5-Fluorouracil injection — Indian WHO-GMP supply, FOLFOX-ready, with 46-hour pump compatibility on file.
Fluoropyrimidine antimetabolite, the backbone of colorectal, gastric, pancreatic, breast and head-and-neck cancer regimens. 250mg, 500mg, 1g and 5g vials from Indian WHO-GMP facilities — with continuous-infusion pump compatibility data on file for the 46-hour FOLFOX delivery profile NHS oncology day-units run.
Multiple WHO-GMP partner lines · 250mg, 500mg, 1g and 5g vials · CTD dossier on file · WHO PQ pathway supported.
Active ingredient
Fluorouracil (5-FU), a fluorinated pyrimidine analogue. Mechanism: 5-FU is metabolised intracellularly to FdUMP, which forms a covalent ternary complex with thymidylate synthase and the cofactor 5,10-methylene-tetrahydrofolate, blocking dTMP synthesis. The fluoropyrimidine RNA-incorporation pathway adds a second cytotoxic mechanism. Leucovorin (folinic acid) stabilises the ternary complex and is co-administered in modern colorectal regimens.
Strengths stocked
250mg/5ml, 500mg/10ml, 1g/20ml, 5g/100ml — all at 50 mg/ml. The 5g pack format is the highest-volume tender line for 46-hour continuous-infusion FOLFOX/FOLFIRI/FOLFIRINOX protocols where the dose is filled into a portable elastomeric pump. 250mg and 500mg vials cover bolus dosing in CMF and head-and-neck protocols.
Indications
Colorectal (FOLFOX, FOLFIRI, FOLFOXIRI); gastric (FLOT, ECF); pancreatic (FOLFIRINOX); breast (CMF, FAC, FEC); head-and-neck (with cisplatin and radiotherapy); anal cancer (Nigro protocol); hepatobiliary palliation. WHO Essential Medicines List core-item cytotoxic, WHO Prequalification roster active. We supply only the 5-FU component of combination regimens.
Storage
15-25°C, protected from light. Do not refrigerate — low temperature causes precipitation of fluorouracil out of solution; if crystallisation is visible, gently warm the vial to 60°C with shaking until clear, then cool to body temperature before use, per the standard SmPC. Room-temperature lanes only; no cold-chain on this molecule.
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton, hospital pack. Type-I clear glass vial, halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and leaflet in destination-regulator language. The 5g/100ml pack ships in a tamper-evident over-carton for portable-pump preparation.
Hospital pharmacies, oncology day-units and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. 5-Fluorouracil is exported only.
United Kingdom
5-Fluorouracil is widely supplied across UK NHS hospital pharmacies and is on the standard adult oncology formulary at all major teaching trusts. Where the primary licensed supplier cannot fill against scheduled FOLFOX/FOLFIRI day-unit demand, the MHRA Specials / named-patient import route is available — see MHRA Specials. Pump-compatibility data for the 46-hour elastomeric infuser format is supplied with the pre-dispatch pack on request.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards (NUPCO, Saudi MoH; MoHAP, DHA, DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store; MoPH Qatar; MoH Oman; NHRA Bahrain) and hospital pharmacy purchase orders to King Faisal Specialist Hospital, Hamad Medical Corporation, SEHA, Mediclinic, Aster, NMC. SFDA, MoHAP and GCC central registration supported with a full CTD dossier.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania
Public-sector oncology tenders (NAFDAC-registered for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA-registered for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania) and teaching-hospital supply. WHO Prequalification supported where the tender specifies it. Global Fund, Africa CDC and NGO procurement (MSF, Direct Relief) routed through the same manufacturing lines.
Germany, France, Philippines
Supply via licensed importers under §72 AMG (Germany), ANSM equivalent (France) and FDA Philippines, with Qualified Person (QP) certification on EU arrival. CTD dossier and CoPP prepared for BfArM, ANSM and FDA Philippines recognition. Named-patient (Einzelimport in Germany, ATU in France) route available.
DPD deficiency screening, hand-foot syndrome, and the 46-hour pump — these are the three things that make or break 5-FU clinical safety.
