Tofacitinib tablets

Form: Tablets

Strength: 5 mg, 10 mg

Reference Brands: Xeljanz(US & EU)

Category: Arthritis

Tofacitinib tablets are approved in the EU and US for rheumatoid arthritis and other autoimmune diseases. In the EU, Pfizer’s Xeljanz is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on comprehensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for tofacitinib tablets, ensuring adherence to European and American standards for safe, effective treatment of autoimmune conditions, helping you navigate complex regulatory landscapes seamlessly.