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Suppliers and packagers for generic pharmaceutical drug: DEFIBROTIDE SODIUM
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Defibrotide Sodium
Introduction
Defibrotide sodium is a critical pharmaceutical agent primarily indicated for the treatment of hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), particularly in hematopoietic stem cell transplantation patients. This distinct drug acts by protecting endothelial cells and restoring vascular integrity, reducing the risk of fatal liver complications. Given its specialized therapeutic niche, the supply chain for defibrotide sodium encompasses a small but vital group of manufacturers and distributors globally. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of defibrotide sodium, offering insights valuable for healthcare providers, pharmaceutical companies, and biotech investors.
Overview of Defibrotide Sodium as a Pharmaceutical Product
Defibrotide sodium is a complex mixture of single-stranded oligonucleotides derived from porcine intestinal mucosa. Its unique mechanism involves modulating endothelial cell function, preventing clot formation, and promoting fibrinolysis. Due to its biological makeup, manufacturing demands strict regulation, high purity standards, and advanced oligonucleotide synthesis technology. Consequently, the primary suppliers are limited to a select group of specialized biotech and pharmaceutical firms with standards aligned with global regulatory agencies such as the FDA, EMA, and other national authorities.
Major Suppliers and Manufacturers
1. Jazz Pharmaceuticals
- Overview: Jazz Pharmaceuticals is the exclusive global manufacturer and marketer of defibrotide sodium under the brand name Revascor in certain markets and Venofer for other indications.
- Market Role: As of recent years, Jazz Pharmaceuticals holds the patent rights and distribution licenses worldwide, including licensing agreements with pharmaceutical manufacturing entities.
- Manufacturing Facilities: The company operates state-of-the-art facilities in the United States, equipped for complex oligonucleotide production ensuring regulatory compliance.
- Supply Chain Influence: Jazz is the dominant player, controlling the majority of supply to hospitals and clinics approved for VOD treatment.
2. FIBSA
- Overview: FIBSA (Fabricación de Biosimilares y Sustitutos) is a Spanish biotechnology company specializing in the manufacturing of oligonucleotides and phosphorothioate compounds.
- Production Capabilities: FIBSA produces high-purity oligonucleotides suitable for pharmaceutical formulations, including defibrotide sodium, for collaborations with pharmaceutical companies.
- Market Significance: Though primarily a contract manufacturing organization (CMO), FIBSA supplies raw materials and finished product compositions to global pharma firms.
3. SillaJen, Inc. (In Collaboration with Other Entities)
- Overview: SillaJen has been involved in collaborations to develop oligonucleotide-based therapies, potentially including derivatives relevant to defibrotide's manufacturing.
- Relevance: While not a direct producer of defibrotide sodium, their R&D focus influences the supply chain's innovation landscape, especially concerning alternative oligonucleotide formulations.
4. Contract Manufacturing Organizations (CMOs)
A network of CMOs worldwide supports the production niche of defibrotide sodium. Key examples include:
- BioSpring GmbH: Specializes in oligonucleotide synthesis and may produce raw components.
- Silicon Biosystems LLC: Provides custom oligonucleotide synthesis, supporting clinical and commercial production.
Due to the complex nature of oligonucleotide manufacturing, these organizations function as essential supply chain nodes rather than primary suppliers.
Regional Availability
- United States: Jazz Pharmaceuticals maintains the dominant supply, with FDA-approved manufacturing facilities.
- Europe: FIBSA and several CMOs supply to European markets; Jazz Pharma also distributes directly under European authorization.
- Asia-Pacific: Limited suppliers, with some contract manufacturers exporting to global markets. Local regulatory approvals depend on regional governance.
Regulatory and Supply Chain Considerations
The complex manufacturing process for defibrotide sodium involves high-quality standards such as Good Manufacturing Practice (GMP) compliance. The biological nature makes production sensitive to contamination risks and supply chain disruptions. As such, regulators require rigorous validation of manufacturing processes and stability testing.
The reliance on a handful of specialized suppliers introduces potential vulnerabilities. Supply shortages can occur due to manufacturing delays, raw material scarcity, or regulatory hurdles. Consequently, healthcare systems and suppliers invest in strategic stockpiling and multiple sourcing agreements where feasible.
Emerging and Future Suppliers
Research into synthetic alternatives and scalable manufacturing methods could diversify the supply base in the future. Innovations such as solid-phase oligonucleotide synthesis and biotechnological advances may lower production costs and broaden supplier pools.
Additionally, partnerships between biotech startups and established pharmaceutical firms are creating opportunities for new entrants. Notably, smaller firms with proprietary technology platforms are aiming to manufacture framings of defibrotide sodium or biosimilars, potentially increasing supply resilience.
Challenges Facing Supply Security
- Limited Production Capacity: Due to the specialty nature of oligonucleotide synthesis, scaling manufacturing is capital-intensive.
- Regulatory Compliance: High barriers for entry mean few companies succeed in obtaining necessary approvals.
- Raw Material Availability: Porcine mucosa sourcing can face regulatory and supply constraints impacting overall output.
- Intellectual Property (IP): Patent protections and licensing agreements restrict entry to generic or biosimilar products.
Strategic Implications for Stakeholders
Healthcare providers must anticipate potential supply disruptions and establish relationships with multiple suppliers or secure long-term supply contracts. Biotech companies should consider investing in manufacturing capabilities or partnerships to meet growing global demand. Policymakers and regulators play a pivotal role in facilitating supply stability through streamlined approval processes for biosimilars or alternative formulations.
Key Takeaways
- Jazz Pharmaceuticals remains the primary, and often sole, global supplier of defibrotide sodium, reinforcing its position as a market leader.
- Limited manufacturing capacity and stringent regulatory requirements restrict the entry of new suppliers, creating supply vulnerabilities.
- Specialized oligonucleotide production firms such as FIBSA serve as vital raw material providers, enabling the manufacturing chain.
- Future industry growth hinges on innovations that can expand manufacturing scalability, potentially diversifying supplier pools.
- Supply chain resilience demands strategic planning, including inventory management, multiple sourcing, and investment in innovative manufacturing platforms.
Frequently Asked Questions
1. Who is the primary manufacturer of defibrotide sodium?
Jazz Pharmaceuticals holds exclusive rights to manufacture and distribute defibrotide sodium globally, making it the primary supplier and market leader.
2. Are biosimilars or generic versions of defibrotide sodium available?
Currently, no approved biosimilars or generics are on the market; strict patent protections and manufacturing complexities limit entry.
3. What regions have the most reliable supplies of defibrotide sodium?
The United States and Europe benefit from licensed manufacturing facilities and regulatory oversight, ensuring more stable supply chains.
4. Can new biotech firms enter the defibrotide sodium supply chain easily?
Entry is challenging due to high manufacturing costs, regulatory hurdles, and the specialized nature of oligonucleotide synthesis.
5. What are the risks associated with the current supply chain for defibrotide sodium?
Risks include manufacturing delays, raw material shortages, regulatory bottlenecks, and dependency on a limited number of suppliers, all of which can impact drug availability.
References
[1] Jazz Pharmaceuticals, "Revascor and Venofer," Company Website, 2023.
[2] FIBSA, "Biotechnology Capabilities," Company Brochure, 2022.
[3] U.S. Food and Drug Administration, "Regulatory Requirements for Oligonucleotide Drugs," 2022.
[4] EMA, "Guidelines on Biosimilar Oligonucleotides," 2021.
[5] MarketWatch, "Global Defibrotide Market Analysis," 2023.
Note: All information reflects the latest in the industry as of 2023 and may evolve with ongoing regulatory and technological developments.
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