5-FU is dosed BSA-based — typical adjuvant regimens give 400 mg/m² IV bolus + 2,400 mg/m² over 46 hours as continuous infusion (modified FOLFOX-6), repeated every 2 weeks. Bolus-only schedules deliver 600 mg/m² weekly (CMF) or 425 mg/m² × 5 days every 4 weeks. DPD (dihydropyrimidine dehydrogenase) deficiency screening is now mandatory in EU, UK and US oncology practice before first dose — partial or complete deficiency causes severe, sometimes fatal toxicity. Pre-treatment uracilaemia or genotyping for the four common DPYD variants (c.1905+1G>A, c.1679T>G, c.2846A>T, c.1129-5923C>G) is the standard of care. Dose-limiting toxicities are mucositis, hand-foot syndrome (palmar-plantar erythrodysesthesia), myelosuppression and diarrhoea; cardiotoxicity (vasospastic angina, rare ischaemia) is dose-related and infusion-rate-related. Diluent compatibility: 0.9% sodium chloride and 5% glucose are both acceptable, in PVC, polyolefin or polypropylene infusion bags. Avoid pre-mixing with leucovorin in the same line — physical incompatibility causes precipitation. The 46-hour FOLFOX dose is delivered via portable elastomeric pump with the 5g/100ml vial filling the standard 250-300 ml reservoir; pump-compatibility data is supplied with the pre-dispatch pack. Refrigeration causes precipitation — do not store cold; warm and re-dissolve crystallised product at 60°C with shaking before use, then cool.
The documentation pack a regulator actually asks for.
5-Fluorouracil is a WHO EML core-list cytotoxic and WHO PQ-listed. Our role is manufacturer-facing — we sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. WHO PQ dossier annex prepared for tender procurement specifying the WHO Prequalification pathway.
CoA and MoA, per batch
HPLC assay, related substances (5-FU degradation products including F-uracil and F-citrate-aldehyde adducts), pH, particulate matter, sterility, bacterial endotoxin — signed by the manufacturer's authorised QC head. Filter integrity testing and container closure integrity included.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies included in the shipping pack. WHO-PQ certificate available for tender qualification.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany, ANSM for France). DPD-deficiency black-box warning prominently set per current EU/UK regulator requirement. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. 5-FU ships at 15-25°C; cold excursion is the failure mode here — refrigeration crystallises the dose out of solution, so the thermal protocol covers the cold tail, hot tail and recovery procedure (warm to 60°C, agitate until clear, cool before use).
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. DPD-deficiency-related severe toxicity, hand-foot syndrome, and rare cardiac events (vasospastic angina) remain the PSUR priority signals for this molecule.
Complete the FOLFOX, FOLFIRI and FOLFIRINOX regimens.
5-FU regimens are almost always combinations: with leucovorin and oxaliplatin (FOLFOX), with leucovorin and irinotecan (FOLFIRI), or all four (FOLFIRINOX). We carry the full oncology cluster.
Capecitabine
Oral 5-FU prodrug. 150mg / 500mg tablets, FOLFOX-equivalent oral regimens.
Oxaliplatin
Platinum cytotoxic, the 'OX' in FOLFOX. 50mg / 100mg / 200mg vials.
Cisplatin
Platinum cytotoxic, head-and-neck regimens with 5-FU. 10mg / 25mg / 50mg / 100mg vials.
Gemcitabine
Nucleoside antimetabolite, pancreatic cancer alternative regimen. 200mg / 1g / 2g vials.
Paclitaxel
Taxane cytotoxic, breast cancer regimens with 5-FU. 30mg / 100mg / 260mg concentrate.
All oncology →
120+ oncology SKUs: cytotoxics, targeted therapy, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength, vial count, destination market, whether this is NHS hospital pharmacy, GCC tender, African public-sector procurement, or NGO/Global Fund supply, and the target delivery window. Flag if 46-hour pump compatibility documentation is needed for FOLFOX/FOLFIRI/FOLFIRINOX day-unit supply.
