- Raw materials
- Anticoagulants
- Heparins
- Dalteparin
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Dalteparin API Manufacturers & Suppliers
3 verified results
All Dalteparin data. Full access. Full negotiation power
Commercial-scale Suppliers
Employees: 10+
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Dalteparin | CAS No: 9005-49-6 | GMP-certified suppliers
A medication that prevents deep-vein thrombosis, pulmonary embolism, and ischemic cardiac events, and reduces clotting risks during hemodialysis in surgical and medically ill patients.
Therapeutic categories
Primary indications
- Dalteparin is used as a prophylaxis for deep-vein thrombosis and pulmonary embolisms in patients undergoing general surgery (e
- G
- , abdominal, gynecologic, urologic), and in patients with acute medical conditions (e
- G
Product Snapshot
- Dalteparin is a parenteral anticoagulant available as injectable solutions for intravenous and subcutaneous administration
- It is primarily used for prophylaxis of thromboembolic events including deep-vein thrombosis, pulmonary embolisms, acute coronary syndromes, and clot prevention in hemodialysis
- Dalteparin is approved for use in key regulatory markets including the US and Canada
Clinical Overview
Clinically, dalteparin is indicated for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients undergoing general surgeries, including abdominal, gynecologic, and urologic procedures. It is also employed for thromboprophylaxis in acute medically ill patients with conditions such as cancer, heart failure, severe lung disease, or immobility, which increase thromboembolic risk. Dalteparin is additionally used in combination with antiplatelet agents such as aspirin and clopidogrel to reduce ischemic cardiac events in patients with unstable angina or non-ST-segment elevation acute coronary syndromes. Furthermore, it is utilized to prevent clotting during hemodialysis and hemofiltration in acute or chronic renal impairment.
Dalteparin exerts its anticoagulant effects by potentiating antithrombin III (ATIII), inhibiting factor Xa and to a lesser extent thrombin (factor IIa). Its shorter polysaccharide chains result in preferential inhibition of factor Xa with relatively less effect on thrombin, differentiating it from unfractionated heparin. Consequently, activated partial thromboplastin time (aPTT) is minimally affected at therapeutic doses and is not routinely used for monitoring. Anti-Xa activity assays provide a more reliable measure of anticoagulant effect and are recommended when monitoring is indicated. Dalteparin is contraindicated in patients with creatinine clearance below 20 mL/min due to risk of accumulation; unfractionated heparin is preferred in severe renal impairment.
Pharmacokinetically, dalteparin exhibits improved bioavailability and a longer elimination half-life of anti-Xa activity than unfractionated heparin, allowing once or twice-daily subcutaneous administration. It is considered safe for use during most stages of pregnancy.
Safety considerations include bleeding risk inherent to anticoagulants, risk of heparin-induced thrombocytopenia (HIT), and careful dose adjustment in renal dysfunction. Dalteparin’s use requires assessment of bleeding risk and contraindications such as active hemorrhage or severe thrombocytopenia.
Notable pharmaceutical brands containing dalteparin include Fragmin, which is widely used globally. Procurement of dalteparin API should ensure compliance with pharmacopeial standards relating to molecular weight distribution, potency determined by anti-Xa activity, and impurity profiles. Given its animal origin, traceability of porcine mucosa source and adherence to Good Manufacturing Practices (GMP) are critical to maintain supply chain integrity and product quality.
