Cyclophosphamide — Indian WHO-GMP supply for AC, CHOP, R-CHOP and BMT conditioning.
Nitrogen-mustard alkylating prodrug, the 'C' in every classic combination chemotherapy acronym (AC, FAC, FEC, CHOP, R-CHOP, EPOCH, CMF, ICE) plus high-dose stem-cell-transplant conditioning. 200mg, 500mg, 1g and 2g lyophilised vials + 50mg tablets, all from Indian WHO-GMP facilities — with mesna co-administration protocol and haemorrhagic cystitis prevention documentation built into the destination labelling.
Multiple WHO-GMP partner lines · 200mg / 500mg / 1g / 2g vials + 50mg tablets · CTD dossier on file · WHO PQ pathway supported.
Active ingredient
Cyclophosphamide monohydrate, a nitrogen-mustard prodrug. Mechanism: hepatic CYP2B6 (and minor CYP3A4) activation produces 4-hydroxycyclophosphamide which cyclises to phosphoramide mustard (the cytotoxic alkylator) and acrolein (the urotoxic by-product). Phosphoramide mustard alkylates N7 of guanine, forming inter-strand DNA crosslinks. Acrolein is excreted in urine and is responsible for haemorrhagic cystitis — mesna binds and detoxifies acrolein in the urinary tract.
Strengths stocked
Lyophilised IV vials: 200mg, 500mg, 1g and 2g. Reconstitute with sterile water for injection at 20 mg/ml; further dilute in 0.9% NaCl or 5% dextrose for slow IV infusion. 50mg tablets for oral metronomic dosing or maintenance schedules. The 1g and 2g IV vials are the high-volume tender lines for adult AC and CHOP day-unit demand.
Indications
Breast (AC, FAC, FEC, CMF, TC); aggressive NHL (CHOP, R-CHOP, EPOCH); Burkitt and paediatric ALL; MM (CyBorD, VCD); sarcoma (VAC, IVA, VDC/IE); BMT conditioning; severe systemic vasculitis (ANCA, lupus nephritis, Wegener's). WHO EML core. We supply for all approved indications including the off-label rheumatology cytotoxic immunosuppression role.
Storage
Lyophilised vials at 2-8°C for the highest-stability profile, though some manufacturer SmPCs allow 15-25°C with shorter expiry — destination-specific label confirms. Tablets at 15-25°C in original blister. Reconstituted product at 2-8°C for 24 hours; further-diluted infusion at 2-8°C for 24 hours or room temperature for 6 hours. Cold-chain at lyophilised stage gives the longer shelf life.
Shelf life
Vials: 36 months from manufacture; minimum 24 months at dispatch. Tablets: 36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Vials: single vial per carton, hospital pack. Type-I clear glass vial, halobutyl rubber stopper, aluminium seal with flip-off cap. Tablets: aluminium-aluminium blister, 10 per blister, 30 or 100 per carton — destination-market dependent. Outer carton and leaflet in destination-regulator language. Mesna co-administration protocol and haemorrhagic cystitis warning prominently set on SmPC.
Hospital pharmacies, oncology day-units and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Cyclophosphamide is exported only.
United Kingdom
Cyclophosphamide is core NHS oncology day-unit and BMT-unit stock — every adult chemotherapy unit holds it. Where the primary licensed supplier cannot fill against scheduled AC, CHOP or BMT-conditioning demand, the MHRA Specials / named-patient import route is available — see MHRA Specials. NHS Specialist Pharmacy Service-aligned mesna-with-cyclophosphamide prescribing standard is documented in our pre-dispatch pack.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards (NUPCO and Saudi MoH for KSA — King Faisal Specialist Hospital is a major BMT-conditioning buyer; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain) and hospital pharmacy purchase orders. SFDA, MoHAP and GCC central registration supported with a full CTD dossier covering both IV and tablet formulations.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda
Public-sector 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, NDA + NMS for Uganda). WHO Prequalification supported for Global Fund and Africa CDC qualification. Cyclophosphamide is high-volume in African paediatric oncology and Burkitt lymphoma protocols.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under §72 AMG (Germany), ANSM equivalent (France), ANVISA (Brazil), COFEPRIS (Mexico), FDA Philippines, with Qualified Person (QP) certification on EU arrival. CTD dossier and CoPP prepared for BfArM, ANSM, ANVISA, COFEPRIS and FDA Philippines recognition for both IV and tablet formulations.
