Vidaza (azacitidine), a hypomethylating agent licensed for higher-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia, is supplied by M Care as originator brand or WHO-GMP generic against the standard 75 mg per square metre, seven-day subcutaneous dosing schedule, with intravenous administration available where the destination market's licence permits it.
M Care Exports supplies Vidaza (azacitidine), the hypomethylating agent marketed by Bristol Myers Squibb, alongside licensed generic azacitidine for injection. It treats higher-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia in patients unsuitable for stem cell transplant. M Care Exports is a merchant exporter: we source the originator brand and FDA and MHRA-approved generic azacitidine through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Azacitidine exporter and bulk supplier from India.
For hospital haematology-oncology and MoH tender-desk orders, M Care quotes azacitidine for injection against buyer specification: originator Vidaza or WHO-GMP generic, vial count and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because a standard cycle runs seven consecutive dosing days within a 28-day course, we confirm the buyer's vial-per-cycle arithmetic, diluent stock and subcutaneous-versus-intravenous administration route before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Pyrimidine nucleoside analogue; DNA methyltransferase inhibitor (hypomethylating agent), sourced and documented for export.
Azacitidine is a pyrimidine nucleoside analogue that inhibits DNA methyltransferase, reactivating silenced tumour-suppressor genes in abnormal bone-marrow cells; it is cytotoxic at higher exposure and hypomethylating at the doses used clinically. It is given as a subcutaneous injection; the US FDA label also permits a slow intravenous infusion where subcutaneous access is unsuitable, but the EU/UK SmPC licenses subcutaneous administration only, and it is never given orally in this injectable presentation. The FDA label covers refractory anaemia and related myelodysplastic syndrome (MDS) subtypes plus paediatric juvenile myelomonocytic leukaemia; the EU/UK SmPC instead licenses IPSS intermediate-2 and high-risk MDS, chronic myelomonocytic leukaemia with 10-29% marrow blasts, and acute myeloid leukaemia with 20% or more marrow blasts, in adults unfit for stem-cell transplant. Vidaza is supplied as a single 100 mg lyophilised powder vial, reconstituted before dosing; there is no tablet strength of this injectable product.
Active ingredient
Azacitidine. Pyrimidine nucleoside analogue; DNA methyltransferase inhibitor (hypomethylating agent).
Forms and strengths
100 mg per single-dose vial, lyophilised powder for reconstitution.
Indications
Azacitidine, a hypomethylating agent indicated for higher-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia in patients unsuitable for stem cell transplant. Supplied as originator Vidaza and licensed generic single-dose vials from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Subcutaneous, Intravenous. Lyophilised powder for suspension or solution for injection.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for azacitidine are hospital haematology-oncology pharmacies running MDS and AML treatment protocols, national and regional MoH tender desks maintaining cancer-medicine formularies, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting access to hypomethylating-agent therapy in markets where local registration is in place. India is our origin. We do not sell into the Indian market; azacitidine is exported only.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on azacitidine.
Azacitidine's standard adult dose is 75 mg/m2 of body surface area, injected subcutaneously (intravenously in markets whose licence permits it, per the FDA label), daily for 7 days of a 28-day cycle, unchanged for cycle one regardless of baseline haematology values. After reconstitution, the subcutaneous suspension must not be filtered and should be used within 1 hour at room temperature or 8 hours if refrigerated, while the intravenous solution must be administered within 1 hour of preparation, so pharmacy scheduling around cycle-start days matters more than for oral cytotoxics. Anaemia, neutropenia and thrombocytopenia are expected, particularly across the first two cycles, and routine full blood counts should guide any cycle delay or dose reduction. Renal function needs checking each cycle: an unexplained doubling of creatinine or blood urea nitrogen above baseline and the upper limit of normal delays the next cycle and halves the following dose. Premedicate for nausea and vomiting.
The documentation pack a regulator actually asks for.
Unreconstituted Vidaza vials are stored at 25 degrees C, with excursions permitted to 15-30 degrees C per the FDA label, so distribution runs on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics; confirm current shelf-life dating against the batch certificate of analysis, since it is only the reconstituted suspension or solution that needs prompt use or short refrigeration. WHO Essential Medicines List status for azacitidine varies by list edition and indication, so buyers should confirm current EML or EMLc listing directly when building a tender specification rather than assume a fixed status either way. On the brand-versus-generic question, Vidaza remains the originator product, marketed by Bristol Myers Squibb; FDA-approved generic azacitidine has been marketed in the US since 2013 and MHRA/EMA-authorised generics are separately registered across the UK and EU, so buyers genuinely have a brand-or-generic choice for the injectable. Bristol Myers Squibb also markets Onureg, an oral azacitidine tablet licensed only for AML maintenance therapy; it is a distinct product from injectable Vidaza with its own strength and indication, and M Care treats a buyer's request for either as a separate specification rather than an interchangeable substitute.
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.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside azacitidine.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for azacitidine.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Azacitidine supply, the specific questions.
Does a generic version of Vidaza exist?
Yes. FDA-approved generic azacitidine for injection has been marketed in the US since 2013, and MHRA/EMA-authorised generic azacitidine is separately registered across the UK and EU alongside the originator brand Vidaza. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Vidaza to our market?
Yes, on an import basis. We source Vidaza through Bristol Myers Squibb's licensed Indian distribution channels, or the WHO-GMP generic equivalent, and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strength does azacitidine come in?
Vidaza and its generic equivalents are supplied as a single-dose 100 mg lyophilised powder vial, reconstituted before dosing. Tell us your monthly cycle count and typical body-surface-area dosing to size the vial order per cycle.
Is azacitidine given subcutaneously or intravenously?
Subcutaneous injection is the standard route and the only one licensed under the EU/UK SmPC; the US FDA label also permits intravenous infusion where subcutaneous access is unsuitable. Standard subcutaneous practice rotates the injection site across the upper arm, thigh or abdomen over the seven dosing days. Confirm which route and licence your destination market follows before ordering, since the reconstituted preparation differs by route.
Is azacitidine on the WHO Essential Medicines List?
WHO Essential Medicines List status for azacitidine depends on the list edition and indication under review, so tender desks should confirm current EML or EMLc listing directly with WHO rather than assume a fixed status. Either way, specify strength, route and destination-market regulatory documentation on your enquiry so M Care can align the dossier accordingly.
What documentation does M Care provide with an azacitidine shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. We confirm cold-chain is not required for unreconstituted vials, which travel and store at controlled room temperature (25 degrees C, excursions to 15-30 degrees C); shelf-life dating is confirmed against the batch certificate of analysis.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.