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Produced in
India|
Employees: 19
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Audit Report:
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CoAAll certificates
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CoA
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Employees: 25
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Audit Report:
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India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
coa
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coa
Producer
Produced in
China|
Audit Report:
Certifications:
USDMF
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CoAAll certificates
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
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Producer
Produced in
China|
Audit Report:
Certifications:
GMP
|
FDA|
USDMF|
EDMF/ASMF|
CoAAll certificates
GMP
FDA
USDMF
EDMF/ASMF
CoA
Producer
Produced in
India|
Employees: 10000
|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
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Producer
Produced in
China|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Distributor
Produced in
China|
Audit Report:
Certifications:
coa
All certificates
coa
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Ivabradine | CAS No: 155974-00-8 | GMP-certified suppliers
A medication that supports adult and pediatric patients with stable symptomatic chronic or dilated cardiomyopathy‑related heart failure by helping reduce the risk of worsening disease and hospitalization.
Therapeutic categories
BenzazepinesBradycardia-Causing AgentsCardiac TherapyCardiovascular AgentsCytochrome P-450 CYP3A SubstratesCytochrome P-450 CYP3A4 Substrates
Generic name
Ivabradine
Molecule type
small molecule
CAS number
155974-00-8
DrugBank ID
DB09083
Approval status
Approved drug
ATC code
C01EB17
Primary indications
- Ivabradine is indicated by the FDA to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤35%, who are in sinus rhythm with resting heart rate ≥70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use
- It is also indicated for treatment of stable symptomatic heart failure as a result of dilated cardiomyopathy for pediatric patients 6 months of age or more[FDA Label]
Product Snapshot
- Ivabradine is an oral small‑molecule product available mainly as tablets and solution formulations
- It is used for chronic heart failure applications in adult and pediatric patient populations
- It holds approved status in the US, EU, and Canada
Clinical Overview
Ivabradine (CAS 155974-00-8) is a benzazepine-class heart rate–lowering agent indicated for reducing the risk of hospitalization due to worsening chronic heart failure in adults with left ventricular ejection fraction ≤35% who remain in sinus rhythm with a resting heart rate of at least 70 beats per minute. It is also approved for stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients six months of age or older. In clinical practice, it provides rate control without the negative inotropic effects associated with beta blockers or non‑dihydropyridine calcium channel blockers.
Its pharmacology is defined by selective inhibition of hyperpolarization‑activated cyclic nucleotide–gated If channels in the sinoatrial node. By binding from the intracellular side to the channel pore, ivabradine decreases the If current, prolongs diastolic depolarization, and lowers pacemaker firing frequency. This reduces heart rate and myocardial oxygen demand while preserving myocardial contractility and atrioventricular conduction.
Ivabradine shows use‑dependent activity because If channels open during repolarization; thus, drug effect increases at higher intrinsic heart rates. Heart rate reduction is dose dependent up to approximately 30–40 mg daily, above which plasma concentrations plateau. Its active metabolite contributes to the overall bradycardic action.
Ivabradine is a substrate of CYP3A4, and exposure is influenced by strong inhibitors or inducers. It undergoes hepatic metabolism, with biliary and renal elimination of metabolites. Key safety considerations include dose‑related bradycardia, sinus node dysfunction, and QTc prolongation potential. Visual phenomena such as transient luminous effects may occur due to If channel expression in retinal cells. Use may require caution in combination with other QT‑prolonging agents or potent CYP3A4 modulators.
Corlanor is a commonly referenced brand in major markets.
For API procurement, sourcing should emphasize control of stereochemical purity, process‑related impurities, and residual solvent profiles, with verification against compendial specifications and assessment of supplier GMP compliance.
Its pharmacology is defined by selective inhibition of hyperpolarization‑activated cyclic nucleotide–gated If channels in the sinoatrial node. By binding from the intracellular side to the channel pore, ivabradine decreases the If current, prolongs diastolic depolarization, and lowers pacemaker firing frequency. This reduces heart rate and myocardial oxygen demand while preserving myocardial contractility and atrioventricular conduction.
Ivabradine shows use‑dependent activity because If channels open during repolarization; thus, drug effect increases at higher intrinsic heart rates. Heart rate reduction is dose dependent up to approximately 30–40 mg daily, above which plasma concentrations plateau. Its active metabolite contributes to the overall bradycardic action.
Ivabradine is a substrate of CYP3A4, and exposure is influenced by strong inhibitors or inducers. It undergoes hepatic metabolism, with biliary and renal elimination of metabolites. Key safety considerations include dose‑related bradycardia, sinus node dysfunction, and QTc prolongation potential. Visual phenomena such as transient luminous effects may occur due to If channel expression in retinal cells. Use may require caution in combination with other QT‑prolonging agents or potent CYP3A4 modulators.
Corlanor is a commonly referenced brand in major markets.
For API procurement, sourcing should emphasize control of stereochemical purity, process‑related impurities, and residual solvent profiles, with verification against compendial specifications and assessment of supplier GMP compliance.
Identification & chemistry
| Generic name | Ivabradine |
|---|---|
| Molecule type | Small molecule |
| CAS | 155974-00-8 |
| UNII | 3H48L0LPZQ |
| DrugBank ID | DB09083 |
Pharmacology
| Summary | Ivabradine selectively inhibits hyperpolarization‑activated If channels in sinoatrial node cells, slowing diastolic depolarization and reducing pacemaker firing rate. This targeted modulation of HCN2-mediated currents lowers heart rate and decreases myocardial oxygen demand, with activity that increases at higher intrinsic rates due to use‑dependent channel binding. Its active metabolite contributes additional If‑current suppression, reinforcing the overall heart‑rate–lowering effect. |
|---|---|
| Mechanism of action | Ivabradine lowers heart rate by selectively inhibiting If channels ("funny channels") in the heart in a concentration-dependent manner without affecting any other cardiac ionic channels (including calcium or potassium). Ivabradine binds by entering and attaching to a site on the channel pore from the intracellular side and disrupts If ion current flow, which prolongs diastolic depolarization, lowering heart rate. The If currents are located in the sinoatrial node and are the home of all cardiac pacemaker activity. Ivabradine therefore lowers the pacemaker firing rate, consequently lowering heart rate and reducing myocardial oxygen demand. This allows for an improved oxygen supply and therefore mitigation of ischemia, allowing for a higher exercise capacity and reduction in angina episodes. |
| Pharmacodynamics | The funny channels (If) open during repolarization and close during depolarization, making ivabradine's activity dependent on heart rate or the closing and opening of the channels. Therefore ivabradine exhibits use-dependence and is more pharmacologically active at higher heart rates. Ivabradine exhibits a linear dose-dependent heart-rate lowering activity (bradycardic effect) until a maximum dose of 30-40mg. At higher doses, the concentration of ivabradine tends to plateau, reducing risk of serious sinus bradycardia. It has been shown that the metabolite of ivabradine lowers heart rate as well, contributing to ivabradine's overall effect. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 2 | Humans | inhibitor |
ADME / PK
| Absorption | It is recommended to take ivabradine with food to reduce variability in systemic exposure. Administration with food slows absorption by 1 hour, but increases systemic absorption by 20-30%. Ivabradine's oral bioavailability is about 40%. |
|---|---|
| Half-life | 2 hours. |
| Protein binding | 70% bound to plasma proteins. |
| Metabolism | Ivabradine is extensively metabolized by oxidation in the gut and liver by cytochrome P450 3A4 enzyme. Its active metabolite, N-desmethylated derivative, is also metabolized by CYP 3A4. Ivabradine's affinity for CYP 3A4 is low, making it unlikely to affect the metabolism of other drugs; however potent inhibitors or inducers of CYP 3A4 may affect ivabradine's plasma concentration and pharmacodynamic effects and should not be co-administered. |
| Route of elimination | Metabolites are equally excreted in feces and urine. |
| Volume of distribution | ~100 L. |
| Clearance | Total clearance is about 400ml/min; renal clearance about 70ml/min. About 4% is excreted unchanged in urine. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, often requiring solubility‑enhancing strategies for tablet and solution formulations.
- Solid-state stability is generally good, but light and moisture control may be needed during handling and compression due to its benzazepine structure.
