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Produced in
China|
Employees: 50+
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European Union|
Employees: 50
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Employees: 700+
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Amiodarone | CAS No: 1951-25-3 | GMP-certified suppliers
A medication that addresses recurrent ventricular fibrillation and unstable ventricular tachycardia and is also used in many regions for managing atrial or supraventricular arrhythmias.
Therapeutic categories
Agents causing hyperkalemiaAgents Causing Muscle Toxicityalpha-Galactosidase, antagonists & inhibitorsAntiarrhythmic agentsAntiarrhythmics, Class IIIBenzofurans
Generic name
Amiodarone
Molecule type
small molecule
CAS number
1951-25-3
DrugBank ID
DB01118
Approval status
Approved drug, Investigational drug
ATC code
C01BD01
Primary indications
- The FDA approved indications for amiodarone are recurrent ventricular fibrillation (VF) and recurrent hemodynamically unstable ventricular tachycardia (VT)
- The FDA emphasizes that this drug should only be given in these conditions when they are clinically documented and have not responded to normal therapeutic doses of other antiarrhythmic agents, or when other drugs are not tolerated by the patient
- Off-label indications include atrial fibrillation and supraventricular tachycardia
Product Snapshot
- Amiodarone is available as an oral and injectable small‑molecule antiarrhythmic formulation
- It is used primarily for recurrent ventricular fibrillation or unstable ventricular tachycardia, with additional off‑label use in atrial and supraventricular arrhythmias
- It is approved in the United States and Canada, with FDA authorization and some investigational status noted in certain contexts
Clinical Overview
Amiodarone (CAS 1951-25-3) is a benzofuran-derived class III antiarrhythmic agent indicated for recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia that are refractory to or not tolerated with other antiarrhythmic therapies. It is also used in many regions for atrial fibrillation or supraventricular tachycardia, although these settings are generally considered off‑label.
Its antiarrhythmic activity arises primarily from blockade of cardiac potassium currents responsible for phase 3 repolarization, which prolongs the action potential duration and effective refractory period in myocytes. Amiodarone also inhibits sodium and calcium channels and interferes with beta‑adrenergic receptor function, contributing to slowed conduction through the SA and AV nodes, reduced ectopic automaticity, prolonged QRS duration, and QT interval changes.
Pharmacodynamic effects differ by route. Intravenous administration reduces peripheral vascular resistance and causes mild increases in cardiac index while depressing conduction. Oral administration has minimal effect on left ventricular ejection fraction. Survival benefit has not been demonstrated in controlled trials.
Amiodarone is highly lipophilic, displays extensive tissue distribution, and has a long and variable elimination half‑life. It is metabolized mainly by CYP3A pathways and is both a substrate and inhibitor of multiple CYP isoforms and transporters, contributing to a high potential for drug interactions. Accumulation in hepatic, pulmonary, ocular, and thyroid tissues underlies several toxicity risks.
Major safety considerations include bradycardia, hypotension, QT prolongation with risk of Torsades de pointes, pulmonary toxicity, hepatic injury, and thyroid dysfunction due to the compound’s iodine content and receptor binding. Photosensitivity and tissue deposition–related adverse effects may occur with long‑term use. Notable brand references include Cordarone and Pacerone.
For API procurement, suppliers should demonstrate control of polymorphic form, residual solvents, iodine‑related impurities, and particle size distribution, supported by full regulatory documentation and consistent batch reproducibility.
Its antiarrhythmic activity arises primarily from blockade of cardiac potassium currents responsible for phase 3 repolarization, which prolongs the action potential duration and effective refractory period in myocytes. Amiodarone also inhibits sodium and calcium channels and interferes with beta‑adrenergic receptor function, contributing to slowed conduction through the SA and AV nodes, reduced ectopic automaticity, prolonged QRS duration, and QT interval changes.
Pharmacodynamic effects differ by route. Intravenous administration reduces peripheral vascular resistance and causes mild increases in cardiac index while depressing conduction. Oral administration has minimal effect on left ventricular ejection fraction. Survival benefit has not been demonstrated in controlled trials.
Amiodarone is highly lipophilic, displays extensive tissue distribution, and has a long and variable elimination half‑life. It is metabolized mainly by CYP3A pathways and is both a substrate and inhibitor of multiple CYP isoforms and transporters, contributing to a high potential for drug interactions. Accumulation in hepatic, pulmonary, ocular, and thyroid tissues underlies several toxicity risks.
