Pembrolizumab 100mg
Product Overview
| Generic Name | Pembrolizumab 100mg |
| Brand Name(s) | KEYTRUDA |
| Category | Antibodies, monoclonal |
| Form | Biosimilar / Non-Originator Biologic, Intravenous solution, vial |
| Strength | 100 mg/4 mL (25 mg/mL) |
| Therapeutic Class | PD‑1 immune checkpoint inhibitor |
| ATC Code | L01FF02 |
Manufacturing & Regulatory
| Manufacturer | Biosimilar mfg |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 010.000.6153.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | 10 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| 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) | Upon Request, not publicly posted |
| CTD Summary (PDF) | Not publicly available as parallel traded molecule |
Special Notes
Pembrolizumab is a biosimilar / Non-Originator Biologic for institutional, government, or named-patient procurement only. Availability subject to country-specific regulatory approval, import authorization, patent clearance, and local medical prescription. Not for sale where applicable patent, exclusivity, trademark, or regulatory restrictions remain in force. Pembrolizumab is a PD-1 immune checkpoint inhibitors indicated across a range of advanced cancers, including metastatic melanoma, NSCLC, head and neck squamous cell carcinoma, urothelial carcinoma, MSI‑H/dMMR tumors, Hodgkin lymphoma, cervical cancer, gastric/gastroesophageal cancers, hepatocellular carcinoma, triple-negative breast cancer, endometrial carcinoma, biliary tract cancer, and locally advanced head & neck SCC (neoadjuvant/adjuvant)