Inlyta (axitinib) is FDA-licensed both as monotherapy for advanced renal cell carcinoma after prior therapy and in combination with avelumab or pembrolizumab as first-line treatment, so buyers need to specify which regimen a tender is sourcing for.
Inlyta (axitinib) is a tyrosine kinase inhibitor for advanced renal cell carcinoma. FDA labelling licenses it as monotherapy in the second-line setting or in combination with a checkpoint inhibitor as first-line therapy; the EU authorisation currently licenses Inlyta as monotherapy only, for use after failure of prior sunitinib or a cytokine, so buyers should confirm which regimen their destination-market label supports before ordering. M Care sources Inlyta through licensed Indian pharmaceutical distribution channels and dispatches to hospital pharmacies, MoH tender desks and licensed importers across our GCC, African and EU lanes as a merchant exporter, not a manufacturer.
Axitinib exporter and bulk supplier from India.
For tender and bulk hospital procurement, the Mumbai desk quotes Inlyta against confirmed order volume and destination-market licensing status, sourcing stock through licensed Indian pharmaceutical distribution channels rather than open-market resale. Inlyta's core US compound patent has expired, but no FDA-approved generic axitinib has reached market yet (tentative approvals only, as of our last check), and axitinib remains patent-protected in several of our other served markets, so every quote is currently for the originator brand, with CTD/eCTD-ready documentation and controlled-room-temperature logistics since the product is an oral solid, not a cold-chain product. We can structure split-shipment schedules against MoH or NGO tender timelines on request, and confirm current SKU and pack-size availability at enquiry stage rather than off a fixed catalogue.
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.
Tyrosine kinase inhibitor (VEGFR-1, -2, -3 inhibitor), sourced and documented for export.
Axitinib is a small-molecule tyrosine kinase inhibitor that blocks VEGFR-1, -2 and -3, reducing tumour angiogenesis in renal cell carcinoma. It is taken orally and does not require the infusion infrastructure that checkpoint inhibitors like pembrolizumab or avelumab need when co-prescribed.
Per FDA labelling, Inlyta is indicated for adult patients with advanced renal cell carcinoma, either as first-line therapy in combination with avelumab or pembrolizumab, or as monotherapy following failure of one prior systemic treatment. The EU authorisation is narrower: Inlyta is licensed as monotherapy only, for advanced RCC after failure of prior sunitinib or a cytokine, with no combination indication on the current EU product information. Licensed indications vary by destination country; buyers should confirm against the local regulator's approved use before tender submission.
Inlyta is supplied as red film-coated tablets in four strengths: 1 mg (oval), 3 mg (round), 5 mg (triangular) and 7 mg (diamond-shaped), for oral use. As an oral solid, it does not require cold-chain handling; standard controlled-room-temperature storage and transport applies, which simplifies logistics into markets without validated cold lanes.
Active ingredient
axitinib. Tyrosine kinase inhibitor (VEGFR-1, -2, -3 inhibitor).
Forms and strengths
1 mg; 3 mg; 5 mg; 7 mg.
Indications
FDA-licensed for advanced renal cell carcinoma, as first-line therapy in combination with avelumab or pembrolizumab, or as monotherapy after failure of one prior systemic treatment. The EU authorisation is narrower: monotherapy only, after failure of prior sunitinib or a cytokine. Confirm destination-market labelling before tender submission.
Administration
oral. Film-coated tablet.
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 Inlyta typically fall into three groups: oncology-unit hospital pharmacists procuring against a named-patient or formulary line, MoH tender desks in the GCC and Africa running oncology procurement rounds, and licensed importers or wholesalers who hold the destination-market authorisation to bring a Pfizer-licensed oncology product into their territory. NGO and donor-funded procurement (Global Fund, UNICEF-adjacent channels) is less common for axitinib than for infectious-disease drugs, but M Care can support documentation for any qualified buyer.
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 axitinib.
Confirm which regimen the requisition is for, and which indication the destination-market label supports, before quoting: FDA labelling covers both monotherapy and combination use, while the EU label currently authorises monotherapy only. Monotherapy starts at 5 mg twice daily, taken roughly 12 hours apart; where a combination regimen with avelumab or pembrolizumab is on-label or clinically prescribed, it also starts at 5 mg twice daily alongside the immunotherapy infusion schedule. Dose titration for either regimen can range from 2 mg to 10 mg twice daily based on individual tolerability, so pharmacies should stock the 1 mg and 5 mg tablet strengths as a minimum (with 3 mg and 7 mg available in markets where Inlyta is licensed in those strengths) to support dose adjustment without a fresh prescription cycle.
