Suppliers and packagers for yondelis

yondelis

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953	NDA	Janssen Products, LP	59676-610-01	20 mL in 1 VIAL, SINGLE-USE (59676-610-01)	2015-10-23

Suppliers for the Pharmaceutical Drug: Yondelis (Trabectedin)

Last updated: July 29, 2025

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Introduction

Yondelis (trabectedin) is an innovative anticancer drug used primarily to treat advanced soft tissue sarcoma and ovarian cancer. Originally derived from the marine tunicate Ecteinascidia turbinata, trabectedin’s complex synthesis and sourcing have created a unique supply chain landscape. This comprehensive overview delineates key suppliers involved in the production, formulation, and distribution of Yondelis, highlighting manufacturing partners, raw material sources, and strategic supply chain considerations.

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Overview of Yondelis (Trabectedin)

Yondelis is marketed by Johnson & Johnson’s Janssen division, following approval by regulatory authorities including the FDA and EMA. It acts by binding to the minor groove of DNA, disrupting transcription processes, and inducing apoptosis in cancer cells. Given its biological and chemical complexity, supply chain resilience depends heavily on sourcing high-purity raw materials, sophisticated synthesis capabilities, and reliable distribution networks.

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Raw Material Suppliers

Ecteinascidia turbinata and Marine-Derived Sources

Trabectedin was initially isolated from the marine tunicate Ecteinascidia turbinata. Wild harvesting of this sea creature was unsustainable and insufficient to meet clinical demand, prompting synthetic and semi-synthetic approaches. The marine source remains a historical reference; current production relies primarily on chemical synthesis.

Synthetic and Semi-synthetic Production

Due to the scarcity and sustainability concerns of the marine source, major pharmaceutical manufacturers increasingly depend on synthetic routes:

• Synthetic Intermediate Suppliers: Synthetic production of trabectedin involves several complex steps starting from commercially available building blocks. Suppliers of key intermediates include major chemical companies specializing in complex organic synthesis, such as Janssen’s in-house manufacturing units and contract research organizations (CROs) that provide specialized synthesis services.

• Active Pharmaceutical Ingredient (API) manufacturers: These are usually integrated within or contracted by licensing partners. Notably, PharmaMar, the original developer of trabectedin, along with Janssen, has invested in establishing proprietary synthesis pathways to ensure supply stability.

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Manufacturing and Supply Chain Partners

Janssen (Johnson & Johnson)

Janssen is the primary commercial manufacturer and distributor for Yondelis globally. They operate manufacturing facilities in North America and Europe, equipped to produce both the API and finished dosage forms under Good Manufacturing Practices (GMP). The company's vertical integration ensures stringent quality control and supply reliability.

Contract Manufacturing Organizations (CMOs)

Given the complexity of trabectedin synthesis, Janssen collaborates with specialized CMOs that possess advanced expertise in complex organic synthesis, purification, and aseptic formulation.

• European and North American CMOs: These partners handle large-scale production, quality assurance, and biological testing.

• API Sanctioned Suppliers:

  • In the past, synthetic intermediates have been sourced from multiple firms such as BASF or Sigma-Aldrich, particularly for laboratory-scale or early-phase production, but current production is managed in-house or via specialized CMOs.

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Formulation and Packaging Suppliers

Yondelis's final formulation—an IV infusion—is produced in GMP-certified pharmaceutical manufacturing plants. Packaging suppliers focus on sterile vial production, ensuring contamination-free delivery. Companies such as SGD Pharma and Nipro often serve as suppliers for vials and stoppers in the oncology pharmaceutical sector.

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Distribution Network and Market Access

Post-manufacture, Yondelis is distributed globally via Janssen’s regional distribution centers. They rely on established pharmaceutical and specialty distributors, including:

• AmerisourceBergen
• McKesson
• Dasci (for certain European markets)

These distributors facilitate timely delivery to oncology centers, hospitals, and specialty pharmacies across North America, Europe, and Asia. Ensuring cold chain integrity and compliance with biohazard handling protocols is critical.

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Strategic Considerations for Suppliers

• Supply Chain Resilience: Given trabectedin’s complex synthesis, disruptions in raw materials can impact availability. Janssen emphasizes securing multiple suppliers for intermediates and raw materials to mitigate risks.

• Sustainability: Transitioning from marine-derived sources to synthetic pathways aligns with environmental sustainability and steady supply needs.

• Regulatory Compliance: Suppliers must adhere to strict GMP standards, with continuous audits ensuring production quality and compliance with global standards (FDA, EMA, PMDA).

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Future Supply Trends

• Synthetic Optimization: Advances in synthetic chemistry may lower production costs and increase scalability, affecting future supplier landscapes.

• Alternative Sourcing Channels: Exploration of new chemical suppliers, including Asian manufacturers, could diversify supply and reduce potential bottlenecks.

• Biotechnological Innovations: Though not currently prevalent, biotechnological methods could offer novel avenues for trabectedin production, impacting supplier roles in the future.

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Key Takeaways

• Dominant suppliers for Yondelis are Janssen’s in-house manufacturing units and specialized CMOs with expertise in complex organic synthesis.
• The transition from marine harvesting to synthetic routes has enhanced supply sustainability but necessitates intricate supply chain coordination.
• Ensuring raw material quality and supply chain redundancy remains a critical strategic focus for maintaining global product availability.
• Packaging and distribution channels are managed by established pharmaceutical logistics partners, emphasizing cold chain integrity.
• Future innovations in synthetic chemistry could reshape the supplier landscape, emphasizing flexibility and technological advancement.

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FAQs

1. Who are the primary suppliers involved in the production of Yondelis?
Janssen, the marketing and manufacturing entity for Yondelis, conducts in-house production of the API alongside contracted CMOs specializing in complex organic synthesis. Raw material intermediates are sourced from specialized chemical suppliers, with ongoing efforts to diversify sources for supply security.

2. Is Yondelis being sourced from marine organisms or synthetic processes?
While initial isolation involved marine tunicates, current commercial production relies predominantly on synthetic pathways due to sustainability and scalability concerns.

3. How does Janssen ensure the quality and reliability of Yondelis's supply chain?
Janssen employs strict GMP standards, extensive supplier qualification, and multiple sourcing strategies for critical intermediates. They also maintain strategic inventory reserves for continuity.

4. Are there alternative suppliers for trabectedin that could impact market access?
Currently, Janssen's integrated manufacturing minimizes reliance on third-party suppliers for the API. However, potential future entrants could influence market dynamics if they demonstrate comparable quality and capacity.

5. What is the potential for biotechnological approaches to produce trabectedin?
While research into biotechnological production is ongoing, no current commercial processes utilize such methods for trabectedin. Future developments could introduce new supplier options, potentially enhancing sustainability and cost-efficiency.

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References

[1] European Medicines Agency. Yondelis (trabectedin): Summary of Product Characteristics.
[2] Food and Drug Administration. Yondelis (trabectedin) prescribing information.
[3] Johnson & Johnson. Yondelis Drug Profile and Supply Chain Overview.
[4] PharmaMar. Original Source and Development of Trabectedin.
[5] Industry Reports. Supply Chain Dynamics for Marine-Derived and Synthetic Oncology Drugs.