Trastuzumab 440mg
| Product Overview | |
| Generic Name | Trastuzumab 440mg |
| Brand Name(s) | Herceptin |
| Product Type | Biosimilar |
| Form | Intravenous infusion formulations—lyophilized powder or solution |
| Strength | 440 mg |
| Therapeutic Class | Monoclonal antibody targeting HER2/neu (antineoplastic/immunomodulator) |
| ATC Code | L01FD01 |
| Manufacturing & Regulatory | |
| Manufacturer | Roche/Genentech |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | 010.000.5423.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 units |
| Shelf Life | 24 months |
| Storage | 2–8 °C, do not freeze |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—lot-specific Certificate of Analysis |
| SDS | Upon Request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Monoclonal antibody indicated for the treatment of HER2-positive breast cancer (early and metastatic) and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma; Inhibiting tumor cell proliferation.
