- Raw materials
- Antipsychotics
- Atypical antipsychotics
- Aripiprazole
- Suppliers by country
- India
Filters
Filter
Custom request?
Type
Production region
Qualifications
Country of origin
Aripiprazole API from Indian Manufacturers & Suppliers
32 verified results
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Commercial-scale Suppliers
Producer
Produced in
India|
Employees: 10k+
|
Audit Report:
Certifications:
GMP
|
CEP|
USDMF|
MSDS|
BSE/TSEAll certificates
GMP
CEP
USDMF
MSDS
BSE/TSE
ISO9001
CoA
Producer
Produced in
Poland|
Employees: 455+
|
Audit Report:
Certifications:
GMP
|
CEP|
USDMF|
EDMF/ASMF|
MSDSAll certificates
GMP
CEP
USDMF
EDMF/ASMF
MSDS
BSE/TSE
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Distributor
Produced in
Singapore|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
EDMF/ASMFAll certificates
GMP
FDA
CEP
USDMF
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
JDMF
WC
KDMF
CoA
Distributor
Produced in
India|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
CEP|
MSDS|
BSE/TSE|
ISO 9001All certificates
GMP
CEP
MSDS
BSE/TSE
ISO 9001
WC
CoA
Distributor
Produced in
World|
Employees: 200+
|
Audit Report:
Certifications:
GMP
|
CEP|
USDMF|
MSDS|
BSE/TSEAll certificates
GMP
CEP
USDMF
MSDS
BSE/TSE
CoA
Distributor
Produced in
India|
Employees: 25
|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
MSDSAll certificates
GMP
FDA
CEP
USDMF
MSDS
BSE/TSE
ISO9001
CoA
Get full market intelligence report
€399,-
All Aripiprazole data. Full access. Full negotiation power
Distributor
Produced in
Denmark
,
India|
Employees: 150
|
Audit Report:
Certifications:
CoA
All certificates
CoA
Distributor
Produced in
China|
Employees: 50+
|
Audit Report:
Certifications:
MSDS
|
ISO9001|
CoAAll certificates
MSDS
ISO9001
CoA
Get full market intelligence report
€399,-
All Aripiprazole data. Full access. Full negotiation power
Producer
Produced in
India|
Employees: 200+
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
CoAAll certificates
GMP
MSDS
BSE/TSE
CoA
Producer
Produced in
Unknown|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
Unknown|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
WCAll certificates
GMP
FDA
CEP
USDMF
WC
coa
Distributor
Produced in
India|
Audit Report:
Certifications:
GMP
|
USDMF|
MSDS|
BSE/TSE|
ISO9001All certificates
GMP
USDMF
MSDS
BSE/TSE
ISO9001
CoA
WHO-GMP
Get full market intelligence report
€399,-
All Aripiprazole data. Full access. Full negotiation power
Producer
Produced in
United States|
Audit Report:
Certifications:
GMP
|
CoAAll certificates
GMP
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
Slovenia|
Audit Report:
Certifications:
GMP
|
CoAAll certificates
GMP
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
Get full market intelligence report
€399,-
All Aripiprazole data. Full access. Full negotiation power
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
JDMFAll certificates
GMP
FDA
CEP
USDMF
JDMF
WC
coa
Producer
Produced in
United Arab Emirates|
Audit Report:
Certifications:
CEP
|
coaAll certificates
CEP
coa
Producer
Produced in
Hungary|
Audit Report:
Certifications:
GMP
|
CoAAll certificates
GMP
CoA
Get full market intelligence report
€399,-
All Aripiprazole data. Full access. Full negotiation power
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
WC|
CoAAll certificates
USDMF
WC
CoA
Producer
Produced in
India|
Employees: 200+
|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
WC|
CoAAll certificates
GMP
WC
CoA
Take control of your API sourcing
Producer
Produced in
China|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
WCAll certificates
GMP
FDA
CEP
USDMF
WC
coa
JDMF
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
CoAAll certificates
GMP
FDA
CEP
USDMF
CoA
WC
Get full market intelligence report
€399,-
All Aripiprazole data. Full access. Full negotiation power
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
WCAll certificates
GMP
FDA
CEP
USDMF
WC
coa
Producer
Produced in
South Korea|
Audit Report:
Certifications:
JDMF
|
CoAAll certificates
JDMF
CoA
Producer
Produced in
Italy|
Audit Report:
Certifications:
GMP
|
USDMF|
CoAAll certificates
GMP
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
FDA
|
CEP|
USDMF|
ISO|
coaAll certificates
FDA
CEP
USDMF
ISO
coa
EDQM certificate 2017
KDMF
WC
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Aripiprazole | CAS No: 129722-12-9 | GMP-certified suppliers
A medication that supports treatment of schizophrenia, bipolar I episodes, adjunctive major depression, and behavioral symptoms in autism and Tourette’s disorder across key global markets.
