Suppliers and packagers for generic pharmaceutical drug: defibrotide sodium

defibrotide sodium

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

Defibrotide Sodium Suppliers: Who Manufactures Defibrotide API, Drug Product, and Hospital-Use Bulk Supply

Last updated: May 29, 2026

Defibrotide sodium supply is dominated by a small set of injectable-focused manufacturers supplying bulk drug substance and finished vials for hospitals under multiple brand and generic labels. The supplier map is typically governed by (1) whether the supplier is an API manufacturer or a sterile fill-finish/finished-dose manufacturer, (2) whether the finished product is supplied as brand, authorized generic, or independently marketed generic, and (3) whether the supply is confined to specific geographies due to regulatory registrations and patent/IP constraints.

Which companies supply defibrotide sodium (API and finished vials) to pharma and hospitals?

Featured-snippet answer: Defibrotide sodium commercial supply is concentrated among injectable sterile-manufacturing networks that produce defibrotide sodium in vials for hospital administration, with upstream supply coming from specialized API and aseptic fill-finish plants.

How is the supplier chain usually structured?

Defibrotide sodium injectable supply typically splits into two tiers:

• API production (defibrotide sodium drug substance), controlled by APIMF-level registrations and vendor qualification requirements.
• Sterile drug product manufacture (aseptic processing, vial filling, labeling), controlled by DMF/sterile facility inspections, batch release, and supply allocation.

What supplier roles matter for sourcing?

When sourcing for formulary, procurement, or contingency supply, the practical supplier roles are:

• Drug product manufacturer (sterile fill-finish and final QC release).
• Contract manufacturing organization (CMO) for sterile fill-finish under a product label holder.
• Authorized generic / license holder (often controls distribution even if manufacturing is outsourced).
• Importer-of-record for the US and other regulated markets, tied to FDA and local marketing authorization.

What defibrotide sodium products are on the market, and who holds the label?

Featured-snippet answer: Defibrotide sodium is marketed as an injectable product under brand and generic labeling depending on region, with the label holder responsible for FDA labeling and distribution even when manufacturing is outsourced.

Which label holders are relevant in procurement terms?

Procurement teams typically track:

• Brand label holder(s) for the originator product.
• Generic NDA/ANDA label holder(s) for vial supply.
• Distributors and wholesalers that control short-term availability.

Where does defibrotide sodium get manufactured (sterile fill-finish vs API plants)?

Featured-snippet answer: Most procurement risk sits in the sterile fill-finish layer, since batch-level release, aseptic capability, and vial packaging constraints drive allocation during shortages.

Sterile injectable bottlenecks that determine supplier continuity

Common manufacturing constraints that govern supply continuity for injectable defibrotide sodium include:

• Aseptic fill-finish line capacity for vials.
• Sterilization and container closure system qualification.
• Hold times and batch release release sequencing for sterile products.
• Quality systems alignment with DMF/CGMP requirements.

Which suppliers have the strongest regulatory footprints for defibrotide sodium?

Featured-snippet answer: The strongest regulatory footprint is held by manufacturers with a validated sterile facility for the specific dosage form and labeling, and by API suppliers with a DMF history supporting multiple finished-dose applicants.

What regulatory signals procurement teams use

• FDA facility listings tied to the approved NDA/ANDA manufacturing site.
• Inspection history and compliance outcomes for sterile manufacturing.
• DMF/ASMF support for the API used in commercial batches.

How to qualify defibrotide sodium suppliers for procurement?

Featured-snippet answer: Supplier qualification is primarily a document and release framework, centered on sterile manufacturing CGMP evidence, batch release traceability, and consistent labeling compliance.

Qualification checklist procurement teams use

• GMP certificate and site ownership/control clarity for sterile fill-finish.
• Batch CoA availability and release specifications consistency.
• Stability and shelf-life match to procurement window.
• Supply continuity track record and allocated capacity coverage.
• Regulatory documentation alignment (NDA/ANDA-linked manufacturing and labeling).

What are the main generic and authorized-generic supply risks for defibrotide sodium?

Featured-snippet answer: Generic entry can expand supply but raises swap risk at the vial level if formulations, fill/finish processes, or container-closure systems differ. Shortages often persist where only a few sterile lines can support vial packaging.

Paragraph IV and patent risk effect on supply

When patent/IP is still active, supply is often constrained to fewer label holders and may delay additional sources, sustaining dependence on a limited supplier set.

What shortage indicators matter

• Distributor lead-time increases.
• Batch lot substitution or allocation.
• Reduced number of concurrently stocked sources at wholesalers.

Key Takeaways

• Defibrotide sodium supply is concentrated among a small set of sterile injectable capable manufacturers and their upstream API partners.
• Procurement risk typically concentrates in sterile fill-finish capacity and batch release, not only in API availability.
• Supplier selection should be based on regulatory alignment to the exact NDA/ANDA-linked manufacturing and labeling, plus verified CoA traceability and stable shelf-life performance.

FAQs

1) Who can supply defibrotide sodium vials in the US?
Typically the sourcing set is limited to US-distributed NDA/ANDA label holders and their authorized wholesalers, backed by sterile fill-finish facilities qualified for the approved dosage form.

2) Is defibrotide sodium supplied as an API and finished vial or only as a finished product?
Commercial sourcing for hospitals is primarily finished vials; API-only supply is used by manufacturers making their own finished-dose registration.

3) What causes defibrotide sodium shortages most often?
Sterile manufacturing line capacity constraints, aseptic batch release delays, and allocation driven by limited concurrently approved vial-supply capacity.

4) How do container closure system differences affect defibrotide sodium substitution?
They can affect stability and compatibility requirements; procurement substitution policies typically require matching approved product specifications.

5) Do biosimilar concepts apply to defibrotide sodium supply?
Defibrotide sodium is a small molecule; supply is addressed through generic/ANDA-type pathways rather than biosimilar frameworks.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.
3. FDA. DMF Database (Drug Master Files). U.S. Food and Drug Administration.
4. FDA. Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals and API. U.S. Food and Drug Administration.