Magnesium Sulfate API Manufacturers & Suppliers
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Magnesium sulfate | CAS No: 7487-88-9 | GMP-certified suppliers
A medication that provides rapid control of convulsions in severe pre‑eclampsia and eclampsia, supports acute nephritis care, corrects magnesium deficiency, and manages uterine tetany.
Therapeutic categories
Primary indications
- Used for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children
- Also indicated for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia
- Also used in uterine tetany as a myometriat relaxant
Product Snapshot
- Magnesium sulfate is supplied in multiple formulation types, primarily as parenteral injectable solutions and powders for reconstitution, with additional oral and topical forms
- It is used for control of severe pregnancy-related convulsions, correction of acute magnesium deficiency, and management of uterine tetany and related neuromuscular hyperexcitability states
- It is approved for use in the US and Canada, with statuses including approved, investigational, and veterinary‑approved
Clinical Overview
Pharmacologically, magnesium sulfate acts as an anticonvulsant, cathartic, and electrolyte replenisher. It dampens excitability in myometrial muscle cells by directly inhibiting action potentials, uncoupling excitation–contraction processes and reducing contraction frequency and intensity. It contributes to stabilization of cardiac electrophysiology in settings of polymorphic ventricular tachycardia where magnesium-dependent ion flux is disrupted.
The mechanism of action reflects magnesium’s role as a major intracellular cation required for numerous enzymatic reactions. The sulfate salt reduces acetylcholine release at the neuromuscular junction and diminishes striated muscle contractions. Inhibition of calcium influx through voltage-dependent, dihydropyridine-sensitive channels underlies its vasodilatory and smooth muscle relaxant effects, which are clinically relevant during obstetric emergencies.
Absorption and distribution characteristics vary by route; parenteral administration achieves rapid systemic exposure. Magnesium is primarily eliminated renally, and accumulation can occur in renal impairment. Safety considerations include the risk of respiratory depression, hypotension, loss of deep tendon reflexes, and conduction abnormalities at elevated serum magnesium concentrations. Clinical use typically incorporates serum level monitoring and availability of calcium salts for antagonism in cases of toxicity.
Magnesium sulfate is supplied globally in injectable solutions and oral formulations such as osmotic laxatives. When procuring the API, sourcing teams should confirm compliance with pharmacopoeial monographs, control of inorganic impurities, and suitability for parenteral-grade manufacturing where required.
Identification & chemistry
| Generic name | Magnesium sulfate |
|---|---|
| Molecule type | Small molecule |
| CAS | 7487-88-9 |
| UNII | ML30MJ2U7I |
| DrugBank ID | DB00653 |
Pharmacology
| Summary | Magnesium sulfate acts primarily by modulating neurochemical transmission and muscular excitability through inhibition of voltage‑dependent L‑type calcium channels and reduced acetylcholine release at the neuromuscular junction. These actions decrease striated and smooth muscle contractility, including in myometrial and vascular tissues. Its pharmacodynamic profile supports use in conditions characterized by convulsions, abnormal uterine contractility, certain arrhythmias, and acute magnesium deficiency. |
|---|---|
| Mechanism of action | Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Magnesium sulfate reduces striated muscle contractions and blocks peripheral neuromuscular transmission by reducing acetylcholine release at the myoneural junction. Additionally, Magnesium inhibits Ca<sup>2+</sup> influx through dihydropyridine-sensitive, voltage-dependent channels. This accounts for much of its relaxant action on vascular smooth muscle. |
| Pharmacodynamics | Magnesium sulfate is a small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. Magnesium sulfate is gaining popularity as an initial treatment in the management of various dysrhythmias, particularly torsades de pointes, and dyrhythmias secondary to TCA overdose or digitalis toxicity. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Voltage-dependent L-type calcium channel | Humans | inhibitor, blocker |
ADME / PK
| Half-life | 43.2 hours (for newborns) |
|---|---|
| Protein binding | 25-30% |
| Metabolism | None |
| Route of elimination | Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration. |
Formulation & handling
- Highly water‑soluble inorganic salt suitable for oral solutions, suspensions, and effervescent tablets, with minimal formulation challenges related to permeability or food effects.
