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 | Roche/Genentech |
| Country | India/USA/EU |
| 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 | CTD available to regulators; summary available to qualified partners |
Description
Use and Indications for Trastuzumab (150mg and 440mg): Trastuzumab is a monoclonal antibody indicated for the treatment of HER2-positive breast cancer (early and metastatic) and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. It binds to the HER2 receptor, 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)