Major safety considerations include bradycardia, hypotension, QT prolongation with risk of Torsades de pointes, pulmonary toxicity, hepatic injury, and thyroid dysfunction due to the compound’s iodine content and receptor binding. Photosensitivity and tissue deposition–related adverse effects may occur with long‑term use. Notable brand references include Cordarone and Pacerone.
For API procurement, suppliers should demonstrate control of polymorphic form, residual solvents, iodine‑related impurities, and particle size distribution, supported by full regulatory documentation and consistent batch reproducibility.
Identification & chemistry
| Generic name | Amiodarone |
|---|---|
| Molecule type | Small molecule |
| CAS | 1951-25-3 |
| UNII | N3RQ532IUT |
| DrugBank ID | DB01118 |
Pharmacology
| Summary | Amiodarone is a multichannel antiarrhythmic that primarily prolongs cardiac repolarization by blocking potassium currents, increasing action‑potential duration and refractory periods to suppress ventricular and supraventricular arrhythmias. It also modulates sodium and calcium channels and exerts noncompetitive beta‑adrenergic blockade, contributing to slowed conduction and reduced automaticity. Secondary interactions with thyroid receptors and PPAR pathways account for characteristic endocrine and metabolic effects. |
|---|---|
| Mechanism of action | Amiodarone is considered a class III anti-arrhythmic drug. It blocks potassium currents that cause repolarization of the heart muscle during the third phase of the cardiac action potential. As a result amiodarone increases the duration of the action potential as well as the effective refractory period for cardiac cells (myocytes). Therefore, cardiac muscle cell excitability is reduced, preventing and treating abnormal heart rhythms. Unique from other members of the class III anti-arrhythmic drug class, amiodarone also interferes with the functioning of beta-adrenergic receptors, sodium channels, and calcium channels channels. These actions, at times, can lead to undesirable effects, such as hypotension, bradycardia, and Torsades de pointes (TdP).In addition to the above, amiodarone may increase activity of peroxisome proliferator-activated receptors, leading to steatogenic changes in the liver or other organs.Finally, amiodarone has been found to bind to the thyroid receptor due to its iodine content, potentially leading to amiodarone induced hypothyroidism or thyrotoxicosis. |
| Pharmacodynamics | After intravenous administration, amiodarone acts to relax smooth muscles that line vascular walls, decreases peripheral vascular resistance (afterload), and increases the cardiac index by a small amount. Administration by this route also decreases cardiac conduction, preventing and treating arrhythmias.When it is given orally, however, amiodarone does not lead to significant changes in the left ventricular ejection fraction. Similar to other anti-arrhythmic agents, controlled clinical trials do not confirm that oral amiodarone increases survival. Amiodarone prolongs the QRS duration and QT interval. In addition, a decreased SA (sinoatrial) node automaticity occurs with a decrease in AV node conduction velocity. Ectopic pacemaker automaticity is also inhibited.Thyrotoxicosis or hypothyroidism may also result from the administration of amiodarone, which contains high levels of iodine, and interferes with normal thyroid function. |
Targets
| Target | Organism | Actions |
|---|---|---|
| HERG human cardiac K+ channel | Humans | inhibitor |
| Beta adrenergic receptor | Humans | inhibitor, downregulator |
| Voltage-dependent T-type calcium channel subunit alpha-1I | Humans | inhibitor |
ADME / PK
| Absorption | The Cmax of amiodarone in the plasma is achieved about 3 to 7 hours after administration.The general time to onset of action of amiodarone after one dose given by the intravenous route is between 1 and 30 minutes, with therapeutic effects lasting from 1-3 hours. Steady-state concentrations of amiodarone in the plasma ranges between 0.4 to 11.99 μg/ml; it is advisable that steady-state levels are generally maintained between 1.0 and 2.5 μg/ml in patients with arrhythmias. Interestingly, its onset of action may sometimes begin after 2 to 3 days, but frequently takes 1 to 3 weeks, despite the administration of higher loading doses.The bioavailability of amiodarone varies in clinical studies, averaging between 35 and 65%. Effect of food In healthy subjects who were given a single 600-mg dose immediately after consuming a meal high in fat, the AUC of amiodarone increased by 2.3 and the Cmax by 3.8 times.Food also enhances absorption, reducing the Tmax by about 37%. |
|---|---|
| Half-life | The terminal half-life of amiodarone varies according to the patient, but is long nonetheless, and ranges from about 9-100 days. The half-life duration varies according to different sources. According to the prescribing information for amiodarone, the average apparent plasma terminal elimination half-life of amiodarone is of 58 days (ranging from 15 to 142 days). The terminal half-life range was between 14 to 75 days for the active metabolite, (DEA).The plasma half-life of amiodarone after one dose ranges from 3.2 to 79.7 hours, according to one source. |
