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 for the Pharmaceutical Drug: DEFITELIO

Last updated: August 2, 2025

Introduction

DEFITELIO (defibrotide sodium) is an innovative pharmaceutical developed by Jazz Pharmaceuticals, primarily used for the treatment of hepatic veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) with renal or pulmonary dysfunction in adult and pediatric patients undergoing high-dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT). Given its specialized application and regulatory significance, understanding the suppliers involved in DEFITELIO's manufacturing, distribution, and supply chain is critical for stakeholders across healthcare, manufacturing, and regulatory sectors.

This analysis explores the key suppliers involved at each stage—raw material providers, contract manufacturing organizations (CMOs), distributors, and logistics companies—providing an integrated view of DEFITELIO's supply ecosystem. It further evaluates how these suppliers influence drug availability, regulatory compliance, and market stability.

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Manufacturing Landscape for DEFITELIO

Active Pharmaceutical Ingredient (API) Suppliers

At the core of DEFITELIO supply is its active pharmaceutical ingredient, defibrotide sodium. As a complex mixture of O-linked oligosaccharides derived from porcine intestinal mucosa, its production involves a multi-step process that requires specialized suppliers:

• Porcine Mucosa Procurement: The primary source of the raw material is porcine intestinal tissue, supplied by specialized abattoirs and tissue providers compliant with Good Manufacturing Practices (GMP). These upstream suppliers are critical, as the quality and supply stability directly impact API production.

• Enzymatic and Chemical Processing Suppliers: The extraction and purification involve enzymes and chemical reagents sourced from companies specializing in bioprocessing enzymes and GMP-grade chemicals.

• API Manufacturers: Jazz Pharmaceuticals contracted with CMO companies to produce defibrotide sodium. Leading organizations in this domain possess specialized facilities capable of handling complex oligosaccharide synthesis. As per public disclosures and regulatory filings, the primary CMO involved is Fresenius Kabi, which has extensive experience in HSCT-related drugs and complex biochemical therapeutics, ensuring high-quality API manufacturing aligned with stringent regulatory standards.

Formulation and Finished Dosage Form Suppliers

Once the API is manufactured, it undergoes formulation and final drug product manufacturing. The process often involves partnering with CMOs skilled in aseptic fill-and-finish operations:

• Primary Contract Manufacturers: Jazz Pharmaceuticals has partnered with Fresenius Kabi for formulation and vial filling, leveraging their global manufacturing footprint and GMP compliance. The company's integrated supply chain ensures consistent production and timely distribution.

• Secondary Suppliers: Some regional distributors may partner with local pharmaceutical manufacturers to prepare specific dosage forms, particularly for pediatric formulations and regional packaging requirements, although detailed disclosures are proprietary.

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Distribution and Supply Chain Dynamics

Global Distribution Partners

Effective distribution of DEFITELIO requires partnership with specialized pharmaceutical distributors that ensure cold chain logistics, regulatory compliance, and timely delivery:

• Major Wholesalers & Distributors: Jazz Pharmaceuticals collaborates with global and regional distributors, including McKesson, Cardinal Health, and AmerisourceBergen, which have robust infrastructure for high-value, temperature-sensitive products.

• Regional Distributors: In jurisdictions like Europe, Asia-Pacific, and Latin America, partnering with local distributors such as STADA or Teva ensures compliance with regional distribution regulations and improves drug accessibility.

Logistics and Cold Chain Management

Given that DEFITELIO requires strict temperature controls (2-8°C), logistics providers specializing in cold chain management are integral to maintaining potency and shelf life. These include:

• Temperature-Controlled Freight Providers: Companies like DHL Global Forwarding and FedEx Express provide temperature-sensitive transportation solutions with real-time monitoring and contingency protocols.

• Regulatory Compliance & Documentation: Ensuring compliance with regional transportation laws, customs clearance, and import/export regulations is vital, often managed in collaboration with logistics providers and local regulatory agencies.

