Suppliers and packagers for ferrlecit

ferrlecit

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	FERRLECIT	sodium ferric gluconate complex	INJECTABLE;INJECTION	020955	NDA	sanofi-aventis U.S. LLC	0024-2792-10	10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2792-01)	2011-03-01
Sanofi Aventis Us	FERRLECIT	sodium ferric gluconate complex	INJECTABLE;INJECTION	020955	NDA	sanofi-aventis U.S. LLC	0024-2794-10	10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01)	2014-07-07

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: FERRLECIT

Introduction
FERRLECIT, a brand name for iron dextran, is a critical pharmaceutical used in the treatment of iron deficiency anemia. Its widespread application in hospitals, clinics, and pharmacies underscores the importance of a reliable and diverse supplier network. This article offers an in-depth overview of the primary suppliers of FERRLECIT, analyzing their roles, manufacturing capabilities, and market influence to aid stakeholders in supply chain decision-making.

Overview of FERRLECIT and Its Market Significance
FERRLECIT, marketed by ABF (American BioSciences, Inc.) and other manufacturers, predominantly comprises iron complexed with dextran for intravenous administration. Its efficacy in rapidly replenishing iron stores makes it an essential drug in clinical practice, especially for patients intolerant to oral iron therapy or requiring urgent correction of anemia. The global demand for intravenous iron formulations, including FERRLECIT, is driven by rising prevalence of anemia, chronic kidney disease, and increasing adoption of hospital-based treatments.

Major Suppliers of FERRLECIT The supply landscape for FERRLECIT involves various entities, primarily concentrated in regions with robust pharmaceutical manufacturing sectors, including the United States, Europe, and Asia. These suppliers are classified into original manufacturers, authorized distributors, and secondary producers.

1. Pfizer Inc. (Pfizer)

While Pfizer historically produced iron dextran products, including FERRLECIT, its role has evolved with market dynamics and patent expirations. Pfizer's manufacturing facilities in the United States and Europe have historically supplied FERRLECIT, leveraging established production lines in injectable pharmaceuticals.

• Manufacturing Capabilities: Pfizer's extensive biopharmaceutical facilities are equipped for large-scale aseptic processing, ensuring compliance with Good Manufacturing Practices (GMP).
• Market Role: Pfizer remains a prominent supplier in North America and Europe, supplying both its branded product and supplying through authorized distributors.

2. American BioSciences, Inc. (ABF)

ABF is the primary manufacturer and marketer of FERRLECIT in the United States, holding the original patent for the product. Their manufacturing plant is located in the U.S., with a specialized focus on intravenous iron formulations.

• Manufacturing Capabilities: ABF maintains cGMP-certified facilities with sophisticated sterile injection production lines, ensuring high product purity and safety.
• Distribution Network: They supply directly to hospitals, clinics, and pharmacies, and have an extensive distribution network domestically.

3. Fresenius Kabi

Fresenius Kabi is a global leader in infusion therapies and intravenous drugs, including iron dextran formulations. They produce a range of injectable medicines with a focus on quality and safety.

• Manufacturing Capabilities: Their production facilities in Europe and Asia are equipped for sterile, high-volume injectable production, including iron complexes.
• Market Role: Fresenius Kabi supplies FERRLECIT in various markets worldwide, notably in Europe, Asia, and Latin America, through authorized regional distributors.

4. Japan Blood Products Organization (JBPO) / Mochida Pharmaceutical Co., Ltd.

In Japan and parts of Asia, Mochida Pharmaceutical Co. Ltd. supplies iron dextran formulations that conform to local regulatory standards, sometimes branded similarly to FERRLECIT.

• Manufacturing Capabilities: Mochida specializes in blood products and injectable pharmaceuticals, with emphasis on safety and biocompatibility.
• Regional Focus: Their products serve Asian markets and are integrated into local healthcare systems as alternatives or equivalents.

