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Heparin | CAS No: 9005-49-6 | GMP-certified suppliers
A medication that prevents and treats venous and pulmonary thrombotic events, supports cardiovascular embolism prevention, and helps maintain patency in dialysis circuits and surgical procedures.
Therapeutic categories
Primary indications
- Unfractionated heparin is indicated for prophylaxis and treatment of venous thrombosis and its extension, prevention of post-operative deep venous thrombosis and pulmonary embolism and prevention of clotting in arterial and cardiac surgery
- In cardiology, it is used to prevent embolisms in patients with atrial fibrillation and as an adjunct antithrombin therapy in patients with unstable angina and/or non-Q wave myocardial infarctions (i
- E
- Non-ST elevated acute coronary artery syndrome) who are on platelet glycoprotein (IIb/IIIa) receptor inhibitors
Product Snapshot
- Unfractionated heparin is supplied primarily as an injectable anticoagulant API, with additional topical and solution forms for device and procedural use
- It is used across hospital settings for thrombosis prophylaxis/treatment, procedural anticoagulation, and maintenance of extracorporeal and intravascular device patency
- It is approved in the US and Canada, with both approved and investigational listings depending on presentation and use category
Clinical Overview
Pharmacologically, unfractionated heparin exhibits antithrombotic effects by enhancing the activity of antithrombin III. This interaction markedly accelerates the inactivation of thrombin (factor IIa) and factor Xa and, to a lesser extent, factors IXa, XIa, XIIa, and plasmin. Its anticoagulant profile differs from low molecular weight heparins due to higher molecular weight, greater thrombin inhibition, and the requirement for infusion-based administration with routine activated partial thromboplastin time monitoring. Heparin does not lyse existing clots but prevents further propagation. Protamine sulfate can reverse its activity.
Absorption after parenteral administration is immediate, and distribution is largely limited to the intravascular compartment due to strong protein and endothelial binding. Clearance occurs through a combination of rapid, saturable cellular uptake and slower renal elimination. The anticoagulant effect exhibits notable interpatient variability and a narrow therapeutic index.
Safety considerations include bleeding risk, heparin-induced thrombocytopenia, hyperkalemia, and osteoporosis with prolonged use. Clinically used formulations are commonly supplied under hospital brands or as generic unfractionated heparin for intravenous or subcutaneous administration.
For API procurement, suppliers should document source material, control of heterogeneity, absence of adventitious agents, and compliance with pharmacopoeial specifications to ensure consistency of anticoagulant potency and impurity profiles.
Identification & chemistry
| Generic name | Heparin |
|---|---|
| Molecule type | Small molecule |
| CAS | 9005-49-6 |
| UNII | T2410KM04A |
| DrugBank ID | DB01109 |
Pharmacology
| Summary | Unfractionated heparin enhances the activity of antithrombin III, rapidly inhibiting thrombin and factor Xa and reducing propagation of fibrin-rich clots. Its antithrombotic effect stems primarily from this ATIII‑dependent blockade of key coagulation enzymes, with additional interactions involving other activated clotting factors. The drug also binds various proteins, including platelet factor 4 and select growth factors, but its principal pharmacodynamic action is anticoagulation via accelerated neutralization of coagulation targets. |
|---|---|
| Mechanism of action | Under normal circumstances, antithrombin III (ATIII) inactivates thrombin (factor IIa) and factor Xa. This process occurs at a slow rate. Administered heparin binds reversibly to ATIII and leads to almost instantaneous inactivation of factors IIa and Xa The heparin-ATIII complex can also inactivate factors IX, XI, XII and plasmin. The mechanism of action of heparin is ATIII-dependent. It acts mainly by accelerating the rate of the neutralization of certain activated coagulation factors by antithrombin, but other mechanisms may also be involved. The antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Heparin is not a thrombolytic or fibrinolytic. It prevents progression of existing clots by inhibiting further clotting. The lysis of existing clots relies on endogenous thrombolytics. |
| Pharmacodynamics | Unfractionated heparin is a highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. The molecular weight ranges from 3000 to 30,000 daltons. Heparin is obtained from liver, lung, mast cells, and other cells of vertebrates. Heparin is a well-known and commonly used anticoagulant which has antithrombotic properties. Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Small amounts of heparin in combination with antithrombin III, a heparin cofactor,) can inhibit thrombosis by inactivating Factor Xa and thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin prolongs several coagulation tests. Of all the coagulation tests, activated partial prothrombin time (aPTT) is the most clinically important value. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Antithrombin-III | Humans | potentiator |
| Coagulation factor X | Humans | inhibitor |
| P-selectin | Humans | inhibitor |
ADME / PK
