Imatinib mesylate tablets — Indian WHO-GMP supply for CML and GIST tender lines.
First-in-class BCR-ABL and c-KIT tyrosine kinase inhibitor — the targeted therapy that turned CML into a chronic disease managed on a daily oral tablet. 100mg and 400mg film-coated tablets from Indian WHO-GMP facilities, with WHO Prequalification supported for Global Fund and Africa CDC oncology tender qualification.
Multiple WHO-GMP partner lines · 100mg and 400mg film-coated tablets · CTD dossier on file · WHO PQ pathway supported.
Active ingredient
Imatinib mesylate, the salt form of imatinib (4-[(4-methylpiperazin-1-yl)methyl]-N-[4-methyl-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}phenyl]benzamide). Mechanism: ATP-competitive inhibitor of BCR-ABL tyrosine kinase (the fusion oncoprotein driving Ph+ CML and Ph+ ALL), c-KIT (the driver in 80%+ of GIST), and PDGFR-α/β (the drivers in DFSP and HES). Selectivity is the differentiator — imatinib spares wild-type tyrosine kinases at therapeutic doses.
Strengths stocked
100mg and 400mg film-coated tablets. The 400mg tablet is the standard adult CML chronic-phase dose (one tablet daily); 100mg is used for paediatric dosing, dose titration in renal/hepatic impairment, and the GIST adjuvant 400mg starting dose with up-titration capacity to 600-800mg in resistant disease. Both strengths are scored for half-tablet administration in some destination-market labelling.
Indications
Ph+ CML chronic / accelerated / blast phase; KIT+ GIST adjuvant and metastatic; Ph+ ALL with chemotherapy; PDGFR-rearranged MDS/MPD; aggressive systemic mastocytosis (D816V-negative); FIP1L1-PDGFRα-positive HES/CEL; unresectable DFSP. WHO Essential Medicines List core item. We supply for all approved indications.
Storage
15-30°C, in original blister pack to protect from moisture. Imatinib is hygroscopic — keep the blister sealed until use. Standard ambient-temperature dispatch lane; no cold-chain. Discard any tablet showing discolouration or surface degradation.
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Aluminium-aluminium blister, 10 tablets per blister, 30 tablets (3 blisters) or 90 tablets (9 blisters) per carton — destination-market dependent. Outer carton, leaflet and blister foil in destination-regulator language. Patient-information leaflet covers BCR-ABL transcript-monitoring schedule and dose-titration triggers.
Hospital pharmacies, oncology day-units and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Imatinib is exported only.
United Kingdom
Generic imatinib has been routine NHS hospital pharmacy supply since the Glivec patent expired in the UK (2016). Where the primary licensed supplier cannot fill against scheduled CML or GIST patient demand, the MHRA Specials / named-patient import route is available. Imatinib is on the NHS England Cancer Drugs Fund standing list — see MHRA Specials for the shortage-cover documentation pack we prepare manufacturer-side.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards (NUPCO and Saudi MoH for KSA; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain) and hospital pharmacy purchase orders. SFDA, MoHAP and GCC central registration supported with a full CTD dossier. King Faisal Specialist Hospital and SEHA oncology centres are key formulary buyers.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda
Public-sector oncology tenders (NAFDAC-registered for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA-registered for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania, NDA + NMS for Uganda) and teaching-hospital supply. The Max Foundation Glivec International Patient Assistance Programme (GIPAP) transitioned to generic imatinib supply post-2016 — we engage on the patient-access programme replacement schemes. WHO Prequalification supported for Global Fund and Africa CDC qualification.
Germany, France, Brazil, Mexico
Supply via licensed importers under §72 AMG (Germany), ANSM equivalent (France), ANVISA (Brazil), COFEPRIS (Mexico), with Qualified Person (QP) certification on EU arrival. CTD dossier and CoPP prepared for BfArM, ANSM, ANVISA and COFEPRIS recognition. Named-patient (Einzelimport) route available.
Take with food and a large glass of water, monitor BCR-ABL transcripts, and watch for the cytochrome interactions — that's how imatinib stays predictable.
