Dasatinib, Indian WHO-GMP supply of the second-generation BCR-ABL TKI for CML and Ph+ ALL, including imatinib-resistant disease.

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 20, 50, 70 and 80 mg strengths support dose reduction for cytopenia, pleural effusion management and renal or hepatic adjustment. 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.

No. M Care is a merchant exporter. We supply dasatinib from Indian WHO-GMP-certified manufacturers (the major Indian generic lines include Natco, Dr Reddy's, Hetero, BDR and others) and handle export, documentation, registration support, freight and pharmacovigilance set-up. 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, including an EU-GMP-capable line where the destination requires it, and carry the regulatory and logistics paperwork.

Generic dasatinib supply is now well-established and verified per market on every quote. The EU compound patent expired in 2019 and generics are available across the bloc; the US FDA has approved generic dasatinib in all six strengths; and Indian generic supply has been established for years. Generic lanes are broad across sub-Saharan Africa, the GCC, ASEAN and Latin America. Some secondary polymorph and formulation patents persist in particular jurisdictions and timeframes, so we run a per-destination verification on every enquiry and supply only where it is lawful, refusing to quote where a live patent or settlement window blocks supply. We do not supply into India.

Dasatinib is a second-generation BCR-ABL tyrosine kinase inhibitor used in Philadelphia-chromosome-positive leukaemias. In chronic myeloid leukaemia it is used in chronic phase, accelerated phase and blast crisis, both as a first-line option in newly diagnosed chronic-phase CML and, importantly, in patients who are resistant or intolerant to imatinib, because dasatinib is active against most imatinib-resistant BCR-ABL mutations (the exception being the T315I gatekeeper mutation, which needs an alternative agent such as ponatinib). In Philadelphia-positive acute lymphoblastic leukaemia it is used where the disease is resistant or intolerant to prior therapy, and it features in combination regimens. Therapy is guided by molecular monitoring of BCR-ABL transcript levels against milestone responses. A specialist haemato-oncology medicine throughout.

Several priority signals govern use. Myelosuppression (neutropenia, thrombocytopenia and anaemia) is common and managed by count-driven dose modification, with FBC weekly to fortnightly initially then monthly. Fluid retention is characteristic, and pleural effusion is the signature dasatinib toxicity, dose- and schedule-related, managed with chest imaging, dose interruption, diuretics and sometimes corticosteroids. Pulmonary arterial hypertension is an uncommon but serious effect that may develop even after more than a year of treatment and is usually reversible on stopping the drug, so cardiopulmonary assessment at baseline and on symptoms is advised. QT-interval prolongation, bleeding risk through platelet dysfunction, and cardiac dysfunction complete the priority list. Dasatinib is active against most imatinib-resistant BCR-ABL mutations but not the T315I gatekeeper mutation.

Subject to per-market patent and licence verification, with the compound patent expired the lawful lanes are broad. Sub-Saharan African public-sector oncology (SAHPRA, NAFDAC, KEMSA and PPB, FDA Ghana, EFDA, TMDA, NDA). GCC haematology centres (NUPCO and SFDA, MoHAP / DHA / DoH, and the Kuwait, Qatar, Oman and Bahrain ministries) through licensed importers. ASEAN and South Asia (Philippines FDA, Vietnam DAV, Indonesia BPOM, Bangladesh DGDA, Sri Lanka NMRA) and Latin America (Brazil ANVISA, Mexico COFEPRIS). UK and EU supply runs through the post-expiry generic channel where our WHO-GMP partner lines hold the relevant authorisation. We do not supply into India. Full coverage at markets.

Batch-specific Certificate of Analysis (HPLC dasatinib assay, related substances per Ph.Eur./USP, polymorph identity, dissolution profile, content uniformity, water content), Method of Analysis, bioequivalence study report against the Sprycel reference for new registrations, Certificate of Pharmaceutical Product (CoPP) from CDSCO India, WHO-GMP certificate, manufacturing licence, per-destination patent-verification note, Certificate of Origin, and a destination-language pack insert with the molecular-monitoring guidance, the pleural-effusion and pulmonary-arterial-hypertension warnings, the QT and bleeding-risk notes and the T315I-resistance caveat. CTD Module 3 dossier available against an NDA, see dossier preparation.