Fluorouracil 500 mg/10 mL
| Product Overview | |
| Generic Name | Fluorouracil 500 mg/10 mL |
| Brand Name(s) | Adrucil |
| Form | Injectable, single-dose vial (SDV) |
| Strength | 500 mg/ 10 mL |
| Therapeutic Class | Antineoplastic antimetabolite |
| ATC Code | L01BC02 |
| Manufacturing & Regulatory | |
| Manufacturer | Accord Healthcare |
| Country | India/USA/EU |
| GMP Compliance | cGMP-compliant (FDA/EU/WHO |
| DMF/CEP | Mfg-specific DMF/USDMF/CEP not publicly listed |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 36 months |
| Storage | 20–25 °C, protect from light; do not freeze |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Provided per batch |
| SDS | Yes—for API and finished product |
| CTD Summary | Full CTD for originator; generics abridged |
Description
Indications & Usage Colorectal, breast, gastric, pancreatic, skin cancers (IV);
