.
• Triglyceride reduction: 30–60% in hypertriglyceridemic patients.
• HDL‑C increase: 10–35%.
• Minimal effect on LDL‑C in many patients; may reduce small‑dense LDL.
• Anti‑inflammatory and anti‑atherogenic effects via PPARα‑mediated pathways.
Clinical Applications & Research Uses
🩺 Severe Hypertriglyceridemia
Indicated for types IV and V hyperlipoproteinemia; reduces risk of acute pancreatitis in patients with triglycerides > 500 mg/dL.
❤️ Mixed Dyslipidemia
Used alone or with statins (e.g., rosuvastatin) to improve overall lipid profile when statin monotherapy is insufficient.
🧬 Diabetic Dyslipidemia
Effectively addresses the atherogenic lipid triad (high TG, low HDL, small‑dense LDL) common in type 2 diabetes and metabolic syndrome.
🔬 Pharmaceutical Research
Widely employed in preclinical models studying lipid metabolism, PPARα signaling, and novel combination therapies for cardiovascular risk reduction.
Why Choose Henan Haitian Biotechnology?
🏭 GMP‑Certified Production
Our manufacturing base holds veterinary GMP accreditation from China’s Ministry of Agriculture and operates according to ICH Q7‑aligned quality principles, ensuring consistent, pharmaceutical‑grade material.
🔎 Comprehensive Quality Control
Each lot is tested for identity, purity, residual solvents, heavy metals, and particle size. Full documentation — CoA, MSDS, stability data — provided with every shipment.
🌾 End‑to‑End Supply Chain
With 10+ production lines across a 30,000 m² facility, we control synthesis from key intermediates to final API, securing supply stability and cost efficiency for bulk orders.
🌍 Global Logistics Expertise
We deliver to over 30 countries with temperature‑controlled shipping, flexible Incoterms (FOB, CIF, DDP), and pharma‑compliant packaging for safe international transit.
Packaging & Storage
Fenofibrate is stable under normal conditions, but appropriate packaging is critical to prevent moisture uptake. Standard configurations include:
- 1 kg / 5 kg — Vacuum‑sealed aluminum foil bag with desiccant, inside a fiber drum.
- 25 kg — HDPE drum with double LDPE liner, tamper‑evident seal.
- Custom sizes (500 g sample packs, micronized forms) are available on request.
Storage Recommendation: Keep container tightly closed, store at 15–30 °C in a dry, well‑ventilated area. Protect from light. Shelf life is 36 months from the date of manufacture when stored as directed.
Frequently Asked Questions
Fenofibrate is a lipid‑lowering agent used to treat hypertriglyceridemia, mixed dyslipidemia, and diabetic dyslipidemia. It activates PPARα to reduce triglycerides, increase HDL cholesterol, and modify LDL particle size.
Our Fenofibrate API is guaranteed ≥ 99.0% purity by HPLC, conforming to USP/EP monographs. A Certificate of Analysis accompanies each shipment, and we can supply additional impurity profiling on request.
The standard MOQ is 1 kg for trials. Bulk orders of 25 kg and larger benefit from tiered pricing. Reach out to our sales team for a detailed quotation based on your volume and specifications.
Store in a tightly sealed container at room temperature (15‑30 °C), protected from light and moisture. Avoid excessive heat. Under these conditions, the product remains stable for its 36‑month shelf life.
Absolutely. We export worldwide, including to North America, Europe, Asia, the Middle East, and Africa. All shipments are handled with pharmaceutical logistics standards, and we provide the necessary documentation for customs clearance.
Get in Touch
Looking for a reliable Fenofibrate API partner? Our team is ready to assist with samples, pricing, and technical documentation.
🏢 Company: Henan Haitian Biotechnology Co., Ltd.
📍 Address: No.6 Feiyue Road, Shangqiu Development Zone, Henan, China
📞 Tel: +86-370-3166333
📧 Email: haitianbiotech@gmail.com | info@haitianbio.cn
🌐 Website: haitianbio.com
Disclaimer: This Fenofibrate API is intended for pharmaceutical research and manufacturing purposes only. It is not to be used directly for human or veterinary therapeutic administration without appropriate formulation and regulatory approval.
Name Fenofibrate
Synonyms 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid isopropyl ester; Proctofene; Sedufen
Molecular Formula C20H21ClO4
Molecular Weight 360.84
CAS Registry Number 49562-28-9
EINECS 256-376-3
Fenofibrate is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as “fibrates.” Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibrate.
In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help fenofibrate work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.
