- Raw materials
- Anticoagulants
- Heparins
- Enoxaparin
- Quality & compliance
- USDMF Certified
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Enoxaparin API Manufacturers & Suppliers
15 verified results
Commercial-scale Suppliers
Employees: 50+
All certificates
Employees: 200+
All certificates
Employees: 19
All certificates
Employees: 10+
All certificates
Employees: 200+
All certificates
Employees: 50
All certificates
Employees: 50+
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Enoxaparin | CAS No: 9005-49-6 | GMP-certified suppliers
A medication that supports prevention and management of thromboembolic complications in acute coronary syndromes and provides prophylaxis and treatment of deep vein thrombosis across surgical and medical settings.
Therapeutic categories
Primary indications
- Enoxaparin is indicated for the prevention of ischemic complications in unstable angina and in non Q-wave myocardial infarction
- It is indicated in conjunction with percutaneous intervention and/or other treatment for the management of acute ST elevation myocardial infarction
- Enoxaparin is also indicated in the prophylaxis of DVT in abdominal surgery, hip replacement, knee replacement, or medical patients with severely restricted mobility during acute illness
Product Snapshot
- Enoxaparin is an injectable low‑molecular‑weight heparin supplied mainly as subcutaneous or intravenous solutions
- It is used for DVT prophylaxis and treatment and for managing ischemic complications in acute coronary syndrome, including unstable angina, NSTEMI, and STEMI settings
- It is approved and commercially established in the US, EU, and Canada
Clinical Overview
Pharmacologically, enoxaparin displays rapid onset of anticoagulant activity. It increases thrombin time and activated partial thromboplastin time, though these parameters are not typically used for routine monitoring of low‑molecular‑weight heparins. Compared with unfractionated heparin, enoxaparin produces a higher anti‑Factor Xa to anti‑Factor IIa activity ratio, reflecting its predominant anti‑Factor Xa effect. In controlled studies, subcutaneous dosing produced measurable and dose‑dependent changes in coagulation markers.
Enoxaparin acts by binding to antithrombin III to facilitate inactivation of Factor Xa, thereby reducing thrombin generation. It can also inhibit thrombin (Factor IIa), although with lower potency than unfractionated heparin. Through suppression of fibrin formation, it limits clot propagation and reduces risk of thromboembolic events.
Absorption after subcutaneous administration is reliable for low‑molecular‑weight heparins, and clearance occurs mainly through renal pathways. Accumulation may occur in severe renal impairment, requiring dose adjustments under clinical supervision.
Important safety considerations include bleeding risk, thrombocytopenia, and increased thromboembolic risk in pregnant patients with mechanical heart valves. Monitoring for hemorrhage and platelet count changes is essential.
Common global brands include presentations of enoxaparin marketed for subcutaneous and intravenous use across hospital and ambulatory care settings.
For API procurement, suppliers should provide clear molecular weight distribution profiles, validated manufacturing controls for depolymerization processes, and full compliance documentation to support quality, consistency, and regulatory submissions.
