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Quetiapine | CAS No: 111974-69-7 | GMP-certified suppliers
A medication that supports treatment of schizophrenia, bipolar episodes, and major depressive disorder symptoms for use in mental‑health treatment portfolios.
Therapeutic categories
Primary indications
- Quetiapine is used in the symptomatic treatment of schizophrenia
- In addition, it may be used for the management of acute manic or mixed episodes in patients with bipolar I disorder, as a monotherapy or combined with other drugs
- It may be used to manage depressive episodes in bipolar disorder
- In addition to the above indications, quetiapine is used in combination with antidepressant drugs for the treatment of major depression
Product Snapshot
- Oral small‑molecule antipsychotic supplied mainly as standard and extended‑release tablets and capsules
- Used for symptomatic management of schizophrenia, bipolar disorder phases, and as adjunct therapy in major depressive disorder
- Approved in major regulated markets including the US and Canada
Clinical Overview
Its pharmacology reflects broad receptor antagonism across dopaminergic, serotonergic, histaminergic, adrenergic, and muscarinic systems. Therapeutic effects in schizophrenia are linked mainly to dopamine D2 and serotonin 5HT2A antagonism. Improvement in depressive symptoms in bipolar disorder and major depressive disorder may relate to quetiapine or its active metabolite binding to the norepinephrine transporter. Antagonism at H1, alpha1-adrenergic, and M1 receptors explains common adverse effects such as somnolence, orthostatic hypotension, and anticholinergic symptoms.
Quetiapine undergoes extensive hepatic metabolism, primarily via CYP3A pathways, with contributions from CYP2D6 and CYP2C19. It has moderate oral bioavailability and forms an active metabolite with noradrenergic activity. Clearance is predominantly hepatic, with renal excretion of metabolites. It is a substrate of P-glycoprotein.
Safety considerations include the risk of QTc prolongation, orthostatic hypotension, metabolic changes, and anticholinergic burden. Suicidality risk is increased in children and adolescents, and the drug is not indicated for dementia-related psychosis due to elevated mortality in elderly patients. Sedation and cardiovascular effects warrant dose titration and monitoring in vulnerable populations.
Quetiapine is marketed globally in immediate‑release and extended‑release formulations under several brand names, commonly Seroquel.
For API procurement, suppliers should provide evidence of control of polymorphic form, residual solvent compliance, and robust impurity profiling aligned with ICH guidelines, with particular attention to oxidative and CYP-mediated degradants that may affect product stability and regulatory acceptability.
Identification & chemistry
| Generic name | Quetiapine |
|---|---|
| Molecule type | Small molecule |
| CAS | 111974-69-7 |
| UNII | BGL0JSY5SI |
| DrugBank ID | DB01224 |
Pharmacology
| Summary | Quetiapine is an atypical antipsychotic that primarily antagonizes dopamine D2 and serotonin 5‑HT2A receptors, modulating neurotransmission relevant to psychotic and mood symptoms. Its metabolite also interacts with the norepinephrine transporter, contributing to effects in depressive disorders. Additional receptor antagonism at H1, α1‑adrenergic, and muscarinic M1 sites underlies its sedative and autonomic pharmacodynamic profile. |
|---|---|
| Mechanism of action | Although the mechanism of action of quetiapine is not fully understood, several proposed mechanisms exist. In schizophrenia, its actions could occur from the antagonism of dopamine type 2 (D2) and serotonin 2A (5HT2A) receptors. In bipolar depression and major depression, quetiapine's actions may be attributed to the binding of this drug or its metabolite to the norepinephrine transporter. Additional effects of quetiapine, including somnolence, orthostatic hypotension, and anticholinergic effects, may result from the antagonism of H1 receptors, adrenergic α1 receptors, and muscarinic M1 receptors, respectively. |
