Eribulin Mesylate Injection Exporter and Supplier
Eribulin mesylate is a non-taxane microtubule dynamics inhibitor of the halichondrin class, supplied as a 1 mg/2 mL (0.5 mg/mL) single-dose vial for metastatic breast cancer after prior anthracycline and taxane exposure, and for unresectable or metastatic liposarcoma after a prior anthracycline-containing regimen. M Care Exports is an India-based merchant-exporter, trading since 2003, sourcing eribulin from established Indian oncology injectable lines and shipping to importers, distributors and hospital tender buyers across the UK, EU, GCC, Africa, Latin America and South East Asia. Tell us your destination market, pack convention and dossier requirement, and we will quote against a named source line.
Sourcing eribulin vials at wholesale, without pretending to be the factory
Eribulin sits in a narrow band of the oncology market: it is a later-line cytotoxic, licensed only after anthracyclines and taxanes have already been used, so demand arrives in small, irregular, patient-linked quantities rather than large standing volumes. That shapes how we buy it. M Care Exports is a merchant-exporter and wholesaler, not a manufacturer. We hold no production licence and we do not own a filling line for cytotoxic injectables. What we do is aggregate demand across markets, place it against Indian oncology plants that already run eribulin batches, and carry the export paperwork, room-temperature logistics and consolidation that a single importer ordering a handful of vials cannot economically arrange alone. Where a buyer needs product from a WHO-GMP-listed manufacturing line, we source from one and name it in the offer, but that certification belongs to the plant, not to us. M Care's own credential is ISO 9001:2015, covering our trading, documentation and dispatch quality system. Minimum order is set by the source manufacturer's batch-release minimum for the presentation, not by an invented figure on our side, and pricing on a molecule with this few Indian producers moves with batch availability, so it is quoted on request against your specification.
Small-quantity oncology reality
Eribulin moves in vial counts, not pallets. We consolidate multi-molecule oncology orders into one shipment so a small eribulin line does not have to carry the freight cost of a standalone consignment.
Named source line, disclosed
We tell you which Indian plant the batch comes from, its GMP status and its regulatory approvals, before you commit. If your registration needs a specific site, we source to that site rather than substituting quietly.
No cold chain required
Unopened eribulin vials ship at controlled room temperature, which removes the reefer and gel-pack cost that many oncology injectables carry. This materially changes landed cost into African and Latin American destinations.
Batch and expiry discipline
Later-line oncology stock can sit in hospital pharmacies for a long time. We specify minimum residual shelf life in the purchase order and share the CoA plus batch documents against the actual dispatched lot.
Eribulin mesylate at a glance: form, strength and regulatory class
Active ingredient
Eribulin mesylate, a fully synthetic macrocyclic ketone analogue of the marine natural product halichondrin B. It binds tubulin and suppresses microtubule growth without affecting the shortening phase, a mechanism distinct from the taxanes and the vinca alkaloids.
Strengths stocked
1 mg per 2 mL (0.5 mg/mL) single-dose vial is the standard export presentation under the US salt convention. EU-format packs declare the eribulin base content, 0.88 mg per 2 mL (0.44 mg/mL), for the same physical vial. Confirm which convention your registration expects.
Formulation and handling
Clear, colourless aqueous solution for intravenous administration, given undiluted or diluted in 0.9% sodium chloride. Single-dose, preservative-free, no reconstitution step. Handled under cytotoxic precautions at the receiving pharmacy.
Storage
Per the US label, unopened vials are stored at 25 degrees C with excursions permitted between 15 and 30 degrees C, in the original carton, and the label directs: do not freeze or refrigerate. Eribulin is not a cold-chain product. Confirm against the approved label for your destination market.
Regulatory class
ATC L01XX41. A prescription-only cytotoxic antineoplastic in every market we serve, restricted to oncology specialists and hospital pharmacy dispensing. Import licences and cytotoxic handling rules vary by destination.
Reference brands
The originator is Halaven from Eisai. Indian brands in circulation include Teceris (Mylan/Viatris) and Embremma (Emcure), with Ebunat (Natco) also reported. Brands are named here as buyer reference for identifying the molecule, not as an offer of any brand-holder's product.
