Methotrexate Injectable Generics - Manufacturers & Suppliers
Trexall (US)
| Product/Composition:- | Methotrexate Injectable |
|---|---|
| Strength:- | 25 mg/mL, 50 mg/mL, 250 mg/10 mL vial |
| Form:- | Injectable (IV, IM, Subcutaneous) |
| Reference Brands:- | Trexall (US) |
| MOQ | As per the manufacturer batch size |
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Methotrexate injectable inhibits dihydrofolate reductase, blocking DNA synthesis and cell reproduction. It reduces inflammation and suppresses immune activity, making it effective for rheumatoid arthritis and cancer. Benefits include rapid action, versatile administration, disease modulation, and improved joint function in RA, with a proven safety profile when monitored properly.
Methotrexate injectable is approved in the EU and US for treating rheumatoid arthritis, cancer, and autoimmune diseases. In the EU, Pfizer’s Trexall and other generics are regulated by EMA, supported by dossiers demonstrating safety, quality, and efficacy. 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, registration, and compliance, visit PharmaTradz. We support efficient market access for methotrexate injectable formulations, ensuring adherence to European and American standards for safe, effective treatment of autoimmune and oncological conditions.