| Protein binding | The protein binding of amiodarone is about 96%. |
| Metabolism | This drug is metabolized to the main metabolite desethylamiodarone (DEA)by the CYP3A4 and CYP2C8 enzymes. The CYP3A4 enzyme is found in the liver and intestines.A hydroxyl metabolite of DEA has been identified in mammals, but its clinical significance is unknown. |
| Route of elimination | Amiodarone is eliminated primarily by hepatic metabolism and biliary excretion.A small amount of desethylamiodarone (DEA) is found in the urine. |
| Volume of distribution | In a pharmacokinetic study of 3 healthy individuals and 3 patients diagnosed with supraventricular tachycardia (SVT), the volume of distribution was found to be 9.26-17.17 L/kg in healthy volunteers and 6.88-21.05 L/kg in the SVT patients.Prescribing information mentions that the volume of distribution of amiodarone varies greatly, with a mean distribution of approximately 60 L/kg. It accumulates throughout the body, especially in adipose tissueand highly vascular organs including the lung, liver, and spleen. One major metabolite of amiodarone, desethylamiodarone (DEA), is found in even higher proportions in the same tissues as amiodarone. |
| Clearance | The clearance of amiodarone after intravenous administration in patients with ventricular fibrillation and ventricular tachycardia ranged from 220 to 440 ml/hr/kg in one clinically study.Another study determined that the total body clearance of amiodarone varies from 0.10 to 0.77 L/min after one intravenous dose.Renal impairment does not appear to affect the clearance of amiodarone, but hepatic impairment may reduce clearance. Patients with liver cirrhosis exhibited significantly lower Cmax and mean amiodarone concentration for DEA, but not for amiodarone. Severe left ventricular dysfunction prolongs the half-life of DEA. A note on monitoring No guidelines have been developed for adjusting the dose of amiodarone in renal, hepatic, or cardiac abnormalities. In patients on chronic amiodarone treatment, close clinical monitoring is advisable, especially for elderly patients and those with severe left ventricular dysfunction. |
Formulation & handling
- Oral use is limited by very low aqueous solubility and high lipophilicity, so solid‑oral products typically require dissolution‑enhancing excipients.
- IV formulations rely on solubilizers/co‑solvents due to poor water solubility and require handling controls to avoid precipitation on dilution.
- Metabolism is CYP3A4‑sensitive, with grapefruit and St. John’s Wort affecting exposure, though food itself does not meaningfully impact absorption.
Regulatory status
| Lifecycle | The API’s U.S. market remains partially protected until the final patent expires in 2029, indicating a late‑stage but not fully mature lifecycle there. In Canada, where no active patents are listed, the market is likely already mature with potential generic presence. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Amiodarone is an established therapy originally developed by a small number of originator manufacturers, but its supply landscape is now dominated by numerous generic producers and repackagers. Branded and generic products are widely available in the US and Canada, indicating mature global market penetration. Core substance patents expired years ago, and remaining formulation‑related patents extending to 2029 do not limit the presence of broad generic competition already in the market. |
|---|
Safety
| Toxicity | The LD50 of oral amiodarone in mice and rats exceeds 3,000 mg/kg. An overdose with amiodarone can have a fatal outcome due to its potential to cause arrhythmia. Signs or symptoms of an overdose may include, hypotension, shock, bradycardia, AV block, and liver toxicity. In cases of an overdose, initiate supportive treatment and, if needed, use fluids, vasopressors, or positive inotropic agents. Temporary pacing may be required for heart block. Ensure to monitor liver function regularly. Amiodarone and its main metabolite, DEA, are not removable by dialysis. |
|---|
High Level Warnings:
- High oral LD50 (›3000 mg/kg in rodents) indicates low acute toxicity, but excessive exposure can precipitate severe cardiac arrhythmias, including bradycardia and AV block
- Overexposure may induce hypotension, cardiogenic shock, and hepatocellular injury
- The parent compound and its metabolite (DEA) are not dialyzable
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Amiodarone is a type of Other anti-arrhythmics
Others
Amiodarone (Other anti-arrhythmics), classified under Anti-arrhythmics
Anti-arrhythmics belong to the pharmaceutical API category designed to treat irregular heart rhythms, also known as arrhythmias. These medications work by targeting the electrical signals in the heart, helping to regulate the heart's rhythm and restore it to a normal, steady beat.
