Sevelamer 52757-95-6 — China API Manufacturer | USP/EP R&D to Production

China Manufacturing Landscape for Sevelamer

Sevelamer (CAS 52757-95-6) is a non-absorbed phosphate-binding polymer used extensively in the management of hyperphosphatemia in patients with chronic kidney disease undergoing dialysis. As a cross-linked poly(allylamine) polymer, Sevelamer presents unique manufacturing challenges that Chinese specialty polymer manufacturers have mastered through dedicated investment in controlled polymerization technology. Our facility stands as one of a select number of Chinese qualified manufacturers capable of producing pharmaceutical-grade Sevelamer (as both hydrochloride and carbonate salt forms) at commercial scale for global export.

China’s polymer chemistry manufacturing infrastructure provides distinct advantages for Sevelamer production, including access to high-purity allylamine monomers, cross-linking agents, and specialized polymerization equipment. The domestic availability of critical starting materials, combined with engineering expertise in controlled radical polymerization and polymer characterization, positions Chinese manufacturers as the most cost-efficient and technically capable suppliers for this challenging API category.

Manufacturing Process & Facility

Sevelamer synthesis involves controlled cross-linked polymerization of allylamine hydrochloride with epichlorohydrin as the cross-linking agent, conducted in aqueous solution under precisely controlled temperature, pH, and reagent addition rate conditions. The degree of cross-linking, which directly determines the polymer’s phosphate-binding capacity and swelling characteristics, is controlled within tight specification limits through real-time viscosity monitoring and reaction endpoint determination. Post-polymerization processing includes extensive aqueous washing to remove residual monomers and oligomeric species, followed by spray drying or controlled precipitation to achieve target particle size distribution.

For Sevelamer carbonate, an additional ion-exchange step converts the hydrochloride salt to the carbonate form under controlled conditions. The manufacturing facility features dedicated polymer reaction vessels from 1,000 to 10,000 liters, industrial spray dryers with pharmaceutical-grade air handling systems, and particle size classification equipment. The facility operates under China NMPA certification with annual production capacity exceeding 200 metric tons.

Quality Standards & Multi-Pharmacopeial Compliance

Sevelamer produced at our facility complies with USP and EP monograph specifications for both hydrochloride and carbonate forms. Key quality attributes include phosphate-binding capacity tested by standardized in-vitro binding assay, residual monomer content (allylamine) controlled below specified limits by validated GC methods, particle size distribution verified by laser diffraction, swelling index, moisture content, and elemental impurity profiling by ICP-MS. Cross-linking degree is characterized by solid-state NMR and swelling ratio measurements.

Batch-to-batch consistency in binding capacity is maintained within ±5% of target through statistical process control of polymerization parameters. All testing methods are validated in accordance with ICH Q2(R1), and reference standards are qualified against pharmacopeial materials. Stability studies under ICH Q1A long-term and accelerated conditions demonstrate a validated shelf life of 36 months.

Regulatory Documentation

Complete regulatory documentation is provided in CTD format, including Drug Master Files for US FDA and EU ASMF submissions, full process descriptions with critical process parameter identification, in-process control strategies, and validated analytical methods for all specification tests. Additional documentation includes quality certificates, site master files, environmental monitoring reports, and detailed impurity fate and purge analysis. Polymer characterization data including molecular weight distribution, cross-linking density, and functional group analysis is included as standard with every DMF package.

Packaging & Logistics

Sevelamer is packaged in pharmaceutical-grade fiber drums with double PE liners, available in 25 kg and 50 kg net weight configurations. Due to the hygroscopic nature of the polymer, all packaging includes desiccant sachets and moisture barrier overwrap to maintain specification compliance throughout the supply chain. Shipments are arranged via sea freight for bulk orders (FCL and LCL options from Shanghai, Ningbo, or Qingdao ports) and air freight for urgent or sample quantities. Typical sea freight delivery to European ports is 25-35 days; air freight to major international destinations is 5-10 days. Full export documentation including phytosanitary certificates, MSDS, and customs classification support is provided.

Competitive Pricing & Supply Reliability

As a high-volume polymer API, Sevelamer benefits significantly from economies of scale that our large-capacity facility delivers. Competitive pricing eliminates multiple intermediary margins, and our annual contract pricing programs offer additional savings of 10-15% compared to spot market procurement. Lead times for standard orders are 4-6 weeks, with large-volume contracts benefiting from dedicated production campaigns and buffer stock arrangements. Our procurement team maintains strategic raw material inventories sufficient for 3-6 months of production, insulating customers from upstream supply disruptions.

Sevelamer Specifications