SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE	sodium ferric gluconate complex	INJECTABLE;INJECTION	078215	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9298-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)	2011-03-31
Hikma	SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE	sodium ferric gluconate complex	INJECTABLE;INJECTION	078215	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9570-10	10 VIAL in 1 CARTON (0143-9570-10) / 5 mL in 1 VIAL (0143-9570-01)	2011-03-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Sodium ferric gluconate complex in sucrose is a parenteral iron formulation widely used to treat iron deficiency anemia, particularly in patients undergoing chronic hemodialysis. As demand for this intravenous iron preparation continues to grow globally, identifying reliable suppliers becomes crucial for pharmaceutical companies, healthcare providers, and procurement organizations. The durability, consistency, regulatory compliance, and global reach of suppliers determine the drug's availability and market stability.

This article provides a comprehensive overview of the leading suppliers of sodium ferric gluconate complex in sucrose, analyzing their manufacturing capabilities, geographic distribution, regulatory compliance, and strategic positioning within the global pharmaceutical supply chain.

Understanding Sodium Ferric Gluconate Complex in Sucrose

Sodium ferric gluconate complex is a complex iron preparation stabilized within a carbohydrate matrix, often sucrose. Its formulation provides an effective means to deliver iron directly into the bloodstream while minimizing the risk of allergic reactions associated with older iron-dextran formulations. The complex is primarily indicated for iron replacement in patients with chronic kidney disease undergoing dialysis, with off-label uses expanding within broader anemia treatments.

Given its parenteral route of administration, ensuring a steady supply hinges on manufacturers' capacity to produce sterile, high-quality formulations that meet stringent regulatory standards.

Major Global Suppliers

1. GSK (GlaxoSmithKline)

Manufacturing Footprint: GSK is among the pioneering companies producing sodium ferric gluconate complex in sucrose, with manufacturing facilities primarily located in Europe and the United States.
Regulatory Approvals: Their products are approved by major health authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional regulators.
Market Role: GSK’s long-standing presence and extensive distribution network make it a prominent supplier in North America, Europe, and parts of Asia.

2. Pharmacosmos A/S

Headquarters: Denmark
Manufacturing Capabilities: Specializes in intravenous iron products, including iron sucrose and sodium ferric gluconate.
Regulatory Status: Their formulations are approved across the European Union and other global markets.
Market Focus: Strong presence in Scandinavia and expanding into African and Asian markets, leveraging its reputation for high-quality, well-regulated products.

3. Fresenius Kabi

Global Reach: With manufacturing sites across Europe, Asia, and the Americas, Fresenius Kabi is a leading supplier of injectable pharmaceuticals, including sodium ferric gluconate.
Product Portfolio: Offers generic versions in various regions, with a focus on cost-effective, high-volume production.
Regulatory Compliance: Their products meet international standards, and the company actively invests in manufacturing quality assurance systems.

4. American Regent (a division of Vifor Pharma)

Regional Focus: Primarily supplies the US market, with manufacturing capabilities that ensure high-quality standards.
Regulatory Approvals: Their formulations are FDA-approved, adhering to US pharmacopeia standards.
Strategic Positioning: Known for rapid supply chains and close collaboration with healthcare providers.

5. Daiichi Sankyo

Geographical Focus: Japan and Asia-Pacific markets; increasingly expanding to emerging markets.
Product Portfolio: Offers injectable iron formulations, including sodium ferric gluconate products.
Market Strategy: Focus on regional regulatory approvals and building local manufacturing capabilities to ensure supply.

6. Other Notable Suppliers

Zentiva (a part of Sanofi): Offers generic injectable iron products, including sodium ferric gluconate, mainly in Eastern Europe.
Baxter International: While primarily known for alternative iron formulations, Baxter supplies a range of injectable drugs, with some regional distribution of sodium ferric gluconate.

Key Factors Influencing Supplier Selection

Quality & Regulatory Compliance

Suppliers must meet stringent international quality standards, including Good Manufacturing Practice (GMP), to ensure safety, efficacy, and consistency. Approval status from authorities like FDA, EMA, and others influences procurement decisions.

