Dasatinib's absorption falls as gastric pH rises, which makes acid suppression a dispensing question, not a footnote.
The second-generation tyrosine kinase inhibitor used across chronic myeloid leukaemia and Philadelphia-positive ALL, and indicated where CML is resistant or intolerant to prior therapy, imatinib included. The EU product information reports responses across a range of imatinib-resistance mutations, with T315I the exception. Supplied as 20 to 140 mg film-coated tablets from Indian WHO-GMP-certified lines, the generic equivalent of Sprycel. M Care Exports is an exporter, not a manufacturer.
Why the acid-suppression question comes up before the first shipment.
Dasatinib's solubility is pH-dependent (EU product information, section 4.5), and the US label says not to give H2 antagonists or proton-pump inhibitors with it. If an antacid is needed, it goes at least 2 hours before or 2 hours after the dose, never at the same time. In the US label's interaction studies, omeprazole at steady state cut dasatinib AUC by 43% and famotidine cut it by 61%.
Bulk dasatinib tablets for importers, distributors and tender buyers, drawn from WHO-GMP-certified Indian manufacturers. M Care is the exporter, not the maker, and each quote names the manufacturing line behind it.
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.
Film-coated tablets from 20mg to 140mg, the generic equivalent of Sprycel, on WHO-GMP partner lines with per-market patent verification. M Care is an exporter, not a manufacturer.
Active ingredient
Dasatinib, an oral kinase inhibitor acting on BCR-ABL, the SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2 and PDGFR-beta. The US label says it does not appear to be active against T315I, on in vitro data. WHO EML 2023 lists it on the Complementary List for imatinib-resistant chronic myeloid leukaemia.
Strengths stocked
Film-coated tablets 20, 50, 70, 80, 100 and 140 mg, the same six that the US label, the EU product information and WHO EML 2023 list. In adults the starting dose is 100 mg once daily in chronic phase and 140 mg once daily in advanced phase and Ph+ ALL. For cytopenia the label steps a chronic-phase patient down to 80 mg and, in newly diagnosed disease, then to 50 mg. Where a strong CYP3A4 inhibitor cannot be avoided, it suggests considering 20 mg or 40 mg daily. Swallow whole, not crushed, cut or chewed.
Indications
Adults with newly diagnosed Ph+ chronic-phase CML, and with chronic, accelerated or blast-phase CML resistant or intolerant to prior therapy including imatinib. Adults with Ph+ ALL resistant or intolerant to prior therapy. Children aged 1 year and over with Ph+ chronic-phase CML, or with newly diagnosed Ph+ ALL alongside chemotherapy (US label).
Safety signals
No boxed warning and no contraindications on the US label. Its warnings cover myelosuppression, bleeding, fluid retention including pleural effusion, cardiovascular toxicity, pulmonary arterial hypertension, QT prolongation, severe skin reactions, tumour lysis syndrome, embryo-foetal toxicity and hepatotoxicity.
Storage and pack
The US label gives 20°C to 25°C, with excursions between 15°C and 30°C; the EU product information asks for no special storage conditions. Neither storage statement involves refrigeration. The EU pack list for Sprycel has Alu/Alu blisters and HDPE bottles, with bottles of 30 or 60 tablets depending on strength. The US label calls dasatinib an antineoplastic product and asks for special handling and disposal procedures.
Patent & lawful supply
DailyMed lists labels for generic dasatinib tablets from several US labellers alongside Sprycel. Patent positions are national, so we check the patent and licence position for the destination before every quote and quote only where supply is lawful. We do not supply into India.
Haematology and oncology programmes across the established lawful lanes.
India is our origin and we do not sell into the Indian market. For every other destination, supply is cleared country by country before a quote goes out.
Sub-Saharan African public-sector oncology
For KEMSA and PPB in Kenya, NAFDAC in Nigeria and SAHPRA in South Africa, the strength list can be checked against WHO EML 2023, which carries dasatinib on the Complementary List for imatinib-resistant CML as 20, 50, 70, 80, 100 and 140 mg tablets. Ghana (FDA), Ethiopia (EFDA), Tanzania (TMDA) and Uganda (NDA) are handled the same way.
GCC haematology centres
Hospital haematology units buy through licensed importers. In Saudi Arabia the regulator is the SFDA, and in the UAE the registrar is the Emirates Drug Establishment (EDE). We prepare the CTD for MoH registration or GCC central registration, with artwork in the languages the destination regulator asks for.
UK, EU and the post-expiry generic channel
UK and EU supply runs through licensed wholesalers, and only where our WHO-GMP partner lines hold the relevant authorisation. The named-patient and MHRA Specials routes cover individual access cases for CML and Ph+ ALL.
ASEAN, LATAM and haematology networks
Asian and Latin American orders (ANVISA in Brazil, COFEPRIS in Mexico, and the regulators of the Philippines, Vietnam, Indonesia, Bangladesh and Sri Lanka) go through a licensed importer. We name the source line first, so the importer can check it against the local register.