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Regulatory and Quality Considerations

Suppliers involved in the DEFITELIO supply chain must meet rigorous regulatory standards set by bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional authorities. Transparency and GMP compliance are essential for API suppliers, manufacturers, and distributors alike.

• API Suppliers Compliance: API manufacturers like Fresenius Kabi are subject to stringent audits and continuous quality oversight to maintain cGMP certification.

• Distribution Oversight: Distributors must adhere to Good Distribution Practice (GDP) standards, ensuring product integrity until administration.

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Market and Supply Chain Challenges

Despite established supply chains, challenges persist which can impact suppliers for DEFITELIO:

• Raw Material Scarcity: Limited availability of porcine mucosa and biological reagents can constrain API supply. Variability in porcine tissue supply or regulatory restrictions on animal sourcing may cause disruptions.

• Manufacturing Complexities: The intricate synthesis process for defibrotide sodium necessitates specialized facilities and trained personnel, contributing to capacity constraints.

• Regulatory Hurdles: Differences in regional regulations for tissue sourcing, processing, and distribution can create delays or complicate the supply chain.

• Pricing and Market Access: Market dynamics, including competition from biosimilars or alternative therapies, influence supplier strategies and capacity investments.

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Strategic Implications for Stakeholders

For pharmaceutical companies, understanding the supply chain intricacies of DEFITELIO offers insights into risk management, strategic sourcing, and regulatory compliance. Ensuring diverse and quality-assured suppliers for raw materials and manufacturing capacity reduces vulnerability. Partnerships with global distributors and logistic providers enable broader access, especially in emerging markets.

Investors and regulatory bodies must monitor supplier operational stability, capacity expansion plans, and geopolitical factors affecting animal tissue sourcing to anticipate potential supply disruptions. Diversification of suppliers and investing in supply chain resilience are vital to maintaining uninterrupted access to DEFITELIO.

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Key Takeaways

• The supply chain for DEFITELIO hinges on specialized API sourcing from porcine mucosa and complex manufacturing processes that demand high-level GMP compliance.
• Strategic partnerships with global CMOs like Fresenius Kabi facilitate manufacturing, formulation, and packaging.
• Cold chain logistics providers play a critical role in maintaining drug integrity, especially given DEFITELIO’s temperature sensitivity.
• Raw material scarcity, manufacturing complexities, and regulatory variances pose ongoing supply chain risks.
• Diversification and rigorous quality oversight of suppliers are essential to ensure drug availability and regulatory compliance.

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FAQs

1. Who are the primary manufacturers of DEFITELIO’s API?
Fresenius Kabi is the main contract manufacturing organization responsible for producing the defibrotide sodium API, leveraging their expertise in complex biochemical manufacturing.

2. What raw materials are critical in DEFITELIO’s production?
Porcine intestinal mucosa is the primary raw material, sourced from certified abattoirs, alongside specialized enzymes and chemical reagents essential for extraction and purification.

3. Which logistics providers handle DEFITELIO’s distribution?
Major global logistics firms such as DHL Global Forwarding and FedEx Express manage the temperature-sensitive transportation, ensuring adherence to cold chain requirements.

4. Are there regional differences in DEFITELIO’s supply chain?
Yes, regional distributors and regulatory standards influence supply chain configurations, with local partners ensuring compliance and access in various territories.

5. What are the main challenges confronting DEFITELIO supply?
Supply constraints stem from raw material scarcity, manufacturing complexity, regulatory hurdles, and logistical challenges in maintaining cold chain integrity.

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References

1. Jazz Pharmaceuticals, FDA Approval of DEFITELIO (defibrotide sodium), 2016.
2. European Medicines Agency (EMA), Summary of Product Characteristics for DEFITELIO, 2017.
3. Industry reports on biopharmaceutical manufacturing logistics, 2022.
4. FDA and EMA regulatory guidelines on tissue-derived products, 2021.
5. Market analyses on complex biotech drug supply chains, 2023.