Treanda (bendamustine), marketed in Europe as Levact and in the US also as Bendeka, is licensed for chronic lymphocytic leukaemia and rituximab-refractory indolent B-cell non-Hodgkin lymphoma, and FDA-approved generic bendamustine injections now sit alongside the originator brands on hospital oncology formularies.
M Care Exports supplies Treanda (bendamustine hydrochloride), a bifunctional alkylating agent first developed in Germany and marketed internationally as Levact (EU) and as Treanda and Bendeka (US), alongside FDA-approved generic bendamustine injections. It is dosed by body surface area on a protocol that differs between chronic lymphocytic leukaemia and indolent lymphoma. M Care is a merchant exporter: we source Treanda, Levact and generic bendamustine through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Bendamustine exporter and bulk supplier from India.
For hospital oncology pharmacy, wholesaler and tender-desk orders, M Care quotes bendamustine against buyer specification: brand (Treanda/Bendeka/Levact) or generic, 25mg or 100mg lyophilised vial or a ready-to-dilute concentrate, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because bendamustine is prepared and infused as a hazardous cytotoxic drug needing dedicated PPE, closed-system transfer devices and an unbroken 2-8°C cold chain in transit, we confirm the buyer's cold-chain and hazardous-drug handling capability before dispatch, 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.
Bifunctional alkylating agent (nitrogen mustard/benzimidazole), sourced and documented for export.
Bendamustine is a bifunctional alkylating agent combining a nitrogen mustard alkylating group with a benzimidazole ring, giving it a DNA cross-linking and repair profile distinct from other alkylators such as cyclophosphamide. The US label for Treanda and Bendeka covers chronic lymphocytic leukaemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of a rituximab-containing regimen. A UK-licensed SmPC for the same 2.5mg/ml bendamustine formulation (the Levact-referencing generic product) adds first-line chronic lymphocytic leukaemia in defined patient groups and multiple myeloma with prednisone in patients over 65 ineligible for stem-cell transplant and unsuitable for thalidomide or bortezomib. It is an intravenous-only therapy, given as a 30-60 minute infusion after reconstitution and dilution, never oral. Bendamustine is supplied as 25mg and 100mg lyophilised powder vials (the Treanda/Levact format) and as a 100mg/4mL ready-to-dilute concentrate (the Bendeka format and its generics).
Active ingredient
Bendamustine hydrochloride. Bifunctional alkylating agent (nitrogen mustard/benzimidazole).
Forms and strengths
25 mg lyophilised powder for concentrate for solution for infusion, per vial; 100 mg lyophilised powder for concentrate for solution for infusion, per vial; 100 mg/4mL ready-to-dilute solution for infusion, per vial.
Indications
Bendamustine hydrochloride, a bifunctional alkylating agent indicated for chronic lymphocytic leukaemia and rituximab-refractory indolent B-cell non-Hodgkin lymphoma, with EU labelling extending to first-line chronic lymphocytic leukaemia in defined patients and multiple myeloma with prednisone. Supplied as originator Treanda/Bendeka/Levact and licensed generic injections from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Intravenous. Lyophilised powder for concentrate for solution for infusion; also supplied as a ready-to-dilute 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 bendamustine are hospital haemato-oncology pharmacies running a chronic lymphocytic leukaemia or indolent-lymphoma protocol, national and regional MoH tender desks in our GCC and African markets running oncology procurement lists, licensed pharmaceutical wholesalers and importers managing hazardous-drug cold chain, and regulatory affairs teams preparing named-patient or tender dossiers. India is not a served market: bendamustine is exported only, never distributed domestically.
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 bendamustine.
Bendamustine is dosed by body surface area, but the licensed regimen differs sharply by indication: 100mg/m2 on days one and two of a 28-day cycle for chronic lymphocytic leukaemia, against 120mg/m2 on days one and two of a 21-day cycle for indolent lymphoma, so confirm the ordering indication before dispensing rather than assuming one protocol. Keep vials in their outer carton until use; bendamustine is light-sensitive, and compatible diluents differ between the lyophilised and ready-to-dilute presentations, so check the specific product's SmPC or prescribing information before mixing. Infusion reactions, including fever, chills and pruritus, tend to appear from the second cycle onward rather than the first, so have antihistamine, antipyretic and corticosteroid premedication ready for cycle two even where cycle one passed without incident. Myelosuppression is the dominant toxicity: check full blood counts before every cycle and hold or reduce the dose for grade 3-4 neutropenia or thrombocytopenia. Store refrigerated at 2-8°C in transit; a confirmed cold-chain excursion is a rejection trigger, not a use-with-caution one.
The documentation pack a regulator actually asks for.
Bendamustine travels on the same validated cold chain M Care runs for biologics and insulins: vials and ready-to-dilute concentrate are held at 2-8°C from manufacture to point of use, and a confirmed excursion is a rejection trigger. Buyers need batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires it, CTD or eCTD-format dossier support. Bendamustine appears on the WHO Model List of Essential Medicines, first added in 2015 (TRS 994) for chronic lymphocytic leukaemia/small lymphocytic lymphoma and follicular lymphoma, so tender desks can specify it as an EML-listed alkylating agent rather than treat it as a formulary-specific alternative. On the brand-versus-generic question, Treanda and Bendeka (US) and Levact (EU) remain the originator-line products, while FDA-approved generic bendamustine injections from several manufacturers, including ready-to-dilute presentations referencing Bendeka, are separately registered; buyers genuinely have a brand-or-generic choice once a national registration exists. M Care confirms current supply status with the sourcing partner before quoting rather than assuming standing stock.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
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 bendamustine.
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 bendamustine.
- 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.
Bendamustine supply, the specific questions.
Does a generic version of Treanda/Levact exist?
Yes. The FDA has approved generic bendamustine hydrochloride injections from several manufacturers, including ready-to-dilute presentations that reference Bendeka, alongside the originator brands Treanda, Bendeka (US) and Levact (EU). Registration status for generic bendamustine varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Treanda or Levact to our market?
Yes, on an import basis. We source Treanda, Bendeka and Levact through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds. India is not a served market: we export only.
What strengths and pack formats of bendamustine are available?
25mg and 100mg lyophilised powder vials, the Treanda/Levact format, and a 100mg/4mL ready-to-dilute concentrate, the Bendeka format and its generics. Tell us which cycle protocol, chronic lymphocytic leukaemia or indolent lymphoma, your pharmacy is running and we quote the vial mix to match.
Is bendamustine on the WHO Essential Medicines List?
Yes. Bendamustine was added to the WHO Model List of Essential Medicines in 2015 for chronic lymphocytic leukaemia/small lymphocytic lymphoma and follicular lymphoma. Tender desks in our GCC and African markets can specify it as an EML-listed alkylating agent rather than treat it as a formulary-specific alternative.
How is bendamustine stored and shipped?
Refrigerated at 2-8°C from manufacture to point of use, protected from light in its original carton, on the same validated cold chain M Care runs for biologics and insulins. A confirmed cold-chain excursion is a rejection trigger: we do not dispatch, or accept a return shipment, once one is confirmed.
Why does the bendamustine dose change between chronic lymphocytic leukaemia and lymphoma?
Bendamustine is dosed by body surface area, but the licensed regimen differs by indication: 100mg/m2 on days one and two of a 28-day cycle for chronic lymphocytic leukaemia, against 120mg/m2 on days one and two of a 21-day cycle for indolent B-cell non-Hodgkin lymphoma that has progressed after rituximab. We confirm the ordering indication before dispatch so the pack quantity matches the intended cycle count.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.