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Bisoprolol | CAS No: 66722-44-9 | GMP-certified suppliers
A medication that helps manage hypertension and supports treatment of chronic heart failure, atrial fibrillation, and angina to improve overall cardiovascular stability for clinical use.
Therapeutic categories
Primary indications
- Bisoprolol is indicated for the treatment of mild to moderate hypertension
- It may be used off-label to treat heart failure, atrial fibrillation, and angina pectoris
Product Snapshot
- Oral small‑molecule beta‑blocker supplied primarily as film‑coated tablets
- Used for hypertension with additional use in rate‑control and ischemia management contexts
- Approved in major regulated markets including the US and Canada
Clinical Overview
Bisoprolol reduces heart rate and myocardial contractility, leading to a decrease in cardiac output and blood pressure. Clinical data demonstrate reductions in cardiovascular and all‑cause mortality in patients with heart failure and reduced ejection fraction. The antihypertensive effect is primarily linked to competitive antagonism of beta‑1 receptors in cardiac tissue, dampening the hemodynamic response to endogenous catecholamines and lowering myocardial oxygen demand.
Additional mechanisms may contribute to therapeutic action, including reduced renin release from the kidneys and diminished sympathetic nervous system output from central pathways. These combined effects support favorable hemodynamic modulation in chronic cardiovascular disease.
Bisoprolol shows a long half‑life that permits once‑daily dosing. It is a substrate of CYP3A and is also characterized as a P‑glycoprotein substrate and inhibitor. Renal elimination plays a significant role in overall clearance. These attributes support predictable exposure but warrant attention to drug–drug interactions involving CYP3A and transporter pathways, as well as dose adjustments in renal impairment.
Safety considerations include bradycardia, hypotension, fatigue, and potential exacerbation of conduction abnormalities. Due to its beta‑1 selectivity, respiratory adverse effects are less frequent than with nonselective beta‑blockers, though caution remains appropriate in bronchospastic disease. Hyperkalemia has been reported in association with the pharmacologic class.
Bisoprolol is available globally under multiple brand and generic products used in hypertension and heart failure management.
For API procurement, sourcing should prioritize manufacturers with validated control of stereochemistry, impurity profile, and residual solvent levels, along with evidence of consistent beta‑1 selectivity and compliance with regional pharmacopoeial standards.
Identification & chemistry
| Generic name | Bisoprolol |
|---|---|
| Molecule type | Small molecule |
| CAS | 66722-44-9 |
| UNII | Y41JS2NL6U |
| DrugBank ID | DB00612 |
Pharmacology
| Summary | Bisoprolol is a cardioselective beta‑1 adrenergic antagonist that lowers cardiac output by inhibiting beta‑1 receptor–mediated increases in heart rate and contractility. It also reduces renin release and may attenuate central sympathetic outflow, contributing to decreased blood pressure. Its pharmacodynamic profile is characterized by reduced chronotropy, inotropy, and overall cardiac workload. |
|---|---|
