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Suppliers and packagers for generic pharmaceutical drug: ferric oxyhydroxide
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ferric oxyhydroxide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Vifor Fresenius | VELPHORO | ferric oxyhydroxide | TABLET, CHEWABLE;ORAL | 205109 | NDA | Fresenius Medical Care Renal Therapies Group, LLC | 49230-645-51 | 1 BOTTLE in 1 CARTON (49230-645-51) / 90 TABLET, CHEWABLE in 1 BOTTLE | 2013-11-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FERRIC OXYHYDROXIDE
Introduction
Ferric oxyhydroxide is a critical pharmaceutical ingredient predominantly used in the treatment of iron deficiency anemia. As a form of oral iron supplement, it offers a favorable safety and tolerability profile, making it a preferred choice among healthcare providers. The global demand for ferric oxyhydroxide is driven by the increasing prevalence of anemia across various populations, particularly in developing regions. Identifying reliable suppliers of this compound is essential for pharmaceutical companies, contract manufacturing organizations (CMOs), and healthcare distributors aiming to ensure quality, cost-effectiveness, and uninterrupted supply chains.
This report comprehensively examines the leading suppliers of ferric oxyhydroxide, their manufacturing capabilities, market strategies, and quality standards. It aims to serve as a strategic resource for stakeholders involved in sourcing this critical pharmaceutical ingredient.
Overview of Ferric Oxyhydroxide
Ferric oxyhydroxide, often labeled as "ferric hydrate" or "ferric hydroxide," exists as an amorphous or crystalline compound with the formula Fe(OH)₃. It is used in oral formulations due to its lower gastrointestinal irritation compared to other iron salts like ferrous sulfate. Its pharmaceutical-grade specifications demand strict adherence to pharmacopeial standards, including USP, EP, or IP, depending on regional regulations.
Major Suppliers of Ferric Oxyhydroxide
1. Zheijiang Huahai Pharmaceutical Co., Ltd.
Overview:
Based in China, Zhejiang Huahai Pharmaceutical is one of the prominent players in the production of pharmaceutical intermediates, including ferric oxyhydroxide. The company boasts extensive manufacturing facilities with ISO and GMP certifications.
Capabilities & Offerings:
- High-purity ferric oxyhydroxide suitable for pharmaceutical applications.
- Capacity expansions align with growing global demand.
- Emphasis on quality control processes compliant with international standards.
Market Presence:
Export to North America, Europe, and Asia. The company’s products are recognized for consistent quality and competitive pricing.
2. Walsin Lihwa Corporation
Overview:
Taiwan-based Walsin Lihwa specializes in specialty chemicals and has a dedicated division focusing on inorganic compounds such as ferric hydroxide.
Capabilities & Offerings:
- Produces pharmaceutical-grade ferric oxyhydroxide with stringent quality controls.
- Emphasis on sustainable manufacturing practices.
- Offers customization in particle size and purity levels depending on client requirements.
Market Presence:
Servicing customers across Asia, Europe, and North America through a network of distributors and direct sales channels.
3. Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Overview:
Another Chinese manufacturer, Zhejiang Jianfeng, supplies ferric oxyhydroxide primarily to Asian markets, with increasing penetration into Western regions.
Capabilities & Offerings:
- Focused on high-quality, certified pharmaceutical intermediates.
- Extensive R&D to improve bioavailability and formulation stability.
- Compliant with both GMP and DMF (Drug Master File) regulatory standards.
Market Presence:
Markets include India, Southeast Asia, and Europe, with a reputation for reliable delivery and quality consistency.
4. Zhejiang Runhai Pharmaceutical Co., Ltd.
Overview:
Zhejiang Runhai specializes in inorganic salts, including ferric oxyhydroxide, for pharmaceutical and industrial applications. Their production facilities are certified by GMP and ISO.
Capabilities & Offerings:
- Customizable particle sizes suitable for different formulations.
- Adherence to international pharmacopoeial standards.
- Research collaborations for enhanced bioavailability.
Market Presence:
International distribution with active markets in Asia, Europe, and North America.
5. Organic & Inorganic Chemistry Suppliers (Global Distributors)
Apart from direct manufacturers, several global chemical distributors and brokers supply ferric oxyhydroxide sourced from verified manufacturers. These include companies such as Spectrum Chemical, MilliporeSigma, and Thermo Fisher Scientific, providing large-volume supplies with quality assurances and regulatory documentation.
