Romidepsin bulk supplier for pharma manufacturers

Romidepsin 10 mg Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 10 mg

Reference Brands: Istodax (USA/EU)

Romidepsin is a Oncology Cancer Care product available as Injection in strengths 10 mg. It corresponds to the reference brand Istodax (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Romidepsin is an anticancer agent used in the treatment of cutaneous T-cell lymphoma (CTCL) and certain types of peripheral T-cell lymphoma (PTCL) in adult patients who have received prior systemic therapy. It is marketed under the brand name Istodax and is administered intravenously under specialist oncology supervision. Romidepsin belongs to a class of compounds known as depsipeptides and is derived from a natural product originally isolated from the bacterium Chromobacterium violaceum.

Pharmacologically, romidepsin functions as a histone deacetylase (HDAC) inhibitor. Following intracellular activation, it binds to HDAC enzymes and blocks their activity, leading to changes in gene expression within malignant cells. These epigenetic modifications result in cell cycle arrest, cellular differentiation, and programmed cell death (apoptosis). In addition to its direct antitumor effects, romidepsin has been shown to inhibit hypoxia-induced angiogenesis and reduce levels of several heat shock protein 90 (Hsp90)-dependent oncoproteins, further contributing to its antineoplastic activity.

Due to its potent mechanism of action and safety considerations, romidepsin therapy requires careful patient selection, monitoring, and administration in controlled clinical settings.

Romidepsin — third party manufacturing & bulk supply

Romidepsin 10 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

Romidepsin 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 Romidepsin 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

Romidepsin is used to treat cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in adult patients who have received prior systemic therapy.

Romidepsin is a synthetic cyclic peptide compound originally derived from a natural product, formulated as a sterile injectable anticancer agent.

The trade name of romidepsin is Istodax.

Istodax was developed by Gloucester Pharmaceuticals and later acquired and marketed by Celgene, which is now part of Bristol Myers Squibb.

The complete generic name is romidepsin.

The approved brand name is Istodax.

Romidepsin is manufactured in GMP-approved facilities in the USA and other regulated pharmaceutical manufacturing regions, depending on the authorized manufacturer and market.