Pertuzumab 420mg/14mL
| Product Overview | |
| Generic Name | Pertuzumab 420mg/14mL |
| Brand Name(s) | Perjeta |
| 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 |
| Country | USA, India-Mexico for Biosimilars |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Pending |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 5 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 | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Available upon request from manufacturer/distributor |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indications & Usage: Pertuzumab is indicated, in combination with trastuzumab and docetaxel, for: – First‑line 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
