Pharmorubicin (epirubicin), sold in the US as Ellence, is licensed as adjuvant therapy for axillary node-positive breast cancer within the FEC/EC regimen family, and licensed generic epirubicin now sits alongside the Pfizer brand across UK, EU and GCC hospital formularies.
Pharmorubicin (epirubicin hydrochloride), originated by Pfizer and sold in the United States as Ellence, is an anthracycline cytotoxic dosed as part of FEC and EC breast-cancer regimens, chosen over doxorubicin where a lower cardiotoxicity ceiling at equivalent efficacy is wanted. M Care Exports is a merchant exporter: we source the Pfizer brand and licensed generic epirubicin hydrochloride injection through Indian WHO-GMP manufacturing and distribution channels and dispatch against a buyer's own specification, not from our own manufacturing.
Epirubicin exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender orders, M Care quotes epirubicin hydrochloride injection against buyer specification: originator Pharmorubicin/Ellence or a licensed generic line, vial size (10 mg, 50 mg or 200 mg) and destination-market regulatory documentation, drawn from multiple WHO-GMP partner lines on the M Care roster. Because epirubicin's cumulative-dose ceiling and hepatic-impairment dose bands sit differently to doxorubicin's, we confirm the intended regimen (FEC, EC or bladder instillation) at enquiry before we build the quote, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Anthracycline antibiotic cytotoxic, topoisomerase II inhibitor (4'-epi stereoisomer of doxorubicin), sourced and documented for export.
Epirubicin hydrochloride is an anthracycline antibiotic cytotoxic, a stereoisomer of doxorubicin that intercalates into DNA and inhibits topoisomerase II, blocking DNA and RNA synthesis in rapidly dividing tumour cells. The 4'-epi configuration changes its metabolism just enough to lower cardiotoxic and myelosuppressive potential relative to doxorubicin at an equivalent antitumour dose, which is the clinical reason many FEC-based breast-cancer protocols specify epirubicin by name rather than accepting doxorubicin as a substitute.
The EU-harmonised Pharmorubicin SmPC covers breast, ovarian, gastric, lung and colorectal carcinoma, malignant lymphomas, leukaemias and multiple myeloma by systemic intravenous administration, plus superficial bladder cancer and carcinoma-in-situ by intravesical instillation. The FDA label for Ellence is narrower: adjuvant therapy in patients with axillary node-positive primary breast cancer following resection, within the FEC or EC regimen. Destination-country labelling should be checked against this gap before a tender quote is finalised, since a US-registered import and an EU-registered import can carry materially different indication wording for the same molecule.
Epirubicin is supplied as a ready-to-use 2 mg/ml red solution for injection or infusion in 10 mg/5 ml, 50 mg/25 ml and 200 mg/100 ml single-dose vials (the US Ellence line ships in the 50 mg and 200 mg sizes only), given intravenously over a slow push or short infusion, with no reconstitution step required.
Active ingredient
epirubicin hydrochloride. Anthracycline antibiotic cytotoxic, topoisomerase II inhibitor (4'-epi stereoisomer of doxorubicin).
Forms and strengths
10 mg/5ml vial, 2 mg/ml solution for injection/infusion; 50 mg/25ml vial, 2 mg/ml solution for injection/infusion; 200 mg/100ml vial, 2 mg/ml solution for injection/infusion.
Indications
Epirubicin hydrochloride is an anthracycline cytotoxic and stereoisomer of doxorubicin, dosed within FEC and EC breast-cancer regimens for its lower cardiotoxicity and myelosuppression profile at equivalent efficacy. Supplied from Indian WHO-GMP facilities as both originator Pharmorubicin/Ellence and licensed generic lines, to regulated and semi-regulated markets outside the United States.
Administration
intravenous, intravesical. Ready-to-use solution for injection/infusion.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for epirubicin are mainly hospital oncology pharmacists running FEC and EC breast-cancer protocols, urology teams using the intravesical bladder-cancer indication, national and regional MoH tender desks with a standing anthracycline line, licensed pharmaceutical wholesalers and importers stocking hospital oncology ranges, and NGO or foundation procurement programmes supporting breast-cancer treatment access in markets where a lower-cardiotoxicity anthracycline is specified over doxorubicin for patients with borderline cardiac reserve.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on epirubicin.
