Suppliers and packagers for monoferric

monoferric

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171	NDA	Pharmacosmos Therapeutics Inc.	73594-9301-2	5 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3)	2020-01-16
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171	NDA	Pharmacosmos Therapeutics Inc.	73594-9305-1	1 VIAL in 1 BOX (73594-9305-1) / 5 mL in 1 VIAL	2020-01-16
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171	NDA	Pharmacosmos Therapeutics Inc.	73594-9310-1	1 VIAL in 1 BOX (73594-9310-1) / 10 mL in 1 VIAL	2020-01-16

Suppliers for the Pharmaceutical Drug: Monoferric

Introduction
Monoferric, an iron-replacement therapy marketed for treating iron deficiency anemia, has gained prominence within the pharmaceutical landscape owing to its targeted delivery and improved safety profile. As an IV iron formulation, it principally serves patients intolerant to oral iron or requiring rapid replenishment of iron stores. Securing reliable suppliers of Monoferric is fundamental for pharmaceutical companies, healthcare providers, and distributors aiming to ensure drug availability, regulatory compliance, and supply chain stability. This article explores the current supplier landscape for Monoferric, highlights key manufacturing players, and analyzes supply dynamics influencing market access.

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Overview of Monoferric and Its Manufacturing Context
Monoferric, with the active ingredient ferric derisomaltose (ferric derisomaltose), is produced by Pharmacosmos, a leading European pharmaceutical company specializing in iron therapies. As a branded drug, its manufacturing involves complex processes including fermentation, purification, and sterilization, demanding high-quality raw materials and specialized facilities (see [1]).

Given the therapy's niche yet expanding market, the supply chain's robustness hinges on multiple component suppliers: iron salts, carbohydrate complexes, formulation excipients, and sterile manufacturing services. The drug’s manufacturing partnerships are predominantly localized in Europe, with potential regional suppliers filling global demand.

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Pharmacosmos as the Key Manufacturer
Pharmacosmos remains the primary and exclusive supplier of Monoferric. The company operates a dedicated manufacturing plant in Denmark, following stringent European and international quality standards (EMA, FDA). Their integrated supply chain ensures control over raw materials, process validation, and batch consistency, which is paramount for a life-saving product ([2]).

Despite its dominant position, Pharmacosmos often collaborates with third-party suppliers for raw materials, particularly iron salts and complex carbohydrate components. Such dependence underscores the importance of raw material quality, sourced from specialized chemical suppliers globally.

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Raw Material Suppliers and Components
Monoferric’s synthesis involves high-purity ferric salts and derisomaltose, a carbohydrate complex acting as the stabilizer and carrier. The supply chain reliability for these raw materials is critical, with key suppliers worldwide providing:

• Ferric salts (e.g., ferric chloride, ferric ammonium citrate): Suppliers like Shandong Yucheng Chemical Technology (China), or Thermo Fisher Scientific (global), supply pharmaceutical-grade ferric salts. Ensuring consistent quality and supply capacity is crucial for manufacturing continuity.
• Derisomaltose (or analogous carbohydrate derivatives): Typically sourced from specialized carbohydrate producers prevalent in Europe and Asia, such as Cargill or Roquette. The complexity of derivatization and purity standards for pharmaceutical applications restrict supplier options.
• Excipients and sterile filtration materials: Suppliers like Baxter or MilliporeSigma provide the necessary biocompatible excipients, filtration systems, and vials, integrating into the pharmaceutical manufacturing ecosystem.

Supply Chain Challenges: Fluctuations in raw material availability, geopolitical tensions, or raw material price volatility can impact output. Pharmacosmos’s vertical integration aims to mitigate such risks ([3]).

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Distribution and Regional Suppliers
Although Pharmacosmos maintains direct control over manufacturing, regional distribution partners—licensed fulfillment organizations or regional subsidiaries—are instrumental in bridging manufacturing to end-user markets geographically. These entities often act as regional suppliers and inventory holders, ensuring timely delivery, local regulatory compliance, and stock management.

