Pertuzumab 420mg/14mL
Product Overview
| Generic Name | Pertuzumab 420mg/14mL |
| Brand Name(s) | PERJETA® |
| Category | Antineoplastic / Cancer |
| Form | Vial, Concentrate for intravenous infusion |
| Strength | 420 mg/14 mL vial (30 mg/mL) |
| Therapeutic Class | HER2 dimerization inhibitor (recombinant humanized IgG1 monoclonal antibody) |
| ATC Code | L01XC13 |
Manufacturing & Regulatory
| Manufacturer | Genentech, Others in Biosimilars |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Clave: 010.000.6024.00 |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | Refrigerate at 2 °C to 8 °C |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | May be available upon request, not publicly posted |
| CTD Summary (PDF) | Full CTD dossier proprietary; available under commercial agreement/license |
Special Notes
Pertuzumab (biosimilar form) indicated in First Line treatment of HER2, also inn combination with trastuzumab and docetaxel, for treatment of HER2‑positive metastatic or locally recurrent unresectable breast cancer – Neoadjuvant and adjuvant treatment of HER2‑positive early breast cancer at high risk of recurrence