Calquence (acalabrutinib) is an originator BTK inhibitor under AstraZeneca patent, supplied to CLL/SLL and MCL programmes through licensed distribution, not generic manufacture.
Calquence (acalabrutinib) is AstraZeneca's oral BTK inhibitor for chronic lymphocytic leukaemia, small lymphocytic lymphoma and mantle cell lymphoma. M Care sources it as a merchant exporter through licensed Indian distribution channels and moves it to hospital pharmacies, oncology centres and tender desks across our served markets. We do not manufacture Calquence; we manage the paperwork, cold-chain-free logistics and CDSCO export documentation around it.
Acalabrutinib exporter and bulk supplier from India.
For tender and bulk hospital orders, M Care coordinates Calquence procurement through licensed Indian distribution of the AstraZeneca originator product, batch-traceable from source to destination port. Because acalabrutinib's patent has not yet expired in most of our served markets, bulk lots move as branded originator stock rather than generic tonnage. The Mumbai desk handles CDSCO export clearance, COA and batch documentation, and coordinates directly with MoH tender desks and NGO procurement bodies (Global Fund, UNICEF-aligned buyers) on lead times and shipment scheduling.
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.
Acalabrutinib is a second-generation, covalent Bruton's tyrosine kinase (BTK) inhibitor. It binds BTK selectively, blocking B-cell receptor signalling that CLL, SLL and MCL cells depend on for survival and proliferation.
Per the FDA label, Calquence is indicated for adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), and for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, as well as previously untreated MCL in combination with bendamustine and rituximab for patients ineligible for autologous stem cell transplant. Other licensed indications may apply per destination-country labelling.
Calquence is supplied as a 100 mg film-coated tablet (orange, oval, debossed 'ACA 100'), dosed at 100 mg orally approximately every 12 hours. It is an oral solid dose product: no cold chain is required, and it ships and stores at controlled room temperature, distinct from the biologics in our oncology roster.
Active ingredient
acalabrutinib. Bruton's tyrosine kinase (BTK) inhibitor.
Forms and strengths
100 mg.
Indications
Oral BTK inhibitor licensed for chronic lymphocytic leukaemia, small lymphocytic lymphoma, and mantle cell lymphoma per FDA label.
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 typically fall into three groups: hospital and cancer-centre pharmacies dispensing CLL/SLL and MCL regimens, MoH tender desks in GCC and African markets running oncology procurement lines, and licensed importers/wholesalers building out branded oncology ranges for private and NGO-linked hospital networks. NGO procurement bodies sourcing haematology-oncology therapies for donor-funded programmes are also a fit where Calquence sits on an approved treatment protocol.
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 acalabrutinib.
Calquence moved from a capsule to a film-coated tablet formulation; AstraZeneca's current US label covers the tablet only, dosed as 100 mg swallowed whole, approximately every 12 hours, with or without food. Tablets must not be chewed, crushed, dissolved or cut. If a dose is missed by more than 3 hours, the label instructs skipping it and resuming at the next scheduled time rather than doubling up.
The formulation change matters operationally: the earlier capsule required strict spacing from acid-reducing agents (avoiding proton pump inhibitors, staggering H2-receptor antagonists and antacids) because gastric pH affected capsule absorption. The current tablet label states no clinically significant pharmacokinetic difference was observed when acalabrutinib was co-administered with rabeprazole, a proton pump inhibitor, so hospital pharmacies switching patients or writing formulary guidance should confirm which formulation (and which country label) a given batch corresponds to before applying legacy PPI-spacing rules.
As an oral solid dose product, Calquence needs no cold-chain handling in transit or on the ward, unlike the biologic oncology agents on our list. Confirm any patient-specific dose reductions or interruptions for adverse events against the destination-market label, since dose modification tables can differ slightly between the FDA, EMA and other regulator labels.
Acalabrutinib is a small molecule, not a biologic, so the biosimilar pathway does not apply to it; the relevant comparison is a generic, and no licensed generic of acalabrutinib currently exists in any market we serve. Supply runs exclusively through AstraZeneca's licensed distribution chain, so batch traceability back to the originator is the compliance point tender desks should verify, not manufacturer-line counts.
The documentation pack a regulator actually asks for.
Because Calquence is an oral solid dose originator product rather than a biologic, the documentation chain centres on batch traceability and import licensing rather than cold-chain validation. M Care's export desk prepares CDSCO export documentation, certificates of analysis and batch records for each consignment, and coordinates destination-market import requirements (MHRA, SFDA, MOHAP, NAFDAC, PPB, SAHPRA or the relevant national regulator) alongside the buyer's own import licence.
Acalabrutinib remains under patent in the large majority of our served markets, so there is no generic version to source (the biosimilar pathway does not apply to small-molecule drugs like acalabrutinib). Every unit M Care moves is AstraZeneca-branded stock obtained through licensed Indian distribution channels of the originator, not generic manufacture. We state this plainly to tender desks and importers rather than implying a generic alternative exists where none is licensed.
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 acalabrutinib.
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 acalabrutinib.
- 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.
Acalabrutinib supply, the specific questions.
Is there a generic version of Calquence (acalabrutinib)?
No. Acalabrutinib is a small-molecule originator drug still under AstraZeneca patent protection in essentially all of the markets M Care serves, so no licensed generic exists (as a small molecule, it also has no biosimilar pathway, since biosimilars apply only to biologic drugs). Supply runs through licensed distribution of the branded originator product, not generic manufacturing.
Does Calquence need cold-chain shipping?
No. Calquence is a 100 mg film-coated tablet, an oral solid dose product. It ships and stores at controlled room temperature and does not require the cold-chain handling used for M Care's biologic oncology lines.
Can M Care supply Calquence to our market?
Yes. M Care sources Calquence through licensed Indian distribution channels of the AstraZeneca originator and exports on an import-basis: the receiving importer or hospital holds the relevant destination-market import authorisation, and M Care's Mumbai desk manages CDSCO export documentation and batch traceability on our side.
Is Calquence the tablet or the capsule formulation?
AstraZeneca's current US label covers the 100 mg film-coated tablet. An earlier gelatin capsule formulation existed and carried stricter spacing requirements from acid-reducing medicines; the tablet label states no clinically significant interaction with the proton pump inhibitor rabeprazole. Confirm which formulation applies to your destination-market label before setting dispensing or interaction guidance.
What indications is Calquence licensed for?
Per the FDA label, Calquence is indicated for adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), and for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, plus previously untreated MCL in combination with bendamustine and rituximab for transplant-ineligible patients. Other licensed indications may apply per destination-country labelling.
What dosing schedule does Calquence use?
100 mg taken orally approximately every 12 hours, swallowed whole with or without food. Tablets must not be chewed, crushed, dissolved or cut. A dose missed by more than 3 hours is skipped rather than doubled at the next scheduled time.
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.