Blood counts, fluid retention, pulmonary hypertension, acid suppression and the T315I position.
Dasatinib is dosed once daily, with or without food, and the tablet is swallowed whole, not crushed or split. The standard chronic-phase CML dose is 100 mg once daily, and the advanced-phase CML and Ph+ ALL dose is 140 mg once daily, with the label's cytopenia rules stepping a chronic-phase patient down to 80 mg and, for newly diagnosed disease, to 50 mg, and an advanced-phase patient to 100 mg and then 80 mg. The US label carries no boxed warning and no contraindications. Where imatinib has failed or is not tolerated, the EU product information reports responses across a range of imatinib-resistance mutations, with T315I the exception: dasatinib does not appear to be active against it on in vitro data. Three signals dominate the safety profile. Myelosuppression comes first, and the label asks for a full blood count every 2 weeks for 12 weeks and then every 3 months in chronic-phase CML, or weekly for 2 months and then monthly in advanced-phase CML and Ph+ ALL. Fluid retention is second: in the US label, grade 3 or 4 fluid retention occurred in 6% of adult chronic-phase patients and in 8% of adult advanced-phase or Ph+ ALL patients, with grade 3 or 4 pleural effusion in 7% of the latter. New dyspnoea on exertion, pleuritic chest pain or dry cough calls for a chest X-ray, and management is supportive, with diuretics or a short steroid course, dose reduction or interruption. Pulmonary arterial hypertension is third: it can appear at any time, including after more than a year of treatment; it may be reversible on stopping, and the label says to discontinue permanently once it is confirmed. The label also covers bleeding (grade 3 or 4 haemorrhage in 5.8% of adults, mostly with severe thrombocytopenia) and QT prolongation, where low potassium and magnesium are corrected before and during treatment. For the dispensing pharmacist, acid suppression is a practical point: no H2 antagonists or proton-pump inhibitors, and antacids at least 2 hours before or after the dose.
The documentation pack a regulator actually asks for.
We collect the dasatinib documents from the source plant and send one checked set, so the buyer is not chasing the manufacturer for each file.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
CTD Module 3
Drug substance and finished-product data for a film-coated tablet in which dasatinib is present as the monohydrate. The reference tablets contain lactose monohydrate (135 mg in the 100 mg tablet, 189 mg in the 140 mg tablet), so excipient declarations need care. Dissolution, uniformity and stability data are supplied for the climatic zone of the destination.
Bioequivalence
A comparative bioequivalence study report against the Sprycel reference tablet, supplied for new registrations. Gastric acid changes dasatinib exposure, so the source line can be asked which fasting and acid conditions its study used.
Patent verification per market
Each quote carries a short patent note for the destination country: what was checked, and whether supply there is lawful. Where it is not, we say so and do not quote.
Molecular-monitoring annex
A destination-language annex for the receiving haematology service: BCR-ABL transcript monitoring, the label's blood-count schedule, the acid-suppressant rule and the T315I caveat, supplied with the product.
CoA + WHO-GMP per batch
Batch certificate of analysis with assay, related substances, dissolution, uniformity of dosage units and water content, signed by the source plant's QC head. The WHO-GMP certificate and the CoPP come from the Indian state drug regulator, apostilled where the destination asks.
Pharmacovigilance
A named pharmacovigilance contact in the destination once the product is registered, with PSURs to ICH E2C. Reports of pleural effusion, pulmonary arterial hypertension, cytopenias, QT prolongation and bleeding are routed first.
The TKI line of therapy and the supportive shelf.
WHO EML 2023 lists dasatinib, nilotinib and imatinib together on its Complementary List for targeted therapies. Imatinib's entry covers CML, gastrointestinal stromal tumour and Ph+ ALL; the dasatinib and nilotinib entries are for imatinib-resistant CML.
Imatinib
On the WHO EML Complementary List as a 100 mg and 400 mg solid oral form. Dasatinib's US and EU indications include CML that is resistant or intolerant to prior therapy including imatinib.
Nilotinib
The other second-generation BCR-ABL TKI on the EML for imatinib-resistant CML. It comes as capsules where dasatinib is a tablet, and the choice between them rests with the treating haematologist.
Oncology portfolio →
Cytotoxics, targeted therapies, immunomodulators, monoclonal antibodies, hormonal agents and supportive care in one oncology range.
CTD / eCTD dossier preparation
CTD Module 3, comparative bioequivalence and the per-market patent-verification pack assembled for new dasatinib registrations.
GCC MoH registration
Ministry of health and GCC central registration routes for a dasatinib file, with Arabic pack and insert artwork.
South Africa market
SAHPRA registration detail for a dasatinib file in South Africa.
All products →
The full portfolio across 18 therapeutic areas, from anti-infectives and oncology to immunology and surgical disposables.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength mix (20 / 50 / 70 / 80 / 100 / 140 mg), monthly patient count, destination, and channel: haematology centre, CML or Ph+ ALL programme, or tender. Say whether the use is newly diagnosed chronic-phase CML, imatinib-resistant or intolerant CML, or Ph+ ALL, so we match the insert text.
