Suppliers and packagers for cresemba

cresemba

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: CRESEMBA

Last updated: July 29, 2025

Introduction

CRESEMBA (isavuconazonium sulfate) is an antifungal medication developed by Pfizer, primarily used to treat aspergillosis and mucormycosis. Its efficacy, particularly in invasive fungal infections, has made it a critical drug in hospital settings worldwide. As with many high-value pharmaceuticals, the supply chain of CRESEMBA involves multiple stakeholders, including authorized manufacturers, generic producers, and secondary distributors. Understanding the landscape of suppliers for CRESEMBA is vital for healthcare providers, procurement agencies, and investors aiming to ensure uninterrupted access and market stability.

Manufacturers and Original Suppliers

Pfizer, the originator of CRESEMBA, holds exclusive rights to its production. The company is responsible for the drug's formulation, manufacturing, and distribution, compliant with stringent regulatory standards such as the FDA (United States Food and Drug Administration) and EMA (European Medicines Agency). Pfizer's manufacturing facilities are located in key regions including the United States and Europe, ensuring supply security within these markets.

Key Facts:

• Pfizer maintains compliance with Good Manufacturing Practices (GMP).
• Their production facilities incorporate advanced quality controls to match international standards.
• Pfizer is the only authorized manufacturer of CRESEMBA, while licensing agreements may govern other regional distribution rights.

Generic Manufacturers and Licensing Agreements

While Pfizer retains exclusive rights, patent expirations or licensing arrangements can enable other manufacturers to produce biosimilar or generic versions of CRESEMBA under specific markets or regulatory pathways. Currently, CRESEMBA is under patent protection in many jurisdictions, limiting the presence of generics.

However, in regions where patent protection has expired or through invalidation, manufacturers may seek approval for generics. As of 2023, no prominent generic or biosimilar versions have received licensure, but regulatory agencies worldwide are closely monitoring patent statuses.

Potential future suppliers:

• Biogenics: A biotech firm actively seeking licensing opportunities for antifungal biosimilars.
• Makers in India and China: Several local pharmaceutical companies may pursue generic licensing once patents lapse, aligning with local regulatory processes and market demands.

Secondary Distributors and Supply Chain Dynamics

In addition to Pfizer and potential generic producers, a broad network of authorized distributors stock CRESEMBA across different regions. These include:

• Pharmaceutical wholesalers: Large-scale distributors such as McKesson, Cardinal Health, and AmerisourceBergen in the U.S.
• Regional distributors: Specialized companies operating in Europe, Asia, Latin America, and Africa.
• Hospital and healthcare system suppliers: Direct procurement mechanisms within healthcare networks.

The reliability of these supply channels depends heavily on Pfizer's manufacturing capacity, the efficiency of regulatory approvals, and logistics infrastructure.

Supply Chain Risks and Considerations

Given the complexity, several factors influence ongoing supplier reliability for CRESEMBA:

• Patent Protection: The drug's patent status affects the entry of generics, impacting supply competition.
• Manufacturing Capacity: Pfizer's production limits could create shortages if global demand surges—particularly highlighted during the COVID-19 pandemic's strain on pharmaceutical supply chains.
• Regulatory Hurdles: Approval delays or restrictions can limit new suppliers from entering markets.
• Regional Restrictions: Some countries may impose local manufacturing requirements, influencing the availability of CRESEMBA and the entry of new suppliers.

Emerging Trends and Market Dynamics

The landscape of CRESEMBA suppliers is evolving, influenced by:

• Patent expirations: Such events could open markets to biosimilars, enhancing supply and reducing prices.
• Regional licensing agreements: Pfizer might license local manufacturers to produce CRESEMBA in emerging markets to meet regional demands.
• Supply chain digitization: Enhanced tracking and logistics through advanced IT systems improve transparency and reduce shortages.

Conclusion

CRESEMBA remains predominantly supplied by Pfizer, with the potential for generic manufacturers to enter the market following patent expiration or licensing agreements. The current supply chain comprises Pfizer’s manufacturing facilities, authorized distributors, and regional supply riders. Stakeholders should monitor patent statuses, regional regulatory developments, and supply chain innovations to anticipate shifts in supplier landscapes.

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Key Takeaways

• Pfizer is the primary and exclusive supplier of CRESEMBA, ensuring high standards but limiting immediate market competition.
• Future generic or biosimilar entrants depend on patent expirations and regulatory approvals, which could expand supply options.
• Regional licensing agreements and manufacturing partnerships are crucial for global distribution, especially in emerging markets.
• Supply chain vulnerabilities include patent status, manufacturing capacity, and regulatory environments—all factors to monitor.
• Advances in logistics and digital tracking are improving supply chain resilience, reducing shortages, and optimizing procurement strategies.

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FAQs

Q1: Who are the main suppliers of CRESEMBA globally?
Pfizer is the sole authorized manufacturer globally, with distribution handled through a network of regional and national distributors. No generic versions are currently licensed, but future entrants are possible post-patent expiration.

Q2: When might generic manufacturers begin producing CRESEMBA?
Generic production could commence once Pfizer’s patent protections expire or are invalidated in specific jurisdictions. Patent expiry dates are typically 10–15 years from approval, though legal challenges could alter timelines.

Q3: How does Pfizer ensure supply chain security for CRESEMBA?
Pfizer invests in multiple manufacturing plants, employs rigorous quality control standards, and maintains strategic inventory levels. The company also collaborates with authorized distributors to ensure consistent supply.

Q4: Are there regional restrictions affecting CRESEMBA suppliers?
Yes, regional patent laws, regulatory approvals, and local manufacturing mandates influence supply availability. These factors can limit or facilitate local production in specific countries.

Q5: What future market developments could impact CRESEMBA supply?
Patent expiration, licensing agreements, the emergence of biosimilars, and supply chain digitization are key factors shaping the future landscape and potential increase in supply options for CRESEMBA.

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References

1. Pfizer. CRESEMBA (isavuconazonium sulfate) Prescribing Information. 2022.
2. U.S. Food and Drug Administration (FDA). Patent and Exclusivity Data for CRESEMBA. 2023.
3. MarketWatch. "Antifungal Drugs Market Trends and Patent Analysis." 2022.
4. European Medicines Agency (EMA). Regulatory Status of CRESEMBA. 2022.
5. GlobalData. "Pharmaceutical Supply Chain Overview 2023."