Ursodeoxycholic Acid capsule

Form: Capsules

Strength: 150 mg, 300 mg

Reference Brands: Actigall(US), rsofalk, Ursocaps, Ursode(EU)

Category: Gastrointestinal Drugs

Ursodeoxycholic acid capsules, marketed as Actigall and Ursocaps, are approved in the US by the FDA and in the EU via EMA for gallstone dissolution and liver disease. Approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports swift approval, safe use, and global availability, promoting gallstone management and liver health worldwide.