- We clear patent and licence, then pick the line. A short patent and licence note for the destination country. If supply there is not lawful, we say so and stop.
- Price and paperwork. FOB or CIF price, dossier and bioequivalence status, the annex and the documentation pack, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch, in-transit logging and on-arrival inspection. Timing for made-to-order batches is agreed per order.
- After delivery. Batch records, CoA and stability data stay on file. Once the product is registered, the PV contact is opened and adverse-event routing is set up.
Dasatinib supply, the specific questions.
What strengths and pack formats of dasatinib do you supply?
Film-coated tablets across the full CML and Ph+ ALL dosing range: 20, 50, 70, 80, 100 and 140 mg. The 100 mg once-daily is the standard chronic-phase CML dose; 140 mg once-daily is the standard advanced-phase CML and Ph+ ALL dose; the 80 mg and 50 mg tablets match the label's dose reductions for cytopenia, and 20 mg or 40 mg daily is the label's reduced dose when a strong CYP3A4 inhibitor cannot be avoided. Pack formats: Alu-Alu blister and HDPE bottle (30 or 60 tablets) for institutional and tender supply. All from Indian WHO-GMP-certified facilities. Dasatinib is taken once daily, with or without food, and the tablets are not to be crushed or split.
Is M Care a dasatinib manufacturer?
No. M Care is a merchant exporter and owns no plant. Dasatinib comes from Indian WHO-GMP-certified manufacturing lines, and each quote is matched to one line. The CoA is supplied for that line, and the WHO-GMP certificate and CoPP come from the Indian state drug regulator. Where a destination expects an EU-GMP-capable source, we quote from a line that is.
What is the patent and licence position by destination market?
It differs by country, and we settle it before quoting. DailyMed lists labels for generic dasatinib tablets from several US labellers, but patent and licence positions are national, so each enquiry gets its own check against the destination. Where supply would not be lawful we decline the quote. We do not supply into India.
What is dasatinib used for clinically?
Dasatinib is a second-generation BCR-ABL tyrosine kinase inhibitor used in Philadelphia-chromosome-positive leukaemias. In chronic myeloid leukaemia it is used in newly diagnosed chronic-phase CML and in chronic, accelerated or blast-phase CML that is resistant or intolerant to prior therapy including imatinib. The EU product information reports responses across a range of imatinib-resistance mutations, with T315I the exception. In Philadelphia-positive acute lymphoblastic leukaemia the adult indication is disease resistant or intolerant to prior therapy, and the US label also covers children aged 1 year and over with newly diagnosed Ph+ ALL, given with chemotherapy. WHO EML 2023 lists dasatinib for imatinib-resistant CML. Treatment starts under a physician experienced in leukaemia.
What are the key safety points for dasatinib?
The US label has no boxed warning and no contraindications. Its warnings start with myelosuppression: a full blood count every 2 weeks for 12 weeks and then every 3 months in chronic-phase CML, or weekly for 2 months and then monthly in advanced-phase CML and Ph+ ALL. Fluid retention follows, with grade 3 or 4 pleural effusion in 7% of advanced-phase and Ph+ ALL patients. Pulmonary arterial hypertension can appear after more than a year of treatment and, once confirmed, means permanent discontinuation. The label also lists bleeding, cardiac dysfunction, QT prolongation, severe skin reactions, tumour lysis syndrome, embryo-fetal toxicity and hepatotoxicity. For the pharmacist: no H2 antagonists or proton-pump inhibitors, antacids 2 hours before or after the dose, and a reduced dose if a strong CYP3A4 inhibitor cannot be avoided.
Which markets can you ship dasatinib into?
We supply any country where the patent and licence position allows it, with the GCC, Africa and Europe as priority markets. Before a quote we check the national register, the patent position and whether the importer is licensed. The UAE registrar is the Emirates Drug Establishment (EDE), and the Saudi regulator is the SFDA. We do not supply into India. The country pages under markets set out each regulator.
What documentation ships with a dasatinib consignment?
The batch Certificate of Analysis and method of analysis, the WHO-GMP certificate and the Certificate of Pharmaceutical Product (both issued by the Indian state drug regulator), the manufacturing licence, a bioequivalence report against Sprycel for new registrations, a patent note for the destination, a Certificate of Origin and a destination-language pack insert. The insert text covers the acid-suppressant and antacid rule, pleural effusion and pulmonary arterial hypertension, QT prolongation and bleeding, and the T315I caveat. A CTD Module 3 dossier is available against an NDA, see dossier preparation.
Who stands behind this page.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.
Strength mix, monthly patient count, destination, channel and line of therapy (first-line chronic-phase CML, or imatinib-resistant or intolerant, or Ph+ ALL). We verify the patent and licence position per destination as part of the quote and we include the molecular-monitoring annex in every offer. Everything else is on us.