Melphalan tablets and melphalan injection, the conditioning agent ahead of autologous stem cell transplant in multiple myeloma, are quoted by M Care as the Evomela reformulation or a licensed generic line, against your tender specification.
M Care Exports supplies melphalan, a long-established alkylating agent still central to multiple myeloma treatment, both as the 2 mg film-coated tablet for palliative oral dosing and as the intravenous powder for infusion used at high dose ahead of autologous stem cell rescue. We source the Captisol-enabled Evomela formulation and licensed generic melphalan through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Melphalan exporter and bulk supplier from India.
For haemato-oncology pharmacy, transplant-centre and MoH tender orders, M Care quotes melphalan against buyer specification: the 2 mg oral tablet for standard palliative dosing or the 50 mg lyophilised injection for high-dose conditioning, the Evomela reformulation or a licensed generic line, drawn from WHO-GMP sourced manufacturer lines on the M Care roster. Because the tablet form needs 2 to 8 degrees C refrigerated transit while the injection form travels ambient below 30 degrees C protected from light, we confirm which dosage form a buyer needs before routing the shipment, 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.
Alkylating agent, nitrogen mustard derivative (bifunctional alkylating cytotoxic), sourced and documented for export.
Melphalan is a nitrogen mustard derivative, a bifunctional alkylating cytotoxic that cross-links DNA strands to stop malignant plasma cells replicating. It is dosed two distinct ways depending on the formulation: a 2 mg oral film-coated tablet for palliative multiple myeloma regimens (commonly 0.15 mg/kg daily for four days, repeated every six weeks), and a 50 mg powder for solution for infusion used either as low-dose IV chemotherapy (0.4 mg/kg every four weeks) or, at high dose (100 to 200 mg/m squared), as the standard conditioning regimen before autologous stem cell rescue in transplant-eligible myeloma patients. Above 140 mg/m squared, haematopoietic stem cell rescue is mandatory, not optional, per the UK SmPC. Licensed indications on the tablet also cover advanced ovarian adenocarcinoma, and the injection form additionally covers childhood neuroblastoma and, via isolated limb perfusion, localised melanoma or soft-tissue sarcoma of the extremities. The US boxed warning covers severe bone marrow suppression, secondary leukaemia risk and IV hypersensitivity reactions, seen in around 2% of patients on the intravenous form.
Active ingredient
Melphalan (present as melphalan hydrochloride in the injectable formulation). Alkylating agent, nitrogen mustard derivative (bifunctional alkylating cytotoxic).
Forms and strengths
2 mg film-coated tablet; 50 mg powder for solution for injection/infusion, per single-dose vial.
Indications
Melphalan is a bifunctional alkylating cytotoxic of the nitrogen mustard class, indicated for multiple myeloma as both a 2 mg oral tablet for palliative dosing and a 50 mg intravenous formulation used at high dose for stem cell transplant conditioning. Supplied by M Care as the Evomela reformulation or a licensed generic line, sourced through Indian WHO-GMP channels for export.
Administration
Oral, Intravenous. Film-coated tablet and lyophilised powder for solution for 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 melphalan are haemato-oncology and transplant-unit hospital pharmacists managing autologous stem cell transplant conditioning protocols, national and regional MoH tender desks running multiple myeloma treatment lines, licensed pharmaceutical wholesalers and importers stocking cytotoxic oncology ranges, and NGO or foundation procurement programmes supporting cancer-treatment access where local registration is in place. Buyers typing "I'm looking for a melphalan conditioning-dose supplier" or "we need a partner for cytotoxic tender lines" are the ones this page is written for.
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 melphalan.
Melphalan's two formulations are not interchangeable in handling, and mixing them up on a tender line is the single most common ordering error we see. The 2 mg tablet is refrigerated stock, 2 to 8 degrees C, throughout transit and storage, unlike most oral oncology solids. The 50 mg injection is the opposite: stored below 30 degrees C, protected from light, and must never be refrigerated, since refrigeration causes the reconstituted product to precipitate out of solution. It is reconstituted with the solvent supplied with the pack, not saline, shaken vigorously for at least 50 seconds to a 5 mg/ml solution, and any solution left unused after one hour should be discarded. For infusion it must be diluted only in 0.9% sodium chloride, never a dextrose-containing solution, and the total time from reconstitution to the end of the infusion must not exceed 1.5 hours. High-dose conditioning (100 mg/m squared daily for two days) is never given without a confirmed stem cell product on hand, and hydration plus antiemetic premedication is standard given melphalan's high emetogenic potential at this dose. Hypersensitivity reactions, including anaphylaxis, occur in roughly 2% of IV recipients, so resuscitation cover should be in place for the infusion. Shelf life on both dosage forms is 36 months from the manufacturer at dispatch.
