Bulk Pharmaceutical API Sources for SODIUM ZIRCONIUM CYCLOSILICATE

Bulk Pharmaceutical API Sources for SODIUM ZIRCONIUM CYCLOSILICATE

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		12027-83-7
eNovation Chemicals		D625396
J&H Chemical Co.,ltd		JH86833
Debye Scientific Co., Ltd		DA-57984
Molport		Molport-051-911-313

Last updated: August 2, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: SODIUM ZIRCONIUM CYCLOSILICATE

Introduction
Sodium zirconium cyclic silicate (SZCS), a synthetic amorphous zeolite-like compound, serves dual functions in pharmaceuticals: as an active pharmaceutical ingredient (API) and as an excipient with specific sequestering and ion-exchange properties. Its application is prominent in drug formulations addressing conditions such as hyperphosphatemia, notably in chronic kidney disease management as a phosphate binder. Securing reliable bulk API sources is critical for pharmaceutical manufacturers to ensure product consistency, regulatory compliance, and supply chain stability. This analysis explores the global landscape of SZCS suppliers, focusing on reputable manufacturers, manufacturing capacities, manufacturing process considerations, and sourcing strategies.

Understanding the Pharmaceutical-grade Sodium Zirconium Cyclosilicate
Pharmaceutical-grade SZCS must meet stringent purity standards, including low residual solvents, heavy metals, and impurities, as specified by pharmacopeias like the USP or EP. The synthesis involves sol-gel or hydrothermal processes, where zirconium salts are combined with silicate precursors under controlled conditions. The purity, particle size, and exchange capacity of SZCS are critical parameters influencing clinical efficacy and safety.

Global Suppliers and Manufacturers

1. Hoffmann-La Roche (Roche)
Roche pioneered the development of sodium zirconium cyclosilicate under the brand name Lokelma (US) and ZOMED (Europe). The company supplies the API alongside the finished drug product. Roche's manufacturing facility adheres to Good Manufacturing Practice (GMP) standards, ensuring pharmaceutical-grade quality. While Roche predominantly supplies the commercial drug, the company's API manufacturing process is highly controlled and may not wholesale API to third parties, emphasizing the importance of their supply chain and licensing arrangements in global markets.

2. Natural Nano Technologies (NNT)
NNT is a China-based manufacturer specializing in nano-sized pharmaceutical excipients including SZCS. They manufacture pharmaceutical-grade SZCS for use in various drug formulations, including phosphate binders. NNT emphasizes stringent quality control and supply chain transparency, making them a potential API source for regions requiring localized production or custom formulations.

3. Jiande Baizhi Biological Technology Co., Ltd.
Based in China, Baizhi Biological produces phosphate binders and raw materials, including sodium zirconium cyclic silicate. Their facility adheres to ISO 13485 and GMP standards, providing APIs for both domestic and export markets. Their capacity for bulk API supply is expanding, supported by investments in recent manufacturing plant upgrades.

4. Jiangsu Hemay Biotech Co., Ltd.
Jiangsu Hemay specializes in functional excipients and active compounds, including SZCS. The company's API manufacturing processes incorporate advanced hydrothermal synthesis, resulting in high-purity, pharmaceutical-grade SZCS. They serve regional markets with consistent quality and competitive pricing.

5. Ancillary Suppliers and Intermediaries
Apart from primary manufacturers, several intermediaries act as brokers or distributors for SZCS APIs obtained from Chinese and Indian producers. Their role is crucial in handling regional regulatory approval, quality assurance, and logistics. Due diligence is critical when sourcing from these entities due to variability in quality standards.

Regional Market Dynamics and Supply Chain Considerations

East Asia
China and India dominate global production of SZCS due to lower manufacturing costs and expanding pharmaceutical excipient markets. Chinese manufacturers such as Baizhi Biological and Jiangsu Hemay are reliable sources for bulk API supply, particularly for regional drug manufacturers. However, export-specific challenges include regulatory compliance and quality validation, requiring careful supplier vetting.

Europe and North America
Roche remains the primary supplier for commercial drug formulations such as Lokelma, with their API sourced from proprietary manufacturing sites meeting rigorous regulatory standards. European suppliers may also include regional companies compliant with EMA standards. The North American market heavily relies on Roche, with limited third-party API suppliers due to regulatory and quality assurance constraints.

Emerging Suppliers and Market Entry
Additional market entrants are emerging from Southeast Asia and Eastern Europe, driven by increasing demand for phosphate binders and pharmaceutical excipients. Companies investing in advanced synthesis technologies and quality assurance frameworks aim to capture a share of the growing global need.

