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Suppliers and packagers for generic pharmaceutical drug: ferric citrate
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ferric citrate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-2895-20 | 200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20) | 2025-03-20 |
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874 | NDA | Akebia Therapeutics, Inc. | 59922-631-01 | 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01) | 2014-09-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Ferric Citrate
Ferric citrate is a pharmaceutical agent primarily used to treat iron deficiency anemia associated with chronic kidney disease and as a phosphate binder in dialysis patients. It is marketed under brand names such as Auryxia (Fresenius Medical Care) and Radiocitrate (Indian market). Multiple manufacturers supply ferric citrate globally through direct manufacturing, licensing agreements, or contract manufacturing.
Major Manufacturers and Suppliers
1. Keryx Biopharmaceuticals (Auryxia)
- Approved by the U.S. FDA in 2014.
- Licensed manufacturing to Fresenius Medical Care.
- Supplies ferric citrate as an oral iron management solution.
- Distribution spans the U.S. and global markets via licensing agreements.
2. Fresenius Medical Care
- Produces and distributes Auryxia in the U.S.
- Manufactures through its contract manufacturing network.
- Has strategic manufacturing agreements to ensure supply continuity.
3. Indian Manufacturers
- Several Indian pharmaceutical firms produce ferric citrate under various brand names or as raw materials.
- Examples include:
- Lupin Limited
- Sun Pharma
- Cadila Healthcare
- These companies supply both finished formulations and bulk raw materials.
4. Contract Manufacturing Organizations (CMOs)
- Several CMOs partner with pharmaceutical firms to produce ferric citrate:
- Alkem Laboratories
- Dr. Reddy’s Laboratories
- Zydus Cadila
- Offer manufacturing capacity for both domestic and export markets.
5. Raw Material Suppliers
- Raw ferric citrate heptahydrate is sourced from specialized chemical producers.
- Key raw material vendors include:
- GLR Chemical
- Osee Chemicals
- Sigma-Aldrich (part of MilliporeSigma)
- Raw material prices and quality significantly impact end-product supply.
Geographic Distribution & Market Dynamics
| Region | Primary Suppliers | Notes |
|---|---|---|
| U.S. | Keryx (via licensing to Fresenius) | Dominant market for licensed product |
| Europe | Local manufacturers; some licensed supply | Growing demand for phosphate binders |
| India | Multiple domestic firms | Major source of raw materials and formulations |
| Asia-Pacific | Various generic manufacturers | Expanding access due to lower costs |
Supply Chain Considerations
- Regulatory Approvals: Manufacturing firms require approvals from agencies such as the FDA, EMA, or local authorities.
- Quality Standards: Good Manufacturing Practice (GMP) compliance is mandatory.
- Patent Status: Keryx's patent for Auryxia expired in 2022, enabling broader generic manufacturing.
- Raw Material Availability: Fluctuations in the supply of ferric citrate heptahydrate influence downstream production.
Market Risks & Opportunities
- Patent Expiry: Opens opportunities for generic manufacturers.
- Supply Chain Disruptions: Raw material shortages, geopolitical issues affecting manufacturing centers.
- Growing Demand: Rising prevalence of chronic kidney disease drives market expansion.
- Regulatory Variations: Regional approval status determines market access.
Summary of Key Suppliers
| Supplier | Market Scope | Product Type | Certification | Notes |
|---|---|---|---|---|
| Keryx Biopharmaceuticals | North America | Prescription drug (Auryxia) | FDA-approved | Licensee of production |
| Fresenius Medical Care | North America & global | Final formulation | GMP | Produces and supplies |
| Lupin Limited | India | Raw materials & formulations | GMP | Export-focused |
| Sigma-Aldrich | Global | Raw ferric citrate | ISO-certified | Key raw material vendor |
Closing Remarks
The supply of ferric citrate involves a mixture of branded manufacturers, regional generic firms, and raw material producers. Market entry is influenced by patent status, regulatory approval, and manufacturing capacity. Supply chain stability hinges on raw material availability and compliance with international quality standards.
Key Takeaways
- The primary licensed supplier in North America is Keryx Biopharmaceuticals, producing Auryxia via licensing arrangements.
- Multiple Indian firms manufacture both raw ferric citrate and finished formulations, representing a significant share of global supply.
- Patent expiration has enabled new entrants in generic manufacturing, increasing competition.
- Raw material sourcing from specialized chemical suppliers is critical, with geographic and regulatory factors impacting supply chains.
- Growing demand in chronic kidney disease markets supports expanding manufacturing capacity but also poses risks related to raw material shortages and regulatory hurdles.
FAQs
1. Can generic versions of ferric citrate enter the market?
Yes, patent expiry in 2022 has opened opportunities for generic manufacturers to produce and market ferric citrate formulations globally.
2. Which regions have the highest supply of ferric citrate?
The U.S. and India are leading regions due to manufacturing licenses, local production, and raw material availability.
3. What are the key raw materials used to produce ferric citrate?
Ferric citrate heptahydrate is the main raw material, sourced from specialized chemical vendors.
4. Are there any notable licensing or partnership agreements?
Yes. Keryx licensed the manufacturing and distribution rights for Auryxia to Fresenius Medical Care.
5. What regulatory considerations impact ferric citrate supply?
Regulatory approvals from agencies like the FDA, EMA, and local authorities determine manufacturing licensure and market access.
References
[1] U.S. Food and Drug Administration. (2014). Auryxia approval letter.
[2] Keryx Biopharmaceuticals. (2022). Annual report.
[3] Indian pharmaceutical regulatory authorities. (2022). List of approved manufacturers.
[4] Sigma-Aldrich. (2023). Raw material specifications.
[5] MarketsandMarkets. (2022). Global phosphate binder market report.
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