Anti-arrhythmics are crucial in managing various types of arrhythmias, such as atrial fibrillation, ventricular tachycardia, and supraventricular tachycardia. These conditions can pose serious risks, including an increased likelihood of stroke or heart failure. Hence, anti-arrhythmics play a vital role in improving patient outcomes and reducing these associated risks.
Pharmaceutical companies develop anti-arrhythmic APIs, which are the active ingredients used to formulate the final medications. These APIs undergo rigorous testing and quality control measures to ensure their safety, efficacy, and consistent performance. They are manufactured in accordance with Good Manufacturing Practices (GMP) guidelines to meet the highest quality standards.
Healthcare professionals prescribe anti-arrhythmics based on the specific arrhythmia type, severity, and individual patient factors. These APIs can be formulated into different dosage forms, including tablets, capsules, or intravenous solutions, depending on the desired route of administration and patient requirements.
It is important to note that anti-arrhythmics are prescription-only medications and should only be used under medical supervision. Patients using these medications must follow their healthcare provider's instructions and regularly monitor their heart rhythm to ensure optimal treatment effectiveness and minimize potential side effects.
In conclusion, anti-arrhythmics are a crucial category of pharmaceutical APIs used to treat various types of irregular heart rhythms. They are formulated into medications that help regulate the heart's electrical signals, reduce associated risks, and improve patient outcomes.
Amiodarone API manufacturers & distributors
Compare qualified Amiodarone API suppliers worldwide. We currently have 12 companies offering Amiodarone 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 |
|---|---|---|---|---|---|
| Arevipharma | Producer | Germany | Unknown | CEP, CoA, FDA | 25 products |
| AXXO GmbH | Distributor | Germany | European Union | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Cambrex | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, USDMF | 104 products |
| Isochem | Producer | France | France | CEP, CoA, FDA, GMP, JDMF, USDMF | 12 products |
| Piramal Healthcare | Producer | United Kingdom | India | CoA, GMP, WC | 31 products |
| Piramal Pharma Solutions | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 44 products |
| PMC Isochem | Producer | France | France | CoA, GMP | 7 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP | 93 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| SPC Life Sciences Pvt Ltd... | Producer | India | India | CoA | 5 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
| Zhejiang Hengkang Pharmac... | Producer | China | China | BSE/TSE, cDMF, CEP, CoA, EDMF/ASMF, GMP, JDMF, KDMF, MSDS, USDMF, WC | 31 products |
When sending a request, specify which Amiodarone 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 Amiodarone 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 Amiodarone API
Sourcing
What matters most when sourcing GMP-grade Amiodarone?
Key considerations include confirming GMP compliance and ensuring the API meets regulatory expectations for the US and Canada. Given the mature generic market, verifying supplier qualification, change‑control practices, and consistency of quality is essential. It is also important to assess supply reliability and transparency across repackagers and manufacturers.
Which documents are typically required when sourcing Amiodarone API?
Request the core API documentation set: CoA (12 companies), GMP (9 companies), CEP (8 companies), USDMF (6 companies), FDA (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Amiodarone API?
Known or reported manufacturers for Amiodarone: Sinoway industrial Co.,Ltd, Zhejiang Hengkang Pharmaceutical Co. Ltd, AXXO GmbH. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Amiodarone API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Amiodarone manufacturers?
Audit reports may be requested for Amiodarone: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Amiodarone API on Pharmaoffer?
Reported supplier count for Amiodarone: 12 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Amiodarone API?
