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Calcium gluconate | CAS No: 299-28-5 | GMP-certified suppliers
A medication that supports dietary calcium supplementation and helps manage hypocalcemia-related needs, providing cardioprotection in severe hyperkalemia and counteracting magnesium sulfate toxicity.
Therapeutic categories
Primary indications
- Oral calcium salts are used as dietary supplemental therapy for person who may not get enough calcium in their regular diet
- Calcium gluconate is used as a cardioprotective agent in high blood potassium
- Calcium gluconate is the antidote for magnesium sulfate toxicity
Product Snapshot
- Calcium gluconate is available as injectable and oral mineral formulations, with additional topical and vaginal presentations for specific non‑systemic applications
- It is used for calcium supplementation, cardioprotection in hyperkalemia, and as an antidote in magnesium toxicity scenarios
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
The pharmacology of calcium gluconate reflects the physiological roles of elemental calcium. Calcium is required for normal neuromuscular transmission, cardiac electrophysiology, skeletal mineralization, coagulation processes, and cell membrane stability. Approximately 99 percent of total body calcium resides in the skeleton as hydroxyapatite, with continuous exchange between bone and plasma to maintain tightly regulated circulating concentrations.
Calcium gluconate provides calcium in a bioavailable form, supporting metabolic functions including hormone and neurotransmitter release, amino acid uptake, vitamin B12 absorption, and regulation of gastrin secretion. Oral absorption is variable and influenced by vitamin D status and gastrointestinal factors. Intravenous administration ensures immediate systemic availability and is reserved for acute or symptomatic hypocalcemia or electrolyte emergencies.
Calcium Gluconate Injection, USP is a supersaturated sterile solution for intravenous use. Each milliliter contains 94 mg calcium gluconate and stabilizing calcium saccharate. A 10 mL dose provides 93 mg elemental calcium, equivalent to 1 g calcium gluconate.
Safety considerations include the risk of extravasation with intravenous use, potential for hypercalcemia with excessive dosing, and caution in patients with renal impairment or conditions associated with calcium imbalance. Known brands and hospital-use formulations vary by region but follow pharmacopeial standards for concentration and pH.
For API procurement, sourcing should prioritize verified identity, controlled impurity profiles, and compliance with regional pharmacopeial monographs to ensure suitability for both oral and parenteral formulations.
Identification & chemistry
| Generic name | Calcium gluconate |
|---|---|
| Molecule type | Small molecule |
| CAS | 299-28-5 |
| UNII | SQE6VB453K |
| DrugBank ID | DB11126 |
Pharmacology
| Summary | Calcium gluconate provides bioavailable calcium to support essential cellular functions, including neurotransmission, muscle contraction, and cardiac conduction. It helps restore or maintain systemic calcium balance by supplying elemental calcium that participates in bone mineralization and calcium‑dependent signaling pathways. Its pharmacologic effects reflect the normalization of extracellular calcium levels in conditions of deficiency or acute electrolyte disturbances. |
|---|---|
| Mechanism of action | Calcium is essential for the functional integrity of the nervous, muscular, and skeletal systems. It plays a role in normal cardiac function, renal function, respiration, blood coagulation, and cell membrane and capillary permeability. Also, calcium helps to regulate the release and storage of neurotransmitters and hormones, the uptake and binding of amino acids, absorption of vitamin B 12, and gastrin secretion. The major fraction (99%) of calcium is in the skeletal structure primarily as hydroxyapatite, Ca 10(PO 4) 6(OH) 2; small amounts of calcium carbonate and amorphous calcium phosphates are also present. The calcium of bone is in a constant exchange with the calcium of plasma. Since the metabolic functions of calcium are essential for life, when there is a disturbance in the calcium balance because of dietary deficiency or other causes, the stores of calcium in bone may be depleted to fill the body's more acute needs. Therefore, on a chronic basis, normal mineralization of bone depends on adequate amounts of total body calcium. |
| Pharmacodynamics | Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers. |
ADME / PK
| Absorption | Approximately one-fifth to one-third of orally administered calcium is absorbed in the small intestine, depending on presence of vitamin D metabolites, pH in lumen, and on dietary factors, such as calcium binding to fiber or phytates. Calcium absorption is increased when a calcium deficiency is present or when a patient is on a low-calcium diet. In patients with achlorhydria or hypochlorhydria, calcium absorption, especially with the carbonate salt, may be reduced. |
|---|---|
| Protein binding | Moderate, approximately 45% in plasma. |
| Metabolism | Calcium gluconate does not require hepatic metabolism for the release of Ca++ and is as effective as calcium chloride in treating ionic hypocalcemia in the absence of hepatic function. |
| Route of elimination | Renal (20%) - The amount excreted in the urine varies with degree of calcium absorption and whether there is excessive bone loss or failure of renal conservation. Fecal (80%) - Consists mainly of nonabsorbed calcium, with only a small amount of endogenous fecal calcium excreted. |
| Volume of distribution | Not available |
Formulation & handling
- Suitable for aqueous oral and parenteral formulations due to high water solubility and small‑molecule characteristics, with solution stability favoring simple buffered systems.
- Injectable preparations require control of calcium precipitation and compatibility with co‑administered IV drugs to avoid insoluble complexes.
- Oral forms may be taken with food or water, with minimal formulation sensitivity aside from managing calcium–excipient or calcium–anion interactions.
Regulatory status
| Lifecycle | The API remains in an early‑to‑mid lifecycle stage in Canada and the US, with key U.S. patents extending protection into 2037–2038. Market maturity is therefore limited, with generic entry unlikely until patent expiry. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Calcium gluconate is an established injectable and oral mineral product, with branded formulations supplied by a small set of originator holders and widely manufactured as a mature commodity API. Marketed forms are available in North America and internationally, indicating broad global use beyond the US and Canada. The listed US patents extend toward 2037–2038 and appear to cover specific formulations or delivery aspects, while the core compound is longstanding, allowing existing or emerging generic competition where no formulation‑specific protection applies. |
|---|
Safety
| Toxicity | Infants : LDLo (Intramuscular ) : 10gm/kg ; Effects - Brain and coverings : meningeal changes Infants : TDLo ( Intramuscular ) : 143 mg/kg ; Effects - Dermatits Mouse: LD50 ( intravenous ) : 950mg/kg Mouse : LDLo (Oral ) : 10gm/kg |
|---|
- High-dose exposures have produced CNS and meningeal reactions in infant IM toxicity studies (LDLo 10 g/kg), indicating potential risk of neuroirritant effects at extreme concentrations
- Repeated or lower‑dose intramuscular administration has been associated with localized dermal irritation (TDLo 143 mg/kg), relevant for evaluating excipient compatibility and depot formulations
- Acute toxicity in mice shows relatively low lethality via IV administration (LD50 ~950 mg/kg) but markedly higher tolerated oral loads, underscoring route‑dependent safety margins for handling and processing
Calcium gluconate 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 gluconate (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 gluconate API manufacturers & distributors
Compare qualified Calcium gluconate API suppliers worldwide. We currently have 7 companies offering Calcium gluconate 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Givaudan-Lavirotte | Producer | France | France | CoA, GMP | 3 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Ruibang Laboraties | Producer | China | China | CoA, GMP, WC | 10 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 66 products |
When sending a request, specify which Calcium gluconate 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 gluconate 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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