Tasigna (nilotinib) is the second-generation BCR-ABL inhibitor reached for when Philadelphia-positive CML stops answering imatinib.
Labelled for newly diagnosed Ph-positive chronic-phase CML and for chronic-phase and accelerated-phase disease that is resistant or intolerant to prior therapy including imatinib. It is on the WHO Essential Medicines List (2023, complementary list) as 150 mg and 200 mg capsules for imatinib-resistant CML. Dasatinib is another BCR-ABL inhibitor we list for that setting. We source 50, 150 and 200 mg hard capsules, the generic equivalent of Tasigna, from Indian WHO-GMP-certified lines. M Care Exports is a merchant exporter and does not manufacture.
Nilotinib exporter and bulk supplier from India.
Bulk nilotinib capsules for importers, distributors and tender buyers, drawn from WHO-GMP-certified Indian manufacturers. M Care does not manufacture, so every quote names the source line and the batch paperwork that goes with 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.
WHO-GMP partner lines · 50 to 200 mg capsules · generic equivalent of Tasigna · CTD dossier on file · per-market patent verification · exporter, not manufacturer.
Active ingredient
Nilotinib (ATC L01EA03), an oral BCR-ABL tyrosine kinase inhibitor; Tasigna capsules contain it as the hydrochloride monohydrate. The EU SmPC reports efficacy across a variety of imatinib-resistant BCR-ABL mutations, with T315I the exception. Sourced from Indian WHO-GMP-certified lines; M Care does not manufacture.
Strengths stocked
Hard capsules 50, 150 and 200 mg. Adult dose is 300 mg twice daily when newly diagnosed and 400 mg twice daily when resistant or intolerant. The US label gives the paediatric dose as 230 mg/m2 twice daily, rounded to the nearest 50 mg and made up by combining strengths. Doses are about 12 hours apart, fasting: no food for at least 2 hours before and at least 1 hour after.
Indications
US label: newly diagnosed Ph+ chronic-phase CML in adults and children from 1 year of age; adults with chronic-phase or accelerated-phase Ph+ CML resistant or intolerant to prior therapy that included imatinib; children from 1 year with resistant or intolerant disease after a prior TKI. EU SmPC: efficacy data in blast crisis are not available.
Safety signals
US boxed warning: QT prolongation and sudden deaths, with contraindication in hypokalaemia, hypomagnesaemia or long QT syndrome. With food, healthy-volunteer Cmax rose 112% and AUC 82% (EU SmPC), which is why dosing is fasting. The US label also covers cardiac and arterial vascular occlusive events, pancreatitis and raised lipase, hepatotoxicity, myelosuppression and electrolyte abnormalities.
Storage and pack
Tasigna labelling: 20 to 25°C with excursions to 15 to 30°C (US), or not above 30°C in the original package, protected from moisture (EU, shelf life 3 years). EU Tasigna packs are PVC/PVDC/Alu blisters: unit packs of 28 or 40 capsules for 150 and 200 mg, multipacks, and 120 capsules (3 packs of 40) for 50 mg; not all sizes are marketed. A generic line follows its own approved label, which we quote. Ambient lane, no cold chain.
Patent & lawful supply
DailyMed carries US labels for nilotinib capsules from several generic companies beside Tasigna, but patent and licence status is set country by country. We check your destination before each quote and quote only where supply is lawful. Supply into India is outside our scope.
Haematology and oncology programmes across the opening lawful lanes.
We export from India and do not sell into the Indian market. A lane below opens only when the patent and licence check for that country comes back clear.
Sub-Saharan African public-sector oncology
Public-sector buyers in South Africa, Nigeria and Kenya, and in Ghana, Ethiopia, Tanzania and Uganda. The WHO Model List places nilotinib on its complementary list for imatinib-resistant CML, the list for medicines that need specialist diagnostic or monitoring facilities or specialist care.
GCC haematology centres
Gulf haematology centres buy through licensed importers. We prepare the file for MoH registration or GCC central registration, with bilingual Arabic artwork and an annex that spells out the ECG schedule and the fasting rule for the receiving pharmacy.
UK, EU and the generic channel
Tasigna holds an EU marketing authorisation for 50, 150 and 200 mg hard capsules. A generic reaching the UK or EU needs a source line with its own authorisation for that market. For an individual patient without one, the named-patient and MHRA Specials routes apply.
ASEAN, LATAM and haematology networks
Bangladesh, Sri Lanka, Indonesia, Vietnam, the Philippines, Mexico and Brazil are served through licensed importers and oncology tenders. Where the patent check shows supply would not be lawful, we decline instead of quoting.
Empty-stomach dosing, the QT and sudden-death warning, the cardiovascular and metabolic signal, and the imatinib-resistance position.
