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Decitabine bulk supplier for pharma manufacturers

Decitabine Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 50 mg/vial (5 mg/mL once reconstituted)

Reference Brands: Dacogen (USA)

Category: Oncology Cancer Care

Decitabine is a nucleoside analog and hypomethylating agent used in oncology for the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). It works by inhibiting DNA methyltransferase, leading to hypomethylation of DNA and reactivation of silenced genes that control cell differentiation and apoptosis.

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Product Description:

Decitabine is a cytidine analogue that works by disabling rather than destroying. Incorporated into DNA in place of cytidine, it traps DNA methyltransferase irreversibly, so methyl marks are lost as the cell divides. Genes silenced by hypermethylation — including tumour suppressors controlling differentiation and apoptosis — are reactivated. At the low doses used clinically the effect is epigenetic rather than cytotoxic, which is why responses take three or four cycles to appear.

It is used for myelodysplastic syndromes and for acute myeloid leukaemia in older patients unfit for intensive induction, increasingly in combination with venetoclax. Myelosuppression dominates the toxicity profile and counts often fall before they improve, which is the single most important point in managing patients: treatment is commonly abandoned too early. Febrile neutropenia, fatigue, nausea and hyperbilirubinaemia occur.

Sourcing notes. Off patent with several generic manufacturers. Supplied as a lyophilised powder — 50 mg per vial, reconstituting to 5 mg/mL — and the reconstituted solution is unstable, requiring preparation with cold diluent and administration within a short window. Cytotoxic handling. Confirm vial content rather than concentration when quoting.

Decitabine — third party manufacturing & bulk supply

Decitabine 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

Decitabine is supplied as Injection — an injectable dosage form, so the indicative MOQ is 50,000 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 Decitabine 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

Decitabine is listed as Injection in 50 mg/vial (5 mg/mL once reconstituted). Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Decitabine is referenced against Dacogen (USA). Reference brands are shown for identification only and remain the property of their respective trademark owners.

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