Warfarin tablets

Form: Oral Tablets

Strength: 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, 10 mg

Reference Brands: Coumadin(US), Jantoven: (Generic version of Coumadin)

Category: Blood Disorder

Warfarin is a tightly regulated anticoagulant in both the EU and US. In the US, it is approved by the FDA, requiring a comprehensive dossier demonstrating safety, efficacy, and manufacturing practices. In the EU, it is regulated by the EMA and approved through centralized or national procedures, ensuring quality control and pharmacovigilance. As a narrow therapeutic index drug, strict monitoring guidelines are essential. For detailed guidance on dossier preparation, regulatory pathways, and market entry strategies, visit PharmaTradz. Ensuring compliance with regional regulations is crucial for successful approval and safe, effective use of warfarin globally.