Lenvima (lenvatinib) is FDA- and EMA-licensed for thyroid, kidney, liver and endometrial cancers, with no interchangeable generic on the market in most regulated jurisdictions today.
Lenvima (lenvatinib) is an oral multikinase inhibitor used across four solid-tumour indications. M Care sources it through licensed Indian distribution channels as a merchant exporter, not a manufacturer, and dispatches against hospital, tender and NGO procurement requirements.
Lenvatinib exporter and bulk supplier from India.
For tender and bulk hospital orders, M Care's Mumbai desk coordinates Lenvima procurement through licensed Indian channels and prepares CTD/eCTD-ready documentation to support MoH tender submissions and licensed importer requirements. Batch-specific certificates of analysis, certificates of pharmaceutical product and import permits are compiled per shipment. Order volumes and lead times are confirmed against manufacturer allocation at the time of enquiry, since lenvatinib remains an originator-controlled product in most markets.
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.
Multikinase inhibitor (VEGFR1-3, FGFR1-4, PDGFRα, RET, KIT), sourced and documented for export.
Lenvatinib is a multikinase inhibitor. It blocks VEGFR1-3, FGFR1-4, PDGFRα, RET and KIT, which together starve tumours of new blood vessel growth and interrupt proliferation signalling.
Lenvima is licensed for radioactive iodine-refractory differentiated thyroid cancer as monotherapy, unresectable hepatocellular carcinoma as monotherapy, advanced renal cell carcinoma in combination with everolimus (second-line) or pembrolizumab (first-line), and advanced endometrial carcinoma in combination with pembrolizumab for patients with mismatch repair-proficient (pMMR) or non-MSI-high tumours who have progressed after prior systemic therapy and are not candidates for curative surgery or radiation. Buyers should confirm the specific combination-therapy indication approved in their destination market's labelling.
Lenvima is supplied as oral capsules in 4 mg and 10 mg strengths, stored at room temperature. It carries no cold-chain requirement, which simplifies last-mile logistics into markets with inconsistent refrigerated transport.
Active ingredient
lenvatinib mesylate. Multikinase inhibitor (VEGFR1-3, FGFR1-4, PDGFRα, RET, KIT).
Forms and strengths
4 mg capsule; 10 mg capsule.
Indications
Oral multikinase inhibitor licensed for radioactive iodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, and advanced renal cell carcinoma and endometrial carcinoma in combination regimens, per FDA and EMA labelling.
Administration
oral. Capsule.
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.
Oncology procurement desks at private and government hospitals, MoH tender boards in GCC and African markets running solid-tumour formularies, licensed pharmaceutical importers and wholesalers who hold local marketing authorisation for originator oncology brands, and specialist oncology pharmacies stocking targeted therapies.
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 lenvatinib.
Dosing is indication-specific and this is the detail buyers most often get wrong when forecasting pack quantities. Monotherapy for differentiated thyroid cancer is 24 mg once daily (two 10 mg plus one 4 mg capsule). Monotherapy for hepatocellular carcinoma is weight-based: 12 mg once daily for patients 60 kg or above, 8 mg once daily below 60 kg. Combination therapy with everolimus for renal cell carcinoma is 18 mg lenvatinib once daily. Combination therapy with pembrolizumab, used in both first-line renal cell carcinoma and endometrial carcinoma, is 20 mg lenvatinib once daily. Pack configurations should be confirmed against the specific indication a buyer's formulary is stocking for, not assumed uniform.
Capsules are taken with or without food, swallowed whole, at the same time each day. Missed doses can be taken as soon as remembered on the same day, but not doubled up the next day. Dose interruption and stepwise reduction (rather than discontinuation) is the standard label-directed approach to managing adverse reactions such as hypertension, proteinuria or hepatotoxicity, so hospital pharmacists dispensing against a tender contract should expect repeat orders in reduced-strength combinations (e.g. 10 mg plus 4 mg, or 4 mg alone) rather than flat monthly volumes.
No cold chain is required. Capsules are stored at controlled room temperature, which is a genuine logistics advantage over the biologic oncology agents in the same tender basket.
Hypertension is the most common adverse reaction requiring monitoring; blood pressure should be well controlled before starting therapy and monitored regularly thereafter. Renal function, liver function, thyroid-stimulating hormone (for patients not already athyreotic) and urine protein are monitored per label at baseline and periodically during treatment.
The documentation pack a regulator actually asks for.
As an oral solid dose, lenvatinib does not carry the cold-chain validation requirements that apply to biologic oncology agents. M Care's documentation chain for this product covers certificate of analysis, certificate of pharmaceutical product, import permit support and CDSCO export paperwork for each consignment, prepared for MoH tender and licensed-importer submission.
Lenvima is an originator product with patent protection still in force in major markets. There is no FDA-approved or EMA-authorised generic or biosimilar equivalent currently on the market. Supply into any given country runs through the manufacturer's licensed distribution network via M Care's channels; buyers should not expect a generic-substitution option for this molecule at present, and should verify current patent and exclusivity status for their specific destination market before finalising a tender specification.
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 lenvatinib.
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 lenvatinib.
- 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.
Lenvatinib supply, the specific questions.
Is there a generic or biosimilar version of Lenvima (lenvatinib)?
No. Lenvatinib is a small-molecule originator product still under patent protection in most major markets, not a biologic, so 'biosimilar' does not apply. No FDA-approved or EMA-authorised generic version is currently on the market. Supply runs through licensed originator distribution channels. Buyers should check current patent expiry status for their specific market, since this changes over time.
Does Lenvima require cold-chain storage during shipping?
No. Lenvima capsules are stored and shipped at controlled room temperature. This is unlike many newer oncology biologics and simplifies logistics into markets without consistent cold-chain infrastructure.
Can M Care supply Lenvima to our market?
Yes. M Care sources Lenvima through licensed Indian distribution channels as a merchant exporter and dispatches against confirmed orders, subject to the buyer holding the appropriate import authorisation or the order being placed under a government/NGO procurement basis recognised in the destination market.
What indications is Lenvima licensed for?
Radioactive iodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, advanced renal cell carcinoma (in combination with everolimus or pembrolizumab), and advanced endometrial carcinoma in combination with pembrolizumab for patients whose tumours are mismatch repair-proficient (pMMR) or non-MSI-high, following prior systemic therapy. Buyers should confirm which combination indications are approved on their destination country's product labelling.
What strengths and dosing does Lenvima come in?
Capsules are supplied in 4 mg and 10 mg strengths. Daily dose depends on indication: 24 mg for thyroid cancer monotherapy, 8-12 mg (weight-based) for hepatocellular carcinoma, 18 mg in combination with everolimus for renal cell carcinoma, and 20 mg in combination with pembrolizumab for renal cell or endometrial carcinoma.
Does M Care hold manufacturing or WHO-GMP certification for Lenvima?
No. M Care is a merchant exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ status itself. Lenvima is sourced from the originator's licensed Indian distribution channel and supplied with the manufacturer's own quality documentation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
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.