Nilotinib is dosed twice daily, about 12 hours apart, and the instruction that matters most at the dispensing counter is the fasting rule: no food for at least 2 hours before the dose and at least 1 hour after. Food raises exposure (in healthy volunteers Cmax rose 112% and AUC 82%, per the EU SmPC), and the QT effect follows exposure. The capsule is swallowed whole with water. If a patient cannot swallow it, the contents of one capsule go into one teaspoon of apple sauce, taken at once; the SmPC records this as bioequivalent to the intact capsule. A missed dose is not doubled, and grapefruit juice is avoided. Adult doses are 300 mg twice daily for newly diagnosed chronic-phase CML and 400 mg twice daily for resistant or intolerant disease; with hepatic impairment the US label lowers the starting dose, for instance to 200 mg twice daily in newly diagnosed disease. The US label opens with a boxed warning: nilotinib prolongs the QT interval and sudden deaths have been reported (0.3% of 5,661 patients in clinical studies). ECGs are taken at baseline, 7 days after starting, periodically and after any dose change; hypokalaemia and hypomagnesaemia are corrected first; QT-prolonging drugs and strong CYP3A4 inhibitors are avoided. In the newly diagnosed trial, cardiovascular events including arterial vascular occlusive events occurred in 9% of patients on 300 mg twice daily and 15% on 400 mg twice daily, against 3.2% on imatinib, so the label asks for cardiovascular risk factors to be actively managed. Laboratory work is part of the regimen: blood counts every 2 weeks for the first 2 months then monthly, and serum lipase and liver function tests monthly, in each case or as clinically indicated; per the SmPC, blood glucose before and during treatment and lipids before starting, at months 3 and 6, then at least yearly. The SmPC also asks for hepatitis B testing before the first dose. For selected patients with typical BCR-ABL transcripts who have taken nilotinib for at least 3 years and hold a sustained deep molecular response (MR4.5), the US label describes a supervised treatment discontinuation with frequent monitoring afterwards. The SmPC reports efficacy across imatinib-resistant mutations except T315I.
The documentation pack a regulator actually asks for.
Each consignment ships with the papers of the Indian WHO-GMP-certified line that made it. We sit between that plant and your hospital pharmacy, programme or tender desk.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
CTD Module 3
Module 3 for new registrations, set against the Tasigna drug substance, nilotinib hydrochloride monohydrate, whose aqueous solubility falls as pH rises (US label, section 11), so a partner line's salt form and dissolution data are compared with it. The Tasigna capsule contains lactose monohydrate (39.03, 117.08 and 156.11 mg in the 50, 150 and 200 mg capsules, EU SmPC) and the labels advise against use in patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption, so a partner's excipient list is checked against it.
Bioequivalence
Bioequivalence reports against Tasigna for new registrations, stating the feeding condition of the study because food changes nilotinib exposure so much (SmPC: Cmax up 112%, AUC up 82%). The SmPC also records that capsule contents dispersed in apple sauce were bioequivalent to the intact capsule.
Patent verification per market
A written patent and licence note for your destination goes with every quote: where the compound, polymorph, salt and formulation patents stand in that country, and whether supply is lawful. If it is not, the answer is a decline, not a price.
QT and cardiovascular annex
A destination-language annex covering the baseline and day-7 ECG schedule, electrolyte-correction protocol, the empty-stomach dosing rule, and the peripheral-arterial-occlusive-disease and metabolic monitoring, so the receiving haematology service has the safety framework alongside the product.
CoA + WHO-GMP per batch
The batch certificate of analysis reports nilotinib assay, related substances, solid-form identity, dissolution and uniformity of dosage units, signed by the manufacturer's authorised QC head. The CoPP comes from the plant's state drug regulator and is apostilled where the destination asks.
Pharmacovigilance
A named PV contact in the destination market is opened at registration. Adverse-event routing for nilotinib is built around QT prolongation and sudden death, arterial vascular occlusive events, raised lipase and liver enzymes, electrolyte abnormalities and myelosuppression, the headings of the US warnings and precautions.
Other BCR-ABL inhibitors and the services around this one.
For adults, nilotinib's resistant-or-intolerant indication is defined against prior therapy that included imatinib, so the imatinib page is the natural companion.
Imatinib
The prior therapy named in nilotinib's adult resistant-or-intolerant indication. WHO lists it as 100 mg and 400 mg solid oral forms.
Dasatinib
Another BCR-ABL inhibitor for the imatinib-resistant or intolerant setting, as 20 to 140 mg tablets. Its dosing and safety profile differ from nilotinib, and its page sets them out.
CTD / eCTD dossier preparation
CTD Module 3, comparative bioequivalence under fed and fasting conditions, and the per-market patent-verification pack assembled for new nilotinib registrations.
GCC MoH registration
Filing support for Gulf registrations: importer-of-record coordination, bilingual Arabic artwork and formulary paperwork.
South Africa market
The registration route and regulator detail for supply into South Africa.
