Stivarga (regorafenib) is FDA- and EMA-licensed for metastatic colorectal cancer, GIST after imatinib and sunitinib failure, and hepatocellular carcinoma after sorafenib, dosed on a 21-day-on, 7-day-off cycle.
Stivarga (regorafenib), Bayer's oral multikinase inhibitor, is the brand named on the FDA and EMA labels for third-line mCRC, post-TKI GIST and post-sorafenib HCC. M Care sources Stivarga through licensed Indian distribution channels as a merchant exporter and dispatches to hospital pharmacies, MoH tender desks and licensed wholesalers across our 49 served markets.
Regorafenib exporter and bulk supplier from India.
For MoH tenders and hospital-group contracts, the Mumbai desk quotes Stivarga 40 mg tablets against confirmed order volumes and destination import permits, with CTD/eCTD-ready documentation and cold-chain-free logistics since the product is an oral solid with no refrigeration requirement. We do not publish list prices; every quote is built against the buyer's licence, quantity and delivery lane.
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.
Oral multikinase inhibitor (VEGFR1-3, TIE2, PDGFR, FGFR, KIT, RET, RAF/RAF1), sourced and documented for export.
Regorafenib is an oral multikinase inhibitor that blocks angiogenic (VEGFR1-3, TIE2), stromal (PDGFR, FGFR) and oncogenic (KIT, RET, RAF) receptor tyrosine kinases, giving it activity across three distinct solid-tumour settings.
Both the FDA label and the EMA EPAR license Stivarga for adults with metastatic colorectal cancer previously treated with available standard therapies, unresectable or metastatic GIST that has progressed on imatinib and sunitinib, and hepatocellular carcinoma previously treated with sorafenib. It carries a boxed warning for hepatotoxicity, requiring liver function monitoring.
Stivarga is supplied as 40 mg film-coated tablets, dispensed in a treatment pack sized to the 21-day dosing course. It is a room-temperature oral solid with no cold-chain requirement, simplifying last-mile logistics into markets without validated pharma cold storage.
Active ingredient
regorafenib. Oral multikinase inhibitor (VEGFR1-3, TIE2, PDGFR, FGFR, KIT, RET, RAF/RAF1).
Forms and strengths
40 mg.
Indications
Licensed for previously treated metastatic colorectal cancer, GIST progressing on imatinib and sunitinib, and hepatocellular carcinoma previously treated with sorafenib, per FDA and EMA labelling.
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 Stivarga typically fall into three groups: hospital oncology pharmacies and private cancer centres across the GCC and Africa ordering against named-patient or formulary demand, MoH tender desks in Saudi Arabia, Nigeria, Kenya and neighbouring markets running oncology procurement rounds, and licensed importers and wholesalers who hold the market authorisation or import permit for their territory and re-distribute to treating hospitals.
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 regorafenib.
Stivarga is dosed at 160 mg (four 40 mg tablets) once daily for the first 21 days of each 28-day cycle, then withheld for 7 days before the next cycle starts. This 3-weeks-on, 1-week-off rhythm is the single detail every dispensing pharmacist needs to get right: a missed dose within 12 hours can still be taken, but beyond that it is skipped, and the cycle count is not extended to make up for it.
Take tablets with a low-fat breakfast (under 30% fat), at the same time each day, and swallow whole with water. A high-fat meal alters absorption, so counselling on meal timing at dispensing matters as much as the dose itself.
The boxed warning is hepatotoxicity: liver function tests (ALT, AST, bilirubin) are checked before starting, then at least every two weeks for the first two months, then monthly. Dose interruption, reduction (to 120 mg or 80 mg daily) or permanent discontinuation follow defined LFT and clinical thresholds on the label, so procurement teams supplying hospital pharmacies should expect dose-reduced pack requests, not just the standard 160 mg course.
Hand-foot skin reaction and hypertension are the other two adverse effects that drive dose modification in practice; buyers building formulary stock should plan for the 120 mg and 80 mg tablet-count adjustments alongside the full 160 mg course rather than treating Stivarga as a fixed single-strength order.
The documentation pack a regulator actually asks for.
As an oral solid tablet, Stivarga does not require cold-chain handling: M Care's documentation chain for this product covers CDSCO export clearance, batch-level certificates of analysis and pharmacovigilance traceability from the licensed Indian distribution channel through to destination customs, without the temperature-logging requirements that apply to biologics.
Stivarga is a patented, single-source originator brand; Bayer is the sole marketing authorisation holder under both the FDA approval and the EMA centralised authorisation, and no generic version of regorafenib is currently approved by the FDA or EMA. Buyers sourcing regorafenib today are sourcing the Bayer brand through licensed channels, not choosing between brand and generic.
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 regorafenib.
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 regorafenib.
- 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.
Regorafenib supply, the specific questions.
Is there a generic version of Stivarga (regorafenib)?
No. Regorafenib remains under patent, and Bayer is the sole marketing authorisation holder in both the FDA- and EMA-approved markets. M Care sources Stivarga through licensed Indian distribution channels rather than from generic manufacturers.
Can M Care supply Stivarga to my country?
M Care exports to 49 markets across the GCC, Africa, Europe and Southeast Asia. Supply into any specific market is arranged against the buyer's own import licence or the destination MoH's registration and tender terms; contact the Mumbai desk with your market and licence status to confirm the fastest route.
What indications is Stivarga licensed for?
The FDA and EMA both license Stivarga for previously treated metastatic colorectal cancer, GIST that has progressed on both imatinib and sunitinib, and hepatocellular carcinoma previously treated with sorafenib. Other licensed indications may apply per destination-country labelling.
Does Stivarga need cold-chain shipping?
No. Stivarga is an oral tablet stored at controlled room temperature, so it does not require the temperature-monitored cold-chain logistics that biologic oncology products need.
What is the Stivarga dosing schedule buyers should know for demand planning?
The label dose is 160 mg once daily for 21 days of each 28-day cycle, followed by a 7-day break. Hospital pharmacies also request dose-reduced 120 mg and 80 mg packs for patients managed down from the full dose, which is worth factoring into order volumes.
Does M Care hold a manufacturing licence for regorafenib?
No. M Care is a merchant exporter, not a manufacturer. We source Stivarga through Bayer's licensed Indian distribution channels and handle CDSCO export documentation, CTD/eCTD-ready paperwork and dispatch; we do not manufacture or hold WHO-GMP or WHO-PQ status ourselves.
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.