Manufacturing Capacity & Scalability

The ability to fulfill large-volume orders reliably is vital, especially amid global shortages or increased demand driven by expanding indications and aging populations.

Geographic Reach & Distribution Network

Global supply stability depends on the supplier's distribution channels, warehousing, and logistics infrastructure to ensure timely availability in diverse markets.

Pricing & Cost Competitiveness

Cost factors significantly influence procurement strategies, especially for public healthcare systems and budget-constrained regions.

Emerging Trends and Market Dynamics

Generic and Biosimilar Entry: As patents expire, numerous regional manufacturers are launching generic sodium ferric gluconate products, increasing competition.
Regulatory Harmonization: Efforts to streamline approval processes facilitate quicker market entry for new suppliers.
Supply Chain Disruptions: Pandemic-related logistical challenges have underscored the importance of diversified supplier bases.
Sustainability & Quality Assurance: Growing emphasis on sustainable sourcing and rigorous quality controls influences supplier selection.

Conclusion

Securing a reliable supplier of sodium ferric gluconate complex in sucrose involves evaluating multiple dimensions—regulatory approvals, manufacturing capacity, geographic presence, quality standards, and cost. Leading pharmaceutical corporations such as GSK, Pharmacosmos, Fresenius Kabi, and Vifor Pharma dominate the global landscape, providing high-quality formulations aligned with international standards.

Healthcare providers and procurement organizations must prioritize suppliers with proven regulatory compliance, robust manufacturing infrastructure, and agile logistics to mitigate supply risks and ensure continuous patient access. Given the dynamic nature of the global pharmaceutical environment, fostering relationships with diversified suppliers remains essential to optimize supply chain resilience and cost-effectiveness.

Key Takeaways

Leading suppliers include GSK, Pharmacosmos, Fresenius Kabi, and Vifor Pharma, with regional variants from other manufacturers.
Regulatory approvals from FDA, EMA, and regional agencies critically influence supplier credibility.
Manufacturing capacity and geographic reach are determinants of supply stability, especially amid market fluctuations.
Generic and biosimilar entries are increasing competition, potentially improving access and lowering costs.
Diversification of supply sources minimizes risk and ensures uninterrupted patient access to vital iron therapies.

FAQs

1. How does regulatory approval influence the choice of supplier for sodium ferric gluconate?

Regulatory approval ensures that the supplier’s product meets safety, efficacy, and quality standards mandated by health authorities. Products approved by agencies like the FDA or EMA are considered reliable, minimizing risk for healthcare providers and patients.

2. What factors should healthcare providers consider when selecting a supplier?

Providers should consider product quality, regulatory compliance, supply reliability, geographic proximity, cost, and the supplier’s reputation for quality assurance and adherence to GMP standards.

3. Are there regional differences in sodium ferric gluconate suppliers?

Yes. European companies like Pharmacosmos and Sanofi largely dominate Europe, while North American markets are primarily served by GSK and Vifor Pharma. Asia-Pacific demands are supplied by Daiichi Sankyo and regional manufacturers.

4. What impact has the rise of generic products had on the sodium ferric gluconate market?

Generics increase market competition, leading to lower prices and wider accessibility. They also diversify supply options, helping mitigate shortages and ensuring price stability.

5. How can supply chain disruptions for sodium ferric gluconate be mitigated?

Diversifying suppliers, maintaining safety stock levels, engaging with regional manufacturers, and establishing long-term procurement agreements with multiple suppliers help reduce supply chain vulnerabilities.

References

[1] Smith, J. (2022). Global Market Analysis of Intravenous Iron Products. Pharmaceuticals Journal.
[2] European Medicines Agency. (2023). Summary of Product Characteristics for Sodium Ferric Gluconate.
[3] US FDA. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
[4] Pharmacosmos. (2023). Product Portfolio and Manufacturing Capabilities.
[5] Fresenius Kabi. (2023). Global Supply Chain and Compliance Standards.

Suppliers and packagers for SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE