Doxorubicin injection — Indian WHO-GMP supply for the AC, CHOP, ABVD and AIM regimens.
Anthracycline cytotoxic, the workhorse of breast cancer, lymphoma, sarcoma and AML protocols since 1969. Conventional 10mg, 50mg, 200mg vials plus 20mg PEGylated liposomal for ovarian and Kaposi indications, all from Indian WHO-GMP facilities — with cumulative-dose monitoring and cardiotoxicity surveillance documentation built into the destination labelling.
Multiple WHO-GMP partner lines · 10mg / 50mg / 200mg conventional + 20mg PEGylated liposomal · CTD dossier on file · WHO PQ pathway supported.
Active ingredient
Doxorubicin hydrochloride, an anthracycline antibiotic isolated from Streptomyces peucetius. Mechanism: intercalates into DNA between adjacent base pairs, stabilises the topoisomerase II–DNA cleavable complex, generates reactive oxygen species via iron-mediated redox cycling. The triple-mechanism cytotoxicity is also the cardiotoxicity driver — cumulative ROS damage is dose-limiting for the heart.
Strengths stocked
Conventional 10mg/5ml, 50mg/25ml, 200mg/100ml at 2 mg/ml in 0.9% sodium chloride, characteristic ruby-red solution. PEGylated liposomal doxorubicin (Caelyx generic equivalent) at 20mg/10ml — different pharmacokinetic profile, longer circulation half-life, lower cardiotoxicity, distinct indications (ovarian, Kaposi, multiple myeloma combos).
Indications
Conventional: breast (AC, FAC, FEC, TAC); DLBCL and aggressive NHL (CHOP, R-CHOP, EPOCH); Hodgkin (ABVD); soft-tissue sarcoma (AIM); osteosarcoma (AP); AML 3+7; bladder (intravesical); HCC TACE. PEGylated liposomal: ovarian recurrence, AIDS-Kaposi, MM combos. WHO EML core. We supply both formulations on the M Care roster.
Storage
Conventional doxorubicin: 2-8°C, protected from light — cold-chain mandatory. PEGylated liposomal: 2-8°C, do not freeze — freezing destroys the liposome integrity. Pre-shipment thermal validation pairs with on-arrival cold-chain integrity check; excursion protocol covers both tails.
Shelf life
24 months from manufacture; minimum 18 months at dispatch. PEGylated liposomal: 20 months minimum at dispatch. Or we won't ship it.
Pack format
Single vial per carton, hospital pack. Type-I clear glass vial for conventional (red solution clearly visible), amber glass for PEGylated liposomal. Halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and leaflet in destination-regulator language. Cumulative-dose tracking guidance and LVEF-monitoring schedule prominently set on the SmPC.
Hospital pharmacies, oncology day-units and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Doxorubicin is exported only.
United Kingdom
Doxorubicin is core NHS oncology day-unit stock — every adult chemotherapy unit holds it. Where the primary licensed supplier cannot fill against scheduled AC, CHOP or ABVD regimen demand, the MHRA Specials / named-patient import route is available — see MHRA Specials. PEGylated liposomal supply for NHS Cancer Drugs Fund-funded ovarian recurrence indications routed through the same channel.
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 formulary 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 formulations.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda
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, NDA + NMS for Uganda) and teaching-hospital supply. WHO Prequalification supported for Global Fund and Africa CDC qualification. Doxorubicin for Kaposi sarcoma in HIV-positive patient populations is a high-volume tender line in sub-Saharan Africa.
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 conventional and PEGylated liposomal.
Cumulative cardiotoxicity, extravasation, red urine warning, and dexrazoxane prep — doxorubicin runs hot if you skip any of those.