5. Other Regional Manufacturers and Distributors

In addition to the primary players, several regional producers supply iron dextran formulations compatible with FERRLECIT, often under different brand names due to patent differences. These include firms in India, China, and Eastern Europe, which manufacture under licensing agreements or generic formulations approved locally.

Factors Influencing Supplier Selection
Supply chain stakeholders should consider several factors:

• Regulatory Compliance: Suppliers must meet cGMP standards set by regulatory authorities (FDA, EMA, PMDA).
• Manufacturing Capacity: Ability to fulfill demand surges, especially during global health crises.
• Quality Standards: Rigorous quality assurance processes ensure safety and efficacy.
• Distribution Network Reliability: Vital for timely supply, especially in remote or underserved areas.
• Market Authorization: Suppliers’ products must be approved by local health authorities.

Challenges in the FERRLECIT Supply Chain
The supply of FERRLECIT faces challenges such as manufacturing complexity of sterile injectables, stringent regulatory environments, and global disruptions like the COVID-19 pandemic affecting production and logistics. Moreover, patent expirations and the rise of generic alternatives influence market dynamics, leading to increased supplier competition.

Emerging Trends Impacting Suppliers
Recent trends include:

• Manufacturing Diversification: Companies expanding manufacturing bases to reduce geopolitical and supply chain risks.
• Regulatory Harmonization: Streamlined approval processes to facilitate international trade.
• Quality Innovation: Enhanced safety profiles through improved formulation techniques.

Conclusion
The supply of FERRLECIT is anchored by a select group of global and regional pharmaceutical manufacturers, notably Pfizer, ABF, and Fresenius Kabi. Their manufacturing capabilities, regulatory adherence, and distribution networks underpin the drug’s availability worldwide. For healthcare providers and supply chain managers, understanding these suppliers' strengths and limitations informs procurement strategies, risk mitigation, and market positioning.

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Key Takeaways

• Dominant Suppliers: Pfizer (historical), ABF (primary U.S. manufacturer), and Fresenius Kabi (global presence) are key players.
• Supply Chain Risks: Manufacturing complexity and regulatory hurdles pose ongoing risks, necessitating diversified supplier relationships.
• Regional Variations: Asian manufacturers like Mochida offer regional alternatives, often under local regulatory approval.
• Market Dynamics: Patent expirations and generic competition are influencing supplier strategies and market access.
• Strategic Importance: Reliable supply of FERRLECIT is critical for treating anemia, especially in hospital settings, prompting continuous investments in manufacturing and quality assurance.

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FAQs

1. Who are the primary global suppliers of FERRLECIT?
The main global suppliers include Pfizer, American BioSciences (ABF), and Fresenius Kabi. These companies have extensive manufacturing and distribution networks capable of supplying FERRLECIT internationally.

2. Are there regional manufacturers that supply FERRLECIT?
Yes. In Asia, companies like Mochida Pharmaceutical Co., Ltd., supply iron dextran formulations compatible with FERRLECIT, often tailored to local regulatory standards.

3. How does manufacturing complexity affect FERRLECIT supply?
Producing sterile injectable drugs like FERRLECIT requires sophisticated facilities, strict quality controls, and compliance with GMP. Disruptions in manufacturing can lead to shortages and supply delays.

4. What factors should healthcare providers consider when sourcing FERRLECIT?
Providers should focus on supplier regulatory approval, manufacturing capacity, product quality, and supply reliability to ensure continuous patient access.

5. How might future market trends influence FERRLECIT suppliers?
Advances in formulation, increased competition from generics, and evolving regulatory standards are likely to reshape supplier landscapes, prompting investments in technology, quality, and diversification.

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Sources:

1. [1] Pfizer Annual Report 2022, Pfizer website.
2. [2] American BioSciences, Inc. product information and compliance certifications.
3. [3] Fresenius Kabi official product catalog.
4. [4] Mochida Pharmaceutical Co., Ltd. product portfolio and regional approvals.
5. [5] Global pharmaceutical supply chain analysis reports, 2022.