Fluorouracil 500 mg/10 mL

Fluorouracil 500 mg/10 mL

Product Overview

Generic NameFluorouracil 500 mg/10 mL
Brand Name(s)Adrucil
CategoryAntineoplastic / Cancer
FormInjectable, single-dose vial (SDV)
Strength500 mg/ 10 mL
Therapeutic ClassAntineoplastic antimetabolite
ATC CodeL01BC02

Manufacturing & Regulatory

ManufacturerAccord Healthcare
GMP CompliancecGMP-compliant (FDA/EU/WHO
DMF/CEPMfg-specific DMF/USDMF/CEP not publicly listed
COFEPRIS010.000.6220.02
Free Sale CertificateAvailable per batch upon request

Logistics & Export

MOQ10 Vials
Shelf Life36 months
Storage20–25 °C, protect from light; do not freeze
IncotermsEXW/FOB/CIF negotiable
Lead Time10 Days

Documentation Available Upon Request

Certificate of Analysis (PDF)Provided per batch
SDS-Safety Data Sheet (PDF)Yes—for API and finished product
CTD Summary (PDF)Full CTD for originator; generics abridged

Special Notes

Packed 10 vials per box/ctn.
Fluorouracil Injection is a cytotoxic antimetabolite chemotherapy agent used in oncology, commonly as part of combination regimens for colorectal, breast, gastric/stomach, pancreatic, and other solid tumours, depending on the approved local label and treatment protocol. It inhibits DNA synthesis through thymidylate synthase inhibition and may also interfere with RNA function