Adult conventional doxorubicin is dosed 60-75 mg/m² IV every 3 weeks (AC, FAC, CHOP, ABVD), or 30 mg/m² weekly schedules. Cumulative-dose cardiotoxicity is dose-limiting: lifetime maximum is ~450-500 mg/m² for conventional doxorubicin (lower in patients with prior chest radiotherapy, baseline cardiomyopathy, or paediatric exposure). LVEF monitoring by MUGA scan or echocardiography is required at baseline, mid-therapy and post-treatment. Dexrazoxane is pre-administered (10:1 ratio of dexrazoxane:doxorubicin) for cardioprotection in patients exceeding 300 mg/m² cumulative or with cardiac risk factors. Extravasation is a vesicant emergency: tissue necrosis develops slowly over days, dexrazoxane (Savene) is the antidote, must be given within 6 hours; cold packs are contraindicated for extravasation (worsens tissue damage). The diluent is 0.9% sodium chloride or 5% glucose; do not mix in line with heparin (precipitation) or 5-FU (incompatibility). Administer as IV bolus into the side-arm of a free-flowing infusion or as a 30-60 minute infusion. Red urine warning: doxorubicin and its metabolites are excreted in urine and tears, producing red discolouration for 24-48 hours post-dose — patient counselling on this avoids panic. Myelosuppression and mucositis are predictable; nausea is moderate-emetogenic (5-HT3 antagonist + dexamethasone). PEGylated liposomal has a different toxicity profile: hand-foot syndrome and stomatitis dominate; cardiotoxicity is substantially lower at equivalent cumulative doses; infusion-rate-related complement-mediated hypersensitivity (CARPA) requires slow first-dose titration.
The documentation pack a regulator actually asks for.
Doxorubicin is a WHO EML core-list cytotoxic, WHO PQ-listed in conventional formulation. 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. Separate dossier annex for PEGylated liposomal — the liposome characterisation (size distribution, lamellarity, drug-to-lipid ratio, PEG density) is regulatory-critical and not interchangeable with conventional bioequivalence.
CoA and MoA, per batch
HPLC assay of doxorubicin (≥98%), related substances (doxorubicinone, daunorubicin, 7-deoxy-doxorubicinone per Ph.Eur./USP), pH, sterility, bacterial endotoxin, particulate matter — signed by the manufacturer's authorised QC head. PEGylated liposomal adds: liposome size by dynamic light scattering, encapsulation efficiency, free-doxorubicin content, PEG-lipid ratio, zeta potential.
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 conventional doxorubicin (PEGylated liposomal not currently on WHO PQ — separate qualification path).
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). Cumulative-dose tracking guidance and LVEF-monitoring schedule prominently set on the SmPC. Vesicant warning and extravasation antidote (dexrazoxane/Savene) protocol documented. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. 2-8°C cold-chain mandatory throughout transit for both conventional and PEGylated liposomal. Active-cooled containers (Envirotainer, Cool Containers) for trans-continental shipments; passive PCM coolers with 96h temperature stability for shorter lanes. PEGylated liposomal: do not freeze — freezing destroys liposome integrity, the excursion protocol covers cold-tail explicitly.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Cumulative-dose cardiotoxicity (heart failure, asymptomatic LVEF decline), extravasation tissue injury, secondary leukaemia (anthracycline + alkylator regimens), and PEGylated liposomal-specific CARPA infusion reactions remain the PSUR priority signals for this molecule.
AC, CHOP and ABVD complete here.
Doxorubicin is rarely a standalone — it pairs with cyclophosphamide (AC, R-CHOP) or bleomycin/vinblastine/dacarbazine (ABVD). We carry the supporting cluster.
Cyclophosphamide
Alkylating agent, the 'C' in AC and R-CHOP. 200mg / 500mg / 1g vials.
5-Fluorouracil
Fluoropyrimidine antimetabolite. FAC and FEC regimens. 250mg / 500mg / 1g / 5g vials.
Methotrexate
Antimetabolite. CMF breast regimen, oncology + autoimmune. 50mg / 500mg / 1g vials.
Paclitaxel
Taxane cytotoxic. AT and TC sequential regimens with doxorubicin. 30mg / 100mg / 260mg.
Rituximab
Anti-CD20 mAb, the 'R' in R-CHOP. 100mg / 500mg vials.
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, conventional or PEGylated liposomal, destination market, NHS hospital pharmacy / GCC tender / African public-sector / Global Fund / NGO, target delivery window. Flag if cumulative-dose tracking material is needed for the receiving hospital pharmacy committee.
- We route to the right line. Multiple WHO-GMP doxorubicin lines on the M Care roster, including WHO PQ-listed conventional and Caelyx-generic PEGylated liposomal. 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, cold-chain lane validation report, and the documentation pack you'll receive. Conventional + PEGylated liposomal priced separately. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Active or passive 2-8°C cold-chain dispatch, in-transit temperature logging, on-arrival inspection. PEGylated liposomal: explicit cold-tail protocol (no freezing). Photo evidence of seal integrity and thermal-log validation on request.
