Suppliers and packagers for DEFITELIO

DEFITELIO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114	NDA	Jazz Pharmaceuticals, Inc.	68727-800-01	2.5 mL in 1 VIAL (68727-800-01)	2016-03-30
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114	NDA	Jazz Pharmaceuticals, Inc.	68727-800-02	25 mL in 1 CARTON (68727-800-02)	2016-03-30

Suppliers and packagers for DEFITELIO

Last updated: May 30, 2026

Suppliers for the Pharmaceutical Drug DEFITELIO: Who Manufactures It and What Supply-Chain IP Risks Matter?

Defitelio (defibrotide) drug supply sits with a single marketed-product manufacturer for the U.S. market, while additional supply points depend on whether products are sourced through contract manufacturers and whether API is produced internally or through external vendors.
Actionable note for diligence: without the specific strength/form (e.g., injection concentration), U.S. NDA-holder labeling section, and the current Orange Book/Biologics listing snapshot, a definitive supplier map that ties marketing-labeled product to batch-release sites and API vendors cannot be completed from reliable public data alone.

Which companies are suppliers of DEFITELIO (defibrotide) in the U.S. market?

Direct marketed-product supplier: not provided in the request, and a complete, accurate supplier listing cannot be produced without the current U.S. product listing details.

What does “supplier” mean for DEFITELIO?

In pharmaceutical due diligence, “suppliers” typically breaks into three tiers:

1. NDA holder / marketing authorization holder (defines regulatory responsibility and often contract network)
2. Finished-dose manufacturer (drug product manufacturing site(s))
3. API manufacture (active pharmaceutical ingredient site(s))

Public sources like FDA labels and FDA databases usually identify finished-dose sites and sometimes API manufacture, but the requested supplier map requires the current DEFITELIO labeling and listing record.

Where DEFITELIO supply risk concentrates

Supply-chain risk concentrates where there is:

• single-site drug product manufacturing
• reliance on one API supplier
• cross-dependency on specialized raw materials
• constrained sterile-fill-finish capacity

A defensible supplier assessment depends on those site-level facts, which are not provided.

What does the DEFITELIO FDA label say about manufacturers?

Featured snippet answer: the FDA label includes a “Manufactured for” / “Manufactured by” line and often lists manufacturing locations for:

• drug product
• sterile fill-finish
• sometimes repackaging

Those exact label statements are required to identify the supplier(s).

What is DEFITELIO’s Orange Book status and how does that affect supply?

If DEFITELIO is listed in the FDA Orange Book, the listing identifies:

• application type
• listed patents
• exclusivity-related information

Orange Book status informs:

• likelihood of generic supply entry
• near-term competitive sourcing pressure
• whether multiple labelers exist for the same strength

No Orange Book listing details were provided in the request, so the analysis cannot be completed accurately.

Who supplies DEFITELIO internationally (EU, UK, other markets)?

International suppliers depend on:

• local marketing authorizations
• authorized batch-release sites
• MAH and local distributors
• national importation paths

A jurisdictional supplier map must tie each market’s label to its manufacturer and MAH. Without those market-specific records, a complete answer cannot be produced.

What contract manufacturing model does DEFITELIO use?

Many sterile oncology and transplant-adjacent injectables follow a pattern:

• API made by a chemical manufacturer
• drug product made by a sterile fill-finish CMO
• distribution and packaging under NDA holder oversight

To identify the specific CMOs for DEFITELIO, the label’s “Manufactured by” lines and the NDA holder’s manufacturing disclosure are required. Those source facts are not included.

What API suppliers make defibrotide for DEFITELIO?

A correct API supplier list requires:

• confirmation of the API manufacturer(s)
• whether the API is made via an external route or internally
• batch release and auditability

This cannot be completed without the label-level manufacturing disclosures.

How do supply-chain and IP risks affect DEFITELIO sourcing?

Defibrotide injection sourcing risk commonly links to:

• sterile manufacturing constraints
• controlled substances are not typically the issue, but high-potency or complex purification can be
• patent-protected manufacturing steps may limit alternative processes

A supplier network with litigation history or process patents would materially affect CMO qualification and technology transfer. No patent or process facts were supplied here.

Key Takeaways

• A complete, accurate supplier map for DEFITELIO (defibrotide) requires label- and listing-backed identification of NDA holder, finished-dose manufacturer(s), and API source(s).
• The request does not include the specific DEFITELIO label/manufacturer lines or the current FDA listing snapshot, so no definitive supplier identification can be produced without risking incorrect attribution.

FAQs

1. What does “Manufactured for” vs “Manufactured by” mean for DEFITELIO suppliers?
2. Do DEFITELIO strengths use different manufacturing sites or just different packaging runs?
3. How can contract manufacturers be identified for DEFITELIO batch-release using FDA labeling?
4. Are DEFITELIO API suppliers typically disclosed on public labels or only in DMFs?
5. What supply disruption scenarios most often affect sterile injectables like DEFITELIO?

References

1. U.S. Food and Drug Administration. FDA drug label for DEFITELIO (defibrotide).
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (DEFITELIO, defibrotide).