Mesna with high-dose, hydration, urinary output, and the secondary-malignancy lifetime risk — cyclophosphamide is well-trodden but unforgiving.
Standard adult IV dosing varies by regimen: 600 mg/m² in AC every 21 days; 750 mg/m² in CHOP every 21 days; 50-100 mg/m²/day continuous oral metronomic schedules. High-dose BMT conditioning is 60 mg/kg/day × 2 days (Cy120) or 50 mg/kg × 4 days (Cy200), with mesna and aggressive hydration mandatory. Mesna co-administration is required at total daily doses ≥1 g/m² IV or any high-dose regimen — mesna binds urinary acrolein and prevents haemorrhagic cystitis (the dose-limiting bladder toxicity, fatal in untreated severe cases). Mesna dosing is 60-160% of cyclophosphamide dose, split across pre-, concurrent- and post-infusion timepoints. Hydration to 3 L/m²/day with hourly bladder voiding is standard for high-dose; urinary output target ≥100 ml/h. Microscopic haematuria is monitored daily. Cyclophosphamide is moderate-emetogenic at standard dose, high-emetogenic at >1.5 g/m² — triple-antiemetic prophylaxis (5-HT3 + NK1 + dexamethasone) for high-dose. Myelosuppression is dose-limiting; G-CSF support is standard in dose-dense AC and for BMT conditioning. Long-term risks are real: secondary malignancy (myelodysplasia, AML at ~1-2% lifetime risk after standard cumulative exposure), bladder cancer (acrolein-driven, decades latency), gonadotoxicity (premature ovarian failure in females, azoospermia in males — fertility preservation counselling before therapy is standard). Pregnancy is contraindicated. CYP2B6 activation means strong CYP2B6 inducers (rifampicin, phenytoin) accelerate metabolism while inhibitors (ciprofloxacin, voriconazole) slow it — clinically modest but worth flagging in renal/hepatic-impaired patients.
The documentation pack a regulator actually asks for.
Cyclophosphamide 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. Tablet formulation has a separate dossier section covering bioequivalence against reference Endoxan.
CoA and MoA, per batch
HPLC assay of cyclophosphamide (≥98%), related substances (chloroethyl-aziridine, dechloroethyl-cyclophosphamide per Ph.Eur./USP), water content (Karl Fischer), pH on reconstitution, sterility, bacterial endotoxin, particulate matter — signed by the manufacturer's authorised QC head. Tablets add: dissolution, content uniformity, hardness, friability.
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 Global Fund and Africa CDC 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). Mesna co-administration protocol and haemorrhagic cystitis warning prominently set. Secondary-malignancy long-term-risk disclosure per ICH M4 format. Pregnancy contraindication and fertility-preservation counselling note documented. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. Lyophilised vials ship 2-8°C cold-chain (long-stability) or 15-25°C ambient (short-expiry presentation) per destination labelling. Active or passive cold-chain depending on lane length. Tablets ship 15-25°C ambient with humidity logging.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Haemorrhagic cystitis (acute and chronic), secondary myelodysplasia / AML, bladder cancer (long-latency), gonadotoxicity and infertility, plus BMT-conditioning regimen-related cardiotoxicity remain the PSUR priority signals for this molecule.
Complete the AC, CHOP, R-CHOP and BMT conditioning regimens.
Cyclophosphamide is rarely a standalone — it pairs with doxorubicin (AC), the CHOP backbone (with vincristine, prednisolone) plus rituximab (R-CHOP), or fludarabine and rituximab (FCR).
Doxorubicin
Anthracycline, the 'A' in AC and the 'H' (hydroxydaunorubicin) in CHOP. 10mg / 50mg / 200mg + 20mg PEGylated.
5-Fluorouracil
Fluoropyrimidine, the 'F' in CMF and FAC/FEC. 250mg / 500mg / 1g / 5g vials.
Methotrexate
Antimetabolite, the 'M' in CMF. 50mg / 500mg / 1g + tablets 2.5mg / 10mg.
Rituximab
Anti-CD20 mAb, the 'R' in R-CHOP. 100mg / 500mg vials.
