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Losartan | CAS No: 114798-26-4 | GMP-certified suppliers
A medication that manages hypertension, lowers stroke risk in patients with cardiac hypertrophy, and helps slow diabetic nephropathy progression in type 2 diabetes.
Therapeutic categories
Primary indications
- Losartan is indicated to treat hypertension in patients older than 6 years, reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (though this benefit may not extend to patients with African heritage), and to treat diabetic nephropathy with elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension
- Losartan with hydrochlorothiazide is indicated to treat hypertension and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (though this benefit may not extend to patients with African heritage)
Product Snapshot
- Oral small‑molecule formulation supplied mainly as tablets and capsules
- Primary uses include management of hypertension, risk‑reduction of stroke in hypertensive patients with left ventricular hypertrophy, and renal protection in type 2 diabetes with nephropathy
- Approved and marketed in the US and Canada
Clinical Overview
Losartan acts by reversibly and competitively inhibiting angiotensin II binding at the AT1 receptor in vascular smooth muscle and the adrenal gland. Its active metabolite exhibits substantially greater potency and functions as a non‑competitive AT1 inhibitor. Blockade of the renin–angiotensin system reduces vasoconstriction and aldosterone‑mediated sodium retention, lowering blood pressure.
After oral administration, losartan is absorbed and undergoes first‑pass metabolism to its active metabolite. Both parent compound and metabolite are substrates of CYP2C9 and CYP3A pathways, while losartan can inhibit multiple CYP enzymes to varying extents. Elimination involves hepatic metabolism and biliary and renal pathways. Once‑daily dosing is typically sufficient due to the duration of action of the active metabolite.
Safety considerations include monitoring for hypotension, renal function changes, and hyperkalemia. Use should be evaluated carefully in patients with renal artery stenosis or volume depletion. Cases of angioedema have been reported, although less frequently than with ACE inhibitors. Cough incidence is generally similar to placebo or hydrochlorothiazide. Losartan may interact with drugs affecting CYP2C9, CYP3A, transporters such as P‑glycoprotein, or agents that increase serum potassium.
Losartan is available globally under multiple brand and generic products, commonly as losartan potassium and as combinations with hydrochlorothiazide.
For API procurement, buyers should verify compliance with regional pharmacopoeial specifications, assess impurity and solvent profiles, and ensure reliable control of polymorphic form and particle size distribution to support consistent formulation performance.
Identification & chemistry
| Generic name | Losartan |
|---|---|
| Molecule type | Small molecule |
| CAS | 114798-26-4 |
| UNII | JMS50MPO89 |
| DrugBank ID | DB00678 |
Pharmacology
| Summary | Losartan selectively blocks angiotensin II binding at the AT1 receptor, reducing vasoconstrictive and aldosterone-mediated signaling. Its active metabolite provides more potent, longer-lasting AT1 inhibition, supporting sustained modulation of the renin–angiotensin system. The drug’s pharmacodynamic effect centers on lowering vascular resistance and mitigating angiotensin II–driven end‑organ stress. |
|---|---|
| Mechanism of action | Losartan reversibly and competitively prevents angiotensin II binding to the AT<sub>1</sub> receptor in tissues like vascular smooth muscle and the adrenal gland.Losartan and its active metabolite bind the AT<sub>1</sub> receptor with 1000 times more affinity than they bind to the AT<sub>2</sub> receptor.The active metabolite of losartan is 10-40 times more potent by weight than unmetabolized losartan as an inhibitor of AT<sub>1</sub> and is a non-competitive inhibitor.Losartan's prevention of angiotensin II binding causes vascular smooth muscle relaxation, lowering blood pressure. Angiotensin II would otherwise bind to the AT<sub>1</sub> receptor and induce vasoconstriction, raising blood pressure. |
| Pharmacodynamics | Losartan is an angiotensin II receptor blocker used to treat hypertension, diabetic nephropathy, and to reduce the risk of stroke.Losartan has a long duration of action as it is given once daily.Patients taking losartan should be regularly monitored for hypotension, renal function, and potassium levels. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Type-1 angiotensin II receptor | Humans | antagonist |
ADME / PK
| Absorption | Losartan is approximately 33% orally bioavailable.Losartan has a T<sub>max</sub> of 1 hour and the active metabolite has a T<sub>max</sub> of 3-4 hours.Taking losartan with food decreases the C<sub>max</sub> but does only results in a 10% decrease in the AUC of losartan and its active metabolite.A 50-80mg oral dose of losartan leads to a C<sub>max</sub> of 200-250ng/mL. |
|---|---|
| Half-life | The terminal elimination half life of losartan is 1.5-2.5 hours while the active metabolite has a half life of 6-9 hours. |
| Protein binding | Losartan is 98.6-98.8% protein bound and the active metabolite (E-3174) is 99.7% protein bound in serum. |
| Metabolism | Losartan is metabolized to an aldehyde intermediate, E-3179, which is further metabolized to a carboxylic acid, E-3174, by cytochrome P450s like CYP2C9.Losartan can also be hydroxylated to an inactive metabolite, P1.Approximately 14% of losartan is metabolized to E-3174.Losartan can be metabolized by CYP3A4, CYP2C9, and CYP2C10.Losartan can also be glucuronidated by UGT1A1, UGT1A3, UGT1A10, UGT2B7, and UGT 2B17. |
| Route of elimination | A single oral dose of losartan leads to 4% recovery in the urine as unchanged losartan, 6% in the urine as the active metabolite.Oral radiolabelled losartan is 35% recovered in urine and 60% in feces.Intravenous radiolabelled losartan is 45% recovered in urine and 50% in feces. |
| Volume of distribution | The volume of distribution of losartan is 34.4±17.9L and 10.3±1.1L for the active metabolite (E-3174). |
| Clearance | Losartan has a total plasma clearance of 600mL/min and a renal clearance of 75mL/min.E-3174, the active metabolite, has a total plasma clearance of 50mL/min and a renal clearance of 25mL/min. |
Formulation & handling
- Oral small‑molecule API with very low aqueous solubility (high logP), typically requiring solubility‑enhancing strategies for solid‑dose formulations.