The buyers who come to us for eribulin
Eribulin enquiries look different from those for a first-line generic. They are rarely speculative stock builds. Most arrive because a specific oncology unit has a patient who has exhausted anthracycline and taxane options, or because a tender lot demands a non-taxane microtubule agent that the local market does not produce. The patterns below cover most of what reaches our desk.
Hospital and cancer-centre importers
Oncology pharmacies in the GCC and South East Asia sourcing later-line agents directly, usually against a named-patient or hospital-exemption import route. They need documentation to match the import permit exactly and they need a firm dispatch date, because the treatment cycle is already scheduled.
Government and institutional tender buyers
Central medical stores and national cancer programmes in Africa and Latin America running periodic oncology tenders. These need a CoPP, manufacturer GMP evidence, legalised documents and a source line whose regulatory approvals satisfy the tender's pre-qualification clause. We compile that pack alongside your bid team.
Distributors holding an oncology portfolio
Importers who already carry paclitaxel, docetaxel and capecitabine and are adding a non-taxane option so their oncology basket answers a full treatment sequence. They typically want eribulin consolidated into an existing multi-molecule shipment rather than ordered on its own.
Registration and dossier-stage partners
Companies filing eribulin with their national authority for the first time and needing a stable source line, CTD module inputs and manufacturer commitment letters before they can submit. Supply follows registration, so the paperwork sequence matters more than the first order size.
Buyers arriving on a brand name
A share of enquiries search the originator brand rather than the INN. If you came looking for the reference brand, what we can supply is eribulin mesylate injection from Indian manufacturing lines, quoted against the molecule and the source plant, with the brand named only so you can confirm you have the right agent.
Safety and handling notes for procurement and pharmacy teams
Myelosuppression is the dose-limiting toxicity. Eribulin carries no boxed warning in US labelling, but neutropenia is its most consequential adverse effect. In the registrational metastatic breast cancer population, severe neutropenia with an absolute neutrophil count below 500 per cubic millimetre lasting more than seven days occurred in about 12% of patients, and febrile neutropenia in about 5%. Labelling directs that a complete blood count be taken before each dose and that dosing be delayed or reduced for neutropenia or thrombocytopenia. Procurement teams should assume the receiving unit needs CBC monitoring capacity and access to growth-factor support before eribulin is stocked.
Peripheral neuropathy is the leading reason patients stop treatment. Grade 3 peripheral neuropathy affected roughly 8% of breast cancer patients in the same study population, grade 4 about 0.4%, and neuropathy was the most common toxicity leading to discontinuation, at about 5%. That matters for exactly the population eribulin serves, since these patients have usually had prior taxane exposure and may already carry residual neuropathy. Labelling also carries warnings for QT interval prolongation, observed on day 8 and independent of eribulin concentration with none seen on day 1, with particular caution in congestive heart failure, bradyarrhythmias, concomitant QT-prolonging medicines and uncorrected electrolyte abnormalities, so potassium and magnesium correction and ECG monitoring are expected in at-risk patients. Eribulin is also embryo-foetal toxic, with contraception advised during treatment and for a defined period afterwards.
Handling, dose context and storage. The reference regimen in the US label is 1.4 mg/m2 of eribulin mesylate given intravenously over 2 to 5 minutes on days 1 and 8 of a 21-day cycle. EU-format labelling states the same regimen in base terms, as 1.23 mg/m2 of eribulin, which is the identical dose expressed under the other convention. Labelled starting-dose reductions exist for hepatic impairment (1.1 mg/m2 in Child-Pugh A, 0.7 mg/m2 in Child-Pugh B) and for moderate or severe renal impairment, creatinine clearance 15 to 49 mL/min (1.1 mg/m2). Those figures appear here purely as procurement and forecasting context so buyers can estimate vials per patient-cycle. They are not dosing instruction, and all prescribing, dose adjustment and monitoring decisions belong to the treating oncologist working from the approved local label. Eribulin is a cytotoxic requiring closed-system handling, trained compounding staff and cytotoxic waste routes at the receiving site. On storage, note the point that catches out buyers who assume every oncology injectable is cold chain: the US label directs that the unopened vial is stored at 25 degrees C and is not to be frozen or refrigerated, kept in its original carton. Refrigeration at about 4 degrees C applies only to eribulin already drawn into a syringe or diluted, and only for a limited holding period before administration.
"Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.
Documents we provide with an eribulin consignment
Eribulin generics are registered in a limited set of the markets we ship to, so a large share of orders travel on a named-patient, hospital-exemption or tender-specific route. Each of those routes turns on paperwork rather than volume. Here is what we genuinely issue or compile, and who each document actually comes from.
Certificate of Analysis, batch specific
Issued by the manufacturer for the exact lot dispatched to you, covering assay, related substances, sterility, bacterial endotoxins, particulate matter and pH. We do not send a specimen CoA in place of the real one.
Certificate of Pharmaceutical Product (CoPP)
Issued in WHO format by the Indian licensing authority for the manufacturing site, and required by most tender and registration routes. We request, track and legalise it alongside your filing, but it is the manufacturer's document and it names the manufacturer, not M Care.
Manufacturer GMP evidence
The source plant's GMP certificate and product-permission letters. If your tender clause requires a WHO-GMP-listed line, we source from one and give you the evidence. To be explicit: that certification is the plant's. M Care holds ISO 9001:2015 for its own trading and documentation system and claims nothing further.
CTD dossier inputs for registration
For partners filing eribulin locally, we coordinate with the manufacturer on open and closed-part module content, stability data and the commitment letters your authority requires, and we compile the pack alongside your regulatory team through the query cycle.
Export and shipping set
Commercial invoice, packing list, airway bill, country-of-origin certificate, free-sale certificate where applicable, and import-permit-matched labelling. Because unopened eribulin ships at controlled room temperature rather than on cold chain, there is no temperature-excursion logger reconciliation at clearance, which removes a common dispute.
Molecules buyers source alongside Eribulin Mesylate.
Paclitaxel
The taxane that stabilises microtubules rather than suppressing their growth, and one of the agents patients must typically have received before eribulin is indicated.
Docetaxel
The other reference taxane in the breast cancer sequence, commonly stocked in the same oncology basket as eribulin by importers covering a full treatment line.
Capecitabine
An oral antimetabolite used in comparable later-line metastatic breast cancer settings, and the practical alternative where an oral route suits the patient better than an IV cytotoxic.
How ordering works.
- Send the specification, not just the molecule name. Tell us destination country, quantity in vials, whether your paperwork uses the 1 mg/2 mL salt convention or the 0.88 mg base convention, your import route (registered, named-patient, hospital exemption or tender) and any required source-site or regulatory-approval clause. Eribulin batch availability is genuinely narrow, so a vague enquiry cannot be quoted accurately.
- We check live batch availability and quote. We confirm which Indian lines have current or scheduled eribulin batches, what residual shelf life those lots carry, and what the source manufacturer's batch-release minimum is for your presentation. You receive a written offer naming the source plant, with price on request against that specification rather than a list figure.
- Documentation and regulatory alignment. Before dispatch we align the CoPP, GMP evidence, CoA format and labelling against your import permit or tender clause, and legalise where required. For first-time filings this stage runs longest and we work it alongside your regulatory team rather than handing over a folder and stepping back.
- Dispatch, consolidation and tracking. Room-temperature air freight, consolidated with the rest of your oncology order where that reduces landed cost, with cytotoxic-appropriate outer packing and the full document set travelling with the consignment. We track to clearance and stay on the file until the goods are released.
Eribulin Mesylate supply, the specific questions.
Does eribulin need cold chain shipping?
No, and this is the most common misconception on this molecule. The US label directs that unopened eribulin vials be stored at 25 degrees C, with excursions permitted between 15 and 30 degrees C, in the original carton, and states plainly: do not freeze or refrigerate. Refrigeration at about 4 degrees C applies only to eribulin already drawn into a syringe or diluted, and only for a limited holding period before administration. For importers this is good news on landed cost, because it removes reefer freight, gel packs and temperature-logger reconciliation at clearance. Always confirm against the approved label for your destination market.
