Torsemide (Torasemide) API Manufacturers & Suppliers
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Torasemide | CAS No: 56211-40-6 | GMP-certified suppliers
A medication that manages edema from heart, kidney, or liver disease and supports blood pressure control for broad cardiovascular and renal care needs.
Therapeutic categories
Primary indications
- Torasemide is indicated for the treatment of edema associated with congestive heart failure, renal or hepatic diseases
- From this condition, it has been observed that torasemide is very effective in cases of kidney failure
- [FDA label]
- As well, torasemide is approved to be used as an antihypertensive agent either alone or in combination with other antihypertensives
Product Snapshot
- Torasemide is an oral and intravenous small‑molecule diuretic available in multiple tablet and injectable formulations
- It is used for edema associated with heart failure, renal or hepatic disease, and for hypertension management
- It is approved in the US and Canada with full regulatory authorization
Clinical Overview
Torasemide increases urinary excretion of sodium and chloride, producing a high-ceiling diuretic response and reducing extracellular fluid volume. Pharmacodynamic data indicate sustained diuresis with comparatively lower potassium loss than that typically observed with some other loop diuretics. This profile is partially attributed to modulation of the renin‑angiotensin‑aldosterone system, with reductions in aldosterone activity that may contribute to potassium-sparing effects and improvements in markers of cardiac loading conditions.
The mechanism of action involves inhibition of the Na⁺/K⁺/Cl⁻ cotransporter on the luminal surface of epithelial cells in the thick ascending limb of the loop of Henle. Torasemide binds to the chloride site of the transporter, reducing solute reabsorption and lowering medullary oxygen demand. Additional downstream effects on angiotensin II–driven pathways include reduced expression of aldosterone synthase, TGF‑β1, and thromboxane A2.
Absorption, distribution, metabolism, and excretion characteristics vary by population and renal function, but torasemide is known to undergo hepatic metabolism involving CYP2C8 and CYP2C9 pathways and to have transporter interactions including OATP1B1. Safety considerations include risks associated with excessive diuresis, electrolyte imbalances, ototoxicity, and altered glycemic control. Monitoring of renal function and serum electrolytes is recommended, particularly in patients with comorbid cardiovascular or hepatic disease.
Torasemide is available globally under various brand names for oral and parenteral administration. For API procurement, sourcing should prioritize verified manufacturers with robust control of impurities, consistent particle properties suitable for formulation, and complete regulatory documentation to support regional submissions.
Identification & chemistry
| Generic name | Torasemide |
|---|---|
| Molecule type | Small molecule |
| CAS | 56211-40-6 |
| UNII | W31X2H97FB |
| DrugBank ID | DB00214 |
Pharmacology
| Summary | Torasemide is a loop diuretic that inhibits the Na⁺/K⁺/Cl⁻ cotransporter in the thick ascending limb of the loop of Henle, increasing urinary sodium and chloride excretion to reduce extracellular fluid volume. It also modulates the renin‑angiotensin‑aldosterone system, decreasing aldosterone‑related signaling and contributing to a secondary potassium‑sparing effect. These combined actions support its use in conditions characterized by fluid overload and elevated blood pressure. |
|---|---|
| Mechanism of action | As mentioned above, torasemide is part of the loop diuretics and thus, it acts by reducing the oxygen demand in the medullary thick ascending loop of Henle by inhibiting the Na+/K+/Cl- pump on the luminal cell membrane surface.This action is obtained by the binding of torasemide to a chloride ion-binding site of the transport molecule. Torasemide is known to have an effect in the renin-angiotensin-aldosterone system by inhibiting the downstream cascade after the activation of angiotensin II. This inhibition will produce a secondary effect marked by the reduction of the expression of aldosterone synthase, TGF-B1 and thromboxane A2 and a reduction on the aldosterone receptor binding. |
| Pharmacodynamics | It is widely known that administration of torasemide can attenuate renal injury and reduce the severity of acute renal failure. This effect is obtained by increasing urine output and hence, facilitating fluid, acid-base and potassium control.This effect is obtained by the increase in the excretion of urinary sodium and chloride. Several reports have indicated that torasemide presents a long-lasting diuresis and less potassium excretion which can be explained by the effect that torasemide has on the renin-angiotensin-aldosterone system. This effect is very similar to the effect observed with the administration of combination therapy with [furosemide] and [spironolactone] and it is characterized by a decrease in plasma brain natriuretic peptide and improved measurements of left ventricular function. Above the aforementioned effect, torasemide presents a dual effect .in which the inhibition of aldosterone which donates torasemide with a potassium-sparing action. Torasemide has been shown to reduce extracellular fluid volume and blood pressure in hypertensive patients suffering from chronic kidney disease. As well, some reports have indicated that torasemide can reduce myocardial fibrosis by reducing the collagen accumulation. This effect is suggested to be related to the decrease in aldosterone which in order has been shown to reduce the production of the enzyme procollagen type I carboxy-terminal proteinase which is known to be overexpressed in heart failure patients. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Solute carrier family 12 member 2 | Humans | inhibitor |
| Solute carrier family 12 member 1 | Humans | inhibitor |
ADME / PK
| Absorption | Torasemide is the diuretic with the highest oral bioavailability even in advanced stages of chronic kidney disease.This bioavailability tends to be higher than 80% regardless of the patient condition. The maximal serum concentration is reported to be of 1 hour and the absorption parameters are not affected by its use concomitantly with food. |
|---|---|
| Half-life | The average half-life of torasemide is 3.5 hours. |
| Protein binding | Torasemide is found to be highly bound to plasma proteins, representing over 99% of the administered dose. |
| Metabolism | Torasemide is extensively metabolized in the liver and only 20% of the dose remains unchanged and it is recovered in the urine.Metabolized via the hepatic CYP2C8 and CYP2C9 mainly by reactions of hydroxylation, oxidation and reduction to 5 metabolites.The major metabolite, M5, is pharmacologically inactive. There are 2 minor metabolites, M1, possessing one-tenth the activity of torasemide, and M3, equal in activity to torasemide. Overall, torasemide appears to account for 80% of the total diuretic activity, while metabolites M1 and M3 account for 9% and 11%, respectively. |
| Route of elimination | Torasemide is mainly hepatically processed and excreted in the feces from which about 70-80% of the administered dose is excreted by this pathway. On the other hand, about 20-30% of the administered dose is found in the urine. |
| Volume of distribution | The volume of distribution of torasemide is 0.2 L/kg. |
| Clearance | The clearance rate of torasemide is considerably reduced by the presence of renal disorders. |
Formulation & handling
- Oral formulations are feasible for this small‑molecule diuretic, but its low aqueous solubility may require solubility‑enhancing excipients or solid‑state optimization.
