Pemetrexed disodium 500mg
| Product Overview | |
| Generic Name | Pemetrexed disodium 500mg |
| Brand Name(s) | Alimta, Pemrydi RTU, Pemnat, Pemgem, Pexotra |
| Form | Intravenous injection, sterile solution in single-dose vial |
| Strength | 500 mg/20 mL (25 mg/mL) |
| Therapeutic Class | Folate analog metabolic inhibitor for treatment of NSCLC |
| ATC Code | L01BA04 |
| Manufacturing & Regulatory | |
| Manufacturer | Eli Lilly, Pemrydi, Pemnat, Pemgem, Pexotra, Zydus Hospira Oncology (contract for Pfizer) |
| Country | USA, India Zydus – Ahmedabad facility for Pfizer) |
| GMP Compliance | WHO/US FDA/EU/CDSCO GMP |
| DMF/CEP | requires direct inquiry |
| COFEPRIS | 010.000.5453.00 |
| Free Sale Certificate | Yes, available upon request |
| Logistics & Export | |
| MOQ | 10 vials |
| Shelf Life | 24 months |
| Storage | 2–8 °C or 15–25 °C depending on label |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Issued upon request by distributor |
| SDS | Available (GHS-compliant) for cytotoxic injectable |
| CTD Summary | Summary available (e.g., FDA/EU dossiers); full CTD under NDA or fee post-commercial commitment |
Description
Indications & Usage: Pemetrexed is indicated in frontline treatment of non-squamous NSCLC (in combo with cisplatin) and as maintenance therapy; also indicated for malignant pleural mesothelioma. Mechanism: inhibits folate-dependent enzymes, preventing DNA/RNA synthesis. Typical dose: 500 mg/m² IV infusion over 10 minutes every 21 days, with vitamin B₁₂ and folic acid supplementation to reduce toxicity; main toxicities include myelosuppression, mucositis, rash, and rare pulmonary toxicity
