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Risperidone | CAS No: 106266-06-2 | GMP-certified suppliers
A medication that supports management of schizophrenia, acute manic or mixed episodes in bipolar I disorder, and irritability associated with autistic disorder across key global markets.
Therapeutic categories
Primary indications
- Risperidone is indicated for the treatment of schizophrenia and irritability associated with autistic disorder
- It is also indicated as monotherapy, or adjunctly with lithium or valproic acid, for the treatment of acute mania or mixed episodes associated with bipolar I disorder
- Risperidone is additionally indicated in Canada for the short-term symptomatic management of aggression or psychotic symptoms in patients with severe dementia of the Alzheimer type unresponsive to nonpharmacological approaches
Product Snapshot
- Risperidone is an oral small‑molecule antipsychotic available in multiple solid and liquid forms, with long‑acting intramuscular and subcutaneous injectable suspensions also widely used
- It is used for schizophrenia, bipolar I acute mania or mixed episodes, irritability in autistic disorder, and in Canada for short‑term management of aggression or psychotic symptoms in severe Alzheimer‑type dementia
- It is approved in the US, EU, and Canada, with established regulatory status across these markets
Clinical Overview
Risperidone is the parent compound of paliperidone, its primary active metabolite. It is structurally classified as a pyridopyrimidine, comprising a fused pyridine and pyrimidine ring system.
Pharmacologically, risperidone reduces dopaminergic and serotonergic pathway activity in central mesolimbic and mesocortical circuits. It displays high affinity for 5‑HT2A receptors and moderate, transient affinity for D2 receptors. Clinical response correlates with approximately 60 to 70 percent D2 receptor occupancy, while rapid dissociation from these receptors is associated with a lower risk of extrapyramidal symptoms relative to first‑generation antipsychotics. Blockade of 5‑HT2A receptors contributes to attenuation of negative symptoms and may indirectly mitigate extrapyramidal effects by enhancing frontal cortical dopamine release. Risperidone also antagonizes alpha‑1, alpha‑2, and histamine H1 receptors, which may influence both therapeutic and adverse effects.
Risperidone is metabolized to 9‑hydroxyrisperidone primarily via CYP2D6, with contributions from CYP3A pathways. Both parent drug and metabolite contribute to pharmacologic activity. It is a substrate of P‑glycoprotein. Elimination occurs through hepatic metabolism followed by renal excretion.
Safety considerations include dose‑related extrapyramidal symptoms, hyperprolactinemia, orthostatic hypotension, weight gain, metabolic changes, and potential QTc prolongation. Risperidone may lower the seizure threshold and has been associated with neuroleptic malignant syndrome. Serotonergic interactions are possible when combined with other serotonergic agents.
For API procurement, sourcing should ensure control of polymorphic form, residual solvents, and impurities, including limits on process‑related and genotoxic species, with full compliance to applicable pharmacopeial and ICH quality standards.
Identification & chemistry
| Generic name | Risperidone |
|---|---|
| Molecule type | Small molecule |
| CAS | 106266-06-2 |
| UNII | L6UH7ZF8HC |
| DrugBank ID | DB00734 |
Pharmacology
| Summary | Risperidone primarily modulates central dopaminergic and serotonergic signaling through antagonism of D2 and 5‑HT2A receptors, mechanisms associated with reducing positive and negative symptoms of schizophrenia and related mood disturbances. Its higher affinity for 5‑HT2A receptors and moderate, rapidly reversible D2 binding help balance neurotransmission while limiting excessive dopaminergic blockade. The drug also interacts with alpha‑adrenergic and H1 receptors, contributing additional but less well‑defined pharmacodynamic effects. |
|---|---|
| Mechanism of action | Though its precise mechanism of action is not fully understood, current focus is on the ability of risperidone to inhibit the D2 dopaminergic receptors and 5-HT2A serotonergic receptors in the brain. Schizophrenia is thought to result from an excess of dopaminergic D2 and serotonergic 5-HT2A activity, resulting in overactivity of central mesolimbic pathways and mesocortical pathways, respectively. D2 dopaminergic receptors are transiently inhibited by risperidone, reducing dopaminergic neurotransmission, therefore decreasing positive symptoms of schizophrenia, such as delusions and hallucinations.Risperidone binds transiently and with loose affinity to the dopaminergic D2 receptor, with an ideal receptor occupancy of 60-70% for optimal effect.Rapid dissociation of risperidone from the D2 receptors contributes to decreased risk of extrapyramidal symptoms (EPS), which occur with permanent and high occupancy blockade of D2 dopaminergic receptors.Low-affinity binding and rapid dissociation from the D2 receptor distinguish risperidone from the traditional antipsychotic drugs. A higher occupancy rate of D2 receptors is said to increase the risk of extrapyramidal symptoms and is therefore to be avoided. Increased serotonergic mesocortical activity in schizophrenia results