Dalteparin

Form: Subcutaneous (SC) injection

Strength: 2,500 IU, 5,000 IU, 10,000 IU vials

Reference Brands: Fragmin(US & EU)

Category: Blood Disorder

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