The documentation pack a regulator actually asks for.
Melphalan has sat on the WHO Model List of Essential Medicines since 2019 (TRS 1021), listed under cytotoxic medicines for plasma cell myeloma, covering both the 2 mg oral and 50 mg parenteral formulations; the WHO AWaRe antimicrobial-stewardship framework does not apply to melphalan, since AWaRe classifies antibiotics, not cytotoxic agents, and the two are sometimes wrongly conflated in tender documentation. On the brand-versus-generic question, this is not a straightforward substitution: multiple manufacturers hold approved melphalan tablets and injection in the US, UK and EU, including generic lines from established oncology-generic houses, alongside the newer Captisol-enabled Evomela reformulation from Acrotech Biopharma, which was developed specifically to avoid the propylene glycol vehicle used in conventional IV melphalan and to allow a slower, thirty-minute infusion. Buyers should specify which formulation their protocol calls for, since Evomela and conventional melphalan HCl injection are dosed and administered differently even though both deliver the same active molecule. Manufacturer-driven supply gaps on melphalan tablets and injection have been reported from time to time in some markets, which is one reason MoH tender desks in the GCC and Africa increasingly qualify a second or third WHO-GMP source rather than sole-sourcing a cytotoxic line. Melphalan is not a controlled substance; it requires standard cytotoxic-handling and hazardous-drug documentation rather than narcotics licensing.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
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 melphalan.
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 melphalan.
- 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.
Melphalan supply, the specific questions.
We're looking for a melphalan supplier who can quote both the tablet and the injection. Can M Care do both from one dossier?
Yes. We quote the 2 mg oral melphalan tablet and the 50 mg injection for high-dose conditioning as separate line items, each drawn from its own WHO-GMP sourced manufacturer line, and we align the CTD/eCTD or country-specific dossier paperwork to your destination regulator's requirements for each formulation separately, since they are registered and handled differently.
Does the melphalan injection need cold-chain shipping like the tablet does?
No, and this is a common point of confusion. The 2 mg tablet is refrigerated stock at 2 to 8 degrees C throughout transit. The 50 mg injection powder is stored below 30 degrees C, protected from light, and must not be refrigerated, since cold storage causes the reconstituted product to precipitate out of solution. We route each formulation on the correct lane.
We need a partner who can supply Evomela specifically, not just generic melphalan injection. Can you source it?
We can quote Evomela, the Captisol-enabled melphalan for injection from Acrotech Biopharma, alongside conventional melphalan hydrochloride injection and generic lines, through licensed Indian distribution and manufacturing channels. Evomela and conventional IV melphalan are dosed and administered differently even though both are melphalan, so tell us which your protocol specifies and we quote against that exact formulation.
Is melphalan on the WHO Essential Medicines List, and does that affect our MoH tender submission?
Yes. Melphalan has been on the WHO Model List of Essential Medicines since 2019 (TRS 1021), listed under cytotoxic medicines for plasma cell myeloma, covering both the tablet and injection. Many MoH tender desks in our GCC and African markets reference the WHO EML directly in their formulary criteria, which supports melphalan's inclusion on a cytotoxic oncology tender line.
What's the shelf life we can expect on melphalan stock at dispatch?
Both the tablet and the injection carry a 36-month shelf life from the manufacturer. We confirm remaining shelf life against your delivery timeline and destination market's minimum-remaining-shelf-life import requirement before we quote a batch.
We're a licensed importer building a multiple myeloma treatment line for a transplant unit. What do we need to confirm before ordering?
Confirm which formulation your transplant protocol specifies (conventional melphalan injection or Evomela), your required conditioning-dose strength, and whether your unit needs the tablet form for palliative maintenance dosing alongside it. We then align sourcing, dossier documentation and shipping lane (refrigerated for the tablet, ambient light-protected for the injection) to that specification before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
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.