Adult CML chronic-phase starting dose is 400mg once daily, taken with a meal and at least 250 ml of water to minimise GI irritation. Accelerated-phase and blast-crisis dosing is 600-800mg daily, often split. GIST adjuvant after R0 resection is 400mg daily for at least 3 years; metastatic GIST starts at 400mg with up-titration to 600-800mg on progression (KIT-exon 9 mutations get 800mg from the start). Paediatric Ph+ CML dosing is 340 mg/m²/day, capped at 600mg. Treatment is continuous and indefinite — the BCR-ABL fusion gene remains, so stopping causes molecular relapse in the majority. Monitoring: complete blood count weekly for the first 4 weeks then monthly; comprehensive metabolic panel monthly; BCR-ABL transcript by quantitative PCR every 3 months for the first 18 months, then 6-monthly if MMR (major molecular response, BCR-ABL/ABL ≤ 0.1% on the International Scale) is sustained. Dose-limiting toxicities: oedema (especially periorbital), myelosuppression, hepatotoxicity (LFT monitoring), QT-interval prolongation, congestive heart failure (rare). Drug interactions are the prescribing trap: imatinib is a CYP3A4 substrate, so strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St John's wort) reduce exposure; strong inhibitors (ketoconazole, voriconazole, ritonavir) raise it. Imatinib also inhibits CYP2D6, CYP2C9 and CYP3A4 — paracetamol-induced hepatotoxicity risk is real at supratherapeutic paracetamol doses. Co-administration with warfarin requires INR monitoring — switch to LMWH for safer anticoagulation if possible.
The documentation pack a regulator actually asks for.
Imatinib is a WHO EML core-list targeted therapy and WHO PQ-listed. Our role is manufacturer-facing — we sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. Bioequivalence study report included for generic substitution against Glivec — typical pivotal BE study is fasted and fed crossover in healthy volunteers, n=24-36.
CoA and MoA, per batch
HPLC assay of imatinib mesylate, related substances (impurity A, B, C, D, E per Indian Pharmacopoeia / Ph.Eur. / USP), water content (Karl Fischer for the hygroscopic salt), dissolution profile, content uniformity, hardness, friability, disintegration time — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies included in the shipping pack. WHO-PQ certificate available for Global Fund and Africa CDC tender qualification.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). BCR-ABL monitoring schedule and dose-titration triggers documented in the patient leaflet. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on each shipper configuration. Imatinib ships at 15-30°C; the failure mode is moisture — the original blister-foil seal is the integrity-critical packaging and the thermal protocol pairs with humidity logging. Container closure integrity tested on each consignment.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. Cardiac toxicity (CHF, QT prolongation), severe oedema, hepatotoxicity and rare cases of TLS in heavily-pretreated CML remain the PSUR priority signals for this molecule.
Targeted therapy, supportive care and the cytotoxic backbone.
Imatinib is rarely a standalone — Ph+ ALL combines with chemotherapy, GIST relapse moves to second-line TKIs. We carry the supporting cluster.
Capecitabine
Oral fluoropyrimidine. 150mg / 500mg tablets, GI cancer regimens.
5-Fluorouracil
IV fluoropyrimidine. 250mg / 500mg / 1g / 5g vials, FOLFOX/FOLFIRI backbone.
Cisplatin
Platinum cytotoxic. 10mg / 25mg / 50mg / 100mg vials, Ph+ ALL induction regimens.
Bortezomib
Proteasome inhibitor, multiple myeloma. 2mg and 3.5mg lyophilised vials.
Paclitaxel
Taxane cytotoxic. 30mg / 100mg / 260mg concentrate.
All oncology →
120+ oncology SKUs: cytotoxics, targeted therapy, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength, tablet count, destination market, whether this is NHS hospital pharmacy supply, GCC tender, African public-sector procurement, Global Fund / Africa CDC qualification, or NGO supply, and the target delivery window. Flag if the order is for a CML chronic-phase maintenance population (steady continuous demand) versus a tender-award single-shipment.
