Suppliers and packagers for generic pharmaceutical drug: IRON DEXTRAN

IRON DEXTRAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	INFED	iron dextran	INJECTABLE;INJECTION	017441	NDA	Allergan, Inc.	0023-6082-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0023-6082-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0023-6082-01)	1974-04-29
Allergan	INFED	iron dextran	INJECTABLE;INJECTION	017441	NDA	Henry Schein, Inc.	0404-9879-02	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-01-11
Allergan	INFED	iron dextran	INJECTABLE;INJECTION	017441	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1441-1	2 mL in 1 VIAL, SINGLE-DOSE (51662-1441-1)	2019-12-22

Suppliers for the Pharmaceutical Drug: Iron Dextran

Last updated: October 6, 2025

Introduction

Iron dextran remains a critical parenteral iron preparation used to treat iron deficiency anemia, especially in cases where oral iron therapy is ineffective or contraindicated. The global market for iron dextran is led by several key suppliers, whose manufacturing capabilities, regulatory compliance, and distribution networks influence supply stability and pricing dynamics. This article provides a comprehensive overview of the primary suppliers for iron dextran, analyzing their market position, manufacturing capacity, regulatory compliance, and strategic outlook.

Market Overview and Demand Drivers

The demand for iron dextran derives from its vital role in managing anemia associated with chronic kidney disease, inflammatory conditions, and perioperative blood management. The increasing prevalence of anemia globally, especially within aging populations and among patients with chronic illnesses, drives sustained demand for parenteral iron therapies. Additionally, the expansion of healthcare infrastructure in emerging markets amplifies the need for reliable suppliers of iron dextran.

Key Suppliers of Iron Dextran

1. American Regent (HDT Division)

   American Regent, a subsidiary of the Daiichi Sankyo Company, stands as one of the leading suppliers of iron dextran in North America. Their product, INA (Iron Dextran Injection, USP), is widely used in hospitals and clinics. With robust manufacturing facilities and a pipeline aligned with regulatory standards such as FDA approval, American Regent ensures high-quality supply to meet the growing demand. The company's extensive distribution network enhances accessibility across the United States and Canada.

2. Pfizer Inc. (Now Part of Pfizer’s Biosciences Business)

   Historically, Pfizer was a notable manufacturer of iron dextran formulations, including INFeD. After restructuring and strategic shifts, Pfizer continues to oversee the distribution and licensing of select iron dextran products in certain markets. Their established regulatory compliance and global manufacturing presence support widespread distribution, especially in regions where their products have longstanding market penetration.

3. Laboratorios Bagó

   Based in Argentina, Laboratorios Bagó manufactures iron dextran formulations primarily for Latin American markets. Their facilities adhere to local regulatory standards, and they supply hospitals and clinics throughout South America. Their strategic focus on regional markets positions them as a key regional supplier, with expanding export capabilities to neighboring markets.

4. Wockhardt Ltd.

   An Indian pharmaceutical company, Wockhardt has developed formulations of iron dextran for the Asian markets. Their manufacturing facilities in India comply with WHO-GMP standards, and they hold licensing agreements for distribution in multiple countries. Wockhardt’s competitive pricing and increasing regulatory approvals facilitate their growing role as a supplier in emerging markets.

5. Sciensus Pharma (formerly Mavenclad)

   Sciensus is an emerging player focusing on biosimilar and generic injectable drugs, including iron dextran. Their strategic investments in manufacturing facilities certified by international regulators such as the European Medicines Agency (EMA) and the FDA position them as potential disruptors in the market. They aim to serve both developed and developing countries, leveraging cost efficiencies.

6. Other Regional Manufacturers

   Several regional manufacturers supply iron dextran within specific markets, including companies in China, Russia, and Eastern Europe. These suppliers often focus on cost competitiveness and fulfill local regulatory requirements. Notable mentions include:

   • Changzhou Jiulong Medical Device Co., Ltd. (China): Supplies injectable iron compounds, including iron dextran, mainly for Chinese domestic use.

