Bendamustine Hydrochloride bulk supplier for pharma manufacturers

Bendamustine Hydrochloride 25 mg/vial, 100 mg/vial Suppliers & Bulk Manufacturers

Available Forms: Injection (powder for solution)

Available Strengths: 25 mg/vial, 100 mg/vial

Reference Brands: Treanda®, Bendeka®(US), Levact®(EU)

Bendamustine hydrochloride powder for solution in 25 mg and 100 mg vials, a cytotoxic alkylating agent for IV infusion in haematology, for hospital oncology pharmacies, tender buyers and distributors.

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Product Description:

Bendamustine hydrochloride is a cytotoxic alkylating agent. Its nitrogen mustard group cross-links DNA, and a benzimidazole ring gives it some purine analogue-like features, killing dividing lymphoid cells. This page covers lyophilised powder in 25 mg and 100 mg vials for intravenous infusion. The powder form exists because the molecule breaks down in water, so it is reconstituted just before use. Liquid concentrates sold in some markets need different storage and are not interchangeable without checking the label.

Bendamustine is used in chronic lymphocytic leukaemia and indolent B-cell non-Hodgkin lymphoma, including disease progressing after rituximab-based therapy, and in some markets in multiple myeloma. It is often paired with rituximab. Pharmacy reconstitutes the powder with water for injections, then dilutes it in sodium chloride 0.9% as the label directs. Main precautions are marrow suppression, infections, infusion reactions, tumour lysis syndrome and serious skin reactions. Extravasation can injure tissue, and blood counts are checked before each cycle.

Sourcing notes. This is a prescription-only cytotoxic, handled under hazardous-drug rules with safety cabinets or closed-system transfer devices and cytotoxic labels on outer packs. Registration needs a full CTD or ACTD dossier with sterile process validation. Powder vials are usually stored below 25 °C in the carton to protect from light; cold chain applies only to liquid concentrates labelled for it. Ask for a batch CoA with related substances, sterility and endotoxins, a GMP certificate for sterile cytotoxic production, and a CoPP. Specify vial strength and form.

Bendamustine Hydrochloride — third party manufacturing & bulk supply

Bendamustine Hydrochloride 25 mg/vial, 100 mg/vial 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

Bendamustine Hydrochloride is supplied as Injection (powder for solution) — 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 Bendamustine Hydrochloride 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

Bendamustine Hydrochloride is listed as Injection (powder for solution) in 25 mg/vial, 100 mg/vial. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Bendamustine Hydrochloride is referenced against Treanda®, Bendeka®(US), Levact®(EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.