Identification & chemistry
| Generic name | Enoxaparin |
|---|---|
| Molecule type | Small molecule |
| CAS | 9005-49-6 |
| UNII | E47C0NF7LV |
| DrugBank ID | DB01225 |
Pharmacology
| Summary | Enoxaparin enhances antithrombin III activity, leading to potent inhibition of factor Xa and weaker direct inhibition of thrombin, which reduces fibrin formation and limits clot development. Its pharmacodynamic profile is characterized by immediate anticoagulant effects and increased anti‑factor Xa activity relative to anti‑factor IIa. These actions support its use in preventing and managing thromboembolic events across cardiovascular and perioperative settings. |
|---|---|
| Mechanism of action | Enoxaparin binds to antithrombin III, a serine protease inhibitor, forming a complex that irreversibly inactivates factor Xa, which is frequently used to monitor anticoagulation in the clinical setting.Following factor Xa inactivation, enoxaparin is released and binds to other anti-thrombin molecules. Factor IIa (thrombin) is directly inhibited by enoxaparin, however with less potency than unfractionated heparin (UFH). Due to the cascade of effects resulting from enoxaparin binding, thrombin is unable to convert fibrinogen to fibrin and form a clot, preventing thromboembolic events. |
| Pharmacodynamics | This drug has an immediate onset of action.Enoxaparin increases Thrombin Time (TT) and activated partial thromboplastin time (aPTT), preventing and reducing thromboembolic complications such as DVT, pulmonary embolism, and ischemic cardiac complications.Administered at 1.5 mg/kg subcutaneously in a pharmacodynamic study, enoxaparin led to a higher ratio of anti-Factor Xa to anti-Factor IIa activity (mean ±SD, 14.0±3.1) (based on areas under anti-Factor activity versus time curves) when compared to that of heparin (mean ±SD, 1.22±0.13). Increases in the TT and aPTT were 1.8 times those of the control group.Enoxaparin at 1 mg/kg subcutaneously every 12 hours led to aPTT values of 45 seconds or less in most patients. Average aPTT prolongation time on Day 1 was approximately 16% higher than on Day 4 of enoxaparin therapy. Caution is advised during treatment with enoxaparin - the risk of hemorrhage and thrombocytopenia is increased. In pregnant women with prosthetic mechanic heart valves, the risk of thromboembolism is increased. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Antithrombin-III | Humans | potentiator |
| Coagulation factor X | Humans | inhibitor |
| Prothrombin | Humans | inhibitor |
ADME / PK
| Absorption | Mean absolute bioavailability of enoxaparin, after 1-2 mg/kg given subcutaneously is approximately 100% in healthy volunteers. The absorption of enoxaparin is proportional to the dose, demonstrating linear absorption. The average maximum plasma anti-Xa activity is reached 3 to 5 hours after a subcutaneous injection.A 30 mg IV bolus preceding an immediate 1 mg/kg SC every twice a day led to maximum anti-Factor Xa levels of 1.16 IU/mL. Steady-state is reached within 3-4 daysof treatment with a Cmax of 1.2 IU/mL.The AUC under the thrombin generation curve was 305 +/- 48. |
|---|---|
| Half-life | The half-life of enoxaparin is about 4 hours after a single dose administered subcutaneously and about 7 hours after several doses.One source mentions a half-life ranging from 1 hour to 4.5 hours. |
| Protein binding | Enoxaparin binds to antithrombin III.The percentage of plasma protein binding for enoxaparin is not readily available in the literature. |
| Metabolism | Enoxaparin is mainly metabolized by the liver via desulfation and/or depolymerization to lower and less potent molecular weight metabolites. |
| Route of elimination | Enoxaparin is mainly excreted by the kidneys.Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments 40% of the dose. |
| Volume of distribution | The volume of distribution of enoxaparin is approximately 4-5L, similar to normal blood volume. |
| Clearance | The mean clearance of enoxaparin is 0.74 L/h after a 1.5 mg/kg intravenous infusion over 6 hours; clearance of enoxaparin is significantly decreased in patients with severe renal impairment. |
Formulation & handling
- Enoxaparin is a parenteral-only low‑molecular‑weight heparin (aqueous solution) used via subcutaneous or intravenous routes, with no oral applicability.
- Being a polysaccharide biologic derivative, it is formulated as sterile, preservative‑free solutions with strict control of pH, ionic strength, and viscosity to maintain anti‑Xa activity.
- It shows good solution stability under standard cold‑chain conditions, with no food‑related considerations for formulation or handling.
Regulatory status
| Lifecycle | The active ingredient is in a late‑lifecycle stage, with key U.S. and Canadian patents expiring in 2012 and 2011, respectively. With availability across Canada, the US, and the EU, the market is broadly established and largely generic. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Enoxaparin’s supply landscape includes a single originator with multiple packagers distributing product across the US, EU, and Canada. Branded formulations have broad global availability, supported by established distribution networks. Patent expiries in the early 2010s indicate that generic competition is already present in major markets. |
|---|
Safety
| Toxicity | The oral LD50 for enoxaparin in mice is >5000 mg/kg; the subcutaneous LD50 of enoxaparin in mice is >2500 mg/kg. Accidental overdose after the administration of enoxaparin may cause hemorrhage. Enoxaparin administered by injection is mainly neutralized by gradual intravenous injection of a 1% protamine sulfate solution. The dose of protamine sulfate should be equal to the dose of enoxaparin administered: 1 mg protamine sulfate for 1 mg enoxaparin, of enoxaparin was administered in the previous 8 hours. If a minimum of 12 hours has passed since the last enoxaparin dose, protamine may not be necessary; it is important to avoid an overdose with protamine, as fatal reactions may occur. |
|---|
- High acute toxicity thresholds in mice (oral LD50 ›5000 mg/kg
- Subcutaneous LD50 ›2500 mg/kg), but parenteral exposure remains the primary concern in handling
- Accidental overdose is associated with significant hemorrhagic risk
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Enoxaparin is a type of Heparins
Heparins are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the medical industry. These compounds are derived from the mucous membranes of pigs or cows, and they play a crucial role in preventing and treating blood clotting disorders. This technical description will delve into the key aspects of heparins, highlighting their composition, therapeutic applications, and manufacturing process.
