Kisqali (ribociclib) is patent-protected in every major market, so there is no generic tablet to source, only licensed-brand supply chains to verify.
Kisqali (ribociclib), Novartis's originator CDK4/6 inhibitor, has no licensed generic in any of M Care's served markets. We move it through licensed Indian distribution channels for hospital and tender buyers across the GCC, Africa and our other export markets, alongside the regulatory paperwork a QT-monitored oncology brand needs to clear customs.
Ribociclib exporter and bulk supplier from India.
For tender and bulk hospital-formulary supply, M Care sources Kisqali through licensed Indian distribution channels tied to the Novartis originator chain, not from a generic manufacturer, since none exists for this molecule. We handle CTD/eCTD-format documentation, freight matched to the storage instruction printed on the batch actually being supplied, and the batch-release paperwork MoH tender desks and NGO procurement officers ask for. Quantities and delivery lanes are confirmed against the destination country's import licence before we quote.
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.
CDK4/6 (cyclin-dependent kinase 4/6) inhibitor, sourced and documented for export.
Ribociclib is a CDK4/6 (cyclin-dependent kinase 4/6) inhibitor. It blocks the transition from G1 to S phase in the cell cycle in hormone receptor-positive breast cancer cells, given in combination with endocrine therapy rather than as monotherapy.
FDA-approved indications: in combination with an aromatase inhibitor for the adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence; and in combination with an aromatase inhibitor or fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or after progression on prior endocrine therapy. In pre- or perimenopausal women (and in men, for the early-breast-cancer indication), the aromatase inhibitor is combined with an LHRH agonist. Other licensed indications may apply per destination-country labelling.
Marketed as 200 mg film-coated tablets, the only strength on the label; the prescribed dose is achieved with two or three tablets depending on indication. Storage has changed twice in recent years: an EU labelling update from February 2025 introduced refrigerated storage at 2-8C until dispensing, but a further update from February 2026 removed that requirement, extending the authorised shelf life to 2 years at room temperature provided the tablets stay in their original packaging. US labelling has specified room-temperature storage throughout. Because transitional stock can still carry the older instruction, the storage statement on the batch's own packaging and leaflet should always be checked rather than assumed.
Active ingredient
ribociclib (as ribociclib succinate). CDK4/6 (cyclin-dependent kinase 4/6) inhibitor.
Forms and strengths
200 mg tablet.
Indications
Indicated in combination with an aromatase inhibitor or fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer, and in combination with an aromatase inhibitor for high-risk HR-positive, HER2-negative early breast cancer.
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 Kisqali through the Mumbai desk are typically oncology-centre and private-hospital pharmacies, MoH cancer-treatment tender desks in the GCC and African markets we serve, and licensed wholesalers or importers who hold the destination country's oncology import authorisation. Because ribociclib is an originator brand rather than a generic molecule, we do not see NGO bulk-procurement demand of the kind seen for WHO EML generics; buyers are almost always formulary-driven hospital or MoH programmes naming Kisqali specifically.
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 ribociclib.
Dosing differs by indication. For early breast cancer the dose is 400 mg (two 200 mg tablets) once daily; for advanced or metastatic disease it is 600 mg (three 200 mg tablets) once daily. Both regimens run 21 consecutive days on, then 7 days off, in 28-day cycles, taken with or without food at approximately the same time each day. A missed or vomited dose is not replaced; the patient resumes at the next scheduled time.
QTc prolongation is dose-dependent and is the main reason ribociclib needs active monitoring rather than passive dispensing. Obtain a baseline ECG and electrolyte panel before the first dose, repeat the ECG at approximately day 14 of cycle 1, and again as clinically indicated, particularly after any dose adjustment. Correct hypokalaemia or hypomagnesaemia before starting and during treatment. Avoid co-prescribing with other QT-prolonging agents (the label names, among others, amiodarone, quinidine, sotalol, clarithromycin, moxifloxacin, haloperidol, methadone and ondansetron) and with strong CYP3A4 inhibitors or inducers, since ribociclib is a CYP3A4 substrate and moderate CYP3A4 inhibitor itself.
Liver enzymes need the same discipline as the ECG schedule: monitor LFTs every 2 weeks for the first 2 cycles, at the start of each of the following 4 cycles, then as clinically indicated. Hepatotoxicity and neutropenia are the other adverse effects that drive dose interruption or reduction per the label's dose-modification tables, so a full blood count belongs on the same monitoring calendar as the LFTs.
There is no licensed generic or biosimilar equivalent to substitute; ribociclib remains under patent protection, so brand continuity of supply, not brand-versus-generic switching, is the sourcing question for the pharmacy.
The documentation pack a regulator actually asks for.
Kisqali moves through M Care's dossier and documentation workflow the way any originator oncology brand does: CTD/eCTD-format import documentation, batch release certificates tied to the originator's manufacturing chain, and freight documentation matched to whichever storage instruction the batch's own packaging carries, since Novartis revised this requirement twice between February 2025 and February 2026. M Care does not manufacture ribociclib and does not hold WHO-GMP, WHO-PQ or US FDA registration; product is sourced through licensed Indian distribution channels connected to the Novartis originator supply chain, and every consignment is matched to the importer's own destination-country licence before dispatch.
Because ribociclib has no approved generic anywhere in M Care's served markets, the regulatory question buyers raise is supply continuity and storage compliance, not brand-versus-generic selection. We confirm the packaging-specific storage instruction (the older refrigerated-until-dispensed instruction versus the current room-temperature, 2-year-shelf-life instruction) against the batch actually being supplied, since transitional stock means pharmacies need the current instruction printed on that batch, not an assumed one.
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 ribociclib.
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 ribociclib.
- 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.
Ribociclib supply, the specific questions.
Is there a generic version of ribociclib we can source instead of Kisqali?
No. Ribociclib is patent-protected in every major market M Care serves, so there is no licensed generic tablet available. Kisqali is the only branded product on the market for this molecule at present.
Can M Care supply Kisqali to our market?
Yes. We supply Kisqali through licensed Indian distribution channels tied to the originator chain, matched against your country's own import and oncology-product licensing. Import basis and required documentation are confirmed with your regulatory team before we quote.
What are the storage requirements for Kisqali in transit?
This has changed twice recently: an EU labelling update from February 2025 required refrigerated storage at 2-8C until dispensing, but a further update from February 2026 removed that requirement, extending the shelf life to 2 years at room temperature in the original packaging. US packaging has specified room-temperature storage throughout. Because transitional stock can still carry the older instruction, we confirm and match freight conditions to the storage statement printed on the batch actually being supplied.
Does M Care manufacture Kisqali or hold WHO-GMP certification for it?
No. M Care is a merchant exporter, not a manufacturer. We do not hold WHO-GMP, WHO-PQ or US FDA registration; ribociclib is sourced through licensed Indian distribution channels connected to the originator's supply chain, and we handle the export documentation, not the manufacturing.
What dosing information does our pharmacy need before stocking Kisqali?
Dose depends on indication: 400 mg once daily for early breast cancer, 600 mg once daily for advanced/metastatic disease, both on a 21-days-on/7-days-off schedule. Baseline and day-14 ECGs, electrolyte checks, and a defined LFT monitoring calendar are part of safe dispensing, given ribociclib's dose-dependent QTc effect.
Can M Care support a tender submission for Kisqali?
Yes. We prepare CTD/eCTD-format documentation and batch release paperwork for MoH tender desks and hospital procurement, and confirm quantities and delivery lanes against your import licence before submission.
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.