- Raw materials
- Anticoagulants
- Antithrombotics
- Fondaparinux sodium
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Fondaparinux sodium API Manufacturers & Suppliers
7 verified results
All Fondaparinux sodium data. Full access. Full negotiation power
Commercial-scale Suppliers
Employees: 50+
All certificates
Employees: 200+
All certificates
Employees: 10+
All certificates
All certificates
All certificates
Employees: 21,650
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Fondaparinux | CAS No: 104993-28-4 | GMP-certified suppliers
A medication that prevents and treats venous thromboembolism and manages acute coronary syndromes by providing targeted anticoagulation with a low risk of thrombocytopenia.
Therapeutic categories
Primary indications
- Approved for: (1) prophylaxis of VTE for up to one month post surgery in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement and knee surgery
- (2) prophylaxis of VTE patients undergoing abdominal surgery who are at high risk of thromboembolic complications (e
- G
- Patients undergoing abdominal cancer surgery)
Product Snapshot
- Fondaparinux is formulated as an injectable solution for intravenous and subcutaneous administration
- It is primarily indicated for prophylaxis and treatment of venous thromboembolism, acute deep vein thrombosis, pulmonary embolism, and management of acute coronary syndromes
- Fondaparinux is approved for use in key regulatory markets including the United States, Canada, and the European Union
Clinical Overview
Clinically, fondaparinux is approved for the prophylaxis of venous thromboembolism (VTE) in patients undergoing orthopedic surgeries of the lower limbs, such as hip fracture repair, hip replacement, and knee surgery, as well as in patients at high thromboembolic risk during abdominal surgery. It is also indicated for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE). In cardiovascular settings, fondaparinux is used for managing unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) to prevent death and recurrent myocardial infarction. It is also indicated for ST segment elevation myocardial infarction (STEMI) in patients receiving thrombolytic therapy or no reperfusion treatment initially. Fondaparinux is contraindicated as the sole anticoagulant during percutaneous coronary intervention due to an increased risk of catheter thrombosis.
Pharmacokinetic parameters include a primarily renal route of elimination, necessitating caution and dose adjustments in patients with impaired renal function. Routine coagulation monitoring is not typically required; however, anti-factor Xa assays may be utilized in special populations such as pregnant patients or those with renal impairment. Complete blood counts and renal function tests are advised during therapy to monitor safety.
Adverse effects primarily relate to bleeding risk inherent to anticoagulation therapy. The absence of a direct antidote necessitates careful consideration of bleeding risks. Fondaparinux’s chemical structure reduces, but does not eliminate, the potential for heparin-induced thrombocytopenia (HIT), making it a therapeutic alternative in patients with HIT, though rare HIT cases with fondaparinux have been reported.
From an API procurement perspective, fondaparinux synthesis requires stringent control of oligosaccharide chain length and stereochemistry to ensure pharmacological specificity and safety. Manufacturers must ensure compliance with regulatory standards for purity, potency, and residual contaminants, including endotoxins. Given its primary renal excretion, the API’s physicochemical stability and formulation compatibility are critical to maintain bioavailability and therapeutic efficacy in clinical use.
Identification & chemistry
| Generic name | Fondaparinux |
|---|---|
| Molecule type | Small molecule |
| CAS | 104993-28-4 |
| UNII | J177FOW5JL |
| DrugBank ID | DB00569 |
Pharmacology
| Summary | Fondaparinux is a synthetic anticoagulant that exerts antithrombotic effects through selective potentiation of antithrombin III (ATIII)-mediated inhibition of Factor Xa. By inhibiting Factor Xa, it disrupts the coagulation cascade, reducing thrombin generation and subsequent fibrin clot formation. Fondaparinux does not directly inactivate thrombin or affect platelet function and is utilized primarily in the prevention and treatment of venous thromboembolism and acute coronary syndromes. |
|---|---|
| Mechanism of action | The antithrombotic activity of fondaparinux is the result of ATIII-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, Fondaparinux potentiates (about 300 times) the neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development. It is thought that fondaparinux is unlikely to induce thrombocytopenia via a heparin-induced thrombocytopenia (HIT)-like mechanism given its chemical structure . As a result, fondaparinux has been used as an alternative anticoagulant in heparin-induced thrombocytopenia (HIT) patients . However, it is important to note that rare cases of HIT have been reported in patients treated with fondaparinux . |
| Pharmacodynamics | Fondaparinux binds specifically to the natural anticoagulant factor, ATIII. Binding to ATIII potentiates the neutralizing action of ATIII on Factor Xa 300-times. Neutralization of Factor Xa decreases the conversion of prothrombin to thrombin, which subsequently decreases the conversion of fibrinogen to fibrin (loose meshwork). The decrease in thrombin also decreases the activation of Factor XIII, which decreases the conversion of fibrin in its loose meshwork form to its stabilized meshwork form. Disruption of the coagulation cascade effectively decreases the formation of blood clots. Fondaparinux does not inactivate thrombin (activated Factor II). According to the manufacturer, fondaparinux has no known effect on platelet function. In studies comparing fondaparinux to enoxaparin, decreases in platelet levels were observed in similar numbers of patients from both groups (2-5%) . At the recommended dose, Fondaparinux does not affect fibrinolytic activity or bleeding time. There is no antidote for fondaparinux. Monitoring of the anticoagulant activity of fondaparinux is not generally required. The anti-factor Xa assay may be used to monitor therapy in special populations such as those with renal impairment or who are pregnant. Complete blood count (CBC) and kidney function should be monitored during treatment. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Coagulation factor X | Humans | inhibitor |
| Antithrombin-III | Humans | potentiator |
ADME / PK
| Absorption | 100% bioavailability when administered subcutaneously |
|---|---|
| Half-life | 17-21 hours |
| Protein binding | 94% <i>in vitro</i> protein binding specifically to ATIII |
| Metabolism | Not metabolized |
| Route of elimination | In individuals with normal kidney function, fondaparinux is eliminated in urine mainly as unchanged drug. |
| Volume of distribution | * 7 - 11 L (healthy adults), distributed primarily in blood |
Formulation & handling
- Fondaparinux is a highly water-soluble small molecule formulated exclusively for parenteral administration via intravenous and subcutaneous routes.
