Suppliers and packagers for zepzelca

zepzelca

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	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702	NDA	Jazz Pharmaceuticals, Inc.	68727-712-01	8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)	2020-06-15

Suppliers for the Pharmaceutical Drug: Zepzelca (Lurbinectedin)

Last updated: July 29, 2025

Introduction

Zepzelca, containing the active ingredient lurbinectedin, is an innovative anticancer agent primarily approved for the treatment of metastatic small cell lung cancer (SCLC), especially in patients who have progressed after platinum-based chemotherapy. Its unique mechanism involves inhibiting transcription and inducing apoptosis by binding to DNA minor grooves. As a specialty chemotherapeutic agent, Zepzelca’s manufacturing and supply chain involve a limited number of high-quality suppliers, ensuring strict compliance with Good Manufacturing Practices (GMP). This overview explores the key suppliers underpinning Zepzelca’s production, their roles, and the implications for stakeholders.

Manufacturing and Supply Chain Overview

The production of Zepzelca requires complex synthetic processes, advanced formulation techniques, and strict quality controls. Its active pharmaceutical ingredient (API), lurbinectedin, is synthesized through multi-step chemical processes, demanding specialized raw materials supplied by select vendors globally. The finished drug formulation is often supplied in vials or pre-filled syringes, requiring dependable fill-finish and packaging partners.

The supply chain's integrity hinges on several primary suppliers across different stages:

• Raw material providers for key intermediates and starting materials.
• API manufacturers responsible for synthesizing lurbinectedin.
• Fill-finish and packaging service providers.
• Logistics and distribution entities ensuring timely delivery worldwide.

Primary Suppliers of Lurbinectedin API

1. Pharma Mar S.A.

Pharma Mar, S.A., a Spanish biopharmaceutical company, is the originator and exclusive marketer of Zepzelca. The company is responsible for the overall development, manufacturing, and commercialization. Pharma Mar’s manufacturing facilities in Spain are equipped to produce the API through proprietary synthetic pathways. Their internal manufacturing capabilities or partnerships with specialized contract manufacturing organizations (CMOs) ensure controlled, GMP-compliant API supply.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of lurbinectedin synthesis, Pharma Mar has partnered with select CMOs for large-scale API production and supply chain scalability. These CMOs possess advanced chemical synthesis facilities capable of producing high-purity lurbinectedin. Their roles include:

• Scaling up laboratory synthesis.
• Ensuring batch-to-batch consistency.
• Maintaining regulatory compliance.

While specific CMO names remain undisclosed due to confidentiality agreements, market analysis suggests engagement with organizations experienced in complex alkaloid or marine-derived compound synthesis.

3. Raw Material Suppliers

The synthesis of lurbinectedin involves sourcing high-quality raw materials and intermediates, including specialized solvents, catalysts, and building blocks. Leading chemical suppliers such as Sigma-Aldrich (Merck), Thermo Fisher Scientific, or other Tier 1 chemical providers supply these materials. The dependence on these raw material suppliers introduces risks related to supply disruptions, regulatory changes, or geopolitical factors.

Supply Chain of Raw Materials and Intermediates

Raw materials are pivotal for maintaining production continuity of lurbinectedin. Suppliers who provide the rare or specialized chemicals used as precursors or catalysts are integral to the supply chain's stability. The sourcing often involves:

• Specialty chemical firms for bespoke intermediates.
• Global chemical suppliers adhering to GMP standards.
• Local or regional suppliers for standard chemicals.

Tracking these suppliers is challenging, owing to the proprietary nature of pharmaceutical manufacturing.

Finished Product Manufacturing and Distribution

1. Fill and Finish Partners

Once the API is synthesized and purified, it is transferred to fill-finish facilities for formulation into the final dosage forms. Core providers for such services typically include:

• Catalent Inc.
• Thermo Fisher Scientific
• Baxter International

These firms are recognized for pharmaceutical vial filling and sterile packaging with validated processes aligned with GMP.

2. Logistics and Distribution Partners

Post-manufacturing, distribution relies on global logistics firms experienced in handling sensitive pharmaceuticals:

• UPS Healthcare
• DHL Supply Chain
• World Courier

They ensure temperature-controlled, secure transport tailored to the drug’s stability requirements.

Strategic Considerations and Risks

Supplier Concentration

Pharma Mar’s reliance on a small pool of specialized CMOs and raw material suppliers heightens risks related to supply chain disruptions. Any issue at the manufacturing or raw material level could delay product availability, impacting patient access and revenue.

Regulatory and Quality Compliance

Suppliers must adhere to stringent GMP standards mandated by regulatory authorities like the FDA and EMA. Non-compliance can compromise supply quality and lead to regulatory actions.

Future Supply Expansion

To mitigate risks, Pharma Mar and partners might diversify suppliers or establish additional manufacturing sites. Strategic inventory management and supply chain resilience are crucial as demand for Zepzelca grows.

Emerging Trends and Industry Implications

• Increased investment in API manufacturing capacity for complex marine-derived compounds.
• Adoption of digital supply chain tracking and blockchain for transparency.
• Potential for localization of key raw materials to reduce geopolitical risks.

Conclusion

Zepzelca’s supply chain is characterized by reliance on specialized suppliers, primarily Pharma Mar’s internal manufacturing and selected CMOs, complemented by sophisticated raw material providers and logistics firms. Ensuring a resilient and compliant supply chain is critical to maintaining availability for patients and maximizing commercial viability.

---

Key Takeaways

• Pharma Mar centrally oversees Zepzelca’s production, leveraging partnerships with specialized CMOs.
• The complex synthesis of lurbinectedin depends on a limited number of high-quality raw material suppliers.
• Robust quality management and diversified sourcing strategies are vital to minimize supply risks.
• Strategic investments in capacity and supply chain transparency are necessary to meet growing demand.
• Regulatory compliance remains a cornerstone of supply chain integrity for this high-value, specialty drug.

---

FAQs

1. Who are the main manufacturers involved in producing Zepzelca?
Pharma Mar manages the core manufacturing process, often collaborating with contract manufacturing organizations (CMOs) for large-scale API production, and partners with fill-finish service providers like Catalent for final formulation and packaging.

2. What raw materials are critical for the synthesis of lurbinectedin?
Key raw materials include specialty intermediates, solvents, catalysts, and building blocks sourced from chemical suppliers experienced in GMP manufacturing of complex molecules.

3. How does Pharma Mar ensure supply chain resilience?
The company diversifies supplier relationships, maintains inventory buffers, and closely monitors regulatory compliance and quality standards to prevent disruptions.

4. Are there any risks related to the current supply chain of Zepzelca?
Yes, dependence on a limited number of specialized CMOs and raw material suppliers poses risks, including supply delays, quality issues, and geopolitical influences affecting raw material availability.

5. What trends are shaping the future of Zepzelca’s supply chain?
Industry trends include increasing capacity investments, digitalization of supply chains for better traceability, and efforts to localize raw material sourcing to reduce vulnerabilities.

---

References

[1] Pharma Mar S.A., Official Website. (2023). Zepzelca (Lurbinectedin): Product Information.
[2] US Food and Drug Administration (FDA). (2020). Zepzelca (Lurbinectedin) Prescribing Information.
[3] Industry Reports. (2022). Global Supply Chain Strategies for Complex Oncology Drugs.
[4] Contract Manufacturing Insights. (2021). Partnerships in Cancer Drug Production.
[5] Logistics Providers. (2023). Cold Chain Solutions for Oncology Pharmaceuticals.

Note: Specific supplier names (e.g., CMOs, raw material providers) are often confidential; publicly available information is limited to broad industry insights.