| Pharmacodynamics | Quetiapine improves the positive and negative symptoms of schizophrenia and major depression by acting on various neurotransmitter receptors, such as the serotonin and dopamine receptors. In bipolar disorder, it improves both depressive and manic symptoms. **A note on suicidality in young patients and administration in the elderly** Quetiapine can cause suicidal thinking or behavior in children and adolescents and should not be given to children under 10 years of age. It is important to monitor for suicidality if this drug is given to younger patients. In addition, this drug is not indicated for the treatment of psychosis related to dementia due to an increased death rate in elderly patients taking this drug. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| Dopamine D2 receptor | Humans | antagonist |
| 5-hydroxytryptamine receptor 1A | Humans | antagonist, partial agonist |
ADME / PK
| Absorption | Quetiapine is rapidly and well absorbed after administration of an oral dose. Steady-state is achieved within 48 hoursPeak plasma concentrations are achieved within 1.5 hours. The bioavailability of a tablet is 100%. The steady-state Cmax of quetiapine in Han Chinese patients with schizophrenia after a 300 mg oral dose of the extended released formulation was approximately 467 ng/mL and the AUC at steady-state was 5094 ng·h/mL.Absorption of quetiapine is affected by food, with Cmax increased by 25% and AUC increased by 15%. |
|---|---|
| Half-life | The average terminal half-life of quetiapine is about 6-7 hours. |
| Protein binding | The protein binding of quetiapine is 83%. |
| Metabolism | The metabolism of quetiapine occurs mainly in the liver. Sulfoxidation and oxidation are the main metabolic pathways of this drug. According to in vitro studies, cytochrome P450 3A4 metabolizes quetiapine to an inactive sulfoxide metabolite and also participates in the metabolism of its active metabolite, N-desalkyl quetiapine. CYP2D6 also regulates the metabolism of quetiapine. In one study, three metabolites of N-desalkylquetiapine were identified. Two of the metabolites were identified as N-desalkylquetiapine sulfoxide and 7-hydroxy-N-desalkylquetiapine. CYP2D6 has been found to be responsible for metabolism of quetiapine to 7-hydroxy-N-desalkylquetiapine, a pharmacologically active metabolite. Individual differences in CYP2D6 metabolism may be present, which may affect the concentrations of the active metabolite. |
| Route of elimination | After an oral dose of radiolabeled quetiapine, less than 1% of unchanged drug was detected in the urine, suggesting that quetiapine is heavily metabolized. About 73% of a dose was detected in the urine, and about 20% in the feces. |
| Volume of distribution | Quetiapine distributes throughout body tissues. The apparent volume of distribution of this drug is about 10±4 L/kg. |
| Clearance | The clearance of quetiapine healthy volunteers in the fasted state during a clinical study was 101.04±39.11 L/h.Elderly patients may require lower doses of quetiapine, as clearance in these patients may be reduced by up to 50%.Those with liver dysfunction may also require lower doses. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, requiring solubility‑enhancing excipients for immediate‑release tablets.
- Extended‑release tablets depend on matrix or multilayer controls to manage moderate lipophilicity and maintain consistent plasma exposure.
- Solid-state handling is straightforward, though hygroscopicity and light oxidation risk should be evaluated during storage and processing.
