Suppliers and packagers for ONIVYDE

ONIVYDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0043-1	1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE	2015-10-22

Suppliers for ONIVYDE (liposomal irinotecan): key manufacturers, contract roles, and regulatory-linked sourcing

Last updated: May 26, 2026

ONIVYDE (liposomal irinotecan; irinotecan encapsulated in a liposome) is supplied in the US by Servier Pharmaceuticals LLC (marketing authorization holder for FDA-labeled products) and historically manufactured/label-specified through a controlled supply chain tied to Onivyde’s NDA labeling and cGMP manufacturing sites. Public data most directly supports the identification of the primary marketing and sourcing entity and the manufacturing-and-testing footprint that supports FDA release, as reflected in the FDA label and Orange Book for ONIVYDE.

Who manufactures ONIVYDE and supplies it to US wholesalers and hospitals?

Answer: ONIVYDE is marketed in the US by Servier Pharmaceuticals LLC; the product supply is supported by cGMP manufacturing and testing sites disclosed in FDA labeling.

What entities are tied to ONIVYDE’s US regulatory product

• Marketing authorization / label holder (US): Servier Pharmaceuticals LLC (ONIVYDE label holder).
• Manufacturing and control (site-level sourcing): listed in the FDA Prescribing Information under “How Supplied/Storage” and within manufacturing descriptions tied to NDA labeling.
• Regulatory release testing: tied to the same FDA-labeled manufacturing/controls network described in labeling.

What “supplier” means in ONIVYDE’s context

In pharma purchasing, ONIVYDE “suppliers” typically break into two buckets:

1. Label-holder and distribution supplier (who sells to wholesalers, group purchasing organizations, and health systems).
2. cGMP manufacturers and packagers (who produce drug substance drug product, fill-finish, and conduct release testing).

For ONIVYDE, the first bucket is directly identifiable via the FDA label; the second bucket is identifiable via label-listed manufacturing sites.

What are the cGMP manufacturing and fill-finish suppliers listed for ONIVYDE?

Answer: The FDA label lists ONIVYDE’s manufacturer/packager and the associated cGMP sites used for drug product production and release testing.

Manufacturing network items that appear in the ONIVYDE label

The ONIVYDE label typically includes:

• Drug product manufacturer/labeler
• Packager and/or repacker
• Storage conditions
• NDC-specific presentation details (vial size and concentration)
• Potential site references that allow pharmacy procurement teams to map a given NDC to a specific manufacturing facility

How procurement teams use this for sourcing

• Group buying and hospital formularies usually require mapping to:
  • The NDC on the carton
  • The site information tied to the NDC in the label
  • The lot release documentation that corresponds to the manufacturing site chain

Supplier mapping by dosage form

ONIVYDE is supplied as a liposomal irinotecan injection in vial presentations. Each NDC presentation maps to the same label supply chain described in the prescribing information, unless labeling updates specify site changes.

Does ONIVYDE have multiple suppliers for drug substance and drug product?

Answer: ONIVYDE’s “supplier” structure is best treated as a controlled cGMP network rather than a broad multi-supplier commodity model. The FDA label describes the manufacturing and packaging chain used for the approved NDA product.

Drug substance vs drug product sourcing

Even when multiple firms participate in upstream steps, the FDA release burden for ONIVYDE is tied to the NDA’s approved manufacturing and testing controls. Purchasers should align sourcing decisions to:

• Drug product release testing and batch release
• Fill-finish and packaging site qualification
• Stability and storage-defined performance (label-specific)

What is the Orange Book status of ONIVYDE and what does it imply for sourcing?

Answer: ONIVYDE’s Orange Book listing indicates the approved NDA product and can be used to identify whether follow-on approvals or listed generics affect supply and procurement.

How Orange Book affects “supplier” risk

Orange Book does not list “suppliers” directly, but it:

• Confirms the NDA holder (aligned with label holder)
• Shows whether there are other approved versions that could alter supply options
• Helps procurement and litigation teams map the legal status underpinning supply continuity

Are there biosimilar or generic suppliers competing with ONIVYDE?

Answer: ONIVYDE is a small-molecule (liposomal formulation) product, so biosimilar frameworks do not apply. Generic competition depends on whether ANDA products exist for the liposomal irinotecan formulation and whether patent/exclusivity barriers allow entry.

Practical sourcing implications

• If no ANDA product is approved or launched, ONIVYDE supply is concentrated in the NDA-controlled chain.
• If ANDAs exist, purchasers can diversify by NDC and manufacturer, subject to interchangeability under pharmacy and payer policies.

Supplier list snapshot: entities buyers typically contract with for ONIVYDE

Answer: The supplier landscape is anchored on Servier Pharmaceuticals LLC as the US label holder/distributor, with manufacturing sites disclosed in ONIVYDE prescribing information.

Supply function	What to look for in procurement	Identifiable entity
US marketing/distribution	US label holder on FDA Prescribing Information	Servier Pharmaceuticals LLC
NDA product manufacturing	Manufacturer and/or packager section in label	Label-listed cGMP manufacturer/packager (site names appear in the FDA label)
Batch release and QC testing	Label references to manufacturing/controls	Label-linked QC release site network
Hospital procurement	NDC-specific product from wholesaler/distributor	Same NDA-controlled product chain

Key compliance-linked sourcing constraints for ONIVYDE

• Cold-chain and storage requirements are label-defined.
• Lot traceability supports adverse event reporting and regulatory compliance.
• Manufacturing site changes typically require variation reporting and updated label materials if they affect release strategy, packaging, or significant process elements.

Key Takeaways

• ONIVYDE’s US supply is anchored to Servier Pharmaceuticals LLC as the label holder for the FDA-approved product.
• The operational “supplier” chain for cGMP manufacturing and release testing is disclosed in ONIVYDE’s FDA prescribing information, typically mapped at the NDC presentation level.
• Generic or alternative-labeled suppliers depend on Orange Book and patent/exclusivity status, which is what determines whether ANDA sourcing diversification exists in practice.

FAQs

1) Who is listed as the label holder for ONIVYDE in the US?
Servier Pharmaceuticals LLC.

2) What documentation should sourcing teams request from distributors for ONIVYDE lots?
Lot-level traceability aligned to the FDA-labeled manufacturing and release testing chain and NDC-specific packaging.

3) Does ONIVYDE face biosimilar competition?
No. ONIVYDE is not a biologic; it is a liposomal formulation of irinotecan.

4) Can purchasers substitute a different ONIVYDE NDC if manufacturing sites differ?
Substitution should follow label/NDC-specific product mapping and payer/pharmacy interchange rules, with site differences handled via traceability and compliance documentation.

5) What is the first place to confirm the “true” ONIVYDE manufacturer for procurement?
The FDA Prescribing Information for ONIVYDE, which lists the manufacturing/packaging details used for approved product supply.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Onivyde (liposomal irinotecan) Prescribing Information. FDA label.
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Onivyde listing). FDA.