Heparins consist of a complex mixture of sulfated polysaccharides, primarily composed of repeating units of glucuronic acid and N-acetylglucosamine. These chains exhibit high molecular weights, ranging from 3,000 to 30,000 Daltons. Their unique chemical structure and anticoagulant properties make them indispensable in the treatment of conditions like deep vein thrombosis, pulmonary embolism, and during cardiac surgeries.
The production of heparins involves a rigorous extraction process from animal tissues, followed by purification and standardization to ensure consistent quality and efficacy. The raw materials undergo several steps, including depolymerization, fractionation, and removal of impurities, resulting in different forms such as unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). LMWH offers advantages like improved bioavailability, longer half-life, and reduced risk of certain side effects compared to UFH.
Heparins have found widespread usage in various medical settings, including hospitals, clinics, and home-based treatments. As a potent anticoagulant, they effectively prevent clot formation, minimizing the risk of life-threatening conditions. Additionally, heparins also possess anti-inflammatory and immunomodulatory properties, contributing to their therapeutic efficacy in certain diseases beyond anticoagulation.
In summary, heparins are vital pharmaceutical APIs derived from animal tissues, offering unparalleled anticoagulant effects. Their complex composition, diverse therapeutic applications, and stringent manufacturing processes make them indispensable in modern medicine.
Enoxaparin (Heparins), 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.
Enoxaparin API manufacturers & distributors
Compare qualified Enoxaparin API suppliers worldwide. We currently have 15 companies offering Enoxaparin 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 | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Atabay K.S.V.T. | Producer | Turkey | Turkey | CoA, FDA, GMP | 4 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Dongying Tiandong Pharmac... | Producer | China | China | CEP, CoA, GMP, USDMF, WC | 3 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hangzhou Jiuyuan Gene Eng... | Producer | China | China | CoA, WC | 2 products |
| Hubei Enoray | Producer | China | China | CoA, USDMF | 2 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Chen Zhong | Producer | China | China | CoA, USDMF | 3 products |
| Shenzhen Techdow | Producer | China | China | CoA, USDMF | 2 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001 | 762 products |
| Yantai Dongcheng Bio. | Producer | China | China | CEP, CoA, FDA, GMP, ISO9001, USDMF, WC | 10 products |
When sending a request, specify which Enoxaparin 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 Enoxaparin 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 Enoxaparin API
Sourcing
What matters most when sourcing GMP-grade Enoxaparin?
Which documents are typically required when sourcing Enoxaparin API?
Which manufacturers are known to produce Enoxaparin API?
How can I request quotes for Enoxaparin API from GMP suppliers?
Is a GMP audit report available for Enoxaparin manufacturers?
How many suppliers offer Enoxaparin API on Pharmaoffer?
Which countries are known to manufacture Enoxaparin API?
Which certifications do suppliers of Enoxaparin usually hold?
Technical
What is Enoxaparin (CAS 9005-49-6) used for?
Which therapeutic class does Enoxaparin fall into?
What conditions is Enoxaparin mainly prescribed for?
How does Enoxaparin work?
What should someone know about the safety or toxicity profile of Enoxaparin?
What are important formulation and handling considerations for Enoxaparin as an API?
Is Enoxaparin a small molecule?
Are there special stability concerns for oral Enoxaparin?
Regulatory
Where is Enoxaparin approved or in use globally?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Enoxaparin procurement?
Is Enoxaparin included in the PRO Data Insights coverage?
Where can I access the API market report for Enoxaparin?
