Suppliers and packagers for generic pharmaceutical drug: isavuconazonium sulfate

isavuconazonium sulfate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500	NDA	Astellas Pharma US, Inc.	0469-0520-02	2 BLISTER PACK in 1 CARTON (0469-0520-02) / 7 CAPSULE in 1 BLISTER PACK	2015-11-04
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500	NDA	Astellas Pharma US, Inc.	0469-2860-35	7 BLISTER PACK in 1 CARTON (0469-2860-35) / 5 CAPSULE in 1 BLISTER PACK	2022-11-22
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501	NDA	Astellas Pharma US, Inc.	0469-0420-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2015-03-06

Suppliers for the Pharmaceutical Drug: Isavuconazonium Sulfate

Last updated: July 29, 2025

Introduction

Isavuconazonium sulfate, marketed under the brand name Cresemba among others, is an oral and intravenous antifungal agent primarily used to treat invasive aspergillosis and mucormycosis. As a prodrug of isavuconazole, it inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis essential for fungal cell membrane integrity. Given its critical role in combating invasive fungal infections, understanding its supply chain dynamics, key suppliers, and manufacturing landscape is vital for healthcare providers, pharmaceutical companies, and policymakers aiming for reliable access and supply security.

Manufacturers and Global Supply Landscape

The manufacturing of isavuconazonium sulfate involves complex chemical synthesis, requiring high-standard Good Manufacturing Practice (GMP) compliance. Currently, the manufacturing and supply of this antifungal are concentrated among a limited number of pharmaceutical companies, predominantly those with proven expertise in antifungal agents and sterile injectable formulations.

1. Pfizer Inc.

Pfizer holds a significant market share through its licensing agreement with Basilea Pharmaceutica, the original developer of isavuconazonium sulfate. Pfizer acquired rights to commercialize Cresemba globally, including the U.S., Canada, and various other markets. As of recent reports, Pfizer is the primary mass producer of this medication, making it a central supplier in the global pharmaceutical supply chain.

Basilea Pharmaceutica, based in Switzerland, initially developed the drug and conducted early clinical trials, but Pfizer's strategic acquisition and licensing agreement accredited it as the dominant manufacturer and distributor worldwide ([1]).

2. Basilea Pharmaceutica

Basilea remains involved in the research, development, and manufacturing process of isavuconazonium sulfate but mainly through licensing arrangements with Pfizer. They retain intellectual property rights and are responsible for ensuring the quality of the active pharmaceutical ingredient (API) supplied under license. Their production facilities are located in Europe, and they provide APIs or intermediates for Pfizer’s manufacturing plants.

3. Contract Manufacturing Organizations (CMOs)

In recent years, pharmaceutical companies often outsource manufacturing to specialized CMOs to meet demand and maintain supply stability. Several reputable CMOs with capabilities in sterile injectable drug production manufacture parts of the supply chain for isavuconazonium sulfate.

For instance, CordenPharma, a division of Ireland’s Siegfried Group, specializes in sterile production and may produce intermediates or final products under contract ([2]). Other CMOs involved include Patheon (a part of Thermo Fisher Scientific), Catalent, and Cambrex, which have the capacity for complex injectable formulations.

Supply Chain Challenges and Considerations

The potent and complex synthesis of isavuconazonium sulfate limits rapid or widespread manufacturing expansion. Supply chain disruptions—such as those seen during the COVID-19 pandemic—can impact raw material availability, manufacturing schedules, and distribution channels.

Furthermore, the API's synthesis involves multiple steps with specialized precursors, some of which are sourced globally, increasing exposure to geopolitical risks and supply shocks. Heavy regulation and quality standards impose additional barriers to scaling production quickly.

Market Dynamics and Future Supply Predictions

The small number of large-scale manufacturers currently dominating the supply landscape places a premium on supply security. As demand increases, especially amid rising invasive fungal infections in immunocompromised patients, manufacturers may seek to expand capacity.

Pfizer’s continued investment in supply chain expansion, including regional manufacturing facilities and potential new licensing or partnerships, is critical for meeting global demand. Additionally, ongoing R&D for generic formulations or biosimilars could alter the competitive landscape, potentially increasing supply sources.

Regulatory Approvals and Market Access

Manufacturers require approval from regulatory authorities such as the FDA, EMA, and other regional agencies before initiating large-scale production. The approval process includes rigorous quality assessments, which ensure drug safety and efficacy but may slow market entry or expansion.

Patent protections and exclusivities influence market dynamics. Pfizer’s patent portfolio for Cresemba provides temporary market exclusivity, though expiration timelines could gradually lead to generic manufacturing, increasing the number of suppliers over time.

Emerging Suppliers and Local Manufacturers

In regions with high fungal infection prevalence, local or regional production of isavuconazonium sulfate warrants attention. While currently limited, the potential for biosimilar or generic development exists, especially post-patent expiry, which could diversify supply sources globally.

Joint ventures, licensing agreements, and technology transfer initiatives by established pharmaceutical companies could unlock new suppliers, thereby reducing reliance on a few dominant entities.

Conclusion

The primary supplier for isavuconazonium sulfate remains Pfizer, leveraging licensed manufacturing from Basilea and a network of CMO partnerships to meet global demand. Supply chain resilience depends on Pfizer’s capacity expansion, regulatory navigation, and sourcing of raw materials. Future market dynamics may shift as patents expire and new entrants seek to establish manufacturing capabilities, crucial for ensuring stable supply for patients worldwide.

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Key Takeaways

• Dominant Supplier: Pfizer is the primary global supplier of isavuconazonium sulfate, utilizing licensed manufacturing and CMO partnerships.
• Manufacturing Complexity: The drug’s synthesis involves complex, multi-step processes with specialized raw materials, constraining rapid capacity expansion.
• Supply Chain Risks: Disruptions in raw material sourcing, regulatory delays, and geopolitical factors influence supply stability.
• Market Evolution: Patent expirations and biosimilar development could diversify future supply sources, impacting pricing and availability.
• Strategic Implications: Stakeholders should monitor Pfizer’s capacity investments and regional manufacturing initiatives to assess supply security.

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FAQs

1. Who are the main manufacturers of isavuconazonium sulfate?
Pfizer, through licensed production and partnerships, is the primary manufacturer globally, with Basilea Pharmaceutica involved in initial development and licensing. Several CMOs also produce intermediates or the final product under contract.

2. Can new suppliers enter the market for isavuconazonium sulfate?
Yes. Post-patent expiry and with technological advancements, new manufacturers, especially regional firms, could establish production, increasing supply diversity.

3. What challenges affect the manufacturing supply of isavuconazonium sulfate?
The synthesis complexity, raw material sourcing, regulatory requirements, and the need for GMP compliance are significant challenges limiting rapid scaling.

4. How does patent protection influence the number of suppliers?
Patent protections limit generic production, consolidating supply among patent holders like Pfizer. Expiration opens opportunities for new entrants and biosimilar development.

5. What is the role of CMOs in the supply chain?
CMOs provide specialized manufacturing services, including sterile formulation and active pharmaceutical ingredient synthesis, enabling capacity expansion and risk mitigation.

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References

[1] Basilea Pharmaceutica. (2022). Annual Report and Corporate Overview.

[2] CordenPharma. (2023). Manufacturing Capabilities for Complex Injectable Drugs.