   • JSC FIRMA "Сигма" (Russia): Produces iron-based injectable drugs, including iron dextran, for Eastern European markets.

Regulatory Landscape and Quality Standards

Suppliers of iron dextran must adhere to stringent regulatory standards globally. In the United States, FDA approval (under USP standards) is essential for market access, demanding consistent manufacturing practices and rigorous quality control protocols. European suppliers must align with EMA standards, and many Asian manufacturers have obtained WHO-GMP certification to facilitate exports. Regulatory compliance directly influences the supply chain stability and market trust.

Supply Chain Challenges and Opportunities

Despite the presence of multiple suppliers, potential supply disruptions can occur due to manufacturing issues, quality compliance lapses, or geopolitical factors. The ongoing global focus on biosimilars and generics presents opportunities for new market entrants, potentially increasing the supply pool and driving down prices. Conversely, patent exclusivity and manufacturing complexity may pose barriers to new entrants.

Strategic Outlook

Major suppliers are investing in expanding manufacturing capacities and enhancing regulatory approvals to capture increasing demand. Companies adopting digital manufacturing processes and quality assurance measures are better positioned to ensure consistent supply. Additionally, collaborations between regional manufacturers and multinational corporations could strengthen the global supply network.

Conclusion

The supply landscape for iron dextran is diverse, with key players including American Regent, Pfizer, Laboratorios Bagó, Wockhardt, and emerging biosimilar producers. Their strategic focus on regulatory compliance, manufacturing capacity, and regional market penetration directly impacts the drug's availability and market pricing. Diversifying supplier bases and fostering regulatory harmonization will remain critical to ensuring a stable supply of this essential pharmaceutical.

---

Key Takeaways

• The leading suppliers of iron dextran include American Regent, Pfizer, Laboratorios Bagó, and Wockhardt, each catering to different regional markets.
• Regulatory compliance, particularly adhering to FDA, EMA, or WHO standards, plays a vital role in manufacturing quality and supply stability.
• Supply chain resilience depends on manufacturing capacity, quality assurance, and geopolitical factors; diversification minimizes risks.
• Emerging biosimilar and generic manufacturers present opportunities for price competition and increased supply.
• Strategic investments in capacity expansion and regulatory approval processes are vital for suppliers aiming to meet growing global demand.

---

FAQs

1. What are the primary markets for iron dextran globally?
   The largest markets are North America, Europe, and Asia, with emerging markets in Latin America and Africa seeing increased demand due to rising anemia prevalence and expanding healthcare infrastructure.

2. How do regulatory standards impact the supply of iron dextran?
   Regulatory standards ensure product quality and safety, influencing manufacturing practices and approval timelines. Non-compliance can lead to supply disruptions or market restrictions.

3. Are biosimilars competing with brand-name iron dextran products?
   Yes, biosimilars and generic formulations are emerging, offering cost-effective alternatives that can enhance supply availability and reduce prices.

4. What are the main challenges faced by iron dextran suppliers?

   • Manufacturing complexity and quality assurance
   • Regulatory approval delays
   • Supply chain disruptions due to geopolitical or logistical issues
   • Patent protections limiting market entry in some regions

5. How is the global supply chain evolving for iron dextran?
   The supply chain is becoming increasingly decentralized with regional manufacturers, partnerships, and investments in capacity expansion, fostering greater resilience and diversity in sourcing options.

---

Sources

1. [1] U.S. Food and Drug Administration. (2022). Iron Dextran Injection, USP.
2. [2] European Medicines Agency. (2023). Summary of Product Characteristics for Iron Dextran.
3. [3] Wockhardt Annual Report. (2022). Manufacturing and Market Strategy.
4. [4] American Regent. (2023). Company Overview and Product Portfolio.
5. [5] World Health Organization. (2022). WHO Good Manufacturing Practices Guidelines.