Suppliers and packagers for vyxeos

vyxeos

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 Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401	NDA	Jazz Pharmaceuticals, Inc.	68727-745-01	20 mL in 1 VIAL (68727-745-01)	2017-08-03
Jazz Pharms Therap	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401	NDA	Jazz Pharmaceuticals, Inc.	68727-745-02	40 mL in 1 CARTON (68727-745-02)	2017-08-03

Suppliers for the Pharmaceutical Drug: Vyxeos

Last updated: August 1, 2025

Introduction

Vyxeos (daunorubicin and cytarabine) is an innovative chemotherapeutic combination developed and marketed primarily for the treatment of acute myeloid leukemia (AML). Regulated by the U.S. Food and Drug Administration (FDA) since 2017, Vyxeos represents a significant advancement in targeted cancer treatment, combining two chemotherapeutic agents within a liposomal formulation to optimize delivery and efficacy. As a specialized drug with complex manufacturing requirements, understanding its suppliers—comprising active pharmaceutical ingredient (API) producers, formulation specialists, and packaging firms—is critical for stakeholders across the pharmaceutical supply chain.

This analysis comprehensively explores Vyxeos's supply landscape, including key manufacturers, raw material sources, formulation partners, and distribution channels, providing insights vital for business and procurement strategies within the oncology pharmaceuticals market.

1. Manufacturer Overview and Market Presence

Jazz Pharmaceuticals, headquartered in Dublin, Ireland, is the sole marketer and distributor of Vyxeos globally, following its acquisition of Celator Pharmaceuticals in 2017. The drug’s unique liposomal formulation demands rigorous manufacturing standards, involving proprietary technologies that restrict manufacturing to specific facilities with specialized capabilities.

While Jazz Pharmaceuticals handles commercialization, the manufacturing of Vyxeos hinges on complex partnerships with multiple suppliers along the supply chain, particularly for its API components.

2. Active Pharmaceutical Ingredient (API) Suppliers

Vyxeos comprises two primary APIs: daunorubicin and cytarabine. These cytotoxic agents are critical to the drug’s therapeutic profile and require high purity, stability, and compliance with Good Manufacturing Practice (GMP) standards.

• Daunorubicin Suppliers:
  Daunorubicin is derived either through semi-synthetic extraction from actinobacteria or via total chemical synthesis. Key producers include:

  • Pfizer Inc. (formerly Hospira): A leading global supplier, Pfizer manufactures daunorubicin for both generic and proprietary formulations, including Vyxeos. Their GMP-certified plants in the United States and Europe ensure high-quality API production.

  • Sun Pharmaceutical Industries: A major Indian pharmaceutical company, Sun Pharma supplies daunorubicin in bulk, primarily targeting generic oncology drugs and proprietary formulations like Vyxeos.

  • Teva Pharmaceutical Industries: Teva produces daunorubicin as part of its cytotoxic API portfolio, with supply chains spanning North America, Europe, and Asia.

• Cytarabine Suppliers:
  Cytarabine (Ara-C) is a nucleoside analog synthesized via chemical methods. Notable manufacturers include:

  • FRESENIUS Kabi: A global leader in cytotoxic APIs, FRESENIUS manufactures high-grade cytarabine used in institutional and commercial applications.

  • Cipla Ltd.: An Indian key supplier of cytarabine, offering high-quality APIs to global markets.

  • Hospira (a Pfizer subsidiary): Historically a significant cytarabine supplier, now part of Pfizer's integrated supply chain.

3. Liposomal Formulation and Packaging

The liposomal encapsulation process is critical to Vyxeos’s unique delivery mechanism. This process necessitates specialized formulation technology, with manufacturing typically conducted at Jazz Pharmaceuticals’s licensed facilities. The lipids used for encapsulation are sourced from specialized suppliers who meet pharmaceutical-grade specifications.

• Liposomal Components Suppliers:

  • Lipoid GmbH: A prominent provider of phospholipids used in liposomal formulations, including DSPC and cholesterol, critical for Vyxeos's stability.
  • Avanti Polar Lipids: Supplies lipids such as DSPC, cholesterol, and PEGylated lipids used in liposome manufacturing.

