Trastuzumab 150mg
| Product Overview | |
| Generic Name | Trastuzumab 150mg |
| Brand Name(s) | Herceptin |
| Form | Vial, Intravenous infusion formulations—lyophilized pwd or sol. |
| Strength | 150 mg |
| Therapeutic Class | Monoclonal antibody targeting HER2/neu (antineoplastic/immunomodulator) |
| ATC Code | L01FD01 |
| Manufacturing & Regulatory | |
| Manufacturer | Zydus, INTAS, others |
| Country | EU, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | Clave: 010.000.5423.00 |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 units |
| Shelf Life | 24 months |
| Storage | 2–8 °C |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Not Avail. |
| CTD Summary | Not publicly available as a CTD for an approved finished medicine |
Description
A biosimilar version of Herceptin - monoclonal antibody indicated for treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. Inhibiting tumor cell proliferation. Both 150mg and 440mg presentations are used based on dosing requirements and treatment protocols. Cofepris approvals to Zydus Lifesciences Ltd (Mamitra)
