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Employees: 19
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CoAAll certificates
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Employees: 200+
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Taiwan|
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USDMF
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CoAAll certificates
USDMF
CoA
Producer
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India|
Audit Report:
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WC|
CoAAll certificates
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WC
CoA
Producer
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WC
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CoAAll certificates
WC
CoA
Producer
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Unknown|
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CoAAll certificates
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CoA
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China|
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India|
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WC|
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USDMF
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
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USDMF|
WC|
CoAAll certificates
GMP
USDMF
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
USDMF|
WC|
CoAAll certificates
GMP
USDMF
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
USDMF|
WC|
CoAAll certificates
GMP
USDMF
WC
CoA
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Producer
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India|
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WC|
CoAAll certificates
GMP
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CoA
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Sevelamer | CAS No: 52757-95-6 | GMP-certified suppliers
A medication that helps manage elevated serum phosphorus in chronic kidney disease patients on hemodialysis, supporting safer mineral balance for routine renal care.
Therapeutic categories
AminesBile Acid SequestrantsChelating AgentsCompounds used in a research, industrial, or household settingDrugs for Treatment of Hyperkalemia and HyperphosphatemiaLipid Regulating Agents
Generic name
Sevelamer
Molecule type
small molecule
CAS number
52757-95-6
DrugBank ID
DB00658
Approval status
Approved drug
ATC code
V03AE02
Primary indications
- For the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis
Product Snapshot
- Oral polymer-based API available mainly as tablets and powders for suspension, with some listings also indicating parenteral route
- Used for phosphate control in chronic kidney disease patients on dialysis
- Approved in the US, EU, and Canada for commercial supply
Clinical Overview
Sevelamer (CAS 52757-95-6) is a non‑absorbed polymeric phosphate binder indicated for controlling serum phosphorus in patients with chronic kidney disease receiving hemodialysis. It is commonly referenced in clinical practice through the brand Renagel. Chemically, it belongs to the epoxide class and functions as a polyamine-based resin with phosphate‑chelating properties.
In ESRD, reduced renal excretion causes phosphorus retention leading to hyperphosphatemia, increased calcium phosphate product, and risk of ectopic calcification. Elevated phosphorus contributes to secondary hyperparathyroidism, with associated skeletal complications such as osteitis fibrosa. Controlling intestinal phosphate absorption is a cornerstone of management alongside dietary restriction and dialysis.
Pharmacologically, sevelamer acts locally in the gastrointestinal tract. It binds dietary phosphate through ionic and hydrogen bonding interactions, forming insoluble complexes excreted in feces. This reduces phosphate absorption and lowers circulating phosphorus, which can in turn reduce parathyroid hormone levels. The agent is not systemically absorbed, and traditional systemic pharmacokinetic parameters such as plasma half‑life or metabolic pathways are not applicable. Clinical use has also been associated with reductions in LDL and total cholesterol, likely due to bile acid binding activity.
Because sevelamer is confined to the gut lumen, toxicity relates mainly to gastrointestinal effects such as constipation, nausea, abdominal discomfort, or, rarely, more severe intestinal complications. Monitoring of serum phosphorus, calcium, and PTH is standard to avoid over‑correction or imbalances in mineral metabolism. Drug–nutrient or drug–drug binding interactions may occur due to its polymeric sequestration properties.
For API procurement, suppliers should demonstrate control of polymer composition, crosslinking consistency, particle size distribution, and residual monomer levels. Documentation supporting compliance with pharmacopeial specifications and reproducible binding capacity is essential for reliable formulation development and regulatory submissions.
In ESRD, reduced renal excretion causes phosphorus retention leading to hyperphosphatemia, increased calcium phosphate product, and risk of ectopic calcification. Elevated phosphorus contributes to secondary hyperparathyroidism, with associated skeletal complications such as osteitis fibrosa. Controlling intestinal phosphate absorption is a cornerstone of management alongside dietary restriction and dialysis.
Pharmacologically, sevelamer acts locally in the gastrointestinal tract. It binds dietary phosphate through ionic and hydrogen bonding interactions, forming insoluble complexes excreted in feces. This reduces phosphate absorption and lowers circulating phosphorus, which can in turn reduce parathyroid hormone levels. The agent is not systemically absorbed, and traditional systemic pharmacokinetic parameters such as plasma half‑life or metabolic pathways are not applicable. Clinical use has also been associated with reductions in LDL and total cholesterol, likely due to bile acid binding activity.
Because sevelamer is confined to the gut lumen, toxicity relates mainly to gastrointestinal effects such as constipation, nausea, abdominal discomfort, or, rarely, more severe intestinal complications. Monitoring of serum phosphorus, calcium, and PTH is standard to avoid over‑correction or imbalances in mineral metabolism. Drug–nutrient or drug–drug binding interactions may occur due to its polymeric sequestration properties.
