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Azacitidine Tablet bulk supplier for pharma manufacturers

Azacitidine Tablet Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 200 mg, 300 mg

Reference Brands: Onureg (USA)

Category: Oncology Cancer Care

Azacitidine is used in the treatment of some kinds of blood cancer. It is used for the treatment of adult patients with all subtypes of Myelodysplastic Syndrome (MDS). It may be also used to treat other conditions, as determined by the doctor. Azacitidine Tablet is available in Tablets and strengths such as 200 mg, 300 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Azacitidine Tablet is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Azacitidine Tablet can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Azacitidine, marketed under the brand name Vidaza among others, is a chemotherapeutic agent used primarily in the treatment of myelodysplastic syndromes (MDS), myeloid leukemia, and juvenile myelomonocytic leukemia. As a chemical analog of cytidine, a nucleoside found in DNA and RNA, azacitidine integrates into nucleic acids and exerts its therapeutic effects by interfering with abnormal DNA methylation, ultimately promoting the reactivation of silenced genes that regulate normal cell growth and differentiation.

First synthesized in Czechoslovakia alongside its deoxy derivative, decitabine, azacitidine was developed as a potential cancer therapy. It received approval from the U.S. Food and Drug Administration (FDA) on May 19, 2004, for the treatment of myelodysplastic syndromes. Clinical studies have demonstrated its efficacy in normalizing blood cell counts and bone marrow morphology, with a significant proportion of patients experiencing reduced dependence on blood transfusions. Azacitidine represents a key therapeutic option for managing hematologic malignancies, offering improved hematologic function and quality of life for patients with MDS and related disorders.

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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.

Yes, Azacitidine Tablet is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Azacitidine Tablet is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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