Inlyta can be taken with or without food; tablets should be swallowed whole with water, not crushed or split. This is a meaningful counselling point versus other oncology TKIs that carry food-timing restrictions.
Hypertension is the most common early adverse effect, usually within the first month of therapy, and blood pressure should be monitored from treatment start. Where axitinib is combined with a checkpoint inhibitor, hepatotoxicity and thyroid dysfunction (TSH monitoring at baseline and periodically) are more frequent than with axitinib monotherapy, so combination-regimen orders should prompt a check that the receiving pharmacy has liver-function and TSH monitoring built into its protocol. Proteinuria should also be checked at baseline; therapy is withheld above 2 g/24-hour proteinuria and resumed at a reduced dose once it resolves.
Strong CYP3A4/5 inhibitors require roughly a 50% dose reduction for axitinib, and moderate hepatic impairment calls for a lower starting dose with severe hepatic impairment not recommended; flag any co-medication or hepatic-impairment context on the order so the correct pack size and counselling material accompany the shipment.
The documentation pack a regulator actually asks for.
Axitinib is an oral solid, so the documentation chain centres on CTD/eCTD dossier support, certificates of analysis and batch traceability through licensed Indian distribution channels, rather than the cold-chain validation records needed for a biologic. M Care can provide import documentation aligned to Central Drugs Standard Control Organisation (CDSCO, India) export licensure for every consignment.
Axitinib's core US compound patent has expired, but no FDA-approved generic axitinib has reached market yet (only tentative approvals on file at the time of writing), and Inlyta remains under patent protection in several of the other markets we serve; buyers should treat brand-name Inlyta as the only currently licensed sourcing route in most jurisdictions, and confirm patent and generic-entry status locally given how quickly this could change.
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 axitinib.
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 axitinib.
- 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.
Axitinib supply, the specific questions.
Is there a generic version of Inlyta (axitinib) we can source instead?
Not yet in most of the markets M Care serves. Inlyta's core US compound patent has expired, but no FDA-approved generic axitinib has reached market (only tentative approvals so far), and axitinib remains patent-protected in the major GCC, African and EU markets we ship into. Inlyta is the only FDA- and EMA-licensed brand currently available; we source it through licensed Indian pharmaceutical distribution channels. There is no generic line to substitute at present, though buyers evaluating alternatives closer to patent expiry should ask us for a current check.
Can M Care supply Inlyta to my country?
Yes. M Care is a licensed Indian merchant exporter; we source Inlyta through licensed Indian pharmaceutical distribution channels and dispatch on an import basis to your market, subject to your national regulator's marketing authorisation or named-patient import route for the product. Tell us the destination country and buyer type (hospital, importer, MoH tender) and we will confirm the applicable import pathway and documentation.
Does axitinib need cold-chain shipping?
No. Inlyta is an oral film-coated tablet stored and transported at controlled room temperature, unlike the checkpoint inhibitors it is sometimes prescribed alongside. This simplifies logistics considerably compared with a biologic infusion product.
What tablet strengths does Inlyta come in?
Inlyta is marketed in 1 mg and 5 mg film-coated tablets in the US; the EU authorisation additionally includes 3 mg and 7 mg strengths. Together these cover the dose-titration range of 2 mg to 10 mg twice daily used in clinical practice. Confirm which strengths are licensed in your destination market when placing an order.
Is axitinib used alone or combined with immunotherapy?
Both, depending on the treatment line and the destination-market label. FDA labelling licenses axitinib as first-line therapy in combination with avelumab or pembrolizumab, and separately as monotherapy for patients whose renal cell carcinoma has progressed after one prior systemic treatment. The EU authorisation currently licenses Inlyta for monotherapy only, after failure of prior sunitinib or a cytokine. Confirm which regimen and which destination-market label applies when placing an order, since monitoring requirements differ.
What documentation does M Care provide with an Inlyta shipment?
We provide CTD/eCTD-ready dossier support, batch-level certificates of analysis and CDSCO export documentation for every consignment, sourced through licensed Indian pharmaceutical distribution channels. We do not manufacture axitinib and do not claim WHO-GMP or WHO-PQ status ourselves; we are a merchant exporter of a Pfizer-originated, licensed product.
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.