| Absorption | Heparin is not absorbed through the gastrointestinal tract and is therefore administered via a parenteral route. Peak plasma concentration and the onset of action are achieved immediately after intravenous administration. Plasma heparin concentrations may be increased and activated partial thromboplastin times (aPTTs) may be more prolonged in geriatric adults (older than 60 years of age) compared with younger adults. |
|---|---|
| Half-life | The plasma half-life is dose-dependent, and it ranges from 0.5 to 2 h.For the purpose of choosing a protamine dose, heparin can be assumed to have a half-life of about 30 minutes after intravenous injection.The plasma half-life of heparin increases from about 30 min after an IV bolus of 25 units/kg to 60 minutes with a 100 unit/kg dose or to about 150 minutes with a 400 unit/kg dose. |
| Protein binding | Heparin is highly bound to antithrombin, fibrinogens, globulins, serum proteases, and lipoproteins. |
| Metabolism | Heparin does not undergo enzymatic degradation. |
| Route of elimination | Heparin undergoes biphasic clearance, a) rapid saturable clearance (zero-order process due to binding to proteins, endothelial cells, and macrophages), and b) slower first-order elimination. Low doses of heparin are cleared mostly by a saturable, rapid, zero-order process. Slower first-order elimination usually occurs with very high doses of heparin and is dependent on renal function.High-molecular-weight moieties are cleared more rapidly than lower molecular-weight moieties. |
| Volume of distribution | The volume of distribution is 0.07 L/kg.Although heparin does not distribute into adipose tissues, clinicians should use actual body weight in obese patients to account for extra vasculature. |
| Clearance | The clearance in adults receiving a bolus dose of 75 units/kg and preterm newborns receiving a bolus dose of 100 units/kg were calculated to be 0.43 ml/kg/min and 1.49 ml/kg/min respectively. |
Formulation & handling
- Heparin is a large polysaccharide anticoagulant primarily formulated as aqueous solutions for IV or SC administration, requiring preservation of polymer integrity and control of ionic strength.
- The API is sensitive to microbial contamination and should be handled with attention to pH and compatibility, as activity can vary with formulation excipients and container surfaces.
- Topical gels and ointments rely on maintaining macromolecule stability in hydrated semisolid systems, with minimal systemic absorption but susceptibility to microbial and viscosity changes.
Regulatory status
| Lifecycle | Several U.S. patents covering the API expire between late 2024 and mid‑2025, while a later‑expiring patent extends protection into 2042, indicating a mixed maturity profile. In the U.S. and Canadian markets, this suggests partial near‑term loss of exclusivity alongside remaining long‑term protection. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Heparin is an established anticoagulant with no single active originator, and its supply chain is supported by numerous packagers and manufacturers that handle formulation and distribution rather than proprietary API production. Branded presentations appear in the US and Canada, alongside widely available non‑branded products. Several listed US patents expire in 2024–2025, indicating that most core protections have lapsed, while a later‑expiring patent likely relates to a specific formulation or delivery system; overall, the market already supports broad generic competition. |
|---|
Safety
| Toxicity | In mouse, the median lethal dose is greater than 5000 mg/kg. Another side effect is heparin-induced thrombocytopenia (HIT syndrome). Platelet counts usually do not fall until between days 5 and 12 of heparin therapy. HIT is caused by an immunological reaction that makes platelets form clots within the blood vessels, thereby using up coagulation factors. It can progress to thrombotic complications such as arterial thrombosis, gangrene, stroke, myocardial infarction and disseminated intravascular coagulation. Symptoms of overdose may show excessive prolongation of aPTT or by bleeding, which may be internal or external, major or minor. Therapeutic doses of heparin give for at least 4 months have been associated with osteoporosis and spontaneous vertebral fractures. Osteoporosis may be reversible once heparin is discontinued. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates. Toxicity appears to have resulted from administration of large amounts (i.e., about 100–400 mg/kg daily) of benzyl alcohol in these neonates. Its use is principally associated with the use of bacteriostatic 0.9% sodium chloride intravascular flush or endotracheal tube lavage solutions. |
|---|
- High-dose exposure demonstrates low acute lethality in mice (›5000 mg/kg), but excessive anticoagulant activity can manifest as marked aPTT prolongation and internal or external bleeding, requiring controlled handling during formulation and QC processes
- Risk of immune‑mediated heparin‑induced thrombocytopenia (HIT) necessitates monitoring for pro‑thrombotic platelet activation in development or manufacturing settings where platelet-interaction assays or biological materials are used
- Prolonged therapeutic‑range exposure is associated with bone demineralization and reversible osteoporosis, and benzyl alcohol–preserved preparations have documented toxicity in neonate models at high mg/kg loads, informing excipient selection and storage controls
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.
