Suppliers and packagers for CANCIDAS

CANCIDAS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227	NDA	Merck Sharp & Dohme LLC	0006-3822-10	1 VIAL, SINGLE-USE in 1 CARTON (0006-3822-10) / 10.8 mL in 1 VIAL, SINGLE-USE	2001-01-26
Merck	CANCIDAS	caspofungin acetate	POWDER;INTRAVENOUS	021227	NDA	Merck Sharp & Dohme LLC	0006-3823-10	1 VIAL, SINGLE-USE in 1 CARTON (0006-3823-10) / 10.8 mL in 1 VIAL, SINGLE-USE	2001-01-26

Suppliers for the Pharmaceutical Drug: CANCIDAS

Last updated: August 2, 2025

Introduction

CANCIDAS (caspofungin acetate) is a prescription antifungal medication belonging to the echinocandin class. It’s predominantly used to treat invasive fungal infections such as candidemia, intra-abdominal abscesses, and esophageal candidiasis, particularly in immunocompromised patients. The manufacturing, sourcing, and supply chain integrity of CANCIDAS are critical to ensure consistent availability, regulatory compliance, and competitive advantage. This article provides a comprehensive overview of the major suppliers involved in the production and distribution of CANCIDAS, analyzing their roles in the supply chain and implications for stakeholders.

Manufacturers of CANCIDAS

1. Pfizer Inc.

Pfizer remains the primary patent holder and manufacturer of CANCIDAS. The drug was developed through Pfizer’s research pipeline and received FDA approval in 2001. Pfizer’s extensive global manufacturing network ensures reliable supply, leveraging state-of-the-art pharmaceutical production facilities compliant with Good Manufacturing Practices (GMP).

Manufacturing Sites and Capabilities
Pfizer operates multiple manufacturing sites dedicated to sterile injectable production, including facilities in the United States and worldwide, primarily focused on large-scale aseptic processing that guarantees high product quality and purity. These facilities also adhere to regulatory standards set by the FDA, EMA, and other global agencies, securing supply chain stability.

Supply Chain Strategy
Pfizer maintains strategic partnerships with Contract Manufacturing Organizations (CMOs) for capacity expansion and risk mitigation. The company also invests in global logistics networks to facilitate timely distribution to hospitals and specialty pharmacies worldwide.

2. Contract Manufacturing Organizations (CMOs)

While Pfizer produces CANCIDAS predominantly in-house, certain regional supply components may be sourced through CMOs. These organizations provide sterile drug formulation, filling, and packaging services, ensuring scalability and flexibility in response to market demand.

Notable CMOs involved in sterile API and final product manufacturing include:

• Lonza Group
• Samsung Biologics
• Catalent, Inc.

These firms are recognized for their rigorous quality standards, serving as vital suppliers in the global pharmaceutical ecosystem for critical injectable drugs like CANCIDAS.

Supply Chain and Distribution Partners

1. Wholesalers and Distributors

Antifungal drugs like CANCIDAS are distributed via a network of specialized pharmaceutical wholesalers and distributors, including:

• McKesson Corporation
• AmerisourceBergen Corporation
• Cardinal Health

These entities ensure that hospitals, clinics, and specialty pharmacies have continuous access, especially given CANCIDAS’s importance in treating life-threatening infections.

2. Regional and Global Distributors

Given its specialty status, CANCIDAS is often supplied through regional distributors with expertise in handling sterile injectables. These distributors are critical for navigating local regulatory landscapes, customs procedures, and logistics, particularly in emerging markets.

Supply Chain Challenges and Risk Management

1. Raw Material Sourcing

CANCIDAS’s active pharmaceutical ingredient (API), caspofungin acetate, requires synthesis of complex echinocandin compounds derived from fungi and optimized chemical routes. Sourcing raw materials involves several specialized chemical suppliers, often concentrated in specific regions like China and Europe, posing risks related to geopolitical stability, quality, and supply disruptions.

