Suppliers and packagers for generic pharmaceutical drug: FERRIC CARBOXYMALTOSE

FERRIC CARBOXYMALTOSE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0602-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0620-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2021-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0650-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) / 15 mL in 1 VIAL, SINGLE-DOSE	2013-08-12

Suppliers for the Pharmaceutical Drug: FERRIC CARBOXYMALTOSE

Last updated: November 3, 2025

Introduction

FERRIC CARBOXYMALTOSE is an innovative oral iron complex used primarily to treat iron deficiency anemia. Offering superior gastrointestinal tolerability compared to traditional iron salts, ferric carboxymaltose has gained popularity among healthcare providers worldwide. Its manufacturing relies on specialized suppliers capable of producing high-quality, pharmaceutically pure ferric carboxymaltose. This article delineates the key suppliers, focusing on their manufacturing capacities, market positioning, regulatory compliance, and strategic significance within the global pharmaceutical supply chain.

Understanding Ferric Carboxymaltose: The Product Profile

Ferric carboxymaltose is a complex of ferric iron with a carbohydrate core of carboxymaltose, stabilizing iron in a bioavailable form that bypasses some gastrointestinal side effects. It is administered intravenously or as an oral formulation, with the majority of commercial formulations being injectables administered under medical supervision. Leading drug manufacturers source ferric carboxymaltose from specialized suppliers who ensure the raw material's chemical consistency, purity, and regulatory compliance.

Leading Suppliers of Ferric Carboxymaltose

1. Vifor Pharma Group

   Vifor Pharma, a Swiss-based global specialty pharmaceuticals company, is a pioneer in the production and commercialization of ferric carboxymaltose under the brand name Ferinject (also known as Injectafer in North America). The company has developed proprietary manufacturing processes, ensuring high-quality standards and consistent supply. Vifor's vertically integrated operations encompass sourcing of raw materials, manufacturing, and distribution, enabling tight quality control and reliability in supply chains.

   Their manufacturing facilities are equipped with state-of-the-art facilities adhering to Good Manufacturing Practices (GMP), certified by relevant regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Vifor Pharma’s strategic investments in capacity expansion have made them a dominant supplier globally in the iron deficiency treatment space.

2. GF Autoimmunity & Blood Therapy Division (Grifols)

   Grifols, a Spanish multinational, acquired certain assets from LD Micro and other biotech firms to enhance its portfolio of intravenous iron products, including ferric carboxymaltose. Grifols’ manufacturing division leverages extensive expertise in plasma-derived and biopharmaceutical products, adopting top-tier GMP standards. Their production facilities in Spain and North America are certified to ensure supply stability for global markets.

   Grifols' focus on pharmaceutical-grade carbohydrate complexes has positioned it as a strategic alternative supplier, especially for markets where Vifor’s proprietary processes face regional regulatory challenges.

3. Shanghai Fudan Pharmaceutical Co., Ltd.

   Chinese pharmaceutical manufacturers such as Shanghai Fudan Pharmaceutical produce ferric carboxymaltose for domestic and export markets. Their process involves sourcing raw carbohydrate and iron components, followed by complex conjugation and stabilization. Regulatory compliance with Chinese GMP standards and increasingly, with European and U.S. standards, makes these suppliers increasingly credible for international distribution.

   Their supply chain benefits from lower manufacturing costs, making them an attractive option for generic or off-patent formulations. However, regulatory approval in key markets remains a critical barrier; thus, their global export success is contingent upon stringent quality assurance and registration processes.

4. Lupin Limited

   An Indian multinational, Lupin manufactures injectable iron complexes, including ferric carboxymaltose, aimed at both domestic and emerging markets. Their manufacturing facilities in India conform to international GMP standards and have obtained WHO prequalification status, facilitating MBs’ pipelines into regulated markets.

   Lupin’s strategic focus on affordability and scalable manufacturing makes it a significant player, especially in regions with high demand for iron deficiency treatments.

5. Other Notable Suppliers

   • Fresenius Kabi: An established manufacturer of injectable pharmaceuticals, including intravenous iron preparations, with a focus on European and Asian markets.
   • Pfizer: While primarily marketing its branded formulations, Pfizer sources ferric carboxymaltose from specialized contract manufacturers operating under strict quality standards.
   • Amneal Pharmaceuticals: Emerging as a supplier, especially within North America, leveraging strategic licensing agreements with European manufacturers.