Therapeutic categories
Adrenergic alpha-1 Receptor AntagonistsAdrenergic alpha-AntagonistsAdrenergic AntagonistsAgents producing tachycardiaAgents that produce hypertensionAnticholinergic Agents
Generic name
Aripiprazole
Molecule type
small molecule
CAS number
129722-12-9
DrugBank ID
DB01238
Approval status
Approved drug, Investigational drug
ATC code
N05AX12
Primary indications
- Aripiprazole is indicated for the treatment of acute manic and mixed episodes associated with bipolar I disorder, irritability associated with autism spectrum disorder, schizophrenia, and Tourette's disorder
- It is also used as an adjunctive treatment of major depressive disorder
- [L45859 An injectable formulation of aripiprazole is indicated for agitation associated with schizophrenia or bipolar mania
- Finally, an extended-release, bimonthly injection formulation of aripiprazole is indicated for the treatment of adult schizophrenia and maintenance therapy for adult bipolar I disorder
Product Snapshot
- Aripiprazole is available as an oral small-molecule formulation and multiple intramuscular injectable and extended‑release suspension formulations
- It is used across schizophrenia, bipolar I disorder (acute episodes and maintenance), irritability in autism spectrum disorder, Tourette’s disorder, agitation in schizophrenia or bipolar mania, and as an adjunct in major depressive disorder
- It is approved in the US, Canada, and EU with additional investigational programs in some regions
Clinical Overview
Aripiprazole (CAS 129722-12-9) is an atypical antipsychotic of the phenylpiperazine class used globally for schizophrenia, bipolar I disorder, adjunctive treatment of major depressive disorder, irritability associated with autism spectrum disorder, and Tourette’s disorder. Oral formulations are widely deployed for chronic management, while short‑acting intramuscular injection is indicated for agitation in schizophrenia or bipolar mania. An extended‑release bimonthly injectable form is approved for adult schizophrenia and maintenance therapy in bipolar I disorder.
Aripiprazole exhibits high affinity for dopamine D2 and D3 receptors and serotonin 5‑HT1A and 5‑HT2A receptors, with Ki values in the low nanomolar range. It also shows moderate affinity for several additional dopaminergic, serotonergic, adrenergic alpha‑1, and histaminergic receptors. It has minimal affinity for muscarinic receptors. This broad receptor profile contributes both to therapeutic actions and to certain adverse effects.
The mechanism involves partial agonism at D2 and 5‑HT1A receptors combined with antagonism at 5‑HT2A receptors. Partial agonism at D2 receptors allows modulation of dopaminergic tone, reducing signaling when dopamine concentrations are high and enhancing signaling when they are low. This stabilizing effect is considered central to antipsychotic and mood‑modulating activity. Antagonism at alpha‑1 adrenergic receptors is associated with orthostatic hypotension risk.
Aripiprazole is metabolized primarily by CYP2D6 and CYP3A pathways, producing an active metabolite, dehydro‑aripiprazole. It has a long elimination half‑life, supporting once‑daily oral dosing and extended‑release injectable formulations. The compound is a P‑glycoprotein substrate and may interact with strong CYP inhibitors or inducers. Safety considerations include akathisia, extrapyramidal symptoms, metabolic effects, hypotension, and potential QTc effects. It also carries a risk of serotonin syndrome when combined with serotonergic agents.
Notable global brand contexts include oral and injectable formulations used across psychiatric care settings.
For API procurement, sourcing should focus on consistent polymorph control, validated impurity profiles, and compliance with pharmacopoeial monographs and regional regulatory expectations to support formulation robustness and dossier quality.
