Leflunomide tablets

Form: Tablets

Strength: 10 mg, 20 mg

Reference Brands: Arava(US & EU)

Category: Arthritis

Leflunomide tablets are approved in the EU and US for treating rheumatoid arthritis. In the EU, Sanofi’s Arava is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive 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 facilitate efficient market access for leflunomide tablets, ensuring adherence to European and American standards for safe, effective RA management.