in negative symptoms, such as depression and decreased motivation. The high-affinity binding of risperidone to 5-HT2A receptors leads to a decrease in serotonergic activity. In addition, 5-HT2A receptor blockade results in decreased risk of extrapyramidal symptoms, likely by increasing dopamine release from the frontal cortex, and not the nigrostriatal tract. Dopamine level is therefore not completely inhibited.Through the above mechanisms, both serotonergic and D2 blockade by risperidone are thought to synergistically work to decrease the risk of extrapyramidal symptoms. Risperidone has also been said to be an antagonist of alpha-1 (α1), alpha-2 (α2), and histamine (H1) receptors.Blockade of these receptors is thought to improve symptoms of schizophrenia, however the exact mechanism of action on these receptors is not fully understood at this time. |
| Pharmacodynamics | The primary action of risperidone is to decrease dopaminergic and serotonergic pathway activity in the brain, therefore decreasing symptoms of schizophrenia and mood disorders. Risperidone has a high binding affinity for serotonergic 5-HT2A receptors when compared to dopaminergic D2 receptors in the brain.Risperidone binds to D2 receptors with a lower affinity than first-generation antipsychotic drugs, which bind with very high affinity. A reduction in extrapyramidal symptoms with risperidone, when compared to its predecessors, is likely a result of its moderate affinity for dopaminergic D2 receptors. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| Dopamine D2 receptor | Humans | antagonist |
| Alpha-1B adrenergic receptor | Humans | antagonist |
ADME / PK
| Absorption | Well absorbed. The absolute oral bioavailability of risperidone is 70% (CV=25%). The relative oral bioavailability of risperidone from a tablet is 94% (CV=10%) when compared to a solution. |
|---|---|
| Half-life | 3 hours in extensive metabolizers Up to 20 hours in poor metabolizers |
| Protein binding | Risperidone and its active metabolite, 9-hydroxyrisperidone, are ~88% and ~77% protein-bound in human plasma, respectively.They each bind to both serum albumin and alpha-1-acid glycoprotein. |
| Metabolism | Extensively metabolized by hepatic cytochrome P450 2D6 isozyme to 9-hydroxyrisperidone (i.e. [paliperidone]), which has approximately the same receptor binding affinity as risperidone.Hydroxylation is dependent on debrisoquine 4-hydroxylase and metabolism is sensitive to genetic polymorphisms in debrisoquine 4-hydroxylase.Risperidone also undergoes N-dealkylation to a lesser extent. |
| Route of elimination | Risperidone is extensively metabolized in the liver. In healthy elderly subjects, renal clearance of both risperidone and 9-hydroxyrisperidone was decreased, and elimination half-lives are prolonged compared to young healthy subjects. |
| Volume of distribution | The volume of distribution of risperidone is approximately 1 to 2 L/kg. |
| Clearance | Risperidone is cleared by the kidneys. Clearance is decreased in the elderly and those with a creatinine clearance (ClCr) between 15-59 mL/min, in whom clearance is decreased by approximately 60%. |
Formulation & handling
- Oral formulations rely on a small‑molecule API with low aqueous solubility, benefiting from solid‑state control and solubility‑enhancing excipients for reliable absorption.
- Extended‑release intramuscular and subcutaneous products require stable depot‑forming suspensions or lyophilized powders with controlled reconstitution and particle-size management.
- Food has minimal impact on absorption, allowing flexible administration without special fed/fasted considerations.
Regulatory status
| Lifecycle | Most patent protections in the United States and Canada expired between 2013 and 2021, indicating the API is in a late lifecycle stage with established generic availability. With presence across Canada, the EU, and the US, the product is marketed in mature, well‑genericsed regions. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Risperidone was originally developed by an originator company within the Janssen/Ortho‑McNeil group, but the current supply landscape is dominated by a broad set of global generic manufacturers and repackagers across North America, Europe, and India. Branded and generic products are widely available in the US, EU, and Canada. Key patents in the US and Canada have expired, supporting the extensive generic competition already present in the market. |
|---|
Safety
| Toxicity | Symptoms of overdose include lethargy, dystonia/spasm, tachycardia, bradycardia, and seizures. LD<sub>50</sub>=57.7 mg/kg (rat, oral) and 34 mg/kg (rat, intravenous). |
|---|
- Overdose may produce CNS and autonomic effects including lethargy, dystonia or muscle spasms, heart‑rate abnormalities (tachycardia or bradycardia), and seizures
- Acute toxicity is moderate to high, with reported LD50 values of 57
- 7 mg/kg (rat, oral) and 34 mg/kg (rat, IV), indicating increased hazard with parenteral exposure
Risperidone is a type of Atypical antipsychotics
Atypical antipsychotics belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various mental disorders, particularly schizophrenia and bipolar disorder. These medications are designed to alleviate the symptoms of psychosis by targeting specific neuroreceptors in the brain.
