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Calcium carbonate | CAS No: 471-34-1 | GMP-certified suppliers
A medication that provides relief from heartburn and acid indigestion while supporting calcium supplementation needs, including addressing dietary deficiency states and hypocalcemia.
Therapeutic categories
Primary indications
- For relief of heartburn and acid indigestion
- May also be used as a nutritional supplement or to treat hypocalcemia
Product Snapshot
- Calcium carbonate is supplied primarily as an oral small‑molecule mineral excipient across chewable tablets, effervescent forms, suspensions, and multiple topical and dental preparations, with limited parenteral use
- It is used for acid neutralization in heartburn and indigestion, and as a calcium source for supplementation or correction of hypocalcemia
- It is marketed in the US and Canada with approved and investigational statuses depending on the specific dosage form
Clinical Overview
Its antacid activity results from direct neutralization of hydrochloric acid in gastric secretions. The increase in intragastric pH reduces pepsin activity and may attenuate proteolytic injury. Neutralization produces calcium chloride, carbon dioxide, and water, with most calcium chloride subsequently forming insoluble calcium salts. Pharmacodynamic effects include enhanced bicarbonate and prostaglandin availability, which can support mucosal defense. The acid-neutralizing capacity is approximately 58 mEq per 15 mL of standard suspension.
As a calcium supplement, calcium carbonate increases systemic calcium levels following dissolution and absorption. This contributes to maintenance of bone mineralization and correction of calcium deficits. Its absorption is pH dependent and occurs primarily in the small intestine. Unabsorbed calcium is excreted in feces, while absorbed fractions are subject to renal elimination. Systemic exposure varies with gastric acidity, vitamin D status, and concomitant food intake.
Safety considerations include the potential for hypercalcemia, milk-alkali syndrome with excessive intake, and calcium-alkali interactions that can influence the absorption of certain oral drugs. Belching and gastrointestinal discomfort may occur due to carbon dioxide generation. Use in patients with renal impairment requires caution because of reduced calcium clearance.
Calcium carbonate is present in numerous over-the-counter antacid and supplement formulations globally. For API procurement, manufacturers should ensure compliance with pharmacopoeial specifications, control of particle size distribution for consistent dissolution, and verification of elemental impurity limits consistent with ICH guidance.
Identification & chemistry
| Generic name | Calcium carbonate |
|---|---|
| Molecule type | Small molecule |
| CAS | 471-34-1 |
| UNII | H0G9379FGK |
| DrugBank ID | DB06724 |
Pharmacology
| Summary | Calcium carbonate neutralizes gastric hydrochloric acid, raising intragastric pH and reducing pepsin activity, while modestly increasing bicarbonate and prostaglandin levels. Acid neutralization produces calcium chloride, which is largely converted to insoluble calcium salts in the gut. When used as a supplement, it increases systemic calcium stores. |
|---|---|
| Mechanism of action | Calcium carbonate is a basic inorganic salt that acts by neutralizing hydrochloric acid in gastric secretions. It also inhibits the action of pepsin by increasing the pH and via adsorption. Cytoprotective effects may occur through increases in bicarbonate ion (HCO<sub>3</sub><sup>-</sup>) and prostaglandins. Neutralization of hydrochloric acid results in the formation of calcium chloride, carbon dioxide and water. Approximately 90% of calcium chloride is converted to insoluble calcium salts (e.g. calcium carbonate and calcium phosphate). |
| Pharmacodynamics | Gastric-peptic disease occurs as a result of an imbalance between protective factors, such as mucus, bicarbonate, and prostaglandin secretion, and aggressive factors, such as hydrochloric acid, pepsin, and <i>Helicobacter pylori</i> (<i>H. pylori</i>). Antacids work by restoring acid-base balance, attenuating the pepsin activity and increasing bicarbonate and prostaglandin secretion. The acid-neutralizing capacity of calcium carbonate is 58 mEq/15 ml. When used as a nutritional supplement, calcium carbonate acts by directly increasing calcium stores within the body. |
ADME / PK
| Absorption | Maximal absorption occurs at doses of 500 mg or less taken with food. Oral bioavailability depends on intestinal pH, the presence of food and dosage. |
|---|---|
| Protein binding | Calcium acts as a co-factor to numerous enzymes. |
| Metabolism | None. |
| Route of elimination | Excreted mainly in the feces. The majority of renally filtered calcium is reabsorbed in the ascending limb of the loop of Henle and the proximal and distal convoluted tubules. Also secreted by sweat glands. |
| Volume of distribution | Calcium is rapidly distributed taken up by skeletal tissues following absorption and distribution into extracellular fluids. Bone contains 99% of the body's calcium and the remaining 1% is approximately equally distributed between intracellular and extracellular fluids. |
Formulation & handling
- Oral formulations rely on its limited acidity-dependent solubility, so dispersion and particle-size control are important for consistent bioavailability.