I am looking for a Halaven supplier. Can you supply the brand?
Halaven is the originator brand of eribulin mesylate, marketed by Eisai, and it is named here only so you can confirm you are looking at the right molecule. What M Care Exports supplies is eribulin mesylate injection sourced from Indian manufacturing lines, quoted against the INN and a named source plant. If your tender or prescription specifically requires the originator brand, that has to be bought through the brand holder's own distribution channel in your market, and we will tell you so rather than substituting quietly. If your requirement is the molecule, tell us the strength, quantity and destination and we will quote.
Is eribulin on the WHO Essential Medicines List or WHO prequalified?
No on both counts, and buyers writing tender specifications should know this before drafting. Eribulin does not appear on the WHO Model List of Essential Medicines, including the 24th list published in 2025, and there is no WHO-prequalified eribulin finished product. WHO prequalification has centred on HIV, TB, malaria, reproductive health and vaccines, and its extension into cancer so far runs through a biotherapeutics pilot covering products such as rituximab and trastuzumab rather than small-molecule cytotoxics, so the absence of eribulin says nothing about product quality. If your tender clause requires WHO PQ, eribulin cannot satisfy it from any source and the clause needs revisiting. What we can supply against is a WHO-GMP-listed manufacturing line with a CoPP in WHO format, which is what most oncology tenders actually specify.
Why is the vial labelled 1 mg on some packs and 0.88 mg on others?
Because two labelling conventions describe the same physical vial. The US convention declares the salt, giving 1 mg of eribulin mesylate per 2 mL, or 0.5 mg/mL. EU-format packs declare the base, giving 0.88 mg of eribulin per 2 mL, or 0.44 mg/mL. The contents are identical. The same split runs through the dose statement, where the US label reads 1.4 mg/m2 of the mesylate and the EU label reads 1.23 mg/m2 of the base for the same regimen. This causes real problems at registration and at customs when a purchase order quotes one convention and the import permit quotes the other. Tell us which convention your authority expects and we will match the artwork and the documentation to it.
What is the minimum order quantity for eribulin injection?
It is set by the source manufacturer's batch-release minimum for the presentation, not by a figure M Care invents. Eribulin runs on comparatively few Indian oncology lines and batches are scheduled rather than continuous, so the practical minimum tracks what the plant will release and when its next batch runs. In practice this molecule moves in vial counts rather than cartons, and the more useful lever is consolidation: adding eribulin to an existing oncology shipment usually beats trying to negotiate the batch minimum downwards. Send your quantity and destination and we will tell you the real number for the current batch position.
How does eribulin differ from the taxanes we already stock?
Mechanistically and commercially. Eribulin is a non-taxane microtubule dynamics inhibitor, a synthetic analogue of halichondrin B. It binds tubulin and suppresses microtubule growth without affecting the shortening phase, whereas taxanes such as paclitaxel and docetaxel stabilise microtubules against disassembly. That difference is the reason eribulin exists in the treatment sequence: its licensed breast cancer indication begins after an anthracycline and a taxane have already been used. Commercially, that means eribulin does not compete with your taxane lines, it extends the sequence past them, and it also carries a liposarcoma indication that no taxane holds.
Can M Care register eribulin in our market on our behalf?
No, and any exporter who says otherwise is overselling. A marketing authorisation is held by an applicant established in your country, normally you or your local agent. What we genuinely do is compile the dossier alongside you: we coordinate with the source manufacturer on CTD module content, stability data, site information and the commitment letters your authority asks for, we obtain and legalise the CoPP and GMP evidence, and we stay on the file through the query cycle. The filing, the fees and the authorisation remain yours. We are the supply and documentation partner behind it, not the applicant.
Tell us the market and the batch position you need
Eribulin availability tracks batch schedules on a small number of Indian oncology lines, so the useful conversation starts with your destination country, vial quantity, pack convention (1 mg/2 mL salt or 0.88 mg base) and import route. Send those and we will come back with a written offer naming the source plant, its GMP status, current residual shelf life and the document set your permit or tender requires. Price on request against your specification. If eribulin turns out to be the wrong fit for your clause, we will say so.