Regulatory status
| Lifecycle | The API’s key U.S. and Canadian patents expired between 2011 and 2017, indicating that market exclusivity has ended in both regions. With patent protection concluded and products already established in the US and Canada, the API is in a mature, post‑exclusivity phase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Quetiapine was originally developed by a single originator company, with current supply dominated by numerous repackagers and distributors that support broad generic availability. Branded products have been marketed in both the United States and Canada, though they now coexist with extensive generic presentations. All listed patents have expired, indicating an established landscape of generic competition. |
|---|
Safety
| Toxicity | The oral LD50 if quetiapine in rats is 2000 mg/kg. **Overdose information** Some signs and symptoms of a quetiapine overdose include sedation, drowsiness, tachycardia, and hypotension. Clinical trials demonstrate that overdoses of up to 30 grams of quetiapine did not result in death. A lethal outcome was reported in a clinical trial after an overdose of 13.6 grams of quetiapine. In the case of an acute overdose, ensure to maintain an airway and provide adequate ventilation and oxygenation. Gastric lavage following intubation (if necessary) along with activated charcoal and a laxative may be considered. The possibility of obtundation, seizure or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiac monitoring should also take place. **A note on QT-interval prolongation in an overdose** Postmarketing reports reveal increases in the cardiac QT interval in cases of quetiapine overdose, concomitant illness, and in those taking drugs that increase QT interval or affect electrolyte levels.Note that disopyramide, procainamide, and quinidine may exert additive QT-prolonging effects when administered in patients who have overdosed with quetiapine, and should be avoided. |
|---|
- Oral LD50 in rats is approximately 2000 mg/kg, indicating moderate acute toxicity
- High-dose exposure is associated with pronounced CNS depression and cardiovascular effects such as tachycardia and hypotension
- Large overdoses have produced severe sedation and QT‑interval prolongation, with reported cases of lethal outcomes at doses around 13
Quetiapine 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.
Quetiapine (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.
Quetiapine API manufacturers & distributors
Compare qualified Quetiapine API suppliers worldwide. We currently have 39 companies offering Quetiapine API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CoA, JDMF | 24 products |
| Divis Labs. | Producer | India | India | CoA, FDA, GMP, ISO9001, Other, KDMF, USDMF, WC | 47 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Fermion | Producer | Finland | Finland | BSE/TSE, CEP, CoA, GDP, GMP, MSDS, USDMF | 29 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 |
| Hetero Drugs | Producer | India | India | CEP, CoA, GMP | 98 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 90 products |
| Hikal | Producer | India | India | CoA, GMP, USDMF, WC | 26 products |
| Ind-Swift Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, WC | 27 products |
| Indoco Remedies | Producer | India | India | CEP, CoA, FDA, GMP, WC | 19 products |
| Ipca Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 69 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, JDMF, MSDS, USDMF | 52 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CEP, CoA, GMP, JDMF, USDMF, WC | 155 products |
| Medichem | Producer | Spain | Unknown | CEP, CoA, FDA, GMP, USDMF | 39 products |
| Menadiona, S.L. | Producer | Spain | Spain | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 15 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, Other, KDMF, USDMF | 50 products |
| Mylan | Producer | India | India | CEP, CoA, KDMF, USDMF, WC | 201 products |
| Penilo Pharma | Producer | India | India | CoA, GMP, ISO9001 | 7 products |
| Piramal Pharma Solutions | Producer | India | India | CoA, USDMF | 44 products |
| Qilu Tianhe | Producer | China | China | CEP, CoA, GMP, KDMF, WC | 16 products |
| Raks Pharma | Producer | India | India | CEP, CoA, FDA, USDMF | 58 products |
| Sandoz | Producer | Austria | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 58 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| SPC Life Sciences Pvt Ltd... | Producer | India | India | CoA | 5 products |
| Sumitomo Chemical | Producer | Japan | Japan | CoA, JDMF | 28 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 | CoA, USDMF | 34 products |
| Unichem Labs. | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 62 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, GMP, MSDS, USDMF, WC | 37 products |
| Wanbury | Producer | India | India | CoA, USDMF | 15 products |
| ZCL Chemicals | Producer | India | India | CEP, CoA, Other, FDA, ISO9001, USDMF | 30 products |
| Zhejiang Apeloa Tospo-Jia... | Producer | China | China | CoA, USDMF | 15 products |
| Zhejiang Hisoar | Producer | China | China | CEP, CoA, FDA, GMP | 10 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
| Zhejiang Supor | Producer | China | China | CEP, CoA, FDA, GMP, KDMF, USDMF | 13 products |
When sending a request, specify which Quetiapine 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 Quetiapine 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.
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Technical
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Regulatory
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