Pembrolizumab 100mg/4mL
| Product Overview | |
| Generic Name | Pembrolizumab 100mg/4mL |
| Brand Name(s) | Keytruda, Biosimilar-Pembrolizumab |
| Form | Intravenous solution, vial (concentrate for infusion) |
| Strength | 100 mg/4 mL (25 mg/mL) |
| Therapeutic Class | PD‑1 immune checkpoint inhibitor |
| ATC Code | L01FF02 |
| Manufacturing & Regulatory | |
| Manufacturer | Merck |
| Country | USA, India, Mexico, Biosimilars |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indications & Usage: Pembrolizumab (Keytruda & it's Biosimilar Presentations) are 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
