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Calcium Acetate API Manufacturers & Suppliers
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Calcium acetate | CAS No: 62-54-4 | GMP-certified suppliers
A medication that helps manage hyperphosphatemia in patients with chronic kidney disease by reducing dietary phosphate levels to support reliable treatment control.
Therapeutic categories
Primary indications
- Calcium acetate is one of a number of calcium salts used to treat hyperphosphatemia (too much phosphate in the blood) in patients with kidney disease
Product Snapshot
- Calcium acetate is primarily supplied as an oral small‑molecule mineral salt, with additional topical and parenteral formulations available
- It is used for phosphate binding to manage hyperphosphatemia associated with kidney disease
- It is approved in the US and Canada, with some formulations designated as investigational
Clinical Overview
The clinical indication for calcium acetate is the management of hyperphosphatemia in patients with chronic kidney disease, particularly those with advanced renal insufficiency or receiving maintenance dialysis. In this population, impaired renal excretion leads to phosphate retention, which contributes to secondary hyperparathyroidism, renal osteodystrophy, and soft‑tissue calcification. Dietary restriction or dialysis alone is usually insufficient to maintain phosphate control, necessitating use of binders.
Pharmacologically, calcium acetate is highly soluble at neutral pH, releasing calcium ions in the proximal small intestine. These ions bind dietary phosphate to form insoluble calcium phosphate, which is eliminated in the feces. This reduces phosphate absorption and helps maintain serum phosphorus within clinically acceptable targets. The mechanism of action does not involve systemic pharmacologic activity, as the effect is localized to the gastrointestinal tract.
Absorption of the calcium component varies and may contribute to calcium load, which requires monitoring in patients at risk for hypercalcemia. As an inorganic salt with local action, traditional ADME characterization is limited, but unbound dietary phosphate is excreted unchanged, and systemic exposure to acetate is minimal at therapeutic doses.
Safety considerations focus on risks of hypercalcemia, potential for vascular or soft‑tissue calcification, and gastrointestinal effects such as nausea or constipation. Concomitant use with other calcium sources increases the likelihood of elevated serum calcium. Calcium acetate is available globally in multiple generic oral formulations intended for use with meals.
For API procurement, suppliers should provide material meeting pharmacopeial specifications with controlled water content due to hygroscopicity. Verification of elemental impurities, particle size consistency, and stability under typical storage conditions is recommended for formulation reliability.
Identification & chemistry
| Generic name | Calcium acetate |
|---|---|
| Molecule type | Small molecule |
| CAS | 62-54-4 |
| UNII | Y882YXF34X |
| DrugBank ID | DB00258 |
Pharmacology
| Summary | Calcium acetate acts as an intestinal phosphate binder, combining with dietary phosphate to form insoluble complexes that are excreted rather than absorbed. By reducing phosphate uptake, it helps limit phosphate retention that contributes to hyperphosphatemia and secondary hyperparathyroidism in advanced kidney disease. Its high solubility at neutral pH facilitates rapid availability of calcium for phosphate binding in the proximal small intestine. |
|---|---|
| Mechanism of action | Calcium acetate and other calcium salts are phosphate binders. They work by binding with the phosphate in the food you eat, so that it is eliminated from the body without being absorbed. |
| Pharmacodynamics | Patients with advanced renal insufficiency (creatinine clearance less than 30 ml/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate when taken with meals combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium acetate is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Phosphate | Humans | binder |
ADME / PK
| Absorption | 40% is absorbed in the fasting state and approximately 30% is absorbed in the nonfasting state following oral administration. |
|---|---|
| Route of elimination | Calcium acetate when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. |
Formulation & handling
- Highly water‑soluble small molecule suitable for oral solid and liquid formulations, with calcium–phosphate complexation influencing performance in fed conditions.
- Available as aqueous injectable solutions requiring control of pH and ionic strength to maintain solubility and prevent precipitation.
- Topical forms use its high solubility and solid‑state stability, with minimal sensitivity to environmental conditions during handling.
Regulatory status
| Lifecycle | Most foundational U.S. patents have expired, while several later‑expiring protections (2027–2030) suggest the API remains in a mid‑to‑late lifecycle phase. In the US and Canada, market maturity is advancing but still partly shaped by remaining exclusivities. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The supply landscape for calcium acetate includes a small group of established manufacturers supported by multiple U.S.‑based packagers, indicating a mature and well‑distributed domestic supply chain. Branded products are primarily present in the United States and Canada, with limited evidence of broader global commercialization. Several patents have already expired while others extend to 2027–2030, suggesting that generic competition is already present for older protections and may expand further as remaining patents lapse. |
|---|
Safety
| Toxicity | Oral, rat: LD<sub>50</sub> = 4280 mg/kg. Symptoms of overdose include mild hypercalcemia (constipation; loss of appetite; nausea and vomiting), and severe hypercalcemia (confusion; full or partial loss of consciousness; incoherent speech). |
|---|
- Oral rat LD50 approximately 4280 mg/kg, indicating low acute toxicity but necessitating standard controls to prevent accidental ingestion
- Overexposure may elicit hypercalcemia‑related effects, ranging from gastrointestinal disturbance to CNS impairment at higher systemic levels
- Handle powders with precautions to limit inhalation and environmental calcium load, as elevated bioavailable calcium can disrupt cellular and electrolyte balance
Calcium Acetate is a type of Phosphate binders
Phosphate binders are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in managing phosphate levels in the body. They are commonly used in the treatment of chronic kidney disease (CKD) and end-stage renal disease (ESRD), where patients often experience elevated levels of phosphate in their blood.
Phosphate binders are designed to bind with dietary phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream. By doing so, they help to regulate phosphate levels and reduce the risk of complications associated with hyperphosphatemia, such as cardiovascular disease and bone disorders.
These pharmaceutical APIs are available in different forms, including calcium-based binders, aluminum-based binders, and iron-based binders. Calcium-based binders work by exchanging calcium ions for phosphate ions, forming insoluble calcium phosphate complexes that are then eliminated through the feces. Aluminum-based binders also form insoluble complexes but are less commonly used due to concerns about aluminum toxicity. Iron-based binders, on the other hand, work by binding phosphate in the gastrointestinal tract and are often preferred in patients with iron deficiency.
Phosphate binders provide an essential therapeutic option for patients with CKD and ESRD to effectively manage their phosphate levels. They are typically prescribed as part of a comprehensive treatment plan, which may include dietary modifications and other medications. Close monitoring of phosphate levels is necessary to ensure optimal dosing and minimize the risk of adverse effects.
In summary, phosphate binders are valuable pharmaceutical APIs used to control phosphate levels in patients with CKD and ESRD. They play a crucial role in preventing complications associated with elevated phosphate levels and contribute to the overall management of these conditions.
Calcium Acetate (Phosphate binders), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Calcium Acetate API manufacturers & distributors
Compare qualified Calcium Acetate API suppliers worldwide. We currently have 4 companies offering Calcium Acetate API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Dr. Paul Lohmann GmbH & C... | Producer | Germany | Germany | CEP, CoA, GMP | 49 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Justesa Imagen | Producer | Spain | Spain | CoA, GMP | 15 products |
When sending a request, specify which Calcium Acetate 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 Calcium Acetate 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 Calcium Acetate API
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Technical
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Regulatory
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Pharmaoffer
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