Rituximab 100mg/10mL
| Product Overview | |
| Generic Name | Rituximab 100mg/10mL |
| Brand Name(s) | Rituxan, Mabthera |
| Form | Intravenous solution, concentrate for infusion |
| Strength | 100 mg/10 mL |
| Therapeutic Class | Monoclonal antibody targeting CD20 (antineoplastic/immunomodulator) |
| ATC Code | L01FA01 |
| Manufacturing & Regulatory | |
| Manufacturer | Biogen/Genentech/Roche |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | Batch-specific |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 100 units |
| Shelf Life | 24 months |
| Storage | 2–8 °C |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Upon Request |
| CTD Summary | Full CTD for originator; generics abridged |
Description
Use and Indications for Rituximab: Rituximab is a monoclonal antibody indicated for the treatment of certain B-cell malignancies and autoimmune disorders. Approved uses include non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (in combination with methotrexate), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). It targets CD20-positive B lymphocytes, leading to their depletion.