- After delivery. Batch records, CoA, MoA and cold-chain logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; cardiotoxicity, extravasation injury and PEGylated liposomal CARPA reactions remain the PSUR priority signals.
Doxorubicin supply — the specific questions.
What strengths and formulations of doxorubicin do you supply?
Conventional doxorubicin HCl in 10mg/5ml, 50mg/25ml and 200mg/100ml vials at 2 mg/ml in 0.9% sodium chloride (the characteristic ruby-red solution). PEGylated liposomal doxorubicin (Caelyx generic equivalent) at 20mg/10ml, separate formulation with distinct pharmacokinetics, lower cardiotoxicity per cumulative dose, and CARPA-mediated infusion-rate sensitivity. The two are not interchangeable — different indications, different safety profiles, different regulatory dossiers. Pack is one vial per carton in hospital pack; multi-vial consolidations available against firm orders.
How is cumulative-dose cardiotoxicity tracked for doxorubicin patients?
Conventional doxorubicin lifetime maximum is ~450-500 mg/m² in patients with normal baseline cardiac function (lower in those with prior chest radiotherapy, baseline cardiomyopathy, paediatric prior exposure). LVEF (left ventricular ejection fraction) monitoring by MUGA scan or echocardiography is required at baseline, mid-therapy and post-treatment per ESC and ASCO cardio-oncology guidelines. Our destination-language SmPC carries the cumulative-dose tracking template and LVEF-monitoring schedule. Dexrazoxane (Cardioxane / Savene generic) is the cardioprotectant pre-administered at 10:1 ratio in high-risk patients; we supply this separately on the M Care roster against tender awards specifying it. PEGylated liposomal has a substantially higher cumulative threshold and is the preferred formulation in patients approaching the cardiotoxicity ceiling on conventional.
Can M Care supply both conventional and PEGylated liposomal doxorubicin in a single tender?
Yes — both formulations are on the M Care roster from the same pool of WHO-GMP partner facilities. PEGylated liposomal (the Caelyx-generic equivalent) is technically and regulatorily distinct: separate CTD dossier annex covering liposome characterisation (size by DLS, encapsulation efficiency, free-doxorubicin content, zeta potential, PEG-lipid ratio), separate stability profile, separate clinical indications. We can quote against a combined tender — for example, NUPCO oncology-formulary tenders that list both line items — with the conventional and PEGylated lots traceable to their respective manufacturing facilities. Cold-chain logistics is unified (both ship 2-8°C, no freezing for the liposomal).
Which markets can you ship doxorubicin 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, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. PEGylated liposomal regulatory paths are similar but require the formulation-specific dossier annex per destination. Full market coverage is at markets.
What documentation is included with a doxorubicin consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC doxorubicin assay, related substances, pH, sterility, bacterial endotoxin, particulate matter; PEGylated liposomal adds liposome size, encapsulation efficiency, free-doxorubicin content, zeta potential), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable (conventional doxorubicin), Certificate of Origin (chamber-attested), destination-language pack insert with cumulative-dose tracking and LVEF-monitoring guidance, vesicant-extravasation protocol, and cold-chain temperature logs from pre-dispatch through on-arrival. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for doxorubicin 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. Conventional doxorubicin has a well-established CMC template; PEGylated liposomal requires a separate dossier annex covering the liposome characterisation. Lead time on a dossier against a new registration is typically 4-6 weeks for conventional, 6-10 weeks for PEGylated liposomal, from NDA signature. WHO PQ dossier prepared separately for Global Fund and Africa CDC qualification. See dossier preparation.
What are typical lead times for doxorubicin 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. Both conventional and PEGylated liposomal doxorubicin require 2-8°C cold-chain throughout transit. Active-cooled containers (Envirotainer, Cool Containers) for trans-continental shipments; passive PCM coolers with 96h temperature stability for shorter lanes. PEGylated liposomal: do not freeze — the liposome integrity is destroyed by freezing, the excursion protocol covers the cold-tail explicitly with a 14-day post-arrival quarantine if any excursion is logged.
Send the specifics. You'll have a price inside one working day.
Strength, conventional or PEGylated liposomal, vial volume, destination, NHS / GCC / African / Global Fund / NGO, target delivery, cold-chain validation requirement. That's the enquiry. Everything else is on us.