- Formulation and labeling should account for known grapefruit interaction, which may affect product use conditions.
Regulatory status
| Lifecycle | The API is approaching late‑stage market maturity, with key U.S. patents expiring in August 2026. Given established availability in the US, EU, and Canada, the market is positioned for increased generic competition as these protections lapse. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Ivabradine is supplied by a single originator manufacturer, with branded products marketed across major regions including the US, EU, and Canada. Its U.S. patents expire in 2026, indicating that generic entry is expected soon where not already available in other regions. The current landscape is therefore transitioning from exclusively originator‑led supply toward potential multi‑source competition. |
|---|
Safety
| Toxicity | Ivabradine may cause fetal toxicity when administered to pregnant women. Animal studies in pregnant rats have shown embryo-fetal toxicity and cardiac teratogenic effects. Effective contraception in women is recommended while using ivabradine. |
|---|
High Level Warnings:
- Embryo‑fetal toxicity documented in animal models, including cardiac teratogenicity observed in rat studies
- Classified as a developmental hazard
- Compounds should be handled to prevent exposure of pregnant personnel
Ivabradine is a type of Anti-anginal agents
Anti-anginal agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) used for the treatment of angina, a condition characterized by chest pain or discomfort caused by reduced blood flow to the heart muscle. These APIs target the underlying cause of angina, which is often related to insufficient blood supply to the heart.
One commonly used anti-anginal agent is nitroglycerin, which belongs to the class of organic nitrates. Nitroglycerin works by dilating blood vessels, including the coronary arteries that supply blood to the heart. This dilation improves blood flow to the heart, relieving chest pain and reducing the workload on the heart.
Another class of anti-anginal agents is calcium channel blockers (CCBs). CCBs inhibit the movement of calcium ions into heart muscle cells and blood vessel walls. By doing so, they relax and widen blood vessels, enhancing blood flow to the heart and reducing the frequency and severity of angina episodes.
Beta blockers are also commonly used in the treatment of angina. These agents block the effects of adrenaline and other stress hormones on the heart, resulting in reduced heart rate and blood pressure. By slowing down the heart's activity, beta blockers decrease the demand for oxygen and reduce angina symptoms.
Anti-anginal agents play a crucial role in managing angina, providing relief to patients and improving their quality of life. It is important to consult with healthcare professionals for proper diagnosis, prescription, and usage of these pharmaceutical APIs to ensure safe and effective treatment of angina.
Ivabradine API manufacturers & distributors
Compare qualified Ivabradine API suppliers worldwide. We currently have 11 companies offering Ivabradine API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Beijing Huikang Boyuan | Producer | China | China | CoA, USDMF | 10 products |
| Biocon | Producer | India | India | CoA, GMP, WC | 36 products |
| Fuxing Long Rui Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Drugs | Producer | India | India | CoA, USDMF | 98 products |
| Ind-Swift Labs. | Producer | India | India | CoA, GMP, WC | 27 products |
| Maithri Labs. | Producer | India | India | CoA, USDMF | 5 products |
| Menovo | Producer | China | China | CoA, EDMF/ASMF, FDA, GMP, USDMF | 27 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Utopharm (Shanghai) Compa... | Producer | China | China | CoA | 12 products |
When sending a request, specify which Ivabradine 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 Ivabradine 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 Ivabradine API
Sourcing
What matters most when sourcing GMP-grade Ivabradine?
When sourcing GMP‑grade Ivabradine, confirm compliance with US, EU, and Canadian regulatory requirements. Given the current single‑originator supply, verify the manufacturer’s GMP status and consistency of quality documentation. Patent expiry in the US in 2026 signals a shift toward potential multi‑source supply, so monitoring changes in availability and regulatory filings is essential.
Which documents are typically required when sourcing Ivabradine API?
Request the core API documentation set: CoA (11 companies), USDMF (5 companies), GMP (5 companies), FDA (3 companies), WC (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Ivabradine API?
Known or reported manufacturers for Ivabradine: Global Pharma Tek, SETV Global. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Ivabradine 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 Ivabradine manufacturers?
Audit reports may be requested for Ivabradine: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Ivabradine API on Pharmaoffer?