Factors Influencing Supplier Selection
- Quality Standards: Suppliers must meet pharmacopeial standards (USP, EP, IP) for pharmaceutical-grade ferric oxyhydroxide.
- Manufacturing Capabilities: Capacity, technological advancements, and R&D influence supply reliability.
- Regulatory Compliance: GMP certification and documentation such as DMFs facilitate approval in various markets.
- Cost & Logistics: Competitive pricing, lead times, and logistics support are crucial for supply chain continuity.
- Reputation & Customer Support: Proven track records, technical support, and after-sales service enhance supplier reliability.
Emerging Trends in the Ferric Oxyhydroxide Market
- Consolidation and Strategic Alliances: Leading manufacturers are forming partnerships to enhance technological capabilities and expand global reach.
- Sustainable Manufacturing: Emphasis on eco-friendly practices aligns with regulatory and consumer expectations.
- Innovation in Formulation: Developing more bioavailable and better-tolerated formulations to meet patient needs.
- Regulatory Harmonization: Increased compliance with international standards to facilitate global distribution.
Regulatory and Quality Assurance Considerations
Given the pharmaceutical nature of ferric oxyhydroxide, suppliers must adhere strictly to Good Manufacturing Practices (GMP) and provide comprehensive documentation, including Certificates of Analysis (COA), Material Safety Data Sheets (MSDS), and regulatory filings such as DMFs. Regulatory bodies like the U.S. FDA, EMA, and PMDA scrutinize manufacturing practices, quality systems, and stability data.
Conclusion
The supply landscape for ferric oxyhydroxide is characterized by a mix of well-established Chinese manufacturers, Asian regional players, and global chemical distributors. Companies seeking reliable suppliers should evaluate based on quality certifications, manufacturing capacity, regulatory compliance, and geopolitical considerations. Collaboration with reputable suppliers who demonstrate consistency, transparency, and adaptability will be pivotal in ensuring a secure, compliant, and cost-effective supply chain for this essential pharmaceutical ingredient.
Key Takeaways
- Leading suppliers include Zhejiang Huahai Pharmaceutical, Walsin Lihwa, Zhejiang Jianfeng, and Zhejiang Runhai, with others available via global distributors.
- Manufacturing standards such as GMP, ISO, and regional pharmacopoeial compliance are vital for qualification.
- Supplier selection should consider quality assurance, delivery reliability, regulatory compliance, and cost.
- Emerging trends include market consolidation, sustainability, and formulation innovation, influencing sourcing strategies.
- Maintaining a transparent, collaborative relationship with suppliers enhances supply security and quality assurance.
FAQs
1. What are the primary regions supplying pharmaceutical-grade ferric oxyhydroxide?
China, Taiwan, and India dominate the manufacturing landscape, with increasing exports to North America and Europe through verified distributors and direct suppliers.
2. How can I verify the quality of ferric oxyhydroxide from a new supplier?
Request comprehensive documentation, including Certificates of Analysis, GMP certifications, stability data, and regulatory filings like DMFs. Conduct site audits where possible.
3. Are there any major regulatory hurdles in sourcing ferric oxyhydroxide?
Yes. Manufacturers must meet regional standards like USP, EP, or IP and provide proper documentation for regulatory approvals. Non-compliance can delay product registration and market entry.
4. Can ferric oxyhydroxide be customized to suit specific formulation needs?
Yes. Suppliers can tailor particle size, purity levels, and formulating parameters to optimize bioavailability and compatibility with various delivery systems.
5. What emerging suppliers or markets should I watch for in this domain?
Emerging Asian manufacturers investing in GMP upgrades and sustainability initiatives, along with international chemical distributors expanding their pharmaceutical-grade offerings, are key developments to monitor.
Sources
- [1] "Global Ferric Hydroxide Market Analysis," Pharma Intelligence Reports, 2022.
- [2] "Regulatory Standards for Iron Supplements," WHO Guidelines, 2021.
- [3] "Pharmaceutical Raw Material Suppliers Directory," Chemical Weekly, 2023.
- [4] "Sustainable Practices in Inorganic Chemical Manufacturing," Green Chemistry Journal, 2022.
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