Unlike traditional antipsychotics, atypical antipsychotics exhibit a different pharmacological profile, providing a more favorable side effect profile and improved efficacy. These medications primarily act on dopamine and serotonin receptors, regulating the neurotransmitter levels in the brain to restore the chemical balance.
The mechanism of action of atypical antipsychotics involves blocking dopamine receptors, particularly D2 receptors, as well as modulating serotonin receptors, notably 5-HT2A receptors. By inhibiting excessive dopamine transmission and enhancing serotonin activity, atypical antipsychotics help reduce hallucinations, delusions, and other psychotic symptoms.
Some commonly used atypical antipsychotics include risperidone, olanzapine, quetiapine, and aripiprazole. These APIs are typically formulated into oral tablets or capsules for convenient administration.
Despite their effectiveness, atypical antipsychotics may have potential side effects such as weight gain, metabolic abnormalities, sedation, and extrapyramidal symptoms. Therefore, close monitoring and individualized treatment plans are essential to ensure optimal therapeutic outcomes.
In conclusion, atypical antipsychotics are a crucial subcategory of APIs used in the treatment of mental disorders. Their distinct pharmacological profile and mechanism of action make them valuable in managing psychosis while minimizing adverse effects.
Risperidone (Atypical antipsychotics), classified under Antipsychotics
Antipsychotics belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category used to treat psychiatric disorders such as schizophrenia, bipolar disorder, and other related conditions. These medications play a crucial role in managing symptoms associated with psychosis, including hallucinations, delusions, and disorganized thinking.
Antipsychotics work by modulating the levels of neurotransmitters in the brain, particularly dopamine and serotonin. They can be categorized into two classes: first-generation (typical) antipsychotics and second-generation (atypical) antipsychotics. Typical antipsychotics primarily target dopamine receptors, while atypical antipsychotics also affect serotonin receptors.
The pharmaceutical API category of antipsychotics includes various well-known drugs, such as haloperidol, chlorpromazine, risperidone, quetiapine, and olanzapine. These APIs are often formulated into different dosage forms, including tablets, capsules, injections, and oral suspensions, to provide flexibility in administration and patient-specific needs.
Antipsychotics offer relief from psychotic symptoms by stabilizing the imbalanced neurotransmitter activity in the brain. However, they may also have certain side effects, such as sedation, weight gain, extrapyramidal symptoms, and metabolic disturbances. It is essential for healthcare professionals to carefully monitor patients receiving antipsychotic treatment to optimize therapeutic benefits while minimizing adverse effects.
In summary, antipsychotics are a vital category of pharmaceutical APIs used to manage psychiatric disorders by modulating neurotransmitter activity in the brain. Their effectiveness in treating psychosis has made them a cornerstone of mental health treatment, providing much-needed relief to individuals suffering from these conditions.
Risperidone API manufacturers & distributors
Compare qualified Risperidone API suppliers worldwide. We currently have 21 companies offering Risperidone 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 |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CEP, CoA, KDMF, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | CoA, GMP | 70 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| ICROM | Producer | Italy | Italy | CoA, GMP, KDMF, USDMF | 19 products |
| Infar, S.A. | Producer | Spain | Spain | CoA, GMP | 7 products |
| Ipca Labs. | Producer | India | India | CoA, USDMF | 69 products |
| Janssen Pharma | Producer | Belgium | Unknown | CEP, CoA, GMP, KDMF, USDMF | 63 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, JDMF, MSDS, USDMF | 52 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 155 products |
| Medichem | Producer | Spain | Spain | CEP, CoA, FDA, GMP | 39 products |
| Mylan | Producer | India | India | CEP, CoA, JDMF, KDMF, USDMF, WC | 201 products |
| Rpg Life Sciences | Producer | India | India | CEP, CoA, KDMF, WC | 13 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Torrent Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF | 34 products |
| Wuxi Jida Pharma | Producer | China | China | CEP, CoA, GMP, USDMF | 3 products |
When sending a request, specify which Risperidone 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 Risperidone 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 Risperidone API
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Technical
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Regulatory
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