- Food can delay absorption without changing overall exposure, so formulations generally do not need food‑dependent release control.
- Stable as a solid; standard handling for hydrophobic crystalline APIs applies, with attention to uniform dispersion in tablet and suspension matrices.
Regulatory status
| Lifecycle | The active ingredient’s key U.S. and Canadian patents expired between 2009 and 2012, indicating that market exclusivity has ended in both regions. As a result, the product is in a mature, post‑patent stage in the United States and Canada. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Losartan was originally developed by Merck, with numerous generic manufacturers now active, reflecting a mature post‑patent market. Branded and generic products are widely established in the US and Canada. Patent expiries in both regions occurred more than a decade ago, supporting broad and ongoing generic competition. |
|---|
Safety
| Toxicity | The oral TDLO in mice is 1000mg/kg and in rats is 2000mg/kg.In humans the TDLO for men is 10mg/kg/2W and for women is 1mg/kg/1D. Symptoms of overdose are likely to include hypotension, tachycardia, or bradycardia due to vagal stimulation.Supportive treatment should be instituted for symptomatic hypotension.Hemodialysis will not remove losartan or its active metabolite due to their high rates of protein binding. |
|---|
- Oral TDLO values indicate relatively low acute toxicity in animals (1000 mg/kg in mice
- 2000 mg/kg in rats) but markedly lower human TDLOs, reflecting higher sensitivity to exposure
- Overexposure may elicit cardiovascular responses such as hypotension, tachycardia, or vagally mediated bradycardia
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Losartan Potassium is a type of Angiotensin Receptor Blockers
Angiotensin Receptor Blockers (ARBs) are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) commonly used in the treatment of hypertension and various cardiovascular conditions. ARBs work by selectively blocking the angiotensin II type 1 receptors, which are responsible for causing vasoconstriction and promoting the release of aldosterone, a hormone that regulates blood pressure and fluid balance.
These APIs are highly effective in reducing blood pressure by preventing angiotensin II from binding to its receptors, thereby dilating blood vessels and reducing peripheral resistance. By inhibiting the angiotensin II signaling pathway, ARBs help relax and widen the blood vessels, which subsequently lowers blood pressure.
Some commonly prescribed ARBs include losartan, valsartan, and candesartan. These drugs offer several advantages over other antihypertensive medications, such as a lower risk of side effects and better tolerability. ARBs are also considered beneficial for patients with certain comorbidities, including heart failure and diabetic nephropathy.
Pharmaceutical companies play a crucial role in the development and manufacturing of high-quality ARB APIs. Stringent quality control measures and adherence to regulatory guidelines ensure the safety, efficacy, and reliability of these APIs. Moreover, the market demand for ARBs is consistently growing, presenting a significant opportunity for pharmaceutical companies to cater to the increasing medical needs of patients suffering from hypertension and related cardiovascular conditions.
In conclusion, Angiotensin Receptor Blockers (ARBs) are a valuable subcategory of pharmaceutical APIs that effectively manage hypertension and cardiovascular diseases. With their ability to target the angiotensin II receptors, ARBs provide a reliable therapeutic option for patients and contribute to improving overall cardiovascular health.
Losartan Potassium (Angiotensin Receptor Blockers), 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.
Losartan Potassium API manufacturers & distributors
Compare qualified Losartan Potassium API suppliers worldwide. We currently have 33 companies offering Losartan Potassium 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 |
|---|---|---|---|---|---|
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 235 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, WC | 164 products |
| Divis Labs. | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, Other, KDMF | 47 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 70 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, KDMF, MSDS, USDMF | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hamari Chemicals | Producer | Japan | Japan | CoA, JDMF | 12 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CoA, JDMF | 18 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 90 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 69 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| Kolon Life Science | Producer | South Korea | South Korea | CoA, JDMF | 32 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Menovo | Producer | China | China | CEP, CoA, EDMF/ASMF, FDA, GMP, WC | 27 products |
| Micro Labs | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 38 products |
| Mylan | Producer | India | India | CEP, CoA, JDMF, KDMF, USDMF, WC | 201 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, JDMF | 51 products |
| Rui Laboratories Private ... | Producer | India | India | BSE/TSE, CoA, GDP, GMP, ISO9001, MSDS, WHO-GMP | 3 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 62 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC | 37 products |
| Zhejiang Changming | Producer | China | China | CoA, WC | 19 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, USDMF | 69 products |
| Zhejiang Tianyu | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 10 products |
When sending a request, specify which Losartan Potassium 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 Losartan Potassium 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 Losartan Potassium API
Sourcing
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Technical
What is Losartan Potassium (CAS 114798-26-4) used for?
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How does Losartan Potassium work?
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Is Losartan Potassium a small molecule?
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Regulatory
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Pharmaoffer
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