Bulk Pharmaceutical API Sources for FERRLECIT

Bulk Pharmaceutical API Sources for FERRLECIT

Vendor	Vendor Homepage	Vendor Sku	API Url
J&H Chemical Co.,ltd		JH264231
Starshine Chemical		2023-05-9C03158

Bulk Active Pharmaceutical Ingredient (API) Sources for FERRLECIT

Last updated: November 14, 2025

Introduction

Ferrlecit, a brand name for sodium ferric gluconate complex in sucrose, is an intravenous (IV) iron therapy indicated primarily for iron deficiency anemia in patients undergoing chronic hemodialysis. As a critical drug in the management of anemia for this demographic, the quality and integrity of its Active Pharmaceutical Ingredient (API) are paramount. Ensuring a reliable, high-quality supply of sodium ferric gluconate is vital for pharmaceutical manufacturers, healthcare providers, and patients alike. This article provides a comprehensive overview of current APIs sources, supplier landscape, and quality considerations pertinent to Ferrlecit manufacturing.

Understanding Sodium Ferric Gluconate API

Chemical Profile & Role:
Sodium ferric gluconate is a complex iron compound where ferric iron (Fe^3+) is chelated with gluconate ligands, facilitating intravenous delivery of bioavailable iron. Its API stability and purity directly influence the safety, efficacy, and manufacturing consistency of Ferrlecit products.

Manufacturing Considerations:
Developing and sourcing GMP-compliant APIs for sodium ferric gluconate require sophisticated synthetic pathways, strict quality control, and adherence to pharmacopeial standards, such as USP or EP. The complexity of iron carbohydrate complexes underscores the importance of selecting suppliers with proven track records.

Global API Suppliers for Sodium Ferric Gluconate

Major Suppliers and Manufacturers

1. Pfizer Inc.

   • API Role: As the original manufacturer of Ferrlecit, Pfizer maintained proprietary control over the API. Historically, Pfizer sourced sodium ferric gluconate from specialized chemical suppliers during the product's inception.

   • Current Status: Pfizer's manufacturing facilities for sodium ferric gluconate are domestically based, with a focus on quality and regulatory compliance [1].

2. Contamination and Raw Material Suppliers

   • The complex nature of sodium ferric gluconate necessitates partnerships with chemical raw material suppliers. These suppliers provide high-purity gluconic acid, iron salts, and excipients.

3. Generic and Contract API Manufacturers

   • Due to market dynamics, several manufacturers now produce sodium ferric gluconate APIs, especially for generic formulations or biosimilar development.

   • Producers Include:

     • Fresenius Kabi: Known for sterile injectable iron therapies, possibly involved in API procurement or licensing.
     • Baxter International: Engages in production and supply chains involving iron complexes, with some involvement in API sourcing.
     • Local Chinese or Indian API Manufacturers: A rising number of such companies supply high-grade APIs for export markets, contingent upon GMP certification.

Regional API Sourcing Dynamics

• United States & Europe: Focus on strict GMP standards, with most APIs sourced from established, globally compliant manufacturers. Regulatory scrutiny limits reliance on less-established producers.

• Asia-Pacific: Rapidly growing manufacturing bases in China and India host numerous API producers offering sodium ferric gluconate compounds. Notably, these suppliers often serve global markets, subject to regulatory validation.

Regulatory and Quality Considerations

GMP Compliance:
API sources must adhere to Good Manufacturing Practice (GMP) standards enforced by FDA, EMA, or respective regulatory agencies, ensuring purity, stability, and traceability.

Certifications and Documentation:
Suppliers should provide comprehensive Certificates of Analysis (CoA), manufacturing process details, validation reports, and batch records aligned with pharmacopeial standards [2].

Supply Chain Integrity:
Given the critical role of sodium ferric gluconate in patient safety, an unbroken, transparent supply chain minimizes risks related to contamination, substandard quality, or supply disruptions.

Emerging Trends and Alternative Sources

• Development of Synthetic or Recombinant Iron Complexes: Researchers are exploring alternative formulations that might replace traditional APIs, potentially broadening sourcing options.

• Manufacturers’ Vertical Integration: Some pharmaceutical companies increasingly develop in-house API capabilities to better control supply chains and quality parameters.

Key Challenges in API Sourcing for Ferrlecit

• Price Volatility: Fluctuations in raw material costs, especially for raw iron salts and organic ligands.
• Regulatory Barriers: Stringent approvals for APIs from emerging markets can delay or complicate procurement.
• Quality Assurance: Differentiating between genuine GMP-compliant API sources and substandard producers.

Conclusion

Securing a high-quality, reliable source of sodium ferric gluconate API remains essential for the manufacturing of Ferrlecit. Manufacturers primarily rely on well-established suppliers in North America and Europe, alongside an expanding base of Asian producers. Ensuring vendor compliance with GMP standards, maintaining rigorous quality control, and fostering transparent supply chains underpin the safety and efficacy of final formulations.

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Key Takeaways

• Global Diversity of Suppliers: The API landscape includes major pharmaceutical companies and an increasing number of GMP-certified Asian manufacturers.
• Regulatory Vigilance: Strict adherence to GMP and pharmacopeial standards is non-negotiable for API procurement.
• Supply Chain Security: Transparent, traceable sources reduce risks associated with contamination and regulatory non-compliance.
• Market Dynamics: Price fluctuations and evolving regulatory landscapes necessitate ongoing supplier evaluation.
• Innovation Potential: New formulations and manufacturing techniques may diversify future API sources.

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FAQs

1. Who are the leading global suppliers of sodium ferric gluconate API?
Leading suppliers include Pfizer (historically the original manufacturer), along with GMP-certified producers in North America, Europe, China, and India such as Fresenius Kabi, Baxter, and several emerging Asian API manufacturers.

2. What quality standards must API suppliers meet for Ferrlecit production?
Suppliers must comply with GMP standards and provide Certificates of Analysis aligned with USP or EP pharmacopeial requirements to ensure purity, stability, and safety.

3. Are there risks associated with sourcing APIs from emerging markets?
Yes, potential risks include variability in quality, regulatory differences, and supply chain robustness. Due diligence and thorough audits are essential to mitigate these risks.

4. How do supply chain disruptions impact Ferrlecit manufacturing?
Disruptions in API supply can lead to manufacturing delays, drug shortages, and compromised product quality. Diversifying sources and maintaining strategic inventories are common mitigation strategies.

5. What future developments could influence API sourcing for Ferrlecit?
Advances in synthetic iron complexes, recombinant technology, or vertical integration may broaden or alter API sourcing options, potentially improving supply stability and cost-efficiency.

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References

[1] Pfizer Inc. — Official product information and manufacturing updates.
[2] FDA Drug Establishments Current Registration Site: Good Manufacturing Practice (GMP) standards for APIs.