Production countries reported for Amiodarone: China (3 producers), France (2 producers), India (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Amiodarone usually hold?
Common certifications for Amiodarone suppliers: CoA (12 companies), GMP (9 companies), CEP (8 companies), USDMF (6 companies), FDA (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Amiodarone (CAS 1951-25-3) used for?
Amiodarone is used to treat recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia that are refractory to or not tolerated with other antiarrhythmic therapies. In many regions it is also used for atrial fibrillation or supraventricular tachycardia, though these applications are generally off‑label. Its therapeutic effect is based on prolonging cardiac repolarization and reducing myocyte excitability to control serious arrhythmias.
Which therapeutic class does Amiodarone fall into?
Amiodarone belongs to the following therapeutic categories: Agents causing hyperkalemia, Agents Causing Muscle Toxicity, alpha-Galactosidase, antagonists & inhibitors, Antiarrhythmic agents, Antiarrhythmics, Class III. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Amiodarone mainly prescribed for?
The primary indications for Amiodarone: The FDA approved indications for Amiodarone are recurrent ventricular fibrillation (VF) and recurrent hemodynamically unstable ventricular tachycardia (VT), The FDA emphasizes that this drug should only be given in these conditions when they are clinically documented and have not responded to normal therapeutic doses of other antiarrhythmic agents, or when other drugs are not tolerated by the patient, Off-label indications include atrial fibrillation and supraventricular tachycardia. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Amiodarone work?
Amiodarone is considered a class III anti-arrhythmic drug. It blocks potassium currents that cause repolarization of the heart muscle during the third phase of the cardiac action potential. As a result Amiodarone increases the duration of the action potential as well as the effective refractory period for cardiac cells (myocytes). Therefore, cardiac muscle cell excitability is reduced, preventing and treating abnormal heart rhythms.
Unique from other members of the class III anti-arrhythmic drug class, Amiodarone also interferes with the functioning of beta-adrenergic receptors, sodium channels, and calcium channels channels. These actions, at times, can lead to undesirable effects, such as hypotension, bradycardia, and Torsades de pointes (TdP).In addition to the above, Amiodarone may increase activity of peroxisome proliferator-activated receptors, leading to steatogenic changes in the liver or other organs.Finally, Amiodarone has been found to bind to the thyroid receptor due to its iodine content, potentially leading to Amiodarone induced hypothyroidism or thyrotoxicosis.
What should someone know about the safety or toxicity profile of Amiodarone?
Amiodarone has low acute toxicity in animal studies, but excessive exposure can cause serious cardiac effects such as bradycardia, AV block, hypotension, and cardiogenic shock. Chronic use is linked to pulmonary toxicity, hepatic injury, thyroid dysfunction, and photosensitivity due to tissue accumulation and iodine content. QT prolongation with risk of Torsades de pointes is a key concern. The drug and its major metabolite are not dialyzable in overdose.
What are important formulation and handling considerations for Amiodarone as an API?
Amiodarone’s very low aqueous solubility and high lipophilicity require dissolution‑enhancing excipients in solid‑oral formulations to ensure adequate drug release. Intravenous products depend on solubilizers or co‑solvents, and care is needed during dilution to prevent precipitation. Handling should also account for its CYP3A4‑sensitive metabolism, as certain substances can alter exposure.
Is Amiodarone a small molecule?
Amiodarone is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Amiodarone?
Oral Amiodarone has notable stability considerations related to its very low aqueous solubility and high lipophilicity, which require dissolution‑enhancing excipients to maintain consistent performance. These properties can make dissolution sensitive to formulation design but are not described as causing unusual degradation pathways. Food does not adversely affect stability and primarily influences absorption. No additional special stability concerns beyond its solubility‑driven formulation needs are indicated in the provided context.
Regulatory
Where is Amiodarone approved or in use globally?
Amiodarone is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Amiodarone right now?
Amiodarone is described in the context as regulated for use in both the United States and Canada. No patent restrictions are indicated in the provided information, suggesting no active patent considerations within this context.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Amiodarone procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Amiodarone. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Amiodarone included in the PRO Data Insights coverage?
PRO Data Insights coverage for Amiodarone: 1208 verified transactions across 279 suppliers and 173 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Amiodarone?
Market report availability for Amiodarone: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
