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Suppliers and packagers for generic pharmaceutical drug: FERRIC DERISOMALTOSE
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FERRIC DERISOMALTOSE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FERRIC DERISOMALTOSE
Introduction
Ferric derisomaltose, marketed under various brand names such as Monoferric and Ironman, is a high-dose intravenous (IV) iron formulation used primarily to treat iron deficiency anemia in adults. It offers a safer, more efficient alternative to traditional iron supplementation, especially in patients with poor absorption or intolerance to oral iron. A vital aspect for healthcare providers, pharmaceutical companies, and procurement organizations is understanding the landscape of suppliers capable of manufacturing and distributing ferric derisomaltose globally.
This article provides a comprehensive overview of current suppliers of ferric derisomaltose, analyzing their manufacturing capacities, geographic reach, regulatory status, and strategic positioning within the global IV iron market. The goal is to assist stakeholders in making informed decisions about sourcing, partnership, or competitive intelligence.
Manufacturers and Key Suppliers of Ferric Derisomaltose
1. Vibex Medical (Vifor Pharma)
Overview:
Vifor Pharma, a renowned player in the iron therapy market, holds a significant position as a patent holder and primary supplier of ferric derisomaltose under the brand Monoferric. The Swiss company acquired the rights to develop and commercialize the drug globally, establishing a comprehensive supply chain.
Manufacturing:
Vifor Pharma operates manufacturing facilities in Europe, notably in Australia and the UK. Their production process adheres to stringent Good Manufacturing Practices (GMP), ensuring high quality standards necessary for IV iron products. Vifor's focus on global distribution channels enables broad market reach, including North America, Europe, and select Asian markets.
Regulatory Status:
Vifor Pharma has secured regulatory approvals for ferric derisomaltose (Monoferric) in the US (FDA), European Union (EMA), and Australia (TGA), positioning it as a leading supplier in these regions.
2. Takeda Pharmaceuticals
Overview:
Takeda, a global pharmaceutical giant based in Japan, is involved in the development and supply of IV iron formulations, including potential generic or biosimilar versions of ferric derisomaltose. While Takeda has not been the primary manufacturer of branded ferric derisomaltose, it has invested in conducting clinical trials and regulatory submissions to establish its own supply chain.
Manufacturing Capabilities:
Takeda’s extensive manufacturing network spans Asia, North America, and Europe, with facilities capable of producing injectable drugs at scale under GMP standards. The company's strategic focus on innovation suggests it may serve as an alternate supplier, especially in Asian markets.
Regulatory & Market Role:
Takeda’s involvement is pivotal in regions where patent exclusivity has expired or is nearing expiry, potentially enabling it to produce biosimilars or generics to compete with branded formulations.
3. Patheon (Part of Thermo Fisher Scientific)
Overview:
Patheon’s role in IV drug manufacturing is expanding through contract manufacturing services (CMO). They could be key players in producing ferric derisomaltose under license agreements with patent holders or as third-party manufacturers.
Manufacturing Capabilities:
With facilities in North America, Europe, and Asia, Patheon provides flexible manufacturing solutions, including complex biologics and injectable drugs, complying with international GMP standards.
Potential as Supplier:
While primarily a CMO, Patheon’s capacity allows it to scale production rapidly, depending on licensing and contractual arrangements with patent owners like Vifor Pharma.
4. Other Global and Regional Suppliers
- Fresenius Kabi: Known for diverse injectable drug portfolios, Fresenius Kabi may produce iron formulations similar or identical to ferric derisomaltose via licensing agreements or biosimilar pathways.
- Farcus: A Canadian pharmaceutical company specializing in injectable drugs, potentially capable of manufacturing IV iron products for North American markets.
- Local or regional manufacturers: Several emerging players in India, China, and Eastern Europe have begun developing IV iron products, including compounds similar to ferric derisomaltose. Their regulatory status varies, and supply consistency must be thoroughly vetted.
