Dalteparin Suppliers & Bulk Manufacturers
Available Forms: Subcutaneous (SC) injection
Available Strengths: 2,500 IU, 5,000 IU, 10,000 IU vials
Reference Brands: Fragmin(US & EU)
Category: Blood Disorder
Heparin Sodium enhances antithrombin III activity, inhibiting thrombin and factor Xa, which prevents blood clot formation. It is used to treat and prevent thrombosis, pulmonary embolism, and during surgeries. Benefits include rapid anticoagulation, reducing clot risk, improving blood flow, and supporting trauma or surgical procedures.
Product Description: Heparin Sodium is regulated as a high-risk medicinal product in both the EU and US. In the US, it is approved by the FDA, requiring a comprehensive dossier demonstrating safety, efficacy, and manufacturing quality. In the EU, it is regulated by the EMA and approved through a centralized or national authorization process. Both regions mandate strict quality controls, including purity, potency, and stability assessments. For detailed regulatory guidance, dossier preparation, and market entry strategies, visit PharmaTradz. Ensuring compliance with regional regulations is essential for successful commercialization of Heparin Sodium products in global markets
Dalteparin — third party manufacturing & bulk supply
Dalteparin is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Dalteparin listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Dalteparin →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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