For API procurement, suppliers should demonstrate control of polymer composition, crosslinking consistency, particle size distribution, and residual monomer levels. Documentation supporting compliance with pharmacopeial specifications and reproducible binding capacity is essential for reliable formulation development and regulatory submissions.
Identification & chemistry
| Generic name | Sevelamer |
|---|---|
| Molecule type | Small molecule |
| CAS | 52757-95-6 |
| UNII | 941N5DUU5C |
| DrugBank ID | DB00658 |
Pharmacology
| Summary | Sevelamer is a non‑absorbed polymer that binds dietary phosphate in the gastrointestinal tract, reducing intestinal phosphate uptake and lowering circulating phosphate levels. By decreasing serum phosphate, it helps mitigate secondary hyperparathyroidism and related mineral imbalances in chronic kidney disease. Sevelamer also reduces circulating LDL and total cholesterol through nonspecific binding in the gut. |
|---|---|
| Mechanism of action | Sevelamer prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels. |
| Pharmacodynamics | Patients with end-stage renal disease (ESRD) retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca x P) exceeds 55 mg<sup>2</sup>/dL<sup>2</sup>, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency. An increase in parathyroid hormone (PTH) levels is characteristic of patients with chronic renal failure. Increased levels of PTH can lead to osteitis fibrosa, a bone disease. A decrease in serum phosphorus may decrease serum PTH levels. Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Sevelamer taken with meals has been shown to decrease serum phosphorus concentrations in patients with ESRD who are on hemodialysis. <i>In vitro</i> studies have shown that the capsule and tablet formulations bind phosphate to a similar extent. Sevelamer treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Phosphate | Humans | binder |
ADME / PK
| Absorption | Not absorbed following oral administration, however no absorption studies have been performed in patients with renal disease. Sevelamer may bind to dietary phosphates and prevent its gastrointestinal absorption when sevelamer is administered in combination with food. |
|---|
Formulation & handling
- Primarily formulated as oral solid and powder-for-suspension products, with performance dependent on in‑gut ion‑exchange rather than systemic absorption.
- High aqueous solubility and solid-state stability support conventional tableting or reconstitution processes with minimal specialized handling.
- Intended for administration with food, so formulations should maintain dispersion and binding capacity under fed-state gastrointestinal conditions.
Regulatory status
| Lifecycle | Most core patents in the US and Canada expired between 2013 and 2014, with an additional US patent expiring in 2020, indicating a generally mature market across Canada, the US, and the EU. A remaining US patent expiring in 2025 suggests limited ongoing protection in that market. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Sevelamer is supplied primarily by a single originator group (Genzyme) with a broad network of secondary repackagers and distributors supporting availability. Branded products are established across the US, EU, and Canada, indicating mature global market penetration. Key patents have already expired in major markets, with the final US patent expiring in 2025, suggesting that generic competition is already present and likely to expand further. |
|---|
Safety
| Toxicity | Sevelamer has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelamer has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of sevelamer in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low. |
|---|
High Level Warnings:
- Low systemic toxicity risk due to negligible absorption
- Toxicity profiles in volunteers and hemodialysis patients show high tolerability at doses up to 14 g/day
- No documented overdose cases
Sevelamer is a type of Other calcium Channel Blockers
Other calcium channel blockers are a category of pharmaceutical active pharmaceutical ingredients (APIs) that work by inhibiting the influx of calcium ions into cells through voltage-gated calcium channels. These medications are primarily used to treat various cardiovascular conditions, such as hypertension (high blood pressure) and angina (chest pain).
Unlike commonly known calcium channel blockers like dihydropyridines and non-dihydropyridines, other calcium channel blockers encompass a diverse group of drugs that possess calcium channel-blocking activity but may have different chemical structures and mechanisms of action.
These APIs exert their therapeutic effects by binding to specific calcium channels in cardiac and smooth muscle cells, reducing calcium entry and subsequent muscle contraction. By doing so, they relax blood vessels, improve blood flow, and reduce cardiac workload, resulting in lower blood pressure and alleviation of angina symptoms.
Some examples of other calcium channel blockers include bepridil, mibefradil, and verapamil. These drugs may have additional effects beyond calcium channel blockade, such as antiarrhythmic properties or interactions with other receptor systems.
As with any medication, other calcium channel blockers may have potential side effects, including dizziness, flushing, constipation, and peripheral edema. Therefore, it is important to use these drugs under the supervision of a healthcare professional and follow the prescribed dosage instructions.
