Baricitinib tablets

Form: Tablets

Strength: 2 mg, 4 mg

Reference Brands: Olumiant®(EU & US- Emergency Use Authorization (EUA)

Category: Arthritis

Baricitinib tablets are approved in the EU and US for moderate to severe rheumatoid arthritis. In the EU, Eli Lilly’s Olumiant is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical trial data and biosimilarity assessments. Both regions require detailed dossiers for approval and continuous pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate efficient market access for baricitinib tablets, ensuring adherence to European and American standards for safe, effective management of autoimmune diseases, helping you navigate complex regulatory landscapes seamlessly.