For example:

• In the United States, approved distribution channels typically involve licensing arrangements with entities such as Sagent Pharmaceuticals, which may source from Pharmacosmos under supply agreements.
• In other regions, regional distributors or importers act as intermediaries.

Alternate or Generic Options
There are currently no generic equivalents for Monoferric that are approved globally. However, other IV iron formulations—such as ferric carboxymaltose (e.g., Injectafer, Ferinject)—compete within the same therapeutic space, supplied by different manufacturers including Vifor Pharma and Cadila Healthcare. Their supplier landscapes are similarly characterized by specialized manufacturing facilities and raw material sourcing complexities.

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Quality Assurance and Regulatory Oversight
The sole manufacturer status imposes reliance on Pharmacosmos’s quality controls and regulatory compliance. Pharmaceutical companies seeking Monoferric-related supplies must verify the supplier’s adherence to GMP standards and regulatory approvals (EMA, FDA). Certification processes involve audits, batch testing, and validation reports, which are integral for supply assurance.

Supply Chain Resilience and Future Trends
Market dynamics suggest increasing interest in manufacturing diversification. Potential strategies include identifying alternative raw material suppliers, developing biosimilar or generic versions, and establishing regional manufacturing hubs. This diversification would mitigate risks associated with supply disruptions, geopolitical issues, or surge demands (e.g., COVID-19 pandemic).

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Key Takeaways

Last updated: August 5, 2025

• Exclusive Manufacturing by Pharmacosmos: Monoferric’s primary production source is Pharmacosmos, with high barriers to entry for competitors given technical complexity and regulatory compliance.
• Critical Raw Material Suppliers: Dependence on global suppliers for ferric salts and carbohydrate complexes underscores the importance of supply chain diversification.
• Regional Distribution Partners: These entities facilitate timely regional access, though they are dependent on the centralized manufacturer’s output.
• Supply Chain Risks and Mitigation: Fluctuations in raw materials, geopolitical tensions, or increased demand necessitate proactive risk management, including supplier diversification.
• Future Outlook: Market entrants seeking to manufacture alternatives must navigate stringent regulatory pathways and complex manufacturing processes.

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FAQs

1. Who is the primary supplier of Monoferric?
Pharmacosmos is the exclusive manufacturer and primary supplier of Monoferric, overseeing the entire production process within their Denmark-based plant.

2. Are there any approved generic versions of Monoferric?
Currently, no generic equivalents of Monoferric have received global regulatory approval; the market is dominated by the branded formulation.

3. What raw materials are essential for Monoferric manufacturing?
Key raw materials include pharmaceutical-grade ferric salts—such as ferric chloride or ferric ammonium citrate—and derisomaltose or similar carbohydrate complexes used as stabilizers and carriers.

4. How can supply chain disruptions for Monoferric be mitigated?
Diversifying raw material sourcing, establishing regional manufacturing hubs, and engaging multiple approved suppliers can mitigate risks associated with reliance on a single manufacturer or supplier.

5. What regulatory considerations are involved in sourcing Monoferric?
Suppliers and distributors must comply with GMP standards, possess approval from relevant regulatory agencies (EMA, FDA), and ensure batch-to-batch consistency to meet safety and efficacy requirements.

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References
[1] EMA. Monoferric (ferric derisomaltose): European Medicines Agency dossier. 2022.
[2] Pharmacosmos. Corporate overview and manufacturing capabilities. 2023.
[3] Industry reports on supply chain management and risk mitigation in pharmaceutical manufacturing.

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Conclusion
The supply landscape for Monoferric remains singularly governed by Pharmacosmos, with the integrity of raw materials and regional distribution strategies forming the backbone of supply assurance. As demand grows, stakeholders must monitor raw material sourcing, geopolitical influences, and regulatory developments to ensure uninterrupted access to this critical therapeutic. Building a resilient supply chain, with diversified sourcing and strategic regional partnerships, will be essential to sustaining Monoferric availability in global markets.