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Suppliers and packagers for generic pharmaceutical drug: ferric maltol
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ferric maltol
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320 | NDA | Shield TX (UK) Ltd | 73059-001-10 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC | 2021-07-01 |
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320 | NDA | Shield TX (UK) Ltd | 73059-001-60 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC | 2021-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ferric Maltol
Introduction
Ferric maltol is an iron-based pharmaceutical formulation utilized primarily for the treatment of iron deficiency anemia, especially in patients with inflammatory bowel disease (IBD). Its unique formulation facilitates optimal iron absorption while minimizing gastrointestinal side effects typical of traditional iron therapies. The global supply chain of ferric maltol involves various pharmaceutical manufacturers, distributors, and licensing entities. For stakeholders analyzing market opportunities, regulatory compliance, or procurement avenues, understanding the key suppliers of ferric maltol is essential.
Overview of Ferric Maltol in the Pharmaceutical Market
Ferric maltol, marketed under trade names like Accrufer (previously Feracap), is one of the innovative oral iron therapies approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug's formulation is patented and manufactured by specialized pharmaceutical entities, with some suppliers operating under licensing or distribution agreements.
The demand for ferric maltol is driven by its favorable safety profile and efficacy in chronic conditions requiring long-term iron supplementation. As such, a dedicated supply chain exists, comprising both proprietary manufacturers and authorized distributors.
Key Suppliers of Ferric Maltol
1. Pharma-Grade Manufacturers
Vifor Pharma Group (Switzerland)
- Overview: Vifor Pharma, renowned for its expertise in iron therapies and nephrology, pioneered the development and commercialization of ferric maltol under the brand name Accrufer in North America and other regions. As the original developer, Vifor holds significant manufacturing rights, ensuring quality assurance and adherence to regulatory standards.
- Scope: Vifor's manufacturing facilities produce ferric maltol in compliance with Good Manufacturing Practices (GMP), supplied directly to healthcare providers and distributors globally.
Ferrer International (Spain)
- Overview: Ferrer International manufactures and markets multiple iron-related pharmaceuticals and has agreements to produce ferric maltol for various markets. They have demonstrated capacity in complex iron formulations, leveraging proprietary technology.
- Scope: Ferrer supplies ferric maltol to regional markets, especially within Europe and Latin America, either through direct sales or licensing arrangements.
2. Licensing and Contract Manufacturing Partners
Many pharmaceutical companies rely on contract manufacturing organizations (CMOs) for the production of ferric maltol, given its complex formulation requirements.
- Examples of CMO partners:
- Recipharm: A Swedish-based contract manufacturer with capabilities in oral iron formulations.
- Famar: A Greek CMO with facilities capable of handling complex drug products, including ferric compounds.
These CMOs often produce ferric maltol under license, adhering to strict quality controls and regulatory standards set by the brand owner.
3. Distributors and Regional Suppliers
Regional distribution plays a crucial role in supply logistics. Key authorized distributors include:
- McKesson and Cardinal Health (USA): Act as primary wholesalers stocking Accrufer and other formulations for clinical and hospital use.
- Alliance Healthcare (Europe): Distributes ferric maltol to pharmacies and healthcare centers across Europe.
- NZ Pharmacies (Australia/New Zealand): Certificates of supply to regional healthcare networks.
Regulatory and Licensing Considerations
The production and supply of ferric maltol are tightly regulated. Vifor Pharma holds extensive patents and licensing agreements to manufacture and distribute its formulation globally. Licensing arrangements vary across regions, influencing supplier availability and pricing structures.
For example, in the United States, Accrufer (ferric maltol) was approved by the FDA, with Vifor acting as the licensed manufacturer. Licensing agreements with regional partners or CMOs enable scalable production and distribution.
Market Dynamics and Supply Chain Challenges
- Patent protections and licensing: Limit the number of major suppliers; only authorized entities can legally manufacture and distribute ferric maltol.
- Manufacturing complexity: The iron-derivative formulation requires specialized facilities, constraining large-scale production capacities.
- Global supply bottlenecks: Could arise from raw material shortages, GMP compliance issues, or geopolitical disruptions, affecting availability.
- Emerging generic or biosimilar development: Currently limited, which may influence the future competitive landscape.
Upcoming Trends and Opportunities
- Potential entrants: As patent expirations loom or licensing arrangements evolve, new suppliers could emerge, especially from regions with growing pharmaceutical manufacturing capacity.
- Formulation innovations: Enhancements in iron-delivery systems may diversify supply options or improve manufacturing efficiencies.
- Strategic partnerships: Collaborations between biotech firms and contract manufacturers could expand supply capacity.
Key Takeaways
- Vifor Pharma remains the primary supplier and innovator behind ferric maltol, holding key licensing rights in multiple regions.
- Regional distributors and CMOs play crucial roles in fulfilling supply demands, especially outside North America and Europe.
- Manufacturing capacity and licensing agreements significantly influence supply stability and drug pricing.
- Regulatory compliance is mandatory for all suppliers, with complex formulations requiring specialized production facilities.
- Market entrants may increase as patent protections evolve, presenting potential opportunities for generic developers.
Frequently Asked Questions
1. Who are the primary manufacturers of ferric maltol globally?
Vifor Pharma is the leading manufacturer and patent holder of ferric maltol, producing the drug under the brand name Accrufer. Other regional manufacturers and CMOs supply ferric maltol through licensing agreements, including Ferrer International and specialized CMOs like Recipharm.
2. Are there generic versions of ferric maltol available?
Currently, no widely approved generic versions exist due to patent protections held by Vifor Pharma. Future market entry may depend on patent expiry or licensing agreements with biosimilar manufacturers.
3. How is ferric maltol distributed in different regions?
Distribution varies by region, often managed by authorized distributors such as McKesson in the US or Alliance Healthcare in Europe, and by regional manufacturing licenses held by local pharmaceutical companies.
4. What are supply chain risks for ferric maltol?
Risks include manufacturing disruptions, raw material shortages, regulatory delays, patent litigations, and geopolitical factors that could hamper production or distribution.
5. Can new suppliers enter the market easily?
Entry is limited due to patent protections, the necessity for GMP-compliant manufacturing facilities, and complex formulation processes, which act as significant barriers.
References
[1] Vifor Pharma Group. (2023). Products and Innovations. Available at: https://www.viforpharma.com/portfolio/iron-therapies/
[2] European Medicines Agency. (2021). EMA approves Vifor's Ferric Maltol for iron deficiency anemia.
[3] U.S. Food and Drug Administration. (2022). Accrufer (ferric maltol) prescribing information.
[4] Pharmaceutical Technology. (2022). Contract Manufacturing Trends in Iron Formulations.
[5] MarketWatch. (2023). Iron Deficiency Anemia Drugs Market Overview.
In conclusion, the supply landscape for ferric maltol is primarily centralized around Vifor Pharma under its licensing ecosystem, supported by regional distributors and contract manufacturers. Stakeholders must monitor patent statuses, manufacturing capabilities, and regulatory developments to navigate supply stability effectively.
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