- Effervescent, suspension, and chewable formats help overcome slow dissolution; coadministration with food increases solubilization.
- As an alkaline, inorganic solid with high reactivity toward acids, it should be protected from moisture and formulated to minimize CO₂ generation and incompatibility with acidic excipients.
Regulatory status
| Lifecycle | Most U.S. patents covering the API expired between 2018 and 2022, indicating that the product has transitioned into a mature post‑patent phase. With commercialization limited to the US and Canada, the market is relatively established and shaped primarily by generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Calcium carbonate is supplied by multiple manufacturers, with branded consumer and first‑aid products indicating a diffuse originator base rather than reliance on a single innovator. Its presence across the US and Canadian markets reflects broad commercialization in over‑the‑counter and ancillary healthcare products. All listed US patents have expired, supporting the availability of established generic production and mature multi‑source supply. |
|---|
Calcium carbonate is a type of Calcium regulators
Calcium regulators are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the field of medicine. These compounds play a crucial role in maintaining the balance of calcium levels within the body. Calcium is an essential mineral that participates in numerous physiological processes, including muscle contraction, nerve transmission, and bone health.
Pharmaceutical APIs classified as calcium regulators are designed to modulate the levels of calcium in the body, either by increasing or decreasing its concentration as needed. These APIs act by targeting specific mechanisms involved in calcium regulation, such as calcium channels, transporters, or enzymes.
Calcium regulators find application in the treatment of various medical conditions. For instance, drugs that promote calcium absorption or enhance bone mineral density can be employed to manage osteoporosis, a condition characterized by weak and brittle bones. Conversely, medications that inhibit calcium channels or reduce calcium levels are used in the treatment of conditions like hypertension or cardiac arrhythmias.
The development of calcium regulators involves extensive research and rigorous testing to ensure their safety and efficacy. Pharmaceutical companies invest significant resources in the discovery, synthesis, and optimization of these APIs. Additionally, regulatory authorities closely monitor the production and distribution of calcium regulators to ensure compliance with stringent quality standards.
In summary, calcium regulators are a specialized category of pharmaceutical APIs that play a crucial role in maintaining calcium balance within the body. These compounds are integral to the treatment of various medical conditions and require rigorous research and testing to ensure their effectiveness and safety.
Calcium carbonate (Calcium regulators), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
Calcium carbonate API manufacturers & distributors
Compare qualified Calcium carbonate API suppliers worldwide. We currently have 15 companies offering Calcium carbonate API, with manufacturing taking place in 10 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 |
| Aeon Procare Pvt Ltd (Ash... | Producer | India | India | BSE/TSE, cDMF, CoA, EDMF/ASMF, FDA, GMP, HALAL, ISO9001, Kosher, MSDS, USDMF, WC, WHO-GMP | 5 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Imerys Carbonates | Producer | Austria | Austria | CEP, CoA, GMP | 1 products |
| J.M. Huber | Producer | United States | United States | CEP, CoA, FDA | 1 products |
| Omya Sas | Producer | France | France | CEP, CoA, GMP, USDMF | 1 products |
| Pharm Rx Chemical Corp | Distributor | United States | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Scora SA | Producer | France | France | CEP, CoA, GMP | 1 products |
| Shanghai Nuocheng | Producer | China | China | CEP, CoA | 1 products |
| Società Generale | Producer | Italy | Italy | CEP, CoA | 1 products |
| Specialty Minerals Liffor... | Producer | United Kingdom | United Kingdom | CEP, CoA, GMP | 1 products |
| Spi Pharma | Producer | United States | United States | CoA, GMP, USDMF | 3 products |
| Sudeep Pharma | Producer | India | India | CEP, CoA, WC | 1 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Calcium carbonate 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 carbonate 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.
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Technical
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Regulatory
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