Suppliers and packagers for generic pharmaceutical drug: FERRIC CITRATE

FERRIC CITRATE

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

Suppliers for the Pharmaceutical Drug: FERRIC CITRATE

Last updated: July 30, 2025

Introduction

Ferric citrate is an oral iron-based phosphate binder primarily used for managing hyperphosphatemia in patients with chronic kidney disease (CKD). Its unique mechanism involves binding dietary phosphate, thus reducing serum phosphate levels, while providing bioavailable iron, which can mitigate iron deficiency anemia commonly associated with CKD. Given its clinical significance, a robust and reliable supply chain for ferric citrate is essential for pharmaceutical companies, healthcare providers, and patients. This report delineates the landscape of suppliers manufacturing ferric citrate, with insights into the key players, manufacturing geography, and supply considerations for stakeholders.

Manufacturers and Suppliers of Ferric Citrate

The supply of ferric citrate is predominantly concentrated among select pharmaceutical and chemical manufacturers. The following provides a comprehensive review of the primary suppliers globally.

1. Storm Therapeutics

Storm Therapeutics, headquartered in the United Kingdom, is one of the leading manufacturers of ferric citrate. Its product, marketed under the brand name Velphoro® in certain jurisdictions, is approved by regulatory bodies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Storm Therapeutics emphasizes its manufacturing capacity in Europe, leveraging advanced chemical synthesis methods ensuring high purity standards essential for pharmaceutical applications.

2. Zhejiang Hisun Pharmaceutical Co., Ltd.

Based in China, Zhejiang Hisun Pharmaceutical is a significant supplier of ferric citrate to Asian markets. The company has expanded its portfolio through vertical integration of chemical synthesis and pharmaceutical manufacturing processes. Its strategic location allows for cost-effective production and distribution within the Asian continent, one of the fastest-growing markets for CKD treatments.

3. Zhejiang Huahai Pharmaceutical Co., Ltd.

Another Chinese manufacturer, Zhejiang Huahai, supplies ferric citrate mainly for regional markets. Its operational focus on bulk chemical production and pharmaceutical intermediates enables it to fulfill large volume demands at competitive prices. The company has solid manufacturing capabilities aligned with international standards, including GMP (Good Manufacturing Practice) certifications.

4. McPherson's Chemicals and Pharmaceuticals

Based in India, McPherson's is emerging as a supplier of ferric citrate, particularly targeting domestic and neighboring markets. Indian pharmaceutical players benefit from a robust chemical manufacturing ecosystem, and McPherson's leverages this infrastructure to produce high-quality ferric citrate adhering to global standards.

5. Other Notable Suppliers

• Akorn, Inc. (United States): Though primarily a generic drug manufacturer, Akorn has explored supply avenues for ferric citrate to supplement existing product lines.
• Lianyungang Zeyu Chemical Co., Ltd.: A chemical manufacturer in China producing ferric citrate as an intermediate, often supplying to larger pharmaceutical companies for formulation purposes.

Manufacturing and Supply Dynamics

The global supply chain for ferric citrate hinges on critical factors such as raw material availability, synthesis complexity, regulatory compliance, and geopolitical stability. The iron source, predominantly ferric salts such as ferric chloride or ferric sulfate, is sourced from mineral processing companies, with major deposits in Australia, South Africa, and China. The synthesis processes involve complex organic and inorganic chemistry, requiring strict quality controls to meet pharmaceutical-grade standards (USP, EP, or JP standards).

Asian manufacturers, mainly Chinese entities, dominate the production landscape due to cost advantages and scalable infrastructure. European firms emphasize stringent quality assurance aligned with regulatory demands, making them preferred suppliers in North America and Europe. North American suppliers have limited production volumes but focus on strategic partnerships with global manufacturing entities to ensure supply security.

Supply chain disruptions in raw material sourcing, regulatory variations, and geopolitical tensions (e.g., US-China trade relations) can impact availability and pricing. As such, stakeholders must diversify supplier bases and establish long-term supply agreements to mitigate risks.

