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Fenofibrate | CAS No: 49562-28-9 | GMP-certified suppliers
A medication that supports management of primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia by lowering harmful lipid levels and improving protective HDL cholesterol.
Therapeutic categories
Primary indications
- Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia
- Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia
Product Snapshot
- Oral small‑molecule formulation supplied mainly as capsules and tablets, including standard and extended‑release presentations
- Used for management of primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia as adjunctive dietary therapy
- Approved in major regulated markets including the US, EU, and Canada
Clinical Overview
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.
Identification & chemistry
| Generic name | Fenofibrate |
|---|---|
| Molecule type | Small molecule |
| CAS | 49562-28-9 |
| UNII | U202363UOS |
| DrugBank ID | DB01039 |
Pharmacology
| Summary | Fenofibrate is a fibrate that activates the nuclear receptor PPARα, leading to enhanced lipolysis and modulation of lipid, glucose, and amino acid homeostasis. Its engagement of PPARα drives transcriptional programs that increase lipid metabolism and can generate associated oxidative stress in hepatic tissues. These actions support its use in conditions characterized by elevated LDL‑C, triglycerides, and mixed dyslipidemia. |
|---|---|
| Mechanism of action | Fenofibrate activates peroxisome proliferator activated receptor alpha (PPARα), increasing lipolysis, activating lipoprotein lipase, and reducing apoprotein C-III.PPARα is a nuclear receptor and its activation alters lipid, glucose, and amino acid homeostasis.Activation of PPARα activates transcription of gene transcription and translation that generates peroxisomes filled with hydrogen peroxide, reactive oxygen species, and hydroxyl radicals that also participate in lipolysis.This mechanism of increased lipid metabolism is also associated with increased oxidative stress on the liver.In rare cases this stress can lead to cirrhosis and chronic active hepatitis. |
| Pharmacodynamics | Fenofibrate is a fibrate that activates peroxisome proliferator activated receptor alpha (PPARα) to alter lipid metabolism and treat primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia.Fenofibrate requires once daily dosing and has a half life of 19-27 hours so its duration of action is long.Fenofibrate capsules are given at a dose of 50-150mg daily so the therapeutic index is wide.Patients should be counselled about the risk of rhabdomyolysis, myopathy, and cholelithiasis when taking fibrates. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Peroxisome proliferator-activated receptor alpha | Humans | agonist |
| Nuclear receptor subfamily 1 group I member 2 | Humans | partial agonist |
| Matrix metalloproteinase-25 | Humans | inhibitor |
ADME / PK
| Absorption | A single 300mg oral dose of fenofibrate reaches a C<sub>max</sub> of 6-9.5mg/L with a T<sub>max</sub> of 4-6h in healthy, fasting volunteers. |
|---|---|
| Half-life | Fenofibric acid, the active metabolite of fenofibrate, has a half life of 23 hours.Fenofibrate has a half life of 19-27 hours in healthy subjects and up to 143 hours in patients with renal failure. |
| Protein binding | Fenofibrate is 99% protein bound in serum,primarily to albumin. |
| Metabolism | Fenofibrate is completely hydrolyzed by liver carboxylesterase 1 to fenofibric acid.Fenofibric acid is either glucuronidated or has its carbonyl group reduced to a benzhydrol that is then glucuronidated.Glucuronidation of fenofibrate metabolites is mediated by UGT1A9.Reduction of the carbonyl group is primarily mediated by CBR1 and minorly by AKR1C1, AKR1C2, AKR1C3, and AKR1B1. |
| Route of elimination | 5-25% of a dose of fenofibrate is eliminated in the feces, while 60-88% is eliminated in the urine.70-75% of the dose recovered in the urine is in the form of fenofibryl glucuronide and 16% as fenofibric acid. |
| Volume of distribution | The volume of distribution of fenofibrate is 0.89L/kg,and can be as high as 60L. |
| Clearance | The oral clearance of fenofibrate is 1.1L/h in young adults and 1.2L/h in the elderly. |
Formulation & handling
- Fenofibrate is a highly lipophilic, poorly water‑soluble small molecule typically formulated for oral solid dosage forms, often requiring solubility‑enhancing approaches.
