Suppliers and packagers for CAYSTON

CAYSTON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814	NDA	Gilead Sciences, Inc.	61958-0901-1	2 CARTON in 1 PACKAGE (61958-0901-1) / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE	2010-02-22

Suppliers for the Pharmaceutical Drug: Cayston

Last updated: July 27, 2025

Introduction

Cayston (aztreonam lysine for inhalation) is a prescription medication primarily used to manage respiratory infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis (CF). As a targeted antibiotic, Cayston’s supply chain is critical to ensuring continuous patient access, especially given the complexity of manufacturing biopharmaceuticals and the high stakes involved with chronic disease management. This article explores the key manufacturers, suppliers, and distribution channels involved in Cayston’s supply chain, emphasizing the implications for stakeholders across the healthcare landscape.

Overview of Cayston and Its Manufacturing

Developed by Gilead Sciences, Cayston is a sterile, inhaled formulation of aztreonam, a beta-lactam antibiotic. The drug's production involves specialized processes that include peptide synthesis, formulation into inhalation solutions, and rigorous sterilization protocols. Given these complexities, the supplier landscape extends beyond Gilead to encompass raw material providers, contract manufacturing organizations (CMOs), packaging companies, and distributors.

Key Suppliers and Manufacturing Players

1. Gilead Sciences — The Original Manufacturer

   Gilead Sciences holds the primary patent and manufacturing rights for Cayston. Its role encompasses raw material procurement, formulation development, sterile manufacturing, quality control, and regulatory compliance. Gilead's manufacturing facilities are situated in the United States, adhering to Good Manufacturing Practices (GMP) and global quality standards. The company’s robust supply chain management ensures a steady pipeline of Cayston to global markets, although capacity constraints and manufacturing disruptions can impact supply.

2. Raw Material Suppliers for Aztreonam Lysine

   The active pharmaceutical ingredient (API), aztreonam lysine, is produced by several specialized chemical entities:

   • Specialized Catalyst and Reagent Suppliers: These firms supply key chemical precursors necessary to synthesize aztreonam. Notable suppliers include Sigma-Aldrich (a subsidiary of Merck) and TCI Chemicals, which provide high-purity reagents.

   • API Manufacturers: Contract manufacturers like Lonza, Teva Pharmaceutical Industries, and WuXi AppTec have capabilities for API synthesis and scale-up. Their global presence allows multiple sourcing options for Gilead, reducing dependency on a single supplier and mitigating supply chain risks.

3. Formulation and Packaging Partners

   Cain manufacturing involves highly specialized sterile facilities for inhalation solutions:

   • Contract Manufacturing Organizations (CMOs): Takeda, Catalent, and Recipharm have been involved historically in formulation and filling activities for inhaled antibiotics. These CMOs possess capabilities to produce, sterilize, fill, and package inhalation drugs conforming to regulatory standards.

   • Packaging Suppliers: Companies such as West Pharmaceutical Services provide sterile packaging components like vials, seals, and tubing, critical to maintaining product integrity.

4. Distribution and Supply Chain Logistics

   After manufacturing, Cayston moves through distribution channels to reach pharmacies, hospitals, and clinics:

   • Wholesalers: McKesson, Cardinal Health, and AmerisourceBergen serve as primary distributors for Cayston in the United States.

   • International Distributors: For global markets, regional pharmaceutical distributors operate under licensing agreements with Gilead or local regulatory bodies.

5. Potential Alternate Suppliers and Contingency Sources

   To ensure resilience, Gilead reportedly maintains relationships with multiple API suppliers for aztreonam lysine. In addition, strategic partnerships with CMOs enable rapid scale-up during shortages. However, the specialized nature of inhaled formulations means few companies possess the required manufacturing expertise and facilities, constraining the supplier landscape.

Market and Supply Chain Challenges

• Supply Disruptions: Factors like raw material shortages, manufacturing delays, or regulatory hurdles can impact the supply of Cayston. Supply chain vulnerabilities are heightened due to the complex production process and specialized storage requirements.