| Mechanism of action | Though the mechanism of action of bisoprolol has not been fully elucidated in hypertension, it is thought that therapeutic effects are achieved through the antagonism of β-1adrenoceptors to result in lower cardiac output. Bisoprolol is a competitive, cardioselective β1-adrenergic antagonist. When β1-receptors (located mainly in the heart)are activated by adrenergic neurotransmitters such as epinephrine, both the blood pressure and heart rate increase, leading to greater cardiovascular work, increasing the demand for oxygen. Bisoprolol reduces cardiac workload by decreasing contractility and the need for oxygen through competitive inhibition of β1-adrenergic receptors. Bisoprolol is also thought to reduce the output of renin in the kidneys, which normally increases blood pressure. Additionally, some central nervous system effects of bisoprolol may include diminishing sympathetic nervous system output from the brain, decreasing blood pressure and heart rate. |
| Pharmacodynamics | Bisoprolol decreases heart rate (chronotropy), decreases contractility (inotropy), and reduces blood pressure.The results of various clinical studies indicate that bisoprolol reduces cardiovascular mortality and all-cause mortality in patients with heart failure and decreased cardiac ejection fraction (EF). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Beta-1 adrenergic receptor | Humans | antagonist |
| Beta-2 adrenergic receptor | Humans | antagonist |
ADME / PK
| Absorption | Bisoprolol is well absorbed in the gastrointestinal tract.The AUC is 642.87 g.hr/mL and bioavailability of bisoprolol is about 90% due to the minimal first pass effects.Absorption is unaffected by food intake. Peak plasma concentrations of bisoprolol are attained within 2-4 hours and steady-state concentrations are achieved within 5 days of administration.In a pharmacokinetic study, the mean peak concentration of bisoprolol was 52 micrograms/L.Cmax at steady state concentrations of bisoprolol is 64±21 ng/ml administered at 10 mg daily. |
|---|---|
| Half-life | A pharmacokinetic study in 12 healthy individuals determined the mean plasma half-life of bisoprolol to be 10-12 hours.Another study comprised of healthy patients determined the elimination half-life to be approximately 10 hours.Renal impairment increased the half-life to 18.5 hours. |
| Protein binding | Binding to serum proteins is approximately 30%. |
| Metabolism | Approximately 50% of the bisoprolol dose is eliminated by non-renal pathways. Bisoprolol is metabolized through oxidative metabolic pathways with no subsequent conjugation. Bisoprolol metabolites are polar and, therefore, really eliminated. Major metabolites found in plasma and urine are inactive. Bisoprolol is mainly metabolized by CYP3A4 (95%), whereas CYP2D6 plays a minor role. The CYP3A4-mediated metabolism of bisoprolol appears to be non-stereoselective. |
| Route of elimination | Bisoprolol is eliminated equally by both renal and hepatic pathways. About 50% of an oral dose is excreted unchanged in the urine with the remainder of the dose excreted as inactive bisoprolol metabolites. Under 2% of the ingested dose is found to be excreted in the feces. |
| Volume of distribution | The volume of distribution of bisoprolol is 3.5 L/kg.The mean volume of distribution was found to be 230 L/kg in heart failure patients, which was similar to the volume of distribution in healthy patients.Bisoprolol is known to cross the placenta. |
| Clearance | Total body clearance in healthy patients was determined to be 14.2 L/h. In patients with renal impairment, clearance was reduced to 7.8 L/h. Hepatic dysfunction also reduced the clearance of bisoprolol. |
Formulation & handling
- Oral small‑molecule API suitable for conventional tablet formulations, with no food‑dependent absorption considerations.
- Low aqueous solubility may require standard solubility‑enhancing excipients or particle‑size control for consistent dissolution.
- Solid, moderately lipophilic material (LogP ~2.2) handled using routine controls to prevent dust generation and ensure uniform blending.