- Absorption is food‑dependent, so formulations generally account for increased bioavailability with co‑administration of meals.
- High logP and low aqueous solubility may necessitate lipid‑based systems, micronization, or particle engineering to ensure consistent dissolution and exposure.
Regulatory status
| Lifecycle | Most patent protection for the API has lapsed in the US, Canada, and the EU, with the final known expiries occurring in 2024. Given these expirations and its presence across major markets, the API is in a mature stage of its lifecycle with broad generic availability expected. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Fenofibrate was originally developed by a small number of innovator companies, but today the supply landscape is dominated by numerous generic manufacturers and packagers. Branded and generic products are widely available across the US, EU, and Canada, indicating a well‑established global market. With key US and Canadian patents already expired or nearing expiry, extensive generic competition is present and expected to continue. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is >2g/kg and in mice is 1600mg/kg.The oral TDLO in rats is 9mg/kg. Treat patients with supportive care including monitoring of vital signs and observing clinical status.Recent overdose may be treated with inducing vomiting or gastric lavage.Due to fenofibrate's extensive protein binding, hemodialysis is not expected to be useful. |
|---|
- High-dose oral exposure shows low acute toxicity in rodents (rat LD50 ›2 g/kg
- Mouse LD50 ~1
- 6 g/kg), though sub‑toxic effects occur at much lower levels (rat TDLO 9 mg/kg)
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Fenofibrate is a type of Lipid-lowering agents
Lipid-lowering agents are a category of pharmaceutical active ingredients (APIs) that are widely used in the treatment of hyperlipidemia, a condition characterized by elevated levels of lipids (such as cholesterol and triglycerides) in the blood. These agents play a crucial role in managing lipid abnormalities and reducing the risk of cardiovascular diseases.
One of the most commonly prescribed lipid-lowering agents is statins. Statins work by inhibiting an enzyme called HMG-CoA reductase, which is responsible for the production of cholesterol in the liver. By blocking this enzyme, statins effectively lower cholesterol levels in the bloodstream.
Another class of lipid-lowering agents is fibric acid derivatives, which primarily target triglyceride levels. These agents activate a nuclear receptor known as PPAR-alpha, which regulates lipid metabolism. By activating PPAR-alpha, fibric acid derivatives enhance the breakdown of triglycerides and increase the elimination of fatty acids from the bloodstream.
Additionally, bile acid sequestrants are often used as lipid-lowering agents. These agents bind to bile acids in the intestine, preventing their reabsorption. As a result, the liver utilizes more cholesterol to produce new bile acids, leading to a decrease in circulating cholesterol levels.
Lipid-lowering agents are available in various formulations, including tablets, capsules, and suspensions, allowing for convenient administration. They are usually prescribed alongside lifestyle modifications, such as dietary changes and regular exercise, to optimize the management of hyperlipidemia.
It is important to note that the use of lipid-lowering agents should be under the supervision of a healthcare professional, as they may have potential side effects and interactions with other medications. Proper monitoring of lipid levels and regular follow-up visits are essential for ensuring the effectiveness and safety of these pharmaceutical agents.
Fenofibrate API manufacturers & distributors
Compare qualified Fenofibrate API suppliers worldwide. We currently have 23 companies offering Fenofibrate API, with manufacturing taking place in 8 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Corden Pharma | Producer | Germany | France | CoA, GMP, USDMF | 45 products |
| Derivados Quimicos | Producer | Spain | Spain | CoA, GMP, USDMF | 18 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Harman Finochem | Producer | India | Unknown | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 34 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 98 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 69 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| Orgapharm | Producer | France | France | CoA, USDMF | 9 products |
| PLIVA | Producer | Czech Republic | Croatia | CoA, GMP | 31 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 762 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
| Synkem | Producer | France | France | CEP, CoA, FDA, GMP | 4 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unichem Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 62 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Zhejiang Hengkang Pharmac... | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 31 products |
| Zhejiang Yongtai Pharma | Producer | China | China | CoA, USDMF | 5 products |
When sending a request, specify which Fenofibrate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Fenofibrate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Fenofibrate API
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Technical
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Regulatory
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