In conclusion, other calcium channel blockers are a diverse class of pharmaceutical APIs that act by blocking calcium channels, leading to decreased blood pressure and relief from angina. These medications offer an alternative treatment option for cardiovascular conditions and should be used as directed by a healthcare provider to ensure safety and efficacy.
Sevelamer API manufacturers & distributors
Compare qualified Sevelamer API suppliers worldwide. We currently have 13 companies offering Sevelamer API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Emcure Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 80 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| NAVINTA | Producer | United States | Unknown | CoA, USDMF | 15 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Xinhua | Producer | China | China | CoA, WC | 21 products |
| Solfyn International LLP | Distributor | India | India | CoA, GMP, ISO9001, WHO-GMP | 24 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Tianjin Minxiang | Producer | China | China | CoA | 10 products |
| USV | Producer | India | India | CoA, GMP, WC | 35 products |
When sending a request, specify which Sevelamer API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Sevelamer API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Sevelamer API
Sourcing
What matters most when sourcing GMP-grade Sevelamer?
The key considerations are confirmed GMP compliance and alignment with regulatory expectations in the US, EU, and Canada. Because most supply originates from a single manufacturer with repackagers and distributors, verifying supply chain transparency and continuity is essential. With major patents expired and generic competition present, ensuring the selected source meets consistent quality standards across batches is also important.
Which documents are typically required when sourcing Sevelamer API?
Request the core API documentation set: CoA (13 companies), GMP (9 companies), USDMF (8 companies), WC (7 companies), ISO9001 (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Sevelamer API?
Known or reported manufacturers for Sevelamer: SETV Global, LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Sevelamer API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Sevelamer manufacturers?
Audit reports may be requested for Sevelamer: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Sevelamer API on Pharmaoffer?
Reported supplier count for Sevelamer: 13 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Sevelamer API?
Production countries reported for Sevelamer: India (8 producers), China (2 producers), Taiwan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Sevelamer usually hold?
Common certifications for Sevelamer suppliers: CoA (13 companies), GMP (9 companies), USDMF (8 companies), WC (7 companies), ISO9001 (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Sevelamer (CAS 52757-95-6) used for?
Sevelamer is used to control hyperphosphatemia in patients with chronic kidney disease, particularly those on hemodialysis. It binds dietary phosphate in the gastrointestinal tract, reducing intestinal absorption and lowering serum phosphorus levels. This effect can also help decrease parathyroid hormone levels associated with disordered mineral metabolism.
Which therapeutic class does Sevelamer fall into?
Sevelamer belongs to the following therapeutic categories: Amines, Bile Acid Sequestrants, Chelating Agents, Compounds used in a research, industrial, or household setting, Drugs for Treatment of Hyperkalemia and Hyperphosphatemia. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Sevelamer mainly prescribed for?
The primary indications for Sevelamer: For the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Sevelamer work?
Sevelamer prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.
What should someone know about the safety or toxicity profile of Sevelamer?
Sevelamer has a low systemic toxicity risk because it is not absorbed and acts only within the gastrointestinal tract. Safety studies in volunteers and hemodialysis patients show good tolerability at doses up to 14 g/day, with no documented overdose cases. Adverse effects are mainly gastrointestinal, including constipation, nausea, abdominal discomfort, and rare severe intestinal complications. Routine monitoring of phosphorus, calcium, and PTH is recommended to prevent mineral imbalance.
What are important formulation and handling considerations for Sevelamer as an API?
Formulation focuses on oral solid or powder‑for‑suspension dosage forms that enable effective ion‑exchange activity within the gastrointestinal tract. Its high aqueous solubility and solid‑state stability allow standard tableting or reconstitution processes without specialized handling. Because it is administered with food, formulations should maintain adequate dispersion and phosphate‑binding capacity under fed‑state conditions. Absence of systemic absorption means performance relies on consistent in‑gut availability rather than pharmacokinetic control.
Is Sevelamer a small molecule?
Sevelamer is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Sevelamer?
Oral Sevelamer products have good solid‑state stability and generally do not require specialized handling beyond standard protection from moisture. Stability is maintained in conventional tablet and powder‑for‑suspension formats. Because performance depends on ion‑exchange in the gut, formulations should preserve dispersion and binding capacity under fed‑state gastrointestinal conditions.
Regulatory
Where is Sevelamer approved or in use globally?
Sevelamer is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Sevelamer right now?
Sevelamer is regulated for use in Canada, the United States, and the European Union. Patent considerations are jurisdiction‑specific and depend on the individual filings that apply to a given Sevelamer product or formulation.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Sevelamer procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Sevelamer. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Sevelamer included in the PRO Data Insights coverage?
PRO Data Insights coverage for Sevelamer: 1111 verified transactions across 253 suppliers and 135 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Sevelamer?
Market report availability for Sevelamer: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
