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Suppliers and packagers for ROMIDEPSIN
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ROMIDEPSIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | ROMIDEPSIN | romidepsin | POWDER;INTRAVENOUS | 206254 | ANDA | Fresenius Kabi USA, LLC | 63323-926-88 | 1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03) | 2021-10-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ROMIDEPSIN
Romidepsin Drug Suppliers: Who Manufactures and Supplies It Globally, and What IP/Regulatory Constraints Affect Availability
Romidepsin (Istodax) is supplied through branded commercial channels tied to the original marketing authorization and its manufacturing network. In the US, FDA labeling for Istodax identifies Celgene/Bristol Myers Squibb’s branded program. Global supply is driven by (1) the marketing authorization holder’s manufacturing sites and (2) any approved generics or biosimilar-like substitutes, which in practice has not produced a broad multi-supplier generic market for romidepsin as of the active US branded lifecycle. This makes procurement tightly linked to the branded source and its permitted wholesale/distribution chain.
What companies supply romidepsin (Istodax) to hospitals and wholesalers?
Branded channel (US and major markets):
- Bristol Myers Squibb (BMS) (via the Istodax brand program associated with the original FDA approval; corporate lineage from Celgene after BMS acquisition).
Procurement reality:
- In high-acuity settings (oncology infusion), romidepsin typically moves through the brand’s authorized distributors and hospital pharmacy purchasing arrangements rather than through a diversified generic tender market.
Which manufacturing sites supply romidepsin and where are they located?
A complete, site-by-site supplier mapping requires drug-label “Manufactured for” and “Distributed by” data for each market presentation and strength, plus corresponding GMP manufacturing license holders for each site. This mapping is not available in the provided input, and no complete manufacturing-site table can be produced without it.
Who are the key upstream suppliers for romidepsin API and drug product components?
Upstream suppliers (API maker, key intermediates, excipient sources, sterile fill-finish contractors) are not reliably disclosed in public FDA label text at the level needed for a supplier diligence deliverable. A defensible supplier list requires:
- API manufacturer identity from DMF/EDMF and/or label manufacturing statements
- sterile drug product fill-finish contractor from product application supplements or label “Manufactured by” line
That source-level detail is not provided in the prompt and is not derivable with sufficient completeness here.
What patents protect romidepsin supply and how does exclusivity affect supplier entry?
A supplier list is also constrained by IP and regulatory exclusivity because romidepsin has historically operated as a specialty oncology brand. Without the Orange Book record for each strength/presentation and without the exact patent numbers tied to the formulation and method-of-use, the patent-protection map cannot be constructed.
What is the Orange Book status of romidepsin (Istodax) and which patents block generics?
This requires the specific FDA Orange Book listing for romidepsin drug products and the underlying patents (US numbers), plus the listed expiration dates and exclusivity grants. Those listing details are not included in the provided input, so a correct Orange Book status summary cannot be produced.
Romidepsin supplier landscape by category: distributors vs API producers
Are there multiple approved generic suppliers for romidepsin in the US?
No defensible answer can be given without confirming the current Orange Book generic status and any approved ANDA submissions or permitted substitutable products. The prompt does not include the Orange Book entries or any current generic list.
Are there approved alternate-market suppliers in EU/UK/Canada?
The EU/UK/Canada supplier roster depends on MAH and local distributors plus any national approvals. Without the market authorization holder and national product authorization details, a supplier list by geography cannot be produced accurately.
How to structure a procurement due diligence pack for romidepsin sourcing
A procurement-focused supplier assessment typically includes:
- Authorized distribution chain verification (who can legally supply the product to the buyer’s market)
- GMP manufacturing verification for drug substance and drug product
- Sterility assurance controls and batch release testing responsibility
- Change control history and deviation record summaries
- Regulatory status confirmation by market presentation
A supplier-by-supplier table cannot be completed because the underlying supplier identity data is not present in the prompt.
Key Takeaways
- Romidepsin (Istodax) supply is dominated by the branded program, with Bristol Myers Squibb as the identifiable corporate source on US labeling lineage.
- A complete supplier map covering API manufacturers, sterile drug product manufacturers, fill-finish contractors, and distributor network members cannot be generated from the provided information.
- Patent and Orange Book status, which gate generic entry, also cannot be mapped without the exact Orange Book listing data.
FAQs
- Who is the marketing authorization holder for romidepsin in the US?
- Which strength and presentation of Istodax determines the specific manufacturing and packaging supplier chain?
- Are there any approved generic romidepsin products eligible for substitution under US pharmacy formularies?
- What regulatory submissions (ANDA vs 505(b)(2)) would support a romidepsin non-branded entry?
- How should hospitals verify drug supply chain authenticity for high-risk oncology injectables like romidepsin?
References (APA)
- FDA. (n.d.). Istodax (romidepsin) prescribing information. FDA label database.
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