Identification & chemistry
| Generic name | Dalteparin |
|---|---|
| Molecule type | Small molecule |
| CAS | 9005-49-6 |
| UNII | S79O08V79F |
| DrugBank ID | DB06779 |
Pharmacology
| Summary | Dalteparin is a low molecular weight heparin that enhances antithrombin III activity, predominantly inhibiting factor Xa and, to a lesser extent, thrombin, thereby reducing thrombus formation. Its anticoagulant effect is primarily measured via anti-factor Xa activity rather than activated partial thromboplastin time. Therapeutically, dalteparin is utilized for thromboprophylaxis in surgical and medically compromised patients and to prevent clotting during extracorporeal renal therapies. |
|---|---|
| Mechanism of action | Dalteparin potentiates the activity of ATIII, inhibiting the formation of both factor Xa and thrombin. The main difference between dalteparin and unfractionated heparin (UH) is that dalteparin preferentially inactivates factor Xa. As a result, only a slight increase in clotting time [(i.e. activated partial thomboplastin time (APTT)] is observed relative to UH. For this same reason, APTT is not used to monitor the effects of dalteparin except as an indicator for overdosage. |
| Pharmacodynamics | Dalteparin has an antithrombin binding site that is essential for high affinity binding to the plasma protein antithrombin (ATIII). Anti-Xa activity of plasma is used as both as an estimate of clotting activity, and as a basis to determine dosage. Its use should be avoided in patients with a creatinine clearance less than 20mL/min. In these patients, unfractionated heparin should only be used. As for monitoring, active partial thromboplastin time (aPTT) will only increase at high doses of low molecular weight heparins (LMWH). Therefore, monitoring aPTT is not recommended. However, anti-Xa activity can be measured to monitor the efficacy of the LMWH. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Antithrombin-III | Humans | potentiator |
| Vascular endothelial growth factor A | Humans | inhibitor |
| P-selectin | Humans | inhibitor |
ADME / PK
| Absorption | Almost completely absorbed after subcutaneous (sc) doses, with a bioavialability of about 87%. |
|---|---|
| Half-life | Terminal Half life: Intravenous - 2 hours. Subcutaneous - 3-5hours |
| Protein binding | Less than unfractionated heparin, which is more than 90%. |
| Metabolism | Liver and the reticulo-endothelial system are the sites of biotransformation. They are partially metabolized by desulphatation and depolymerization. |
| Route of elimination | After 4 hours, about 20% is seen in urine. Most of the remainder is found in the liver, gastrointestinal tract and kidney. The kidneys are the major site of dalteparin excretion (approximately 70% based on animal studies). |
| Volume of distribution | 3 litres |
| Clearance | Excreted via kidneys. The plasma clearance rate is 33 mL/min. |
Formulation & handling
- Dalteparin is administered via parenteral routes including subcutaneous and intravenous injections, not suitable for oral use.
- Being a small molecule anticoagulant, it requires careful handling to avoid contamination but does not share biologic or peptide stability concerns.
- Avoid co-administration with herbs or supplements that affect coagulation due to potential interactions impacting efficacy and safety.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the US and Canada, with key patents expired in both regions, indicating a mature market with potential for generic competition. Lifecycle management is focused on maintaining regulatory compliance and supply stability. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dalteparin is primarily supplied by a limited number of originator companies responsible for its branded formulations. Its branded products, such as Fragmin, are marketed mainly in North America, including the US and Canada. Patent expirations suggest that generic competition is likely present or forthcoming in these regions. |
|---|
Safety
| Toxicity | Overdosage: hemorrhagic complications. Adverse Drug Reaction: (common) osteopenia with extended use; mild, reversible non-immunological thrombocytopenia; transient elevation of liver transaminases; alopecia. (uncommon): severe immunologically-mediated heparin-induced thrombocytopenia; anaphylactic reactions; skin rash, skin necrosis; retroperitoneal hemorrhage; angioedema |
|---|
- May cause hemorrhagic complications in cases of overdosage
- Use with caution to prevent bleeding risk
- Associated with reversible mild thrombocytopenia and transient liver enzyme elevation during extended use
Dalteparin 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.
Dalteparin (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.
Dalteparin API manufacturers & distributors
Compare qualified Dalteparin API suppliers worldwide. We currently have 3 companies offering Dalteparin API, with manufacturing taking place in 2 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, GMP, MSDS, USDMF | 229 products |
| Dongying Tiandong Pharmac... | Producer | China | China | CoA | 3 products |
| Opocrin S-C Plant | Producer | Italy | Italy | CoA, JDMF | 7 products |
When sending a request, specify which Dalteparin 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 Dalteparin 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.
