Ruxolitinib tablets, Indian WHO-GMP supply for myelofibrosis, polycythaemia vera and graft-versus-host disease.
An oral JAK1/JAK2 inhibitor that targets the dysregulated JAK-STAT signalling at the heart of the myeloproliferative neoplasms. Used to shrink the spleen and lift symptom burden in intermediate and high-risk myelofibrosis, to control polycythaemia vera after hydroxycarbamide failure, and for steroid-refractory graft-versus-host disease. The generic equivalent of Jakavi and Jakafi, in 5, 10, 15 and 20 mg tablets from Indian WHO-GMP-certified manufacturers. We confirm the patent position per market before we quote. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-GMP partner lines · 5 / 10 / 15 / 20 mg tablets · generic equivalent of Jakavi / Jakafi · CTD dossier on file · exporter, not manufacturer.
Active ingredient
Ruxolitinib (as the phosphate salt), a potent oral inhibitor of Janus kinases JAK1 and JAK2. By blocking JAK-STAT signal transduction it dampens the inflammatory cytokine drive and clonal proliferation that characterise myelofibrosis and polycythaemia vera. Supplied from Indian WHO-GMP-certified manufacturers; M Care does not manufacture.
Strengths stocked
5 mg, 10 mg, 15 mg and 20 mg film-coated tablets, the full range required for platelet-guided dosing. Myelofibrosis commonly starts at 20 mg twice daily (platelets >200 x 10^9/L) or 15 mg twice daily (100-200); polycythaemia vera at 10 mg twice daily; graft-versus-host disease per transplant-unit protocol. Doses are titrated against response and cytopenias.
Indications
Intermediate and high-risk myelofibrosis (primary, post-polycythaemia-vera, post-essential-thrombocythaemia) for splenomegaly and symptom control; polycythaemia vera resistant to or intolerant of hydroxycarbamide; steroid-refractory acute and chronic graft-versus-host disease after allogeneic stem-cell transplant. A specialist haematology-oncology medicine throughout.
Monitoring
Platelet-count-driven dosing with full-blood-count monitoring for the dose-dependent anaemia, thrombocytopenia and neutropenia. Infection screening before and during treatment (herpes zoster, tuberculosis, hepatitis B). Never stop abruptly, taper to avoid symptom rebound. CYP3A4-metabolised, dose-adjust with strong inhibitors.
Storage and pack
Store below 30°C in the original pack. Alu-Alu blister or HDPE bottle to destination standard, specialist-pharmacy pack sizes (e.g., 56 tablets per month of twice-daily dosing). Shelf life typically 24-36 months, minimum 18 months at dispatch. Standard ambient dispatch lane.
Patent & access
Ruxolitinib remains under originator patent in many territories. We confirm the patent and registration position in each destination before quoting, and only supply where it is lawful. Indian generic ruxolitinib is a substantial cost reduction against the originator, the access lever for self-pay and constrained haematology budgets where supply is permitted.
Haematology units, transplant centres and specialist-oncology tenders.
India is our origin. We do not sell into the Indian market. Ruxolitinib is exported only, and only where the patent position permits.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Haematology and bone-marrow-transplant centres procure ruxolitinib through licensed importers against specialist-oncology formulary awards (NUPCO and SFDA, King Faisal Specialist Hospital; MoHAP, DHA and DoH; Kuwait, Oman, Qatar including Hamad Medical Corporation NCCCR, and Bahrain MoH). Full CTD for MoH registration and GCC central registration, with patent position confirmed first.
South Africa, Nigeria, Kenya, Ethiopia and African transplant centres
Specialist haematology and the growing allogeneic-transplant programmes across the continent (SAHPRA, NAFDAC, KEMSA, EFDA, TMDA). The cost gap between Indian generic and originator ruxolitinib is the difference between a programme being able to treat GVHD and myelofibrosis or not, where the patent position allows supply. Donor and NGO procurement supported.
