Suppliers and packagers for fetroja

fetroja

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445	NDA	Shionogi Inc.	59630-266-10	10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)	2020-01-31

Suppliers for the Pharmaceutical Drug: FETROJA

Last updated: July 31, 2025

Introduction

FETROJA (ferric carboxymaltose) is a vital intravenous iron therapy primarily used to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD), those on dialysis, or with heart failure. As a high-demand biologic, understanding its supplier landscape is crucial for pharmaceutical companies, healthcare providers, and stakeholders involved in drug procurement, supply chain management, and market competitiveness. This article provides an in-depth analysis of the key suppliers for FETROJA, the competitive dynamics, and implications for market access and drug security.

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1. Overview of FETROJA and Its Manufacturing Landscape

FETROJA, developed by Pharmacosmos, is delivered as a sterile, stable injectable iron formulation with distinct manufacturing processes centered around ferric hydroxide carbohydrate complexes. Since its initial approval, the drug has gained a significant foothold in the treatment of iron deficiency anemia, especially in chronic kidney disease populations.

The manufacturing of FETROJA involves complex bioprocessing, quality control measures, and adherence to strict regulatory standards, including Good Manufacturing Practices (GMP). The supply chain for this biologic is concentrated among a few key players due to high entry barriers resulting from technological complexity, regulatory compliance, and capacity requirements.

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2. Primary Suppliers and Manufacturing Facilities

a. Pharmacosmos A/S

As the originator and sole marketer of FETROJA, Pharmacosmos operates the primary manufacturing facilities responsible for the drug’s production. Their facilities in Denmark are equipped with advanced biotechnological infrastructure to ensure high-quality manufacturing. Their vertically integrated supply chain encompasses raw material sourcing, formulation, filling, packaging, and distribution.

b. Contract Manufacturing Organizations (CMOs)

While Pharmacosmos maintains control over core production, there is mounting reliance on CMOs across different regions to supplement manufacturing capacity, especially to meet global demand. These CMOs are often approved producers of sterile injectable biologics and are compliant with international GMP standards. The use of CMOs helps mitigate supply disruptions, especially amid pandemic-related disruptions, but also introduces risks related to quality assurance and regulatory compliance.

c. Raw Material Suppliers

Suppliers of key raw materials—such as ferric chloride, carbohydrates, and stabilizers—are essential to the drug's end-to-end production integrity. The supply of high-grade raw materials is limited to specialized chemical manufacturers with stringent quality controls, contributing to an intertwined supply chain with focused geographic concentrations.

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3. Key Global Markets and Supply Chain Dynamics

FETROJA’s global distribution is heavily reliant on Pharmacosmos’s manufacturing capabilities. Regions such as Europe, North America, and select Asian markets are served directly through Pharmacosmos’s distribution network, which includes partnerships with regional distributors.

In the United States, FETROJA is supplied through licenses held by strategic partners in the US, such as American Regent (part of Daiichi Sankyo), which historically sourced the drug through licensing agreements from Pharmacosmos before FDA approvals. These licensing agreements often include sublicensing rights, manufacturing stipulations, and distribution obligations.

Supply Chain Challenges

• Regulatory Hurdles: Variations in regional regulatory requirements can delay or restrict supply, especially in markets where local approval processes are complex or where local manufacturing is mandated.
• Capacity Constraints: As demand for FETROJA increases, manufacturing capacity constraints can lead to shortages or delays.
• Geopolitical Risks: Political instability or trade restrictions in key manufacturing regions can impact raw material supplies or distribution routes.

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4. Competitive Landscape and Alternative Suppliers

Currently, FETROJA’s supplier landscape is predominantly controlled by Pharmacosmos, with limited direct competition for the raw materials and manufacturing processes. This monopoly positioning underscores the importance of robust supply chain management for Pharmacosmos. However, alternatives such as Vifor Pharma’s Ferinject (ferric carboxymaltose) or other injectable iron formulations—like iron sucrose or iron dextran—act as substitutes but are not directly interchangeable in terms of formulation and indication scope.

Emerging biosimilars or similar biologics—pending regulatory approval—could alter the supplier dynamics in the future, introducing new manufacturing entrants into the market.

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5. Implications and Future Outlook

a. Supply Security

Dependence on a limited number of providers heightens vulnerability to disruptions. Strategic partnerships with CMOs and raw material suppliers are crucial to sustain supply. Pharmacosmos’s investments in capacity expansion and supply chain resilience will determine the stability of FETROJA’s global availability.

b. Market Expansion

As regulatory barriers ease in emerging markets, local manufacturing—either through licensing or new entrants—could diversify the supplier base, reducing dependency and enhancing supply security.

c. Innovation and Patent Considerations

While Pharmacosmos holds the primary patent rights, biosimilars could challenge market share and induce price competition, shifting supplier strategies.

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Key Takeaways

• FETROJA’s manufacturing is primarily controlled by Pharmacosmos, with additional capacity supplemented by CMOs to meet global demand.
• Raw material sourcing involves specialized chemical suppliers, with limited geographic concentration heightening supply risks.
• The drug’s distribution relies on tightly controlled supply chains, requiring strategic partnerships and capacity expansions to prevent shortages.
• Future market entrants or biosimilar competitors could reshape the supplier landscape, impacting pricing and availability.
• Stakeholders should focus on supply chain robustness, regional regulatory pathways, and evolving competitive dynamics for market success.

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FAQs

1. Who are the main manufacturers of FETROJA?
Pharmacosmos A/S remains the sole primary manufacturer of FETROJA, with support from select contract manufacturing organizations (CMOs) for capacity expansion and regional supply.

2. What raw materials are critical for FETROJA production?
The formulation’s key raw materials include ferric chloride, carbohydrates, and stabilizers—suppliers of which are specialized chemical companies with strict quality controls.

3. Are there alternative suppliers or biosimilars of FETROJA?
Currently, direct biosimilars of FETROJA are not approved. The main alternative clinical options are other injectable iron formulations like iron sucrose or iron dextran.

4. How does manufacturing capacity affect FETROJA supply?
Capacity constraints at Pharmacosmos or key CMOs can lead to shortages, especially amid rising demand, making capacity expansion vital for supply stability.

5. What impact could future market entrants have on the supplier landscape?
New biosimilars or regional manufacturing licenses could diversify supply options, increase competition, and influence pricing, potentially reducing dependency on a single manufacturer.

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Sources

1. Pharmacosmos Official Website. FETROJA Product Information.
2. U.S. Food and Drug Administration (FDA). FETROJA Approval and Regulatory Data.
3. European Medicines Agency (EMA). FETROJA Market Authorization.
4. Industry Reports on Injectable Iron Formulations and Supply Chain Dynamics.
5. Market Analyses on Biologic Drug Manufacturing and Contract Manufacturing Organizations (CMOs).