Product/Composition:- | Tofacitinib tablets |
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Strength:- | 5 mg, 10 mg |
Form:- | Tablets |
Reference Brands:- | Xeljanz(US & EU) |
MOQ | As per the manufacturer batch size |
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Tofacitinib inhibits Janus kinase (JAK) enzymes, blocking cytokine signaling involved in inflammation. It effectively reduces symptoms and disease progression in rheumatoid arthritis. Benefits include rapid symptom relief, improved joint function, and enhanced quality of life, with an oral formulation providing convenient administration for long-term autoimmune disease management.
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.