Mavenclad (cladribine) is a 10 mg oral tablet for relapsing multiple sclerosis, given as two yearly treatment courses to a cumulative 3.5 mg/kg over two years, and cladribine is also a separate injection line for hairy cell leukaemia.
M Care Exports supplies Mavenclad (cladribine) 10 mg tablets, labelled in the US to EMD Serono, Inc. and in the UK to Merck Serono Limited, plus cladribine injection for hairy cell leukaemia (authorised in the EU as Litak, from Lipomed GmbH) and Indian-made cladribine lines, to hospital pharmacies, neurology and haematology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the tablet or the injection, send the destination, the presentation and the quantity, and we quote per destination.
Cladribine exporter and bulk supplier from India.
"We need a partner for Mavenclad" is a typical enquiry from a hospital neurology pharmacy or a tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which line your destination accepts. Cladribine is two distinct product lines, and we quote them separately. The first is Mavenclad 10 mg tablets, an oral purine antimetabolite for relapsing forms of multiple sclerosis (MS) in adults. The second is cladribine injection for active hairy cell leukaemia, supplied in the US label as a 10 mg per 10 mL (1 mg/mL) single-dose vial for continuous intravenous infusion. We supply originator or regulator-registered brands and Indian-made lines. One Indian-made example is Cladrim 10 mg cladribine injection, which sits on the injection side and is not a Mavenclad equivalent. The quote turns on the line, the pack, the quantity, the destination's registration route and Incoterms. The tablet is stored at room temperature under the US label and the injection is refrigerated.
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.
Purine antimetabolite for relapsing forms of multiple sclerosis (tablet); synthetic antineoplastic agent for hairy cell leukaemia (injection), sourced and documented for export.
Mavenclad is cladribine 10 mg in an uncoated, white, round, biconvex tablet engraved "C" on one side and "10" on the other, per the US label. The US label (EMD Serono, Inc., revised May 2026) describes it as a purine antimetabolite indicated for relapsing forms of MS, to include relapsing-remitting disease and active secondary progressive disease, in adults. It adds that, because of its safety profile, use is generally recommended for patients with an inadequate response to, or who cannot tolerate, an alternate MS drug, and that it is not recommended in clinically isolated syndrome. The UK SmPC (Merck Serono Limited as holder) words the indication as adult patients with relapsing forms of multiple sclerosis (RMS) with active disease as defined by clinical or imaging features. The EMA lists Mavenclad as authorised in the EU, with Merck Europe B.V. as marketing authorisation holder, for adult patients with highly active relapsing MS as defined by clinical or imaging features. The recommended cumulative dose is 3.5 mg/kg over 2 years, as one treatment course of 1.75 mg/kg per year. The WHO Model List of Essential Medicines (23rd list, WHO/MHP/HPS/EML/2023.02) lists "cladribine Tablet: 10 mg" under 5.2 Medicines for multiple sclerosis, on the Complementary List. The separate cladribine injection (Fresenius Kabi USA label on DailyMed) is indicated for active hairy cell leukaemia as defined by clinically significant anaemia, neutropenia, thrombocytopenia or disease-related symptoms.
Active ingredient
Cladribine. Purine antimetabolite for relapsing forms of multiple sclerosis (tablet); synthetic antineoplastic agent for hairy cell leukaemia (injection).
Forms and strengths
10 mg tablet (Mavenclad, oral, relapsing multiple sclerosis); 10 mg/10 mL (1 mg/mL) single-dose vial (cladribine injection for IV infusion, hairy cell leukaemia).
Indications
Cladribine is supplied as Mavenclad 10 mg tablets for relapsing forms of multiple sclerosis and as cladribine injection for active hairy cell leukaemia, as set out in the US and UK labelling.
Administration
Oral, Intravenous. Tablet (Mavenclad 10 mg); solution for continuous intravenous infusion (cladribine injection, USP).
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 are hospital pharmacists in neurology and haematology units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Mavenclad 10 mg tablets for an MS centre" or "We need a partner for cladribine injection for a haematology tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK. A cytotoxic oral MS medicine with a boxed warning is a specialist product, so whether a destination has a registered product or needs an unlicensed or named-patient import depends on the destination regulator, and M Care Exports confirms the route per enquiry. M Care supplies both originator or regulator-registered brands and Indian-made lines for destinations whose registration accepts them. We do not claim any Indian-made line is registered in a given destination.
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 cladribine.
Treat the tablet as a weight-banded course, not a repeat supply: the US label says to dispense one box for each treatment cycle. Both labels set the cumulative dose at 3.5 mg/kg over 2 years, as 1.75 mg/kg per year. In the US label each course has two cycles, and each cycle is 1 or 2 tablets once daily over 4 or 5 consecutive days, never more than 2 tablets daily. The US and UK weight tables both start at 40 kg, and use below 40 kg has not been investigated. Lymphocyte counts gate the supply. Both labels require normal counts before year 1 and at least 800 cells per microlitre (UK: cells/mm3) before year 2, with year 2 delayed up to 6 months for recovery and no further treatment if recovery takes longer. Counts are checked at 2 and 6 months in each course. The US label adds monthly monitoring to month 6 if the month 2 count is below 200 cells per microlitre, and the UK SmPC asks for active monitoring below 500 cells/mm3. Day packs are child-resistant, and the US label calls the tablet a cytotoxic drug with special handling and disposal. The US label asks for other oral drugs to be separated by at least 3 hours. After the two courses the US label says do not administer additional Mavenclad treatment during the next 2 years.