Adjuvant breast-cancer dosing runs 100-120 mg/m² IV per cycle within FEC or EC, given as a single Day 1 dose or split across Day 1 and Day 8, repeated every three to four weeks; bladder-instillation and compromised-marrow patients sit at the lower 50-90 mg/m² end instead, so pack-mix planning should never assume one dose band fits both indications. Cumulative-dose cardiotoxicity is dose-limiting: cardiomyopathy incidence rises from 0.9% at 550 mg/m² to 1.6% at 700 mg/m² and 3.3% at 900 mg/m² cumulative, and 900 mg/m² should generally not be exceeded; baseline and on-treatment LVEF assessment is standard practice. Extravasation is a vesicant emergency: leakage causes blistering, ulceration and necrosis that can require surgical excision, so administration is always into a freely running IV line, never a peripheral cannula left unchecked. Hepatic impairment needs a dose cut before infusion, not after: half-dose for bilirubin 1.2-3 mg/dl or AST 2-4x ULN, quarter-dose above those thresholds. The ready-to-use solution needs no reconstitution but is cold-chain 2-8°C, protect from light, and the solution may gel in the fridge, returning to normal within two to four hours at room temperature before use; discard any unused portion, as there is no preservative. Secondary acute myeloid leukaemia is a recognised late risk, cumulative incidence around 0.55% by eight years, worth flagging in any long-term follow-up counselling pack.
The documentation pack a regulator actually asks for.
Epirubicin is not itself carried on the WHO Model List of Essential Medicines (a direct search of the current list returns no epirubicin entry); doxorubicin is the anthracycline WHO lists for the same breast-cancer indication, so a tender specifying by generic protocol name rather than by originator brand may default to doxorubicin unless the buyer's own oncology guideline names epirubicin specifically for its lower cardiotoxicity profile. M Care's documentation chain for this molecule follows the standard cytotoxic-injectable export file: batch-specific certificate of analysis, WHO-GMP manufacturing site documentation from the sourcing partner, pre-shipment thermal validation for the 2-8°C cold-chain requirement, and CDSCO export paperwork from the Mumbai desk, with CTD/eCTD dossier support for destination markets such as MHRA, SFDA, MOHAP, NAFDAC, PPB or SAHPRA that require local registration or tender-listing evidence before import.
On brand versus generic: Pharmorubicin remains Pfizer's originator product in the EU and UK, marketed in the US as Ellence, and licensed generic epirubicin hydrochloride injection is separately registered and marketed alongside it, including UK lines from manufacturers such as Seacross Pharmaceuticals and medac Pharma. Registration status for generic epirubicin varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender. We do not manufacture epirubicin ourselves and hold no WHO-GMP or WHO-PQ certification in our own name; every batch we export carries its manufacturing partner's own certification.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside epirubicin.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for epirubicin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Epirubicin supply, the specific questions.
Is there a generic version of Pharmorubicin or Ellence?
Yes. Licensed generic epirubicin hydrochloride injection is marketed alongside Pfizer's originator brand in the UK and EU, including lines from manufacturers such as Seacross Pharmaceuticals and medac Pharma. M Care can source either the brand or a generic epirubicin line from a WHO-GMP partner site, depending on what your tender or formulary specification requires.
Why would a hospital choose epirubicin over doxorubicin?
Epirubicin is a stereoisomer of doxorubicin with a lower reported cardiotoxicity and myelosuppression profile at an equivalent antitumour dose, which is why many FEC-based breast-cancer protocols specify it by name rather than accepting doxorubicin as an automatic substitute. The two are not interchangeable on a milligram-for-milligram basis; dosing and cumulative-dose ceilings differ between them.
What strengths of epirubicin does M Care supply?
10 mg/5 ml, 50 mg/25 ml and 200 mg/100 ml single-dose vials of ready-to-use 2 mg/ml solution for injection or infusion, matching the originator Pharmorubicin (EU) presentation and equivalent licensed generic lines; the US Ellence brand ships in the 50 mg and 200 mg sizes only. Tell us your regimen and dosing protocol and we quote the vial-size mix accordingly.
Does epirubicin need cold-chain shipping?
Yes. Epirubicin is a ready-to-use solution that must be stored and shipped at 2-8°C, protected from light, and must not be frozen. M Care runs pre-shipment thermal validation and on-arrival cold-chain checks on every epirubicin consignment, with an excursion protocol defined for the lane.
What is the cumulative dose limit for epirubicin, and why does it matter for supply planning?
Cardiomyopathy risk rises with cumulative exposure, from 0.9% at 550 mg/m² to 3.3% at 900 mg/m², and a lifetime cumulative dose above 900 mg/m² should generally be avoided. Hospital pharmacies use this ceiling to plan patient-level ordering across a treatment course rather than a single bulk order, which affects how M Care structures phased delivery against a tender award.
What documentation does M Care provide with an epirubicin shipment?
Batch-specific certificate of analysis, WHO-GMP manufacturing site documentation from the sourcing partner, cold-chain thermal validation records, and CDSCO export paperwork from India, with CTD/eCTD-format dossier support where the destination regulator requires local registration or tender-listing evidence before import.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.