Heparin sodium is a type of Anticoagulant proteins
Anticoagulant proteins are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in preventing the formation of blood clots. These proteins are naturally occurring substances that interfere with the clotting cascade, a complex series of reactions that lead to blood coagulation.
One of the well-known anticoagulant proteins is hirudin, derived from leeches. Hirudin acts by inhibiting thrombin, a key enzyme involved in blood clot formation. Another notable anticoagulant protein is antithrombin III, which blocks several clotting factors, including thrombin and factors IXa, Xa, XIa, and XIIa. These proteins are widely used in the pharmaceutical industry to develop medications for conditions such as deep vein thrombosis, pulmonary embolism, and stroke prevention.
The production of anticoagulant proteins involves advanced biotechnological processes. Recombinant DNA technology and genetic engineering techniques are employed to produce these proteins in large quantities. The proteins are expressed in host organisms such as bacteria, yeast, or mammalian cells, and then purified through various chromatographic and filtration steps to obtain a highly pure and active form.
The development of anticoagulant proteins has significantly improved the treatment and management of thrombotic disorders. These APIs have proven to be effective in preventing clot formation, reducing the risk of life-threatening complications. However, it is crucial to administer anticoagulant proteins under medical supervision due to their potential side effects and the need for precise dosing.
In conclusion, anticoagulant proteins are a vital subcategory of pharmaceutical APIs that act by inhibiting key components of the clotting cascade. Their production involves advanced biotechnological processes, and they have greatly enhanced the management of thrombotic disorders. Proper medical guidance is essential for their safe and effective use.
Heparin sodium (Anticoagulant proteins), 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.
Heparin sodium API manufacturers & distributors
Compare qualified Heparin sodium API suppliers worldwide. We currently have 25 companies offering Heparin sodium 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 |
|---|---|---|---|---|---|
| API Corp. | Producer | Japan | Japan | CoA, JDMF | 11 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, 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 |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Biofer | Producer | Italy | Italy | CoA, USDMF | 7 products |
| Chr. Olesen Group | Distributor | Denmark | China, Italy | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Dongying Tiandong Pharmac... | Producer | China | China | CoA, KDMF, USDMF, WC | 3 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Italy | CoA, GMP, ISO9001, MSDS | 170 products |
| Fuzhou Medcore Pharmaceut... | Distributor | China | China | CoA, MSDS | 9 products |
| Hubei Enoray | Producer | China | China | CoA, USDMF | 2 products |
| Lab. Derivati Organici | Producer | Italy | Italy | CEP, CoA, GMP | 5 products |
| Leo Pharma | Producer | Denmark | Denmark | CEP, CoA, GMP | 5 products |
| Nanjing King-Friend BC | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 1 products |
| Opocrin S-C Plant | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 7 products |
| Qingdao Jiulong | Producer | China | China | CoA, USDMF, WC | 1 products |
| Reali Tide Biological Tec... | Producer | China | China | CoA, MSDS | 57 products |
| Sandoz | Producer | Austria | Unknown | CoA, USDMF | 58 products |
| Sanofi | Producer | France | Unknown | CoA, USDMF | 93 products |
| Scientific Protein Labs. | Producer | United States | United States | CoA, JDMF, USDMF | 1 products |
| Shandong Chen Zhong | Producer | China | China | CoA, USDMF | 3 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Shenzhen Hepalink | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 1 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
| Yantai Dongcheng Bio. | Producer | China | China | CEP, CoA, FDA, GMP, ISO9001, JDMF, KDMF, USDMF, WC | 10 products |
| Yino Pharma | Producer | China | China | CoA, WC | 2 products |
When sending a request, specify which Heparin 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 Heparin 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.
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Technical
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