Regulatory status
| Lifecycle | Patent expiry in the US and Canada typically marks a transition to a mature stage, with increased generic entry and price competition. The API’s lifecycle in these markets is therefore characterized by post‑expiry market stabilization and established availability. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Bisoprolol’s supply landscape is dominated by multiple generic manufacturers and packagers, reflecting a fully mature, post‑patent market with no single active originator presence in current listings. Branded and authorized‑generic products are available in the US and Canada, indicating established global distribution in major regulated markets. Patent expiry occurred years ago, so widespread generic competition is already well established. |
|---|
Safety
| Toxicity | LD50 information Oral LD50 of bisoprolol in the mouse was 730 mg/kg. Overdose information Signs of a β-blocker overdose include cardiovascular symptoms such as hypotension, congestive heart failure, and bradycardia. Other symptoms such as bronchospasm, and hypoglycemia may occur. If an overdose occurs with bisoprolol, supportive treatment should be initiated. Glucagon has been shown to be beneficial in bradycardia and hypotension associated with beta-blocker overdosage.Hypoglycemia may be managed by administering IV glucose.Monitor the patient and administer atropine in cases of bradycardia, pressors and fluids in the case of hypotension, and conventional heart failure therapy if heart failure occurs. If heart block occurs, the patient must be closely monitored and isoproterenol infusion or transvenous cardiac pacemaker insertion should take place.For the management of overdose-related bronchospasm, administer bronchodilators with or without IV aminophylline. Limited research suggests that bisoprolol fumarate is not removed adequately by hemodialysis sessions. |
|---|
- Oral LD50 in mice is 730 mg/kg, indicating moderate acute toxicity and the need for controlled handling to limit ingestion exposure
- Β‑blocker class effects may include severe cardiovascular depression (hypotension, bradycardia, heart block) under excessive exposure, requiring appropriate facility-level monitoring protocols
- Limited dialyzability and potential for bronchospasm or hypoglycemic effects highlight the importance of strict containment and exposure‑prevention measures during manufacturing and processing
Bisoprolol is a type of Beta blockers
Beta blockers are a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the medical field. These medications work by blocking the effects of adrenaline and other stress hormones on the beta receptors in the body. This action helps to reduce the heart rate and blood pressure, making them effective in treating various cardiovascular conditions.
Beta blockers are commonly prescribed to manage conditions such as hypertension (high blood pressure), angina (chest pain), arrhythmias (irregular heart rhythms), and certain types of heart failure. They can also be used in the prevention of migraines and to alleviate symptoms associated with anxiety disorders.
By targeting the beta receptors, these APIs provide a significant impact on the sympathetic nervous system, reducing the fight-or-flight response and promoting a state of calmness. This mechanism of action allows beta blockers to be effective in controlling heart-related conditions.
Some well-known beta blockers include metoprolol, propranolol, atenolol, and carvedilol. These APIs are available in various forms such as tablets, capsules, and injectables, allowing for flexibility in administration and dosage.
It is important to note that the use of beta blockers should be done under medical supervision due to potential side effects and contraindications. Common side effects may include fatigue, dizziness, cold hands and feet, and sexual dysfunction. Patients with certain conditions like asthma or diabetes may require cautious monitoring while using beta blockers.
In conclusion, beta blockers are a vital subcategory of pharmaceutical APIs used to treat cardiovascular conditions by blocking the effects of stress hormones. Their effectiveness and versatility make them a valuable tool in managing various medical conditions, enhancing the well-being of patients.
Bisoprolol (Beta 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.
Bisoprolol API manufacturers & distributors
Compare qualified Bisoprolol API suppliers worldwide. We currently have 22 companies offering Bisoprolol API, with manufacturing taking place in 10 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, USDMF | 25 products |
| AXXO GmbH | Distributor | Germany | European Union | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Corden Pharma | Producer | Germany | France | CoA, GMP, USDMF | 45 products |
| Easton Biopharmaceuticals | Producer | China | China | CoA, JDMF | 3 products |
| Evonik TC | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 7 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP, USDMF | 35 products |
| Harman Finochem | Producer | India | India | CEP, CoA, FDA, GMP, WC | 34 products |
| Ipca Labs. | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 69 products |
| Kinsy | Producer | Spain | Spain | CEP, CoA, GMP | 9 products |
| Medilux Labs | Producer | India | India | CEP, CoA | 10 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF, USDMF | 50 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 |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sichuan Qingmu Pharmaceut... | Producer | China | China | CEP, CoA, GMP, MSDS, USDMF, WC | 31 products |
| Suanfarma | Distributor | Spain | Spain | CEP, CoA, FDA, GDP, GMP, ISO9001, USDMF | 13 products |
| Synkem | Producer | France | France | CEP, CoA, FDA, GMP | 4 products |
| Taiwan Biotech | Producer | Taiwan | Taiwan | CEP, CoA, USDMF | 1 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 62 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 140 products |
When sending a request, specify which Bisoprolol 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 Bisoprolol 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 Bisoprolol API
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Technical
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Regulatory
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