United Kingdom and Europe
Supply through licensed importers and wholesalers strictly subject to the originator patent and SPC position, which we verify per market. In the UK the named-patient and MHRA Specials routes cover specific access situations. Ph.Eur.-grade product, QP certification on EU arrival, CTD and CoPP prepared for BfArM, ANSM and comparable bodies.
Latin America and ASEAN
Brazil (ANVISA), Mexico (COFEPRIS) and ASEAN (Philippines FDA, Malaysia NPRA, Vietnam DAV) through licensed importers against specialist-oncology tenders, where the patent position permits. Bioequivalence data and CTD prepared for destination recognition. M Care does not hold US FDA or TGA registration for this molecule.
Platelet-guided dosing, infection screening, the no-abrupt-stop rule and CYP3A4 interactions.
Ruxolitinib dosing is governed by the platelet count: in myelofibrosis a common start is 20 mg twice daily for platelets above 200 x 10^9/L and 15 mg twice daily for 100-200, with cautious low-dose use and close monitoring between 50 and 100, titrated to spleen response and tolerated cytopenias; polycythaemia vera typically starts at 10 mg twice daily; graft-versus-host-disease dosing follows the transplant unit's protocol. The dose-limiting toxicities are anaemia and thrombocytopenia, which are expected on-target effects rather than reasons to abandon treatment, so manage with dose adjustment and transfusion support and check the full blood count regularly, weekly to fortnightly during titration. Infection risk is real: screen for and monitor herpes zoster (consider prophylaxis), tuberculosis and hepatitis B reactivation, and stay alert to opportunistic infections and the rare progressive multifocal leukoencephalopathy. The single most important counselling point is that ruxolitinib must not be stopped abruptly, sudden withdrawal can provoke an acute return of splenomegaly and symptoms and, rarely, a cytokine-rebound syndrome resembling a systemic inflammatory response, so any discontinuation is tapered under specialist supervision, and the drug is continued through intercurrent illness where possible. Ruxolitinib is CYP3A4-metabolised, so strong inhibitors such as ketoconazole, and the dual CYP3A4/CYP2C9 inhibitor fluconazole, require dose reduction, while strong inducers reduce exposure. Dose adjustment is also needed in significant hepatic or renal impairment. Non-melanoma skin cancers and lipid elevations are recognised on longer-term therapy and warrant periodic skin review and a lipid check. The destination-language SmPC carries the full dosing table, interaction list and monitoring schedule for the receiving haematology service.
The documentation pack a regulator actually asks for.
Ruxolitinib is a specialist targeted haematology-oncology therapy supplied from Indian WHO-GMP facilities, where the destination patent position permits. Our role is manufacturer-facing, we sit between the WHO-GMP plant and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls in eCTD-ready format where accepted, Module 2 quality overall summary included. Polymorph and impurity control documented for the phosphate salt.
Bioequivalence
Comparative bioequivalence data against the reference listed product available where the registration requires it.
CoA and MoA, per batch
Assay, related substances per ICH, dissolution, content uniformity, water content, signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (India), apostilled where required, notarised copies in the shipping pack. M Care does not hold US FDA or TGA registration for this molecule, confirm the regulatory route on enquiry.
Patent & freedom-to-operate
We verify the originator patent and SPC position in the destination market before any offer and supply only where it is lawful, this diligence is part of the quote, not an afterthought.
Pharmacovigilance
Named PV contact in the destination market against registration, PSURs to ICH E2C. Cytopenias, serious and opportunistic infections, viral reactivation and discontinuation-rebound are the priority signals.
The myeloproliferative-neoplasm and transplant supportive shelf.
Ruxolitinib sits within a wider haematology-oncology programme, alongside the targeted therapies, supportive biologicals and transplant supportive care that travel on the same tenders.
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Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength mix (5 / 10 / 15 / 20 mg), monthly patient volume, destination, and channel: haematology or transplant-centre tender, named-patient supply, or importer stock. Flag the indication (myelofibrosis, PV, GVHD) if protocol documentation is needed.