Oncology portfolio →
The other oncology lines we supply, from cytotoxics to targeted therapy and supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Tell us what you need. Capsule strengths (50, 150, 200 mg), packs per month, destination, and whether the buyer is a hospital, a CML programme or a tender. Say whether the patients are newly diagnosed or imatinib-resistant or intolerant.
- We run the patent and licence check. Compound and secondary patents are reviewed for your country. If supply would be unlawful, we tell you and do not quote.
- Offer. FOB or CIF price, dossier and bioequivalence status, the QT and cardiovascular annex and the documentation list, inside one working day.
- Ship. The manufacturer releases the batch after QC, we dispatch on the ambient lane and log the consignment in transit. Timing is confirmed on the quote.
- Afterwards. Batch records and the CoA are kept for the shelf life of the lot. Adverse-event reports go to the PV contact named at registration, QT and cardiovascular signals first.
Nilotinib supply, the specific questions.
What strengths and pack formats of nilotinib do you supply?
Hard capsules in 50, 150 and 200 mg, the three strengths on the Tasigna label. Adult doses are 300 mg twice daily for newly diagnosed chronic-phase CML and 400 mg twice daily for resistant or intolerant chronic-phase and accelerated-phase disease. The US label sets the paediatric dose at 230 mg/m2 twice daily, rounded to the nearest 50 mg and made up by combining capsule strengths, and it lowers the starting dose in hepatic impairment. WHO lists 150 mg and 200 mg capsules. Pack sizes follow the source line's registered label. For reference, the EU SmPC lists Tasigna 150 mg and 200 mg in PVC/PVDC/Alu blisters as packs of 28 or 40 capsules and 50 mg as 120 capsules (3 packs of 40), and notes that not all pack sizes may be marketed. Doses are taken about 12 hours apart with no food for 2 hours before or 1 hour after.
Is M Care a nilotinib manufacturer?
No. M Care is a merchant exporter and does not run a manufacturing plant. Each order is placed with an Indian WHO-GMP-certified manufacturer, and we handle export documentation, freight, registration support and the pharmacovigilance set-up. If a destination requires an EU-GMP-capable line, we confirm which line that is before you commit.
What is the patent and licence position by destination market?
It is set country by country and it changes, so we check your destination before each quote. Compound, polymorph, salt and formulation patents can expire on different dates, and a country where Tasigna is still protected may differ from one where it is not. DailyMed carries US labels for nilotinib capsules from several generic companies alongside Tasigna, which shows generic nilotinib exists in that market but says nothing about yours. We quote only where supply is lawful and we say so plainly when it is not. We do not supply into India.
Why choose nilotinib over dasatinib after imatinib?
That choice belongs to the prescriber, and we supply whichever agent the programme specifies. What the nilotinib labels put on the table: the US label carries a boxed warning for QT prolongation and sudden deaths and contraindicates use in hypokalaemia, hypomagnesaemia or long QT syndrome; the capsules must be taken fasting; arterial vascular occlusive events were reported in the newly diagnosed trial, so cardiovascular risk factors are managed throughout; and the SmPC reports efficacy across imatinib-resistant mutations except T315I. The dasatinib page covers that medicine's own dosing and safety points.
What are the key safety points for nilotinib?
The US label opens with a boxed warning: nilotinib prolongs the QT interval and sudden deaths have been reported. ECGs are taken at baseline, 7 days after starting, periodically and after dose changes; hypokalaemia and hypomagnesaemia are corrected first; QT-prolonging drugs and strong CYP3A4 inhibitors are avoided; and no food is taken for 2 hours before or 1 hour after a dose. The warnings and precautions then cover myelosuppression (blood counts every 2 weeks for the first 2 months, then monthly), cardiac and arterial vascular occlusive events, pancreatitis and raised serum lipase, hepatotoxicity, electrolyte abnormalities and tumour lysis syndrome. The SmPC adds hepatitis B reactivation, with testing before treatment. Read the registered label for your market for the full list.
Which markets can you ship nilotinib into?
We quote into any country where nilotinib supply is lawful after the patent and licence check, with the Gulf, Africa and Europe as priority markets. Buyers are licensed importers, hospital haematology units and public tenders. We do not supply into India. Regulator detail by country is on our markets pages.
What documentation ships with a nilotinib consignment?
Per batch: a Certificate of Analysis and the Method of Analysis. For new registrations: a bioequivalence report against Tasigna. With the consignment: the WHO-GMP certificate and manufacturing licence of the source line, a CoPP issued by the state drug regulator, a destination patent note and a Certificate of Origin. The pack insert follows the registered label for the destination, so it carries that market's QT warning wording, the fasting instruction and the ECG schedule. Module 3 of the CTD dossier can be shared under a signed 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.
Strengths, monthly volume, destination, channel, and whether the patients are newly diagnosed or imatinib-resistant. The patent check and the QT and cardiovascular annex come with the quote.