- We route to the right line. Multiple WHO-GMP imatinib lines sit on the M Care roster, including WHO PQ-listed manufacturers for Global Fund and Africa CDC tender qualification. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier status per destination, bioequivalence study report for generic substitution, and the documentation pack you'll receive with the shipment. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane with humidity logging (imatinib mesylate is hygroscopic — blister-foil integrity is the critical packaging). On-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal/humidity logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; cardiac toxicity, severe oedema and hepatotoxicity remain the PSUR priority signals.
Imatinib supply — the specific questions.
What strengths of imatinib do you supply?
Imatinib is supplied as 100mg and 400mg film-coated tablets. The 400mg tablet is the standard adult CML chronic-phase dose (one tablet daily with food); 100mg covers paediatric dosing, fine titration in renal/hepatic impairment, and the metastatic-GIST 600-800mg up-titration profile (six or eight 100mg tablets daily). Both are aluminium-aluminium blister, 10 tablets per blister, 30 or 90 tablets per carton depending on destination market. Patient-information leaflet documents the BCR-ABL transcript-monitoring schedule and dose-titration triggers.
Is your imatinib suitable for Global Fund and Africa CDC tender qualification?
Yes — we supply WHO Prequalification-listed imatinib for Global Fund pooled procurement, Africa CDC oncology tender programmes, and country-level public-sector tenders (KEMSA, NAFDAC, CMS Ghana, EPSS, MSD Tanzania) where WHO PQ status is a tender qualification requirement. The WHO PQ certificate is included in the shipping documentation pack. We also carry SAHPRA-registered lines for direct South African public-sector tenders. Bioequivalence study reports are available against NDA for generic substitution qualification with destination authorities.
How does imatinib relate to The Max Foundation GIPAP — and can M Care supply replacement programmes?
The Glivec International Patient Assistance Programme (GIPAP) was Novartis's free-Glivec patient-access scheme for chronic myeloid leukaemia and GIST patients in lower-income countries, run via The Max Foundation. After Glivec patent expiry in 2016, the programme transitioned to discounted generic imatinib supply through partner manufacturers. M Care engages on the replacement-programme side: we supply WHO-GMP and WHO PQ-listed generic imatinib to the manufacturer-tier under the patient-access framework, against Max Foundation pricing and supply terms specified per country. Direct enquiries from oncology centres or treatment foundations operating these replacement schemes are routed through the same channel.
Which markets can you ship imatinib into?
The UK (NHS hospital pharmacy supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers, sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ pathway support, Egypt, Jordan, Iraq on the Levant side, Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). We do not supply into India. Full market coverage is at markets.
What documentation is included with an imatinib consignment?
Every consignment ships with a batch-specific Certificate of Analysis (HPLC assay, related substances, water content by Karl Fischer, dissolution, content uniformity, friability), Method of Analysis, bioequivalence study report (against Glivec) where required for generic substitution, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification certificate where applicable, Certificate of Origin (chamber-attested), destination-language pack insert with BCR-ABL monitoring guidance, and temperature/humidity logs from pre-dispatch through on-arrival. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for imatinib registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Generic imatinib has a well-established CMC template and bioequivalence pivotal study format — lead time on a dossier against a new registration is typically 4-6 weeks from NDA signature. WHO PQ dossier prepared separately for Global Fund and Africa CDC qualification. See dossier preparation.
What are typical lead times for imatinib orders, and does imatinib need cold-chain transit?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (Global Fund, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply with urgency flagged, air-freight out of Mumbai can be on a flight within 72 hours. Made-to-order batches run 8-12 weeks inclusive of QC release and destination artwork. Imatinib does not require cold-chain — it ships at 15-30°C. The integrity-critical factor is moisture: imatinib mesylate is hygroscopic, and the aluminium-aluminium blister foil is the moisture barrier. Humidity is logged with temperature on every consignment, and container closure integrity is tested on dispatch.
Send the specifics. You'll have a price inside one working day.
Strength, tablet volume, destination, NHS hospital pharmacy / GCC tender / African public-sector / Global Fund / NGO, target delivery, BE-study requirement if generic substitution. That's the enquiry. Everything else is on us.