Fludarabine Phosphate bulk supplier for pharma manufacturers

Fludarabine Phosphate Suppliers & Bulk Manufacturers

Available Forms: Injection, tablets

Available Strengths: Injection 50 mg (25 mg/mL); tablets 10 mg

Reference Brands: Fludara (US/EU)

Fludarabine is used in the treatment of type of blood cancer called chronic lymphocytic leukemia (CLL). It may be used to treat other conditions, as determined by the doctor. It is sometimes used with certain other medicines as part of combination chemotherapy.

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Product Description:

Fludarabine is a purine analogue designed to resist adenosine deaminase, the enzyme that destroys its predecessors. Phosphorylated inside the cell, it inhibits DNA polymerase, ribonucleotide reductase and DNA primase, and is incorporated into DNA where it terminates the chain. Unusually for an antimetabolite it also kills resting lymphocytes, which is why it works in a disease as slow-dividing as chronic lymphocytic leukaemia.

It is used for chronic lymphocytic leukaemia, alone or in the FCR combination with cyclophosphamide and rituximab, for indolent lymphomas, and as part of reduced-intensity conditioning before allogeneic stem cell transplant, where its lymphodepleting effect prevents graft rejection. Profound and prolonged T-cell depletion follows treatment and lasts many months, so Pneumocystis and herpes prophylaxis is standard. Autoimmune haemolytic anaemia, transfusion-associated graft-versus-host disease — requiring irradiated blood products for life — and dose-related neurotoxicity are recognised risks.

Sourcing notes. Off patent, available as both injection and tablets, which are not dose-equivalent. Dose must be reduced in renal impairment, so creatinine clearance data belong in any tender specification. Transplant conditioning is now a substantial share of demand. Cytotoxic handling; refrigerated storage for most presentations.

Fludarabine Phosphate — third party manufacturing & bulk supply

Fludarabine Phosphate 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

Fludarabine Phosphate is supplied as Injection, tablets — supplied in more than one dosage form, each with its own manufacturing economics, so the indicative MOQ is a minimum order value of USD 5,000 per product. 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 Fludarabine Phosphate 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

Fludarabine Phosphate is listed as Injection, tablets in Injection 50 mg (25 mg/mL); tablets 10 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Fludarabine Phosphate is referenced against Fludara (US/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.