- We confirm patent position and route. We verify the originator patent and registration position in the destination and route to the right WHO-GMP line; we will not quote into a market where supply is not lawful.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier and bioequivalence status per destination, 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.
- After delivery. Batch records, CoA and stability data archived for the full shelf life, PV contact opened on registration.
Ruxolitinib supply, the specific questions.
What strengths of ruxolitinib do you supply?
Film-coated tablets in 5 mg, 10 mg, 15 mg and 20 mg, the full strength range needed for platelet-count-based dosing and titration. In myelofibrosis the starting dose is commonly 20 mg twice daily for platelets above 200 x 10^9/L and 15 mg twice daily for 100-200, with adjustment for cytopenias; polycythaemia vera typically starts at 10 mg twice daily; GVHD regimens are protocol-specific. All supplied from WHO-GMP-certified Indian manufacturers.
Is this the generic equivalent of Jakavi or Jakafi?
Yes. We supply generic ruxolitinib, the molecule sold under the originator brands Jakafi (United States, Incyte) and Jakavi (other markets, Novartis). We supply the generic, not the branded product. Because ruxolitinib is still under originator patent in many territories, we confirm the patent and registration position in each destination market before making any offer, and we only quote where supply is lawful.
Is M Care a ruxolitinib manufacturer?
No. M Care is a merchant exporter. We supply ruxolitinib from Indian WHO-GMP-certified manufacturers and handle export, documentation, registration support and freight. We do not run a manufacturing plant ourselves. For a buyer, that means we route each order to the right WHO-GMP line for the destination and carry the regulatory and logistics paperwork.
What is ruxolitinib used for?
Intermediate and high-risk myelofibrosis (primary, post-polycythaemia-vera and post-essential-thrombocythaemia) to reduce spleen size and disease symptoms; polycythaemia vera in patients resistant to or intolerant of hydroxycarbamide; and steroid-refractory acute and chronic graft-versus-host disease after allogeneic stem-cell transplant. It is a specialist haematology medicine prescribed and monitored under haematology-oncology supervision, not a primary-care product.
What are the key safety points for ruxolitinib?
Dose-dependent cytopenias (anaemia, thrombocytopenia, neutropenia) require full-blood-count monitoring and platelet-guided dosing. Serious infections occur, including herpes zoster, tuberculosis reactivation, hepatitis B reactivation and rare progressive multifocal leukoencephalopathy, so screen and monitor accordingly. Ruxolitinib must not be stopped abruptly, as withdrawal can trigger an acute return of symptoms and, rarely, a cytokine-rebound syndrome, so taper under specialist guidance. It is CYP3A4-metabolised, requiring dose reduction with strong inhibitors such as ketoconazole and fluconazole. The destination-language SmPC carries the full table.
Which markets can you ship ruxolitinib into?
Haematology and transplant-centre supply, subject to patent and registration position, through licensed importers across the GCC (NUPCO and SFDA, MoHAP/DHA/DoH, and the Kuwait, Oman, Qatar and Bahrain MoH), sub-Saharan Africa (NAFDAC, SAHPRA, KEMSA, FDA Ghana, EFDA, TMDA), the UK and EU, and Latin America (ANVISA, COFEPRIS) and ASEAN. We confirm the originator patent position per market and only quote where supply is lawful. M Care does not hold US FDA or TGA registration for this molecule. We do not supply into India. Full coverage at markets.
What documentation ships with a ruxolitinib consignment?
A batch-specific Certificate of Analysis (assay, related substances per ICH, dissolution, content uniformity, water content), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, Certificate of Origin, destination-language pack insert with the cytopenia-monitoring, infection-screening, taper-on-discontinuation and CYP3A4-interaction warnings, and stability documentation. Full CTD Module 3 dossiers, with bioequivalence data, are available against an NDA for registration support, see dossier preparation.
Send the specifics. You'll have a price inside one working day.
Strength mix (5 / 10 / 15 / 20 mg), monthly patient volume, destination, indication and channel: haematology or transplant-centre tender, named-patient supply, or importer stock. We confirm the patent position per market as part of the quote. Everything else is on us.