Imbruvica (ibrutinib) remains patent-protected in most of M Care's export markets, so supply runs through licensed originator distribution channels rather than generic manufacturers.
Imbruvica (ibrutinib), the Bruton's tyrosine kinase inhibitor from Pharmacyclics/AbbVie/Janssen, is a first-line oral option in CLL/SLL and Waldenstrom's macroglobulinaemia. M Care sources it through licensed Indian distribution channels for hospital tenders, MoH procurement lists and named-patient import requests across our export markets. We are a merchant exporter: we verify licensure, dossier and cold-chain-free logistics for every consignment, we do not manufacture.
Ibrutinib exporter and bulk supplier from India.
For tender and bulk hospital orders, M Care packages Imbruvica supply against the buyer's own registration status in the destination market: MoH-listed tenders (GCC, several African ministries), named-patient/unlicensed-import routes where Imbruvica has no local marketing authorisation, and standing wholesaler stock lines for importers who already hold the product on their formulary. Because ibrutinib is an originator small-molecule oncology brand still under patent and exclusivity protection in most of our export markets, no marketed generic line exists to substitute; every quote is built against verifiable batch documentation from the licensed distribution chain, not a manufacturer price list.
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.
Bruton's tyrosine kinase (BTK) inhibitor, sourced and documented for export.
Ibrutinib is a small-molecule Bruton's tyrosine kinase (BTK) inhibitor. It binds covalently to a cysteine residue in the BTK active site, blocking B-cell receptor signalling that malignant B-cells depend on for survival and proliferation.
FDA-labelled indications are chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), including patients with 17p deletion, Waldenstrom's macroglobulinaemia (WM), and chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy, in patients aged 1 year and older. Buyers should confirm the current label for their destination market, since licensed indications and age cut-offs can vary by regulator.
Imbruvica is supplied as capsules (70 mg, 140 mg), film-coated tablets (140 mg, 280 mg, 420 mg) and a 70 mg/mL oral suspension. Capsules and tablets are stored at controlled room temperature, 20-25C, with brief excursions to 15-30C permitted. The oral suspension is stored at 2-25C, must not be frozen, and any unused suspension is discarded 60 days after first opening. None of the three formats needs cold-chain transport in the WHO-GMP sense; the suspension's lower storage bound is a refrigeration option, not a requirement.
Active ingredient
ibrutinib. Bruton's tyrosine kinase (BTK) inhibitor.
Forms and strengths
70 mg capsule; 140 mg capsule; 140 mg tablet; 280 mg tablet; 420 mg tablet; 70 mg/mL oral suspension.
Indications
Oral BTK inhibitor licensed for chronic lymphocytic leukaemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinaemia, and chronic graft-versus-host disease after failure of prior systemic therapy.
Administration
oral. Capsules, film-coated tablets, and oral suspension.
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.
Demand for Imbruvica through M Care comes mainly from hospital pharmacies and haemato-oncology units placing named-patient or unlicensed-import orders where the brand is not yet locally registered, MoH tender desks in GCC and African markets building oncology formularies, and licensed importers or wholesalers who stock it against an existing local marketing authorisation. We also field enquiries from NGO and Global Fund-adjacent procurement teams sourcing oral oncology therapy for referral hospitals that lack in-country CLL/WM treatment access.
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 ibrutinib.
Dosing is once daily and indication-dependent: 420 mg once daily for CLL/SLL and WM, and 420 mg once daily for cGVHD in patients aged 12 and over (paediatric cGVHD dosing from age 1 to under 12 is weight/BSA-based at 240 mg/m2 once daily, capped at 420 mg). Capsules and tablets are swallowed whole with water; capsules must not be opened, broken or chewed, and tablets must not be cut, crushed or chewed. A missed dose can still be taken the same day if remembered, but the patient should not double up the next day to compensate.
CYP3A interaction management is the single most consequential counselling point for a receiving pharmacist. Strong CYP3A inducers should be avoided outright; moderate or strong CYP3A inhibitors require a reduced ibrutinib dose per the label's interaction table. Grapefruit and Seville oranges are contraindicated with dosing due to CYP3A inhibition. Hepatic impairment also changes the dose: severe impairment means avoiding ibrutinib altogether, mild-to-moderate impairment requires a reduced dose.