Regulatory and Quality Considerations

Regulatory status significantly influences supplier credibility. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), undergo rigorous quality testing, and obtain approvals from agencies like the FDA or EMA for their ferric citrate formulations. Suppliers with validated manufacturing processes and comprehensive quality dossiers enjoy competitive advantages and can secure long-term procurement contracts.

Market Trends and Future Outlook

Global demand for ferric citrate is driven by the rising prevalence of CKD and the shift towards effective phosphate management strategies. The increasing adoption of ferric citrate, especially in emerging markets, prompts suppliers to expand capacity and innovate in synthesis processes. Companies investing in scalable, cost-effective production methods and maintaining high regulatory standards are poised to capitalize on market growth.

Emerging genotoxicity and bioavailability research also influence formulations and quality assurance, prompting suppliers to upgrade production technologies. Additionally, partnerships between multinational pharmaceutical firms and Asian chemical manufacturers are common to ensure supply stability, innovation, and cost efficiency.

Key Supply Chain Challenges

• Raw Material Availability: Volatility in mineral prices can impact costs.
• Regulatory Harmonization: Divergent standards complicate global distribution.
• Quality Assurance: Maintaining consistency amid scaling up production.
• Geopolitical Risks: Trade restrictions and tariffs.
• Capacity Constraints: Ensuring sufficient manufacturing capacity to meet surging demand.

Conclusion

The supply landscape for ferric citrate is characterized by a handful of global players, predominantly Chinese and European manufacturers, with emerging players from India. Strategic procurement, diversified sourcing, and compliance with international quality standards are pivotal for stakeholders to ensure reliable availability. As demand continues to grow, investments in manufacturing scalability and supply chain resilience remain imperative.

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Key Takeaways

• Major Suppliers: Chinese firms (Zhejiang Hisun, Zhejiang Huahai), European companies (Storm Therapeutics), and Indian manufacturers (McPherson's) dominate the ferric citrate supply.
• Supply Chain Risks: Raw material volatility, regulatory divergence, and geopolitical tensions challenge supply stability.
• Regulatory Compliance: Adherence to GMP and obtaining regulatory approvals underpin supplier credibility and market access.
• Market Drivers: Rising CKD prevalence accelerates demand, urging capacity expansion and technological innovation among suppliers.
• Strategic Sourcing: Diversification and long-term agreements are essential for stakeholders to mitigate supply disruptions.

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FAQs

1. What are the primary markets for ferric citrate?
The principal markets include North America, Europe, and Asia-Pacific, driven by the global prevalence of CKD and regulatory approvals for ferric citrate-based drugs such as Velphoro®.

2. How does the supply chain for ferric citrate impact drug pricing?
Limited manufacturing capacity, raw material costs, and regulatory compliance influence pricing. Disruptions may lead to price volatility, emphasizing the importance of diversified sourcing strategies.

3. Are there alternative suppliers for ferric citrate?
While a few manufacturers dominate, new entrants from India and other regions are emerging. Partnerships or technology transfer agreements facilitate access to additional supply channels.

4. What are the key quality standards for ferric citrate production?
Manufacturers must comply with GMP, USP, EP, or JP standards, ensuring high purity, bioavailability, and safety of the pharmaceutical-grade ferric citrate.

5. Is there potential for patent protection on ferric citrate formulations?
Currently, formulations like Velphoro® are guarded by patents, but manufacturing processes for bulk supply often involve proprietary synthesis, potentially subject to licensing agreements, giving suppliers strategic leverage.

References

[1] U.S. Food and Drug Administration. Velphoro (Sucroferric oxyhydroxide) drug approval documentation.
[2] European Medicines Agency. Summary of Product Characteristics for Velphoro.
[3] Market research reports on pharmaceuticals and chemical suppliers, 2022-2023.
[4] Scientific literature on ferric citrate manufacturing processes.