- Widely used in parenteral solutions where concentration, osmolarity, and pH control are critical to avoid irritation and ensure compatibility with aqueous systems.
- Stable as a solid and in aqueous solution; hygroscopicity should be managed in bulk handling to prevent caking and maintain flow properties.
Regulatory status
| Lifecycle | Most U.S. patents covering the API extend to 2037, with one earlier patent having expired in 2023, indicating that the product remains largely within a protected period in its primary markets. Given commercialization in the United States and Canada, the API is still in a mid‑to‑late patent‑protected phase with limited near‑term generic entry expected. |
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| Markets | US, Canada |
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Supply Chain
| Supply chain summary | Magnesium sulfate is supplied by a small group of established manufacturers, with a wider set of packagers supporting distribution. Branded and non‑branded products are present primarily in the US and Canada, reflecting broad clinical and consumer use. Core molecule patents have largely expired, while later‑dated patents appear to relate to specific formulations or uses, indicating that generic competition is already well established for the underlying API. |
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Safety
| Toxicity | LD<sub>50</sub> = 1200 mg/kg (rat, subcutaneous). May be harmful if swallowed. May act as an irritant. Adverse reactions include hypotension, ECG changes, diarrhea, urinary retention, CNS depression and respiratory depression. |
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- Subcutaneous LD50 in rats is 1200 mg/kg
- Oral exposure may be harmful and the compound can exhibit irritant properties
- Reported adverse effects include hypotension, ECG alterations, gastrointestinal disturbances, urinary retention, and CNS and respiratory depression
Magnesium Sulfate is a type of Magnesium Salts
Magnesium salts are a crucial subcategory of active pharmaceutical ingredients (APIs) widely used in the pharmaceutical industry. These salts are compounds formed by combining magnesium with other chemical elements or groups. Magnesium salts are highly valued for their therapeutic properties and play a significant role in various medical applications.
One of the most well-known magnesium salts is magnesium oxide, which is commonly used as a supplement to treat magnesium deficiency in the body. This salt is known for its high bioavailability, making it an effective option for oral administration.
Another important magnesium salt is magnesium sulfate, which finds extensive use in both pharmaceutical and medical settings. It is often utilized in the treatment of conditions such as eclampsia, pre-eclampsia, and magnesium deficiency in pregnant women. Magnesium sulfate can be administered intravenously or orally, depending on the specific medical requirements.
Furthermore, magnesium citrate, a salt formed by combining magnesium with citric acid, is renowned for its laxative properties. It is frequently employed in the formulation of bowel preparations to facilitate bowel movements before medical procedures or surgeries.
The versatility of magnesium salts extends beyond medical applications. They are also utilized in the manufacturing of antacids, laxatives, and various over-the-counter products.
In conclusion, magnesium salts form a significant subcategory of pharmaceutical APIs, offering a wide range of therapeutic benefits. These salts, including magnesium oxide, magnesium sulfate, and magnesium citrate, play vital roles in treating magnesium deficiencies, supporting pregnancy-related conditions, and aiding bowel movements. Their extensive usage and efficacy make them indispensable components in the pharmaceutical industry.
Magnesium Sulfate (Magnesium Salts), 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.
Magnesium Sulfate API manufacturers & distributors
Compare qualified Magnesium Sulfate API suppliers worldwide. We currently have 8 companies offering Magnesium Sulfate API, with manufacturing taking place in 6 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 |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Dr. Paul Lohmann GmbH & C... | Producer | Germany | Germany | CoA, EDMF/ASMF, GMP, MSDS, USDMF | 49 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | BSE/TSE, CoA, GMP, ISO9001, MSDS | 170 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Jost Chemical | Producer | United States | United States | CoA, USDMF | 14 products |
| Tomita Pharmaceutical | Producer | Japan | Japan | CoA, JDMF, USDMF | 10 products |
When sending a request, specify which Magnesium Sulfate 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 Magnesium Sulfate 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.