Reported supplier count for Ivabradine: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Ivabradine API?
Production countries reported for Ivabradine: India (6 producers), China (5 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Ivabradine usually hold?
Common certifications for Ivabradine suppliers: CoA (11 companies), USDMF (5 companies), GMP (5 companies), FDA (3 companies), WC (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Ivabradine (CAS 155974-00-8) used for?
Ivabradine is used to lower heart rate in adults with chronic heart failure and reduced left ventricular ejection fraction who are in sinus rhythm with a resting heart rate of at least 70 beats per minute. It is also indicated for stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients six months of age or older. By selectively inhibiting If channels in the sinoatrial node, it reduces pacemaker activity and myocardial oxygen demand without affecting cardiac contractility.
Which therapeutic class does Ivabradine fall into?
Ivabradine belongs to the following therapeutic categories: Benzazepines, Bradycardia-Causing Agents, Cardiac Therapy, Cardiovascular Agents, Cytochrome P-450 CYP3A Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Ivabradine mainly prescribed for?
The primary indications for Ivabradine: Ivabradine is indicated by the FDA to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤35%, who are in sinus rhythm with resting heart rate ≥70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use, It is also indicated for treatment of stable symptomatic heart failure as a result of dilated cardiomyopathy for pediatric patients 6 months of age or more[FDA Label]. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Ivabradine work?
Ivabradine lowers heart rate by selectively inhibiting If channels ("funny channels") in the heart in a concentration-dependent manner without affecting any other cardiac ionic channels (including calcium or potassium). Ivabradine binds by entering and attaching to a site on the channel pore from the intracellular side and disrupts If ion current flow, which prolongs diastolic depolarization, lowering heart rate. The If currents are located in the sinoatrial node and are the home of all cardiac pacemaker activity. Ivabradine therefore lowers the pacemaker firing rate, consequently lowering heart rate and reducing myocardial oxygen demand. This allows for an improved oxygen supply and therefore mitigation of ischemia, allowing for a higher exercise capacity and reduction in angina episodes.
What should someone know about the safety or toxicity profile of Ivabradine?
Ivabradine’s safety profile is characterized by dose‑related bradycardia, sinus node dysfunction, and a potential for QTc prolongation, which may be accentuated by coadministration with other QT‑prolonging agents or strong CYP3A4 modulators. Transient luminous visual phenomena can occur due to If channel activity in retinal cells. Embryo‑fetal toxicity, including cardiac teratogenicity in animal studies, classifies the compound as a developmental hazard and warrants precautions to prevent exposure of pregnant personnel. Handling of the API should follow controls that limit exposure to impurities and ensure compliance with GMP standards.
What are important formulation and handling considerations for Ivabradine as an API?
Ivabradine’s low aqueous solubility often requires solubility‑enhancing approaches such as appropriate solid dispersion or excipient selection to ensure reliable dissolution in oral formulations. Light and moisture control during handling, granulation, and compression is important to maintain solid‑state stability. Because systemic exposure is influenced by food and CYP3A4 interactions, formulation and labeling should support consistent administration conditions and note the grapefruit interaction. Its sensitivity to strong CYP3A4 modifiers should also be considered when defining product use instructions.
Is Ivabradine a small molecule?
Ivabradine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Ivabradine?
Oral Ivabradine has generally good solid‑state stability, but exposure to light and moisture should be controlled during handling and tablet compression due to its benzazepine structure. Its low aqueous solubility may require solubility‑enhancing formulation approaches to maintain consistent performance. Finished products should also account for the known grapefruit interaction, which may influence labeling and use conditions.
Regulatory
Where is Ivabradine approved or in use globally?
Ivabradine is reported as approved in the following major regions: US, EU, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Ivabradine right now?
Ivabradine is regulated for use in the United States, European Union, and Canada, where its quality, safety, and manufacturing are overseen by the respective health authorities. Patent protection and exclusivities depend on jurisdiction and product-specific filings, and can vary across these regions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Ivabradine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Ivabradine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Ivabradine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Ivabradine: 1012 verified transactions across 320 suppliers and 195 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Ivabradine?
Market report availability for Ivabradine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