- IV solutions require complete dissolution and pH control to maintain clarity and prevent precipitation during storage and administration.
- Food has minimal impact on overall exposure, allowing flexible administration without special dietary considerations.
Regulatory status
| Lifecycle | The API remains in a protected phase in the United States with patent exclusivity extending to 2033, indicating limited generic competition in that market. In the US and Canada, its commercial presence reflects an early‑ to mid‑lifecycle product position. |
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| Markets | US, Canada |
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Supply Chain
| Supply chain summary | Torasemide was originally developed by a single originator company, with numerous generic manufacturers now active in finished‑dose and packaging operations. Branded products such as Demadex are established in North American markets, while the presence of multiple generic producers indicates broad global supply capability beyond the US and Canada. Although a listed US patent extends to 2033, the wide availability of generics suggests it does not block most current formulations, and generic competition is already well established. |
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Safety
| Toxicity | The oral LD50 of torasemide in the rat is 5 g/kg. When overdose occurs, there is a marked diuresis with the danger of loss of fluid and electrolytes which has been seen to lead to somnolence, confusion, hypotension, hyponatremia, hypokalemia, hypochloremic alkalosis, hemoconcentration dehydration and circulatory collapse. This effects can include some gastrointestinal disturbances. There is no increase in tumor incidence with torasemide and it is proven to not be mutagenic, not fetotoxic or teratogenic.[FDA label] |
|---|
- High oral LD50 in rats (~5 g/kg), but excessive exposure can trigger pronounced diuresis with associated risks of electrolyte depletion, hemoconcentration, and circulatory instability
- Reported overdose-related effects include CNS depression (somnolence, confusion), hypotension, and gastrointestinal disturbances
- Non-clinical data show no evidence of mutagenicity, tumorigenicity, fetotoxicity, or teratogenicity
Torasemide is a type of Diuretics
Diuretics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), are compounds commonly used in the treatment of conditions such as hypertension, congestive heart failure, and edema. Diuretics, also known as water pills, function by increasing the production of urine, thereby promoting the excretion of excess water and electrolytes from the body.
There are several types of diuretics, including thiazide diuretics, loop diuretics, and potassium-sparing diuretics. Thiazide diuretics, such as hydrochlorothiazide, work by inhibiting the reabsorption of sodium and chloride in the kidneys, leading to increased urine production. Loop diuretics, such as furosemide, act on the loop of Henle in the kidneys to block the reabsorption of sodium and chloride, resulting in a more potent diuretic effect. Potassium-sparing diuretics, like spironolactone, help retain potassium in the body while still promoting diuresis.
These diuretic APIs are widely used in the pharmaceutical industry to formulate medications that effectively manage fluid retention and related conditions. They are available in various forms, including tablets, capsules, and intravenous formulations. Diuretics are often prescribed as part of combination therapies to enhance their effectiveness and minimize adverse effects.
It is important to note that the use of diuretics should be closely monitored by healthcare professionals due to potential side effects such as electrolyte imbalances, dehydration, and hypotension. Proper dosage and patient-specific considerations are crucial to ensure optimal therapeutic outcomes.
In conclusion, diuretics are a vital subcategory of pharmaceutical APIs used to treat conditions characterized by fluid retention. Their mechanisms of action vary, but they all facilitate increased urine production, assisting the body in eliminating excess fluids. The proper use of diuretics, in combination with medical supervision, can effectively manage various cardiovascular and renal conditions.
Torasemide (Diuretics), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Torasemide API manufacturers & distributors
Compare qualified Torasemide API suppliers worldwide. We currently have 15 companies offering Torasemide API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Arevipharma | Producer | Germany | Unknown | CEP, CoA, FDA | 25 products |
| AXXO GmbH | Distributor | Germany | European Union | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Bioindustria | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 12 products |
| Cosma | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 20 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CoA, GMP | 70 products |
| F Hoffmann-La Roche | Producer | Switzerland | Switzerland | CEP, CoA, FDA | 8 products |
| Harman Finochem | Producer | India | India | CoA, GMP, WC | 34 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Hubei Biocause | Producer | China | China | CEP, CoA, GMP, WC | 12 products |
| Ipca Labs. | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 69 products |
| Medilux Labs | Producer | India | India | CEP, CoA, FDA, GMP, WC | 10 products |
| PLIVA | Producer | Czech Republic | Croatia | CoA, GMP | 31 products |
| Sanochemia Pharma | Producer | Austria | Austria | CEP, CoA, FDA, GMP | 2 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| Zhejiang Dongdong | Producer | China | China | CoA, USDMF | 1 products |
When sending a request, specify which Torasemide 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 Torasemide 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.