Market Dynamics and Supplier Selection Considerations

Clinicians and pharmaceutical companies prioritize several factors when sourcing ferric carboxymaltose:

• Regulatory compliance: Ensuring suppliers adhere to GMP, and possess necessary certifications (EMA, FDA, WHO prequalification).
• Manufacturing capacity and reliability: Ability to meet supply demands, particularly in pandemic or high-demand periods.
• Cost-effectiveness: Balancing quality with pricing, especially in emerging markets.
• Quality assurance and purity: Consistent chemical composition, low impurity levels, and stability.
• Geographical presence and distribution capabilities: Ensuring timely supply in target regions.

Supply Chain Challenges

The complex synthesis of ferric carboxymaltose, involving carbohydrate conjugation and stabilization, limits the number of high-capacity, compliant manufacturers. Additionally, geopolitical factors, such as export restrictions and supply chain disruptions, can influence the availability from certain regions. The reliance on a limited pool of suppliers underscores the need for diversified sourcing strategies by pharmaceutical companies.

Regulatory Considerations

Suppliers must navigate multi-regional regulatory landscapes, with approval processes varying across jurisdictions. Suppliers with established registration and continuous compliance monitoring—like Vifor Pharma and Grifols—offer more security in supply continuity. Conversely, newer entrants or manufacturers in emerging markets often face longer authorization timelines, potentially impacting supply stability.

Future Outlook and Strategic Implications

As demand for ferric carboxymaltose grows globally, particularly in regions with high prevalence of iron deficiency anemia, suppliers are investing in expanding manufacturing capacities and enhancing quality control systems. Strategic partnerships, licensing agreements, and technology transfers are expected to elevate the global supply base.

The segment also anticipates increased competition from bio-similar and alternative iron formulations, prompting existing suppliers to innovate in process efficiency, formulation stability, and delivery mechanisms.

Key Takeaways

• Dominant Suppliers: Vifor Pharma and Grifols lead the global supply of ferric carboxymaltose, backed by robust manufacturing infrastructure and regulatory compliance.
• Emerging Markets: Chinese and Indian manufacturers like Shanghai Fudan and Lupin provide cost-effective options, gaining prominence through quality improvements and regulatory approvals.
• Supply Chain Stability: Dependence on limited high-quality manufacturers underscores the importance of diversification strategies for healthcare providers and distributors.
• Regulatory and Quality Challenges: Maintaining compliance with international standards remains critical to ensure market access and supply continuity.
• Market Expansion and Innovation: Ongoing investments in capacity and technology are vital for meeting increasing global demand, especially in underserved regions.

Conclusion

The supply landscape for ferric carboxymaltose hinges on a handful of established, compliant suppliers capable of high-volume, high-quality production. Major players like Vifor Pharma and Grifols dominate global markets, leveraging extensive regulatory approvals and manufacturing expertise. As demand escalates, the industry anticipates strategic collaborations, capacity enhancements, and regulatory convergences to solidify supply chains and ensure consistent access for patients worldwide.

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FAQs

1. Who are the top global suppliers of ferric carboxymaltose?
   The leading suppliers include Vifor Pharma and Grifols, both possessing extensive manufacturing facilities compliant with international standards. Regional manufacturers like Shanghai Fudan in China and Lupin in India are also significant, especially for cost-sensitive markets.

2. What factors influence a supplier’s eligibility for international markets?
   Regulatory compliance (GMP certifications, EMA/FDA approvals), manufacturing capacity, raw material quality, and supply reliability are key determinants.

3. Are there risks associated with dependency on a limited number of suppliers?
   Yes. Over-reliance can lead to supply disruptions, price volatility, and regulatory challenges, emphasizing the importance of diversified sourcing.

4. How do regulatory standards impact ferric carboxymaltose suppliers?
   Compliance with stringent standards like GMP and timely registration with agencies ensure market access and protect patient safety, directly influencing supplier credibility.

5. What is the future outlook for ferric carboxymaltose suppliers?
   Market expansion driven by increasing demand for iron deficiency treatments worldwide, along with technological innovations, will prompt capacity growth and strategic alliances among suppliers.

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References

[1] Vifor Pharma, "Ferinject (Ferric Carboxymaltose) Product Info," 2022.
[2] Grifols, "Iron Therapy Portfolio," 2023.
[3] World Health Organization, "Prequalification Program for Injectable Drugs," 2021.
[4] U.S. FDA Database, "Approved Iron Drugs," 2022.
[5] Industry Reports, "Global Ferric Carboxymaltose Market," 2022.