• Regulatory Approvals and Quality Assurance: Suppliers must maintain GMP compliance, and any deviation can cause delays or discontinuations. Gilead’s rigorous quality oversight mitigates these risks but can complicate procurement if suppliers face regulatory issues.

• Global Access and Pricing Pressures: Emerging markets face regulatory and logistical hurdles to establish local manufacturing, often relying on imports. Price pressures and reimbursement policies influence supplier dynamics and availability.

Emerging Trends and Future Outlook

• Supply Chain Diversification: Pharmaceutical companies, including Gilead, are increasingly adopting diversified sourcing strategies for APIs and formulation services to mitigate risks.

• Biotechnology Innovations: Advances in manufacturing technologies and biosimilar development could impact Cayston’s supply landscape by introducing alternative sources or formulations.

• Regulatory Developments: Stricter GMP standards and international harmonization efforts may influence supplier qualification processes and manufacturing requirements moving forward.

Conclusion

Cayston’s supply chain comprises a complex network of raw material suppliers, contract manufacturers, packaging partners, and distributors. Gilead Sciences remains the central player, leveraging a diversified supplier base for API production and outsourced formulation capabilities to ensure continuous patient access. Navigating supply disruptions requires concerted efforts from manufacturers and stakeholders to uphold manufacturing standards, diversify sourcing, and strengthen logistical resilience. As the cystic fibrosis treatment landscape evolves, ongoing investments in manufacturing capacity and supplier partnerships will be key to sustaining Cayston’s availability globally.

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Key Takeaways

• Gilead Sciences is the primary manufacturer of Cayston, supported by a network of raw material suppliers and contract manufacturers.
• The supplier landscape for Cayston’s API includes global chemical suppliers and CMOs with expertise in inhalation formulations.
• Supply chain resilience depends on diversified sourcing, robust quality management, and strategic partnerships.
• Disruptions can stem from raw material shortages, manufacturing delays, or regulatory issues, necessitating proactive risk mitigation.
• Emerging manufacturing technologies and regulatory frameworks will shape future supplier dynamics and product availability.

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Frequently Asked Questions (FAQs)

1. Who are the main raw material suppliers for Cayston’s active ingredient?
Major suppliers for aztreonam lysine include chemical manufacturing entities such as Sigma-Aldrich (Merck), TCI Chemicals, and contract manufacturing organizations like Lonza and WuXi AppTec, which produce the API at scale under GMP compliance.

2. Are there alternative suppliers for Cayston’s formulation or API?
While the nature of inhaled antibiotics limits supplier options, Gilead employs multiple API suppliers and contracts with CMOs for formulation, enabling supply diversification to mitigate shortages.

3. How does Gilead ensure quality and compliance across its supplier network?
Gilead rigorously audits suppliers, enforces strict GMP standards, and conducts ongoing quality assessments to maintain product safety and efficacy.

4. What challenges threaten Cayston’s supply chain continuity?
Disruptions may arise from raw material shortages, manufacturing delays, regulatory hurdles, or global logistics issues, especially amid supply chain disruptions caused by events like the COVID-19 pandemic.

5. Are there plans to develop biosimilar or generic versions of Cayston?
As of now, no biosimilar or generic versions of Cayston have been approved; the complex manufacturing process and patent protections serve as barriers. Future developments depend on patent expirations and competitive innovation.

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References

[1] Gilead Sciences. (2021). Cayston (aztreonam lysine for inhalation) prescribing information.
[2] U.S. Food and Drug Administration. (2010). Gilead Sciences receives approval for Cayston (aztreonam lysine for inhalation).
[3] Sigma-Aldrich. (2022). Chemical reagents and APIs.
[4] WuXi AppTec. (2023). Contract manufacturing capabilities for antibiotics.
[5] McKesson Corporation. (2022). Distribution services for pharmaceuticals.