Monitoring on therapy includes monthly complete blood counts for cytopenias and periodic hepatic function checks. Because ibrutinib carries a bleeding risk, anticoagulant and antiplatelet use should be reviewed at initiation, and the label recommends withholding ibrutinib for 3 to 7 days before and after invasive procedures depending on bleeding risk and procedure type. Cardiac monitoring matters too: the label flags Grade 2 or higher cardiac failure and Grade 3 cardiac arrhythmias as reasons to interrupt or adjust therapy, so a new arrhythmia in a patient on ibrutinib is not a background finding to file away.
Storage is straightforward for the capsule and tablet formats: controlled room temperature, no cold chain, retain in original packaging until dispensing. The oral suspension is the one format that needs a temperature-controlled shelf (2-25C, never frozen) and a 60-day in-use discard clock once opened, which matters for any paediatric cGVHD order.
The documentation pack a regulator actually asks for.
Imbruvica is an originator small-molecule oncology brand. No generic version is currently marketed in any of M Care's core export markets: FDA has granted only tentative approval to one generic tablet, blocked from launch by exclusivity, and India's courts have restrained several manufacturers from making or selling generic ibrutinib. As a chemical entity rather than a biologic, it is also not eligible for the biosimilar substitution pathway that applies to monoclonal antibodies. Supply into M Care's export markets runs through licensed Indian distribution channels for the originator product, verified against destination-market import and pharmacovigilance requirements case by case, rather than sourced from a panel of generic manufacturers.
Because the dosage forms are oral solids or a room-temperature-stable suspension, the documentation chain is built around batch release certificates, certificates of analysis, and CTD/eCTD-format dossier support for markets that require local registration, not cold-chain validation records. M Care's Mumbai desk coordinates CDSCO export paperwork on the Indian side and works with the buyer's regulatory team on MHRA (Medicines and Healthcare products Regulatory Agency, UK), SFDA (Saudi Food and Drug Authority), NAFDAC (Nigeria) or equivalent destination-country requirements, including named-patient/unlicensed-import documentation where the brand has no local marketing authorisation yet.
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 ibrutinib.
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 ibrutinib.
- 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.
Ibrutinib supply, the specific questions.
Is there a generic or biosimilar version of Imbruvica we can source instead?
Not yet. Ibrutinib is a patented small-molecule originator product from Pharmacyclics. A generic tablet has received tentative FDA approval but is blocked from sale until exclusivity expires, and no generic is currently marketed in our core export markets. As a chemical entity rather than a biologic, it is not eligible for the biosimilar pathway that applies to antibody drugs. Any supply of ibrutinib we handle today is Imbruvica sourced through licensed originator distribution channels.
Does Imbruvica need cold-chain logistics?
No, for the capsule and tablet forms. Both are stored and shipped at controlled room temperature (20-25C). The oral suspension is the exception: it should be kept at 2-25C, must not be frozen, and has a 60-day in-use discard window once opened, so it needs temperature-controlled handling even though it is not a frozen or deep-refrigerated cold-chain product.
Can M Care supply Imbruvica to a market where it isn't yet locally registered?
Yes. Where Imbruvica has no local marketing authorisation, supply typically moves through the named-patient or unlicensed-import route recognised by the destination regulator, with the receiving hospital or importer providing the physician request and import permit documentation the local authority requires. M Care coordinates the export-side paperwork through CDSCO on the Indian side.
What indications is Imbruvica licensed for?
The FDA label covers chronic lymphocytic leukaemia/small lymphocytic lymphoma, including patients with 17p deletion, Waldenstrom's macroglobulinaemia, and chronic graft-versus-host disease after failure of prior systemic therapy in patients aged 1 and older. Licensed indications can differ by destination-country label, so buyers should confirm against the local regulator's approved indication set.
What dosage strengths and forms does Imbruvica come in?
Capsules at 70 mg and 140 mg, film-coated tablets at 140 mg, 280 mg and 420 mg, and a 70 mg/mL oral suspension for patients who cannot swallow capsules or tablets, including younger paediatric cGVHD patients.
Can M Care supply Imbruvica for a hospital tender?
Yes. We quote against MoH tender specifications and hospital formulary listings across our GCC, African and other export markets, building each quote against verifiable batch and distribution-chain documentation rather than a fixed price list.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-26.
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.