Azacitidine Tablet bulk supplier for pharma manufacturers

Azacitidine Tablet 200 mg, 300 mg Suppliers & Bulk Manufacturers

Q: What company makes Azacitidine?

Onureg® is manufactured and marketed by Celgene Corporation, a subsidiary of Bristol Myers Squibb.

Q: What is the generic name of Azacitidine?

The generic name is azacitidine.

Q: What is the brand name of Azacitidine?

For tablets, the brand name is Onureg®.

Q: Where is Azacitidine manufactured?

Azacitidine tablets (Onureg®) are manufactured in GMP-certified facilities in the USA, with distribution authorized globally under local regulatory approvals.

Available Forms: Tablets

Available Strengths: 200 mg, 300 mg

Reference Brands: Onureg (USA)

Category: Oncology Cancer Care

Azacitidine 200 mg and 300 mg oral tablets, a hypomethylating agent for maintenance therapy in acute myeloid leukaemia. For oncology pharmacies, importers, distributors and tender buyers; not interchangeable with the injection.

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Product Description:

Azacitidine is a hypomethylating agent, a cytidine analogue built into RNA and DNA in dividing cells. It inhibits DNA methyltransferase, which can switch silenced genes back on, and it is directly toxic to abnormal blood-forming cells. This page covers oral film-coated tablets at 200 mg and 300 mg. The tablet is not a swallowable copy of the injection. It gives lower, longer exposure and was developed for a different use, so the two must never be swapped at the same dose or schedule.

Oral azacitidine is approved as maintenance therapy for adults with acute myeloid leukaemia in first complete remission after intensive induction who are not going on to stem cell transplant. The usual schedule is 300 mg once daily on days 1 to 14 of each 28-day cycle, with an antiemetic before each dose for at least the first two cycles. Tablets are swallowed whole. Neutropenia and thrombocytopenia are common, so counts are checked, and nausea and diarrhoea are frequent. The injectable form, not these tablets, is licensed for myelodysplastic syndromes.

Sourcing notes. Azacitidine tablets are a prescription-only cytotoxic medicine, registered nationally, and the dossier should support the oral maintenance indication. Handle as a hazardous drug: wear gloves if a tablet is broken and follow cytotoxic waste rules. Packs are usually bottles with a desiccant or aluminium blisters, kept dry at room temperature. Ask for a batch CoA, GMP certificate from a site approved for cytotoxics, a CoPP and IVb stability. Give strength, pack format and count, and confirm you need oral tablets, not powder for injection.

Azacitidine Tablet — third party manufacturing & bulk supply

Azacitidine Tablet 200 mg, 300 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Azacitidine Tablet is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Azacitidine Tablet listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Azacitidine tablets, marketed under the brand name Onureg®, are used for the maintenance treatment of adult patients with acute myeloid leukemia (AML) who achieved complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy. The tablets help maintain remission, reduce the risk of relapse, and support normal blood cell production.

Azacitidine is a chemical analog of cytidine, a nucleoside found in DNA and RNA. It works by integrating into nucleic acids and inhibiting abnormal DNA methylation, which can reactivate silenced genes and help restore normal cell growth and differentiation.

The oral tablet formulation of azacitidine is sold under the trade name Onureg®.

Onureg® is manufactured and marketed by Celgene Corporation, a subsidiary of Bristol Myers Squibb.

The generic name is azacitidine.

For tablets, the brand name is Onureg®.

Azacitidine tablets (Onureg®) are manufactured in GMP-certified facilities in the USA, with distribution authorized globally under local regulatory approvals.