Dabigatran Capsule

Form: Capsules

Strength: 75 mg, 110 mg, and 150 mg

Reference Brands: Pradaxa(EU & US)

Category: Blood Disorder

Dabigatran, marketed as Pradaxa, is approved in the US by the FDA and in the EU via EMA authorization. Regulatory approval requires a detailed dossier demonstrating safety, efficacy, manufacturing quality, and stability data. In the US, FDA approval involves a comprehensive submission, while the EU approval follows centralized or national procedures. Both regions emphasize pharmacovigilance and clinical data to ensure product compliance. For expert guidance on dossier preparation, regulatory strategies, and market entry, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for successful approval, market access, and ensuring patient safety worldwide with dabigatran capsules.