Methotrexate Tablet

Form: Tablets

Strength: 2.5 mg, 10 mg, 25 mg

Reference Brands: Trexall (US)

Category: Arthritis

Methotrexate tablets are approved in the EU and US for treating rheumatoid arthritis, psoriasis, and certain cancers. In the EU, Pfizer’s Trexall and generic versions are 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, registration, and compliance, visit PharmaTradz. We facilitate efficient market access for methotrexate tablets, ensuring adherence to European and American standards for safe, effective autoimmune and oncological therapy.