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Romidepsin bulk supplier for pharma manufacturers

Romidepsin Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 10 mg

Reference Brands: Istodax (USA/EU)

Category: Oncology Cancer Care

Romidepsin is available in Injection and strengths such as 10 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, Romidepsin 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)

Romidepsin 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:

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.

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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.

Yes, Romidepsin 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, Romidepsin 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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