- We route to the right line. Multiple WHO-GMP 5-FU lines sit on the M Care roster, including WHO PQ-listed manufacturers for Global Fund and Africa CDC tender qualification. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, and the documentation pack you'll receive with the shipment — including the DPD-deficiency black-box warning compliance set for EU/UK markets. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Room-temperature dispatch lane (5-FU is not a cold-chain molecule), in-transit temperature logging with cold-tail protocol coverage, on-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; DPD-deficiency-related severe toxicity, hand-foot syndrome and cardiac events remain the PSUR priority signals.
5-Fluorouracil supply — the specific questions.
What strengths of 5-fluorouracil do you supply?
5-FU is supplied as 250mg/5ml, 500mg/10ml, 1g/20ml and 5g/100ml vials — all at 50 mg/ml in aqueous solution. Pack size is one vial per carton in hospital pack; multi-vial consolidations available against firm orders. The 5g/100ml strength is the highest-volume line for 46-hour continuous-infusion FOLFOX/FOLFIRI/FOLFIRINOX regimens — the dose fills the standard 250-300 ml elastomeric pump reservoir with leucovorin and saline. The 250mg and 500mg vials cover bolus dosing in CMF and head-and-neck protocols.
Is pump-compatibility data available for the 46-hour FOLFOX continuous infusion?
Yes. Compatibility data with the standard portable elastomeric pumps (Easypump, Intermate, ReadyMED, Eclipse, Sapphire) is on file for the 5g/100ml vial when reconstituted in 0.9% sodium chloride or 5% glucose, with leucovorin co-infusion in a separate Y-site only (5-FU and leucovorin are physically incompatible in the same line and will precipitate). Stability is documented at 23-25°C for the 46-hour delivery window in PVC, polyolefin and polypropylene reservoirs. The pre-dispatch pack includes pump-compatibility documentation on request.
How is DPD-deficiency-related toxicity handled in your regulatory dossier?
Pre-treatment DPD (dihydropyrimidine dehydrogenase) deficiency screening is a regulatory requirement in the EU (EMA, ANSM, BfArM), UK (MHRA) and US (FDA) since 2020. Our destination-language pack insert and SmPC carry the DPD-deficiency contraindication and recommended pre-treatment screening (uracilaemia or DPYD genotyping for the four common variants — c.1905+1G>A, c.1679T>G, c.2846A>T, c.1129-5923C>G). The labelling format follows the regulator-specific layout; the manufacturer-side responsibility is the clear warning, and the dispensing-side responsibility (DPD test before first dose) sits with the prescribing oncology centre.
Which markets can you ship 5-FU into?
The UK (NHS hospital pharmacy supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers, sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ pathway support, Egypt, Jordan, Iraq on the Levant side, Germany under §72 AMG, France under ANSM-equivalent route, and the Philippines under FDA Philippines. We do not supply into India. Full market coverage is at markets.
What documentation is included with a 5-FU consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances, pH, particulate matter, sterility, bacterial endotoxin), Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with DPD-deficiency black-box warning, and temperature logs from pre-dispatch through on-arrival. For Global Fund and Africa CDC tenders, the WHO PQ dossier annex is prepared separately. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for 5-FU registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, BfArM, ANSM, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. 5-FU is off-patent across all relevant markets and has a well-established CMC template — lead time on a dossier against a new registration is typically 3-5 weeks from NDA signature. WHO PQ dossiers prepared separately for Global Fund / Africa CDC qualification. See dossier preparation.
What are typical lead times for 5-FU orders, and does 5-FU need cold-chain transit?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply with urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours. Made-to-order batches run 6-10 weeks inclusive of QC release and destination artwork. 5-FU does not require cold-chain — it ships at 15-25°C protected from light, and refrigeration causes precipitation. Transit temperature is logged with cold-tail protocol coverage on every consignment.
Send the specifics. You'll have a price inside one working day.
Strength, volume, destination, NHS hospital pharmacy or GCC/African tender, target delivery, FOLFOX pump documentation if needed. That's the enquiry. Everything else is on us.