Enoxaparin (LMWH)

Form: Subcutaneous (SC) Prefilled Syringes/Injectables

Strength: 30 mg, 40 mg, 40 mg/0.4 mL, 80 mg, 100 mg, 120 mg, 150 mg

Reference Brands: Lovenox(US), Clexane(EU)

Category: Blood Disorder

Enoxaparin is regulated as a biosimilar or medicinal product in the EU and US. In the US, it is approved by the FDA, requiring a detailed dossier demonstrating bioequivalence, safety, efficacy, and manufacturing standards. In the EU, it is authorized through EMA approval, adhering to the biosimilar guidelines. Both regions demand rigorous quality controls, including pharmacovigilance and stability data. For comprehensive guidance on dossier preparation, regulatory pathways, and market entry strategies, visit PharmaTradz. Ensuring compliance with regional regulations is crucial for successful approval and commercialization of enoxaparin products worldwide.