- Due to its anticoagulant activity, co-administration with herbal supplements exhibiting anticoagulant or antiplatelet effects should be avoided to minimize bleeding risk.
- Handling and storage should maintain the integrity of the aqueous injection solutions, considering the molecule's low logP and high solubility.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed in the US, Canada, and EU, with primary patents expired or nearing expiry, indicating a mature market with availability of generic alternatives. Ongoing regulatory exclusivities may vary by region, influencing product lifecycle stages. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Fondaparinux is primarily manufactured and packaged by GlaxoSmithKline, indicating a limited number of originator companies involved. Its branded product, Arixtra, has a presence in multiple markets including the US, Canada, and the EU. Given the brand's established market presence, patent expiry may allow for the introduction of generic competition in these regions. |
|---|
Safety
| Toxicity | As with other anticoagulants, the main concern is increased bleed risk. The risk of hemorrhage may increase with decreased renal function, body mass less than 50 kg, and moderate to severe hepatic function. |
|---|
- Increased risk of hemorrhage associated with use, exacerbated by impaired renal function, low body weight (‹50 kg), and moderate to severe hepatic impairment
- Not suitable as sole anticoagulant during percutaneous coronary intervention (PCI) due to elevated risk of catheter thrombosis
- Handling requires adherence to protocols minimizing exposure to prevent inadvertent anticoagulant effects
Fondaparinux sodium is a type of Antithrombotics
Antithrombotics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in preventing and treating thrombotic disorders, which are characterized by the formation of blood clots within blood vessels. These medications are essential in reducing the risk of thrombosis, such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke, which can lead to severe health complications.
Antithrombotics exert their therapeutic effects through various mechanisms. One commonly used class of antithrombotics is anticoagulants, which inhibit the clotting process by interfering with the formation of blood clots. These drugs include heparin, warfarin, and direct oral anticoagulants (DOACs). They are administered to patients with conditions like atrial fibrillation, venous thromboembolism, or mechanical heart valves to prevent clot formation.
Another class of antithrombotics is antiplatelet agents, which prevent platelet aggregation, an essential step in blood clot formation. Aspirin, clopidogrel, and ticagrelor are well-known antiplatelet drugs used to prevent thrombosis in patients with coronary artery disease, ischemic stroke, or peripheral artery disease.
Antithrombotics are typically prescribed based on the individual patient's risk factors, medical history, and the specific thrombotic condition being treated. Dosage and administration instructions may vary depending on the drug's pharmacokinetic profile and desired therapeutic outcomes.
As with any medication, antithrombotics may have potential side effects, such as increased bleeding risk. Therefore, healthcare professionals carefully assess the patient's overall health status, including any underlying conditions, before prescribing these medications.
In conclusion, antithrombotics are a crucial subcategory of pharmaceutical APIs that play a vital role in preventing and treating thrombotic disorders. By inhibiting clot formation through various mechanisms, these medications significantly contribute to reducing the risk of serious complications associated with blood clots.
Fondaparinux sodium (Antithrombotics), classified under Anticoagulants
Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.
There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.
Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.
While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.
In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.
Fondaparinux sodium API manufacturers & distributors
Compare qualified Fondaparinux sodium API suppliers worldwide. We currently have 7 companies offering Fondaparinux sodium API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | CoA, ISO9001, MSDS | 229 products |
| BrightGene | Producer | China | China | CoA, USDMF | 11 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Reliable Biopharm | Producer | United States | United States | CoA, USDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, FDA, GMP, ISO9001, MSDS, USDMF | 757 products |
When sending a request, specify which Fondaparinux sodium 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 Fondaparinux sodium 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.
