Cetuximab 100mg
| Product Overview | |
| Generic Name | Cetuximab 100mg |
| Brand Name(s) | Erbitux (originator), Cetuxa (biosimilar) |
| Form | Intravenous solution (single-dose vial) |
| Strength | 100 mg per vial (2 mg/mL) |
| Therapeutic Class | EGFR inhibitor; oncology |
| ATC Code | L01FE01 |
| Manufacturing & Regulatory | |
| Manufacturer | Merck; Eli Lilly (API for US/Canada); Enzene Biosciences Ltd/Alkem Oncology |
| Country | India/USA/EU |
| GMP Compliance | WHO/cGMP-compliant |
| DMF/CEP | Erbitux BLA 125084, Biosimilar ENZ‑124 |
| COFEPRIS | Batch-specific |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| Logistics & Export | |
| MOQ | 10 vials |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C); do not freeze |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 3 to 5 Days |
| Documentation | |
| Certificate of Analysis (COA) | Provided per batch |
| SDS | Upon Request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Indications & Usage: Cetuximab is a chimeric (mouse/human) IgG1 monoclonal antibody targeting EGFR, used intravenously in metastatic colorectal and head/neck cancers following established dosing regimens (initial 400 mg/m², then 250 mg/m² weekly)