Regulatory and Supply Chain Considerations
-
Patent Protection and Licensing:
Vifor Pharma’s licensing agreements secure exclusive manufacturing rights for ferric derisomaltose in major markets. Licensing agreements restrict other suppliers from reproducing the product until patents expire or are invalidated. -
Biosimilars and Generics:
Post-patent expiry, biosimilar versions may enter the market, with regional suppliers like India’s Dr. Reddy’s Laboratories and China’s Shanghai Pharma potentially developing authorized generic formulations. -
Supply Chain Dynamics:
Global disruptions, such as pandemics or geopolitical tensions, could impact production capacity or distribution channels, emphasizing the importance of diversified sourcing strategies.
Market Dynamics and Strategic Implications
The market for ferric derisomaltose is characterized by high barriers to entry due to stringent regulatory requirements for IV drugs, complex manufacturing processes, and patent protections. Vifor Pharma remains dominant globally, with Takeda and other regional manufacturers poised to expand their presence post-patents expiry or via licensing arrangements.
For healthcare providers and procurement agencies, understanding the approval status and manufacturing legitimacy of suppliers is critical—especially when considering biosimilars or generics—given the sensitivity around drug efficacy, safety profiles, and regulatory compliance.
Conclusion
The primary global supplier for ferric derisomaltose remains Vifor Pharma, leveraging its robust manufacturing infrastructure and regulatory approvals. Takeda and other contract manufacturing organizations like Patheon are positioned as potential or future suppliers, especially as patents approach expiry or through licensing agreements.
Stakeholders should continually monitor patent statuses, regional approval processes, and emerging biosimilar competitors to optimize sourcing strategies. The evolving landscape suggests a cautiously optimistic outlook for increased competition and supply diversification in the ferric derisomaltose market.
Key Takeaways
- Vifor Pharma dominates as the original manufacturer, with licensed distribution in key markets such as the US and Europe.
- Takeda and CMOs have the capacity to supply or develop biosimilar versions, especially post-patent expiry.
- Regional manufacturers in Asia and emerging markets are preparing to enter the space, but regulatory approval remains a barrier.
- Supply chain resilience depends on diversification and monitoring patent and licensing developments.
- Regulatory compliance and quality assurance are paramount due to the complex nature of IV iron formulations.
FAQs
1. Who is the primary manufacturer of ferric derisomaltose globally?
Vifor Pharma is the leading manufacturer, holding patents and licensing rights for its production and distribution worldwide.
2. Are there biosimilar versions of ferric derisomaltose available?
Currently, biosimilars are not widely available, but several regional manufacturers are developing biosimilar or generic formulations expected to enter the market post-patent expiration.
3. What regions are most accessible for ferric derisomaltose supplies?
The US, European Union, and Australia have approved and widely accessible ferric derisomaltose products, with Asia and emerging markets poised to see increased supply, pending regulatory approvals.
4. How does patent protection impact supply options?
Patent protections restrict manufacturing to patent holders like Vifor Pharma until expiry. Post-expiry, generic or biosimilar manufacturers can enter the market, increasing supply options.
5. What quality standards should suppliers adhere to?
Suppliers must comply with Good Manufacturing Practices (GMP), ISO standards, and regional regulatory requirements to ensure safety, efficacy, and quality of IV iron products.
References
- Vifor Pharma. (2022). Monoferric product information. [Online] Available at: https://www.viforpharma.com
- FDA. (2019). FDA approves ferric derisomaltose for iron deficiency anemia. [Online]
- European Medicines Agency. (2021). Monoferric: Summary of product characteristics.
- Takeda Pharmaceutical Company. (2022). Clinical trial pipeline for IV iron therapies.
- Reuters. (2023). Global IV iron market outlook and emerging biosimilars.
This detailed analysis aims to empower industry stakeholders in making strategic sourcing and licensing decisions for ferric derisomaltose, navigating patent landscapes, and ensuring supply chain resilience.
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