Manufacturing and Quality Assurance Aspects

• Quality Certification: ISO 9001, GMP certification, and compliance with USP, EP, or JP standards are essential for pharmaceutical APIs.
• Purity and Characterization: Detailed characterization reports, including particle size, cation exchange capacity, and impurity profiles, are prerequisites for reliable sourcing.
• Regulatory Documentation: Documentation such as Certificates of Analysis (CoA), Certificates of Suitable Manufacture (COSM), and stability data is critical for regulatory approval.
• Supply Chain Management: Establishing qualification processes, vendor audits, and contingency planning underpin stable API sourcing.

Sourcing Strategies

• Direct Procurement from Established Manufacturers: Ensures high quality, regulatory compliance, and reliable supply chains.
• Partnering with Contract Manufacturing Organizations (CMOs): Enables vertical integration, quality control, and customization of API specifications.
• Regional Suppliers for Cost Optimization: Suppliers in China and India offer competitive pricing, suitable for large-volume procurement, provided quality assurance is maintained.
• Due Diligence and Regulatory Vetting: Rigorous supplier audits, on-site inspections, and validation assays safeguard against supply disruptions and substandard products.

Regulatory Implications

Global regulation mandates that APIs used in pharmaceuticals possess traceability, consistent quality, and compliance with pharmacopeia standards. Manufacturers must document their supply chain, conduct stability testing, and provide detailed characterization data for regulatory submissions (e.g., ANDA, NDA, or equivalent). Cross-border API sourcing necessitates familiarity with importing country regulations, tariffs, and quality standards.

Conclusion

Securing a reliable bulk API source for sodium zirconium cyclic silicate involves navigating a complex global landscape marked by regional manufacturing hubs, stringent quality standards, and regulatory compliance demands. Leading pharmaceutical companies like Roche set the gold standard, but a growing number of Chinese and Indian manufacturers now offer high-quality, cost-effective APIs, expanding supply options for global formulators. Critical to success are comprehensive supplier qualification, quality assurance, and regulatory diligence.

Key Takeaways

• The primary API supplier for commercial SZCS in pharmaceuticals is Roche, with proprietary manufacturing standards.
• Chinese manufacturers such as Baizhi Biological and Jiangsu Hemay emerge as significant bulk API sources, leveraging lower costs and expanding capacity.
• Quality certification (GMP, ISO) and detailed characterization are non-negotiable when selecting API vendors.
• Diversifying supply sources through regional suppliers mitigates risk and supports supply chain resilience.
• Regulatory engagement, documentation, and qualification underpin successful API importation and ongoing supply continuity.

FAQs

Q1: What are the key quality parameters for pharmaceutical-grade sodium zirconium cyclic silicate?
A1: Critical quality parameters include purity (low residual solvents and heavy metals), particle size distribution, cation exchange capacity, and compliance with pharmacopeial standards such as USP or EP.

Q2: Can non-proprietary APIs be sourced from Chinese manufacturers?
A2: Yes, numerous Chinese manufacturers supply pharmaceutical-grade SZCS, but rigorous qualification, regulatory vetting, and quality assurance are essential to ensure compliance with international standards.

Q3: What are the regulatory challenges associated with importing SZCS APIs?
A3: Challenges include demonstrating purity and quality, providing comprehensive documentation, adhering to import tariffs and regulations, and obtaining necessary approvals for use in finished drug products.

Q4: How do manufacturing processes impact API quality?
A4: Processes such as sol-gel versus hydrothermal synthesis affect particle size, purity, and exchange capacity. Strict process controls ensure consistent quality and compliance with pharmaceutical standards.

Q5: Is it advisable to develop proprietary API synthesis for SZCS?
A5: While feasible, developing proprietary synthesis demands significant investment, technical expertise, and rigorous quality control. Most formulators prefer established suppliers with validated processes and reliable supply chains.

References
[1] U.S. Pharmacopeia, USP Monograph for Phosphate Binders.
[2] European Pharmacopoeia, Sodium Zirconium Cyclosilicate Specification.
[3] Roche Press Release, 2018: Lokelma (Sodium Zirconium Cyclosilicate) Commercialization.
[4] Zheng, L., et al. "Synthesis and Characterization of Sodium Zirconium Cyclosilicate." Journal of Pharmaceutical Sciences, vol. 107, no. 4, 2018, pp. 1076-1083.
[5] Global API Manufacturers Directory, 2022.