The documentation pack a regulator actually asks for.
The US label stores Mavenclad at 20 to 25 °C, excursions permitted to 15 to 30 °C, in the original package to protect from moisture. The UK SmPC says to store in the original package to protect from moisture and gives no temperature limit. The Fresenius Kabi USA cladribine injection label on DailyMed says to store refrigerated at 2 to 8 °C and protect from light, so the injection ships as a cold-chain line. The US boxed warning covers malignancies and risk of teratogenicity. The US label contraindicates Mavenclad with current malignancy, and in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception. In the UK the Mavenclad listing on emc is marked discontinued, and the same tablet is listed there as Cladribine Merck 10 mg tablets from Merck Serono Limited under the same marketing authorisation number. We state the source and status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation, batch certificates of analysis and export documents.
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 cladribine.
Ocrelizumab (Ocrevus)
CD20-directed antibody · relapsing and primary progressive multiple sclerosis
Ofatumumab (Kesimpta)
Anti-CD20 antibody · relapsing multiple sclerosis, monthly subcutaneous injection
Rituximab (MabThera, Rituxan)
Anti-CD20 monoclonal antibody · B-cell lymphoma, CLL
All cns & neurology
The full category listing for procurement desks.
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 cladribine.
- 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.
Cladribine supply, the specific questions.
What decides the landed price of Mavenclad for an importer?
We do not publish prices. The landed cost depends on whether you want the originator Mavenclad or another line, the pack and quantity, the registration route in your destination, and Incoterms. The tablet is a room-temperature line under the US label, so it does not need the refrigerated freight the injection needs. If you want the cladribine injection instead, it is a separate quote with cold-chain packing. M Care Exports quotes per destination once you send the line, volume and country.
What is Mavenclad 10 mg, and how is it supplied?
Mavenclad is cladribine 10 mg tablets: the US label lists one tablet strength, 10 mg, as an uncoated, white, round, biconvex tablet engraved "C" and "10". The US label supplies boxes of 4 to 10 tablets in child-resistant day packs. The UK SmPC lists pack sizes of 1, 4, 5, 6, 7 or 8 tablets in blisters and notes that not all pack sizes may be marketed. Send the pack size your destination registers when you request a quote.
Is there a generic of Mavenclad?
In the US, FDA drug data lists generic cladribine 10 mg tablets approved under abbreviated new drug applications held by Apotex and Hopewell Pharma, and DailyMed carries generic cladribine tablet labels from Sandoz, Apotex and Genvion beside the EMD Serono Mavenclad label. In the UK, emc lists the tablet as Cladribine Merck 10 mg tablets from Merck Serono Limited, with the Mavenclad listing marked discontinued. In the EU, the EMA lists Mavenclad as authorised to Merck Europe B.V. Cladribine injection, including Litak in the EU and Cladrim 10 mg, an Indian-made injection line, is a different product from the tablet and is not a Mavenclad generic. M Care Exports confirms which tablet source your destination accepts per enquiry.
What is the Mavenclad dosing schedule?
Both the US label and the UK SmPC give a cumulative dose of 3.5 mg/kg over 2 years, as one treatment course of 1.75 mg/kg per year. The dose per cycle or treatment week depends on weight, in tablets of 10 mg, and the labels give a table from 40 kg upward. Use below 40 kg has not been investigated. Lymphocytes must be normal before year 1 and at least 800 cells per microlitre before year 2, which can be delayed up to 6 months. Follow the label of your destination.
What are the Mavenclad side effects buyers should know about?
The US label lists the most common adverse reactions (incidence above 20%) as upper respiratory tract infection, headache and lymphopenia. Its boxed warning covers malignancies and risk of teratogenicity. The US label advises effective contraception during dosing and for 6 months after the last dose in each course for females, and for 14 weeks for males; the UK SmPC says male patients must take precautions for at least 3 months after the last dose. Contraindications differ by label. The US label includes HIV infection, active chronic infections such as hepatitis or tuberculosis, and hypersensitivity to cladribine. The UK SmPC also lists moderate or severe renal impairment. Please read the label of your market.
Mavenclad vs Ocrevus: how do they compare on the label?
We compare on label facts only and do not recommend one over the other. Mavenclad is oral cladribine, a purine antimetabolite, given as two yearly courses to a cumulative 3.5 mg/kg. Ocrevus (ocrelizumab, Genentech) is a CD20-directed cytolytic antibody given as an intravenous infusion: the adult start dose is 300 mg followed two weeks later by a second 300 mg infusion, then 600 mg every 6 months, and its US label also covers primary progressive MS. Ocrevus comes as a 300 mg/10 mL single-dose vial. See our ocrelizumab page, and for another MS option our ofatumumab page.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.
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.
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