TCS Industries Limited (China-sourced API supplier) supplies Sevelamer — API CAS 52757-95-6 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.
> Overview
| Product Name | Sevelamer |
|---|---|
| Structural Formula |  |
| CAS Number | 52757-95-6 |
| Molecular Formula | Cross-linked poly(allylamine) carbonate |
| Molecular Weight | Cross-linked polymer (MW not applicable) |
| InChIKey | Not applicable (cross-linked polymer) |
| SMILES | Available on request where applicable |
| Appearance | White to off-white powder |
| Purity / Grade | By agreed specification and batch COA |
| Storage | Room temperature, protect from moisture |
Sevelamer (CAS 52757-95-6) is a non-absorbed, cross-linked polyallylamine hydrochloride polymer used as a phosphate binder in chronic kidney disease. It is a white to off-white powder, insoluble in water, that binds dietary phosphate in the gastrointestinal tract through ion exchange. Sevelamer is available as two salt forms: sevelamer hydrochloride (Renagel) and sevelamer carbonate (Renvela).
TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Sevelamer (hydrochloride and carbonate forms) in pharmaceutical grade for global procurement programs.
> Applications
Phosphate binder in chronic kidney disease
Sevelamer binds dietary phosphate in the GI tract through ion exchange and hydrogen bonding, preventing its absorption. It is prescribed for hyperphosphatemia in patients on dialysis. Unlike calcium-based phosphate binders, sevelamer does not contribute to hypercalcemia or vascular calcification. Suki et al. (Kidney Int, 2007, 72:1130–1137) reported that sevelamer treatment was associated with reduced all-cause mortality compared to calcium-based binders in hemodialysis patients.
Additional lipid-lowering effects
Sevelamer has a secondary effect of binding bile acids in the gut, resulting in modest LDL cholesterol reduction (15–30%). This is a beneficial secondary action in CKD patients who often have dyslipidemia. The bile acid binding mechanism is similar to cholestyramine but is not the primary therapeutic intent.
> Sourcing & Supply
TCS Industries Limited supports development, qualification and commercial purchasing discussions for Sevelamer with buyers in Australia, New Zealand, Canada and South Korea.
- Evaluation and commercial quantities: 1 kg samples for analytical qualification; 25 kg drums for production. Hydrochloride and carbonate salt forms available. DMF (Drug Master File) support available from qualified manufacturers.
- Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.
> Quality & Documentation
Key specification parameters include particle size distribution, swelling index, phosphate binding capacity (in vitro), loss on drying, residual monomers (allylamine), heavy metals, and microbial limits. White to off-white powder. Identity by FTIR. Two forms: hydrochloride (HCl salt) and carbonate. Sevelamer is a polymeric material — quality is controlled by cross-linking degree, particle size, and binding capacity rather than traditional assay. Meets internal pharmaceutical specifications (no pharmacopoeial monograph). COA and MSDS are standard.
> Packaging
Sevelamer is a white to off-white powder, hygroscopic. Store at controlled room temperature (15–25 °C) in tightly sealed containers. Standard packaging includes double PE-lined fibre drums (5 kg, 10 kg, or 25 kg). Protect from moisture. Shelf life is typically 24–36 months. Labels and documents are checked before dispatch.
> Pricing & MOQ
Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.
> Regulatory & Compounding Context
Sevelamer is an API (active pharmaceutical ingredient), not a simple excipient. Sevelamer hydrochloride was FDA-approved in 1998 (Renagel). Sevelamer carbonate was FDA-approved in 2007 (Renvela). Both are EMA-authorized. Listed on the WHO Model List of Essential Medicines (2023). Generic sevelamer products require ANDA or equivalent marketing authorization. Manufacturing requires current regulatory compliance for API production.
> Alias Index
- INN: Sevelamer
- CAS Number: 52757-95-6 (base polymer); 152751-57-0 (hydrochloride); 845273-93-0 (carbonate)
- Chemical class: Cross-linked poly(allylamine) polymer
- Brand names: Renagel (HCl), Renvela (carbonate)
- Therapeutic class: Phosphate binder (ATC V03AE02)
- Commercial request terms: sevelamer hydrochloride API, sevelamer carbonate, phosphate binder polymer, Renagel generic, TCS Industries Limited
> FAQ
What is the difference between Sevelamer HCl and Sevelamer Carbonate?
Both bind phosphate equally. Sevelamer HCl releases chloride ions, which can worsen metabolic acidosis in CKD patients. Sevelamer carbonate releases carbonate, which buffers acidosis. Sevelamer carbonate (Renvela) has largely replaced the HCl form (Renagel) in clinical practice due to the metabolic advantage.
What documents are available for Sevelamer orders?
COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.
Do you supply Sevelamer to Australia and Canada?
Yes. We support B2B buyers in Australia, New Zealand, Canada and South Korea, subject to route and document review.
Do you supply New Zealand and South Korea?
Yes. We review Australia, New Zealand, Canada and South Korea for project supply, import documents, packaging and logistics planning before quotation.
How does Sevelamer bind phosphate?
Sevelamer is a positively charged (cationic) polymer at GI pH. It binds negatively charged phosphate ions through ionic interaction and hydrogen bonding in the gastrointestinal lumen. The cross-linked polymer structure prevents absorption — sevelamer and bound phosphate are excreted in feces. Binding capacity is approximately 3–6 mmol phosphate per gram.
Is a DMF available for Sevelamer?
Yes. TCS sources sevelamer from manufacturers who maintain active Drug Master Files (DMFs) filed with the FDA and equivalent regulatory submissions (ASMF/CEP) with EMA. DMF reference letters are provided to support ANDA and generic marketing authorization applications.
Can you arrange samples before commercial purchasing?
Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.
How is Sevelamer packaged for export?
Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.
Can buyer-defined specifications be reviewed?
Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.
What payment terms are normally used?
Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.
What lead time should buyers expect?
Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.
Why is Sevelamer classified as essential medicine?
WHO added sevelamer to the Essential Medicines List because hyperphosphatemia in CKD patients on dialysis leads to vascular calcification and cardiovascular death. Non-calcium-based phosphate binders like sevelamer reduce this risk. Access to affordable sevelamer is a global health priority for dialysis-dependent patients.
Last reviewed: June 2026
> Request a Quote
If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.