Bortezomib
Proteasome inhibitor, MM combos with cyclophosphamide (CyBorD, VCD). 2mg and 3.5mg lyophilised.
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 or tablet count, IV or oral, destination, NHS / GCC tender / African public-sector / BMT-conditioning programme / Global Fund / NGO, target delivery. Flag if mesna co-administration documentation or BMT-conditioning compliance set is needed.
- We route to the right line. Multiple WHO-GMP cyclophosphamide lines 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, mesna co-administration documentation, BMT-conditioning compliance set, and the documentation pack you'll receive. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Cold-chain or ambient dispatch per destination labelling, in-transit temperature logging, 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; haemorrhagic cystitis, secondary malignancy, bladder cancer and gonadotoxicity remain the PSUR priority signals.
Cyclophosphamide supply — the specific questions.
What strengths and formulations of cyclophosphamide do you supply?
Lyophilised IV vials in 200mg, 500mg, 1g and 2g — reconstituted with sterile water for injection at 20 mg/ml, then further diluted in 0.9% NaCl or 5% dextrose for slow IV infusion. 50mg film-coated tablets for oral metronomic and maintenance dosing. The 1g and 2g IV vials are the high-volume tender lines for adult AC, CHOP and BMT-conditioning demand. Pack is one vial per carton or 100-tablet bottle for the oral SKU; multi-vial consolidations available against firm orders.
Is mesna co-administration documentation included in your pre-dispatch pack?
Yes. Mesna co-administration is required at total cyclophosphamide daily doses ≥1 g/m² IV or any high-dose / BMT-conditioning regimen — mesna binds urinary acrolein and prevents haemorrhagic cystitis (the dose-limiting bladder toxicity). Our destination-language SmPC carries the mesna dosing schedule (60-160% of cyclophosphamide dose, split across pre-, concurrent- and post-infusion timepoints) and the hydration / urinary output protocol (3 L/m²/day, ≥100 ml/h target, hourly bladder voiding for high-dose). NHS SPS-aligned mesna-with-cyclophosphamide prescribing standard documented for UK shipments. Mesna is supplied separately on the M Care roster against tender awards specifying it.
Can you supply cyclophosphamide for both oncology and rheumatology cytotoxic immunosuppression?
Yes — same molecule, same WHO-GMP lines. The cytotoxic immunosuppression role in severe systemic vasculitis (ANCA-associated vasculitis, granulomatosis with polyangiitis, lupus nephritis class III/IV) typically uses lower-dose regimens (10-15 mg/kg IV every 2-3 weeks for induction, with mesna and hydration still required) than oncology high-dose. The destination-language SmPC covers both indication categories. We supply against rheumatology specialist-centre orders in the same way as oncology hospital pharmacy orders — PV monitoring is unified.
Which markets can you ship cyclophosphamide 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 — BMT centres at King Faisal Specialist Hospital, Hamad Medical Corporation, SEHA are key buyers — 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, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.
What documentation is included with a cyclophosphamide consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances per Ph.Eur./USP, water content by Karl Fischer, pH on reconstitution, sterility, bacterial endotoxin, particulate matter — tablets add dissolution, content uniformity, hardness, friability), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with mesna co-administration protocol, haemorrhagic cystitis warning, secondary-malignancy disclosure and fertility-preservation counselling note, plus temperature logs from pre-dispatch through on-arrival. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for cyclophosphamide 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, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Cyclophosphamide has a well-established CMC template — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature. WHO PQ dossier prepared separately for Global Fund and Africa CDC qualification. Tablet bioequivalence (against reference Endoxan tablet) is a separate dossier annex. See dossier preparation.
What are typical lead times for cyclophosphamide orders, and what's the cold-chain requirement?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (Global Fund, Africa CDC, 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. Cold-chain requirement varies by destination labelling: lyophilised vials ship 2-8°C cold-chain for the longer-stability presentation, or 15-25°C ambient with shorter expiry where the destination registration accepts it. Tablets ship 15-25°C ambient with humidity logging.
Send the specifics. You'll have a price inside one working day.
Strength, formulation (IV vial / tablet), volume, destination, oncology / BMT-conditioning / rheumatology vasculitis / Global Fund / NGO, target delivery, mesna co-administration documentation if needed. That's the enquiry. Everything else is on us.