Ursodeoxycholic Acid Capsule Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 150 mg, 300 mg

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

Category: Gastrointestinal Drugs

Ursodeoxycholic Acid capsule is available in Capsules and strengths such as 150 mg, 300 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Ursodeoxycholic Acid capsule is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Ursodeoxycholic Acid capsule can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description: 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.