Rituximab Iv Generics - Manufacturers & Suppliers
Rituxan (US); Mabthera (EU)
| Product/Composition:- | Rituximab IV |
|---|---|
| Strength:- | 100 mg/10 mL, 1000 mg/50 mL |
| Form:- | Intravenous (IV) Solution |
| Reference Brands:- | Rituxan (US); Mabthera (EU) |
| MOQ | As per the manufacturer batch size |
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Rituximab IV targets CD20 on B-cells, inducing cell death and reducing abnormal B-cell activity. It effectively treats autoimmune diseases like rheumatoid arthritis and certain cancers. Benefits include rapid symptom relief, slowed disease progression, decreased joint damage, and improved quality of life—all with a well-established safety profile when monitored properly.
Rituximab IV is approved in the EU and US for rheumatoid arthritis, non-Hodgkin’s lymphoma, and other autoimmune diseases. In the EU, brands like Mabthera are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on extensive clinical trial data, biosimilarity studies, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We help facilitate efficient market access for rituximab IV formulations, ensuring adherence to European and American standards for safe, effective biologic therapies.