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.
Dalteparin is available in Subcutaneous (SC) injection
and strengths such as 2,500 IU, 5,000 IU, 10,000 IU vials.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Dalteparin is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Dalteparin can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
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
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