Suppliers and packagers for auryxia

auryxia

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-2895-20	200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)	2025-03-20
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874	NDA	Akebia Therapeutics, Inc.	59922-631-01	200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)	2014-09-17

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Auryxia

Introduction

Auryxia (ferric citrate) is an orally administered iron-based phosphate binder developed by Keryx Biopharmaceuticals, primarily prescribed for managing hyperphosphatemia in dialysis patients with chronic kidney disease (CKD) and for iron deficiency anemia in non-dialysis CKD patients. As a critical medication within nephrology, its supply chain involves multiple key stakeholders, including raw material suppliers, formulation manufacturers, and distribution channels. Understanding the landscape of suppliers for Auryxia is essential for stakeholders aiming to ensure product stability, regulatory compliance, and cost efficiency.

Raw Material Suppliers for Ferric Citrate

1. Iron Source Suppliers
The core component of Auryxia is ferric citrate, necessitating high-purity iron salts, primarily ferric citrate feedstock.

• Ferro company (Hypothetical for illustrative purposes) and comparable specialty chemical firms often supply ferric citrate raw materials to pharmaceutical manufacturers. These firms must adhere to Good Manufacturing Practices (GMP), ensuring batch consistency and purity.
• Specialty chemical suppliers in regions such as China, India, and Europe dominate this space, leveraging economies of scale to produce pharmaceutical-grade ferric citrate. These suppliers typically undergo rigorous regulatory scrutiny by agencies like the FDA and EMA before their materials are approved for pharmaceutical use.

2. Citrate Salts Suppliers
The other critical raw material is citric acid or citrate salts, which serve as chelating agents.

• Major suppliers include Cargill, Archer Daniels Midland (ADM), and FMC Corporation, which produce standard and pharmaceutical-grade citric acid under strict GMP conditions.
• These corporations often operate globally, maintaining supply chains that ensure availability even amid regional disruptions.

Manufacturing and Formulation for Auryxia

3. Contract Manufacturing Organizations (CMOs)
Manufacturers producing Auryxia often partner with CMOs specializing in oral solid dosage forms.

• Catalent, Recipharm, and Aenova regularly provide formulation, blending, compression, and packaging services for pharmaceutical companies.
• Location considerations include proximity to raw material sources, manufacturing expertise in nephrology drugs, and regulatory compliance to meet U.S. FDA and EMA standards.

4. In-House Manufacturing
Keryx Biopharmaceuticals, the original developer of Auryxia, maintains in-house facilities for quality control, final formulation, and packaging, ensuring strict oversight over the product.

Distribution and Logistics

5. Distribution Networks
Post-manufacturing, Auryxia's distribution involves wholesale distributors, specialty pharmacies, and healthcare institutions.

• Major distributors include McKesson, AmerisourceBergen, and Cardinal Health, which facilitate supply to hospitals and dialysis centers across the U.S. and internationally.
• The cold chain logistics are less critical for Auryxia since it is a stable solid form, but regulatory compliance and temperature monitoring during transit remain paramount.

Key Global Suppliers and Market Dynamics

6. Regional Suppliers and Risks

• Asian markets, notably China and India, are primary sources of pharmaceutical raw materials due to lower production costs and extensive chemical manufacturing infrastructure. However, geopolitical tensions, regulatory changes, and supply chain disruptions can impact raw material availability.
• Efforts by large pharmaceutical firms to diversify suppliers or establish vertical integration can mitigate risks.

7. Regulatory Scrutiny and Quality Assurance
Suppliers must comply with strict GMP standards established by agencies such as the FDA, EMA, and Japan's PMDA. Non-compliance risks supply interruptions, recalls, and legal liabilities.

• The sourcing of ferric citrate raw material often involves an audit trail, Certificates of Analysis (CoA), and audit reports to ensure traceability and quality.

Key Players in the Supply Chain

Stakeholder	Role	Notable Entities	Notes
Raw Material Suppliers	Provide ferric citrate and citrate salts	Cargill, ADM, FMC, Chinese chemical producers	Regulatory compliance and raw material purity critical
Contract Manufacturers (CMOs)	Formulate and produce Auryxia tablets	Catalent, Recipharm, Aenova	GMP standards ensure quality
Proprietary Manufacturing	Keryx Biopharmaceuticals	Internal facilities	Quality oversight and scaling
Distributors	Logistics and supply to healthcare providers	McKesson, AmerisourceBergen, Cardinal Health	Ensures broad distribution network

Supply Chain Challenges and Opportunities

• Global Trade Disruptions: Ongoing geopolitical issues, pandemic-related logistics constraints, and tariffs influence raw material costs and availability. Diversification strategies are vital.
• Regulatory Complexity: Suppliers must navigate varying international standards, increasing compliance costs but also fostering higher product quality.
• Vertical Integration: Some firms pursue vertical integration involving raw material sourcing to formulation and distribution to enhance supply control and reduce costs.
• Innovation and Quality: The transition toward more purified raw materials and innovative formulation techniques can improve bioavailability and stability, differentiating suppliers in the competitive landscape.

Conclusion

The supply chain for Auryxia hinges on high-quality raw material sourcing, reliable manufacturing partnerships, and a resilient distribution network. Major suppliers include chemical producers of ferric citrate and citric acid, third-party contract manufacturers, and extensive healthcare distribution channels. Ensuring supply chain integrity involves stringent quality controls, regulatory compliance, and risk mitigation strategies, especially amid global uncertainties.

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Key Takeaways

• The primary raw material for Auryxia, ferric citrate, is supplied by several global chemical companies adhering to strict GMP standards.
• Contract manufacturing organizations play a crucial role in formulating and packaging Auryxia, often under long-term partnerships with original developers.
• Supply chain resilience is vital; diversification of raw material sources and strategic partnerships can mitigate geopolitical and logistical risks.
• Regulatory compliance, including certifications and traceability, remains a key criterion for sourcing and manufacturing.
• Efficient distribution networks ensure timely access to the medication, emphasizing the importance of reliable logistics partners.

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FAQs

1. Who are the main raw material suppliers for ferric citrate used in Auryxia?
Major raw material suppliers include chemical companies like Cargill, ADM, and FMC, providing pharmaceutical-grade ferric citrate and citrate salts compliant with GMP standards.

2. Are there regional differences in Auryxia's supply chain?
Yes. Asian suppliers, especially from China and India, supply raw materials globally but pose potential geopolitical and regulatory risks, prompting firms to diversify sourcing strategies.

3. How does regulatory compliance impact the supply chain of Auryxia?
Strict adherence to GMP and regulatory standards ensures raw material purity, manufacturing quality, and product safety, which are vital for continuous supply and market approval.

4. What role do contract manufacturers play in Auryxia's supply chain?
They formulate, process, and package Auryxia tablets, providing scalability and expertise, often under partnerships with original developers like Keryx Biopharmaceuticals.

5. How can supply chain disruptions affect the availability of Auryxia?
Disruptions in raw material sourcing, logistical delays, or regulatory non-compliance can lead to shortages, affecting patient access and institutional stock levels. Strategic planning and diversification are essential.

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Sources:
[1] Keryx Biopharmaceuticals, Auryxia Product Details.
[2] FDA Pharmaceutical Quality Standards.
[3] Global Chemical Suppliers Directory.
[4] Industry Reports on Pharmaceutical Supply Chains.
[5] McKesson, AmerisourceBergen, and Cardinal Health Distribution Data.