• Packaging and Final Assembly:
  The final Vyxeos vials and packaging materials are supplied by cGMP-certified vendors focusing on sterile glass containers, rubber stoppers, and safety caps—suppliers include Schott AG and West Pharmaceutical Services.

4. Manufacturing and Distribution Partnerships

Given the complexity of liposomal drug manufacturing:

• Contract Manufacturing Organizations (CMOs):
  Jazz Pharmaceuticals collaborates with CMOs specializing in liposomal formulations and sterile manufacturing. These include companies like Fresenius Kabi and Catalent, which possess the requisite infrastructure for aseptic filling, packaging, and quality assurance.

• Supply Chain Localization:
  Although Jazz Pharmaceuticals primarily controls the formulation and final drug distribution, regional manufacturing facilities or partnerships exist to ensure supply continuity across North America, Europe, and Asia.

5. Supply Chain Challenges and Strategic Considerations

The limited number of suppliers for liposomal components and APIs underscores vulnerabilities such as:

• Manufacturing Concentration:
  With few global suppliers for lipids and APIs, disruptions can lead to shortages, emphasizing the need for diversified supplier strategies or long-term supply agreements.

• Regulatory Compliance:
  Ensuring all suppliers meet stringent GMP standards is vital, especially for cytotoxic APIs and liposomal components.

• Intellectual Property (IP) and Proprietary Technologies:
  Vyxeos’s liposomal technology is proprietary, restricting manufacturing to licensed facilities with specific expertise, which limits supplier options but ensures quality control.

Conclusion

The supply ecosystem for Vyxeos is characterized by a select group of API manufacturers and specialized formulation component suppliers, primarily led by global enterprises such as Pfizer, FRESENIUS Kabi, and Lipoid GmbH. Packaging and sterile manufacturing are entrusted to experienced CMOs, with tight regulatory oversight. The complex nature of liposomal drug production necessitates careful supply chain management to mitigate risks associated with concentration and regulatory constraints.

Key Takeaways

• Vyxeos's primary suppliers include Pfizer (API production), FRESENIUS Kabi, and Lipoid GmbH (liposomal components).
• The manufacturing process hinges on proprietary liposomal technology, restricting production to specialized facilities.
• Supply chain vulnerabilities stem from few suppliers for lipids and APIs, necessitating strategic diversification and robust supplier qualification.
• Certifying ongoing GMP compliance among suppliers is vital to prevent shortages and ensure consistent drug quality.
• Building strong supplier relationships and long-term contracts enhances supply stability for this complex therapeutic agent.

FAQs

1. Who are the main API suppliers for Vyxeos?
Pfizer and Sun Pharmaceutical Industries supply daunorubicin, while FRESENIUS Kabi and Cipla are key cytarabine providers, all meeting GMP standards for oncology APIs.

2. How does Vyxeos's liposomal formulation influence its supply chain?
Liposomal technology requires specialized lipids and manufacturing expertise, limiting production to a few licensed facilities, which emphasizes the importance of specialized formulation component suppliers.

3. Are there alternative suppliers for Vyxeos's raw materials?
Currently, the supply chain is concentrated among select global suppliers. While alternatives exist for individual components, proprietary liposomal technology restricts substitution without regulatory approval.

4. What are the risks associated with Vyxeos's supply chain?
Concentration of suppliers for APIs and lipids presents risks of shortages, delayed shipments, or quality issues, underscoring the need for diligent supplier qualification and contingency planning.

5. How does regulatory oversight impact supply stability?
Strict GMP compliance and periodic audits of suppliers ensure consistent quality but may also lead to supply disruptions if standards are not maintained.

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Sources:

[1] Jazz Pharmaceuticals. Vyxeos (daunorubicin and cytarabine) liposomal formulation. FDA approval document, 2017.

[2] U.S. Food and Drug Administration. Vyxeos (daunorubicin and cytarabine) for injection. 2017.

[3] Pfizer Annual Report. API manufacturing capabilities and API suppliers overview, 2022.

[4] FRESENIUS Kabi. Pharmaceutical APIs Portfolio. 2023.

[5] Lipoid GmbH. Lipid components for pharmaceutical applications. Company website, 2022.