2. Manufacturing Bottlenecks

Sterile manufacturing is sensitive to contamination and process disruptions. Any issue at Pfizer’s or CMOs' facilities can lead to supply shortages. Maintaining robust quality assurance protocols and contingency planning is essential to mitigate these risks.

3. Regulatory Hurdles

Stringent regulatory oversight requires ongoing inspections and compliance monitoring. Any non-compliance in manufacturing or distribution can lead to delays or recalls, impacting supply continuity.

4. Market Dynamics and Demand Fluctuations

Increased global demand, especially during health crises such as COVID-19, strains existing manufacturing capacities. Pfizer and partners have responded by expanding production capabilities and establishing supply agreements with governmental and non-governmental entities to meet surges in demand.

Future Outlook and Supplier Trends

1. Diversification of Supply Sources

To enhance resilience, Pfizer and its partners are exploring diversification of raw material sources and establishing secondary manufacturing arrangements. Developing regional manufacturing hubs can reduce reliance on concentrated supply points.

2. Technological Advancements

Adopting advanced bioprocessing and synthetic methodologies can improve yield and reduce production timelines, ensuring steadier supplies. Investing in digital supply chain management systems enhances visibility and responsiveness.

3. Strategic Collaborations and Alliances

Partnerships with contract manufacturers, raw material suppliers, and logistics providers enable scalable and resilient supply chains. Strategic alliances also facilitate rapid response to emerging health needs and new indications for CANCIDAS.

Regulatory and Market Implications

Supply security hinges on regulatory compliance and proactive engagement with authorities. Pfizer’s reputation and market share depend on consistent product quality and availability. Monitoring global regulatory developments assists in preempting supply disruptions and managing inventory more effectively.

Conclusion

CANCIDAS’s supply chain is predominantly controlled by Pfizer, supplemented with partnerships involving CMOs, raw material suppliers, and a broad distribution network. Ensuring continuity of supply involves navigating challenges related to raw material sourcing, manufacturing capacity, regulatory compliance, and market demand. Stakeholders must focus on diversification, technological innovation, and strategic collaborations to mitigate risks and support ongoing treatment needs.

---

Key Takeaways

• Pfizer dominates CANCIDAS manufacturing, leveraging its global facilities and strategic partnerships.
• The supply chain’s complexity originates from sourcing specialized raw materials and maintaining strict sterile manufacturing practices.
• Risks include raw material shortages, manufacturing disruptions, regulatory delays, and demand surges.
• Diversification of suppliers and regional manufacturing hubs are key strategies for supply resilience.
• Active monitoring of regulatory landscapes and technological innovations support stable supply and market competitiveness.

---

FAQs

1. Who are the primary manufacturers of CANCIDAS?
Pfizer Inc. is the sole developer and primary manufacturer of CANCIDAS, with secondary production and formulations handled through global CMOs.

2. What are the main challenges in the supply chain for CANCIDAS?
Key challenges include sourcing complex raw materials, ensuring sterile manufacturing quality, regulatory compliance, and managing demand fluctuations.

3. How does Pfizer ensure the availability of CANCIDAS worldwide?
Through extensive global manufacturing facilities, strategic partnerships with CMOs, and a broad distribution network, Pfizer maintains supply continuity.

4. Are there alternative suppliers or generic versions of CANCIDAS?
Currently, CANCIDAS remains under patent protection, and generic versions are unavailable. Biosimilar or alternative echinocandin drugs are in development but not direct equivalents.

5. What future strategies are in place to enhance CANCIDAS supply resilience?
Pfizer and partners focus on raw material diversification, expanding manufacturing capacity, adopting advanced production technologies, and establishing regional supply hubs.

---

Sources

1. Pfizer Inc. Official Website. (2023). CANCIDAS Product Information.
2. U.S. Food and Drug Administration (FDA). (2001). Approval Letter for Caspofungin.
3. Pharmaceutical technology reports. (2022). Sterile manufacturing and supply chain insights.
4. Industry reports on pharmaceutical supply chain resilience.
5. Pfizer’s quarterly reports and investor presentations.