Aripiprazole exhibits high affinity for dopamine D2 and D3 receptors and serotonin 5‑HT1A and 5‑HT2A receptors, with Ki values in the low nanomolar range. It also shows moderate affinity for several additional dopaminergic, serotonergic, adrenergic alpha‑1, and histaminergic receptors. It has minimal affinity for muscarinic receptors. This broad receptor profile contributes both to therapeutic actions and to certain adverse effects.
The mechanism involves partial agonism at D2 and 5‑HT1A receptors combined with antagonism at 5‑HT2A receptors. Partial agonism at D2 receptors allows modulation of dopaminergic tone, reducing signaling when dopamine concentrations are high and enhancing signaling when they are low. This stabilizing effect is considered central to antipsychotic and mood‑modulating activity. Antagonism at alpha‑1 adrenergic receptors is associated with orthostatic hypotension risk.
Aripiprazole is metabolized primarily by CYP2D6 and CYP3A pathways, producing an active metabolite, dehydro‑aripiprazole. It has a long elimination half‑life, supporting once‑daily oral dosing and extended‑release injectable formulations. The compound is a P‑glycoprotein substrate and may interact with strong CYP inhibitors or inducers. Safety considerations include akathisia, extrapyramidal symptoms, metabolic effects, hypotension, and potential QTc effects. It also carries a risk of serotonin syndrome when combined with serotonergic agents.
Notable global brand contexts include oral and injectable formulations used across psychiatric care settings.
For API procurement, sourcing should focus on consistent polymorph control, validated impurity profiles, and compliance with pharmacopoeial monographs and regional regulatory expectations to support formulation robustness and dossier quality.
Identification & chemistry
| Generic name | Aripiprazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 129722-12-9 |
| UNII | 82VFR53I78 |
| DrugBank ID | DB01238 |
Pharmacology
| Summary | Aripiprazole acts as a dopamine D2 and serotonin 5‑HT1A partial agonist and a 5‑HT2A antagonist, producing receptor‑dependent modulation of dopaminergic and serotonergic signaling. Its pharmacodynamic profile is characterized by high affinity for multiple dopamine and serotonin receptor subtypes, with additional interactions at adrenergic and histamine receptors that contribute to its overall activity. These combined actions support its therapeutic use across psychotic, mood, and neurobehavioral disorders. |
|---|---|
| Mechanism of action | The antipsychotic action of aripiprazole is likely due to its partial agonist activity on D2 and 5-HT<sub>1A</sub> receptors as well as its antagonist activity at 5-HT<sub>2A</sub> receptors; however, the exact mechanism has not been fully elucidated.One of the mechanisms that have been proposed is that aripiprazole both stimulates and inhibits dopamine as it engages the D2 receptor. It lowers dopamine neuronal firing at high dopamine concentrations and increases dopamine firing at low concentrations. Its partial agonist activity gives aripiprazole an intermediate level of dopaminergic neuronal tone between full agonist and antagonist of the D2 receptor.In addition, some adverse effects may be due to action on other receptors.For example, orthostatic hypotension may be explained by antagonism of the adrenergic alpha-1 receptors. |
| Pharmacodynamics | Aripiprazole exhibits high affinity for dopamine D<sub>2</sub> and D<sub>3</sub>, serotonin 5-HT<sub>1a</sub> and 5-HT<sub>2a</sub> receptors (Ki values of 0.34 nM, 0.8 nM, 1.7 nM, and 3.4 nM, respectively), moderate affinity for dopamine D<sub>4</sub>, serotonin 5-HT<sub>2c</sub> and 5-HT<sub>7</sub>, alpha<sub>1</sub>-adrenergic and histamine H<sub>1</sub> receptors (Ki values of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC<sub>50</sub>>1000 nM). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D2 receptor | Humans | antagonist, partial agonist |
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| 5-hydroxytryptamine receptor 1A | Humans | partial agonist |
ADME / PK
| Absorption | Tablet: Aripiprazole is well absorbed after administration of the tablet, with peak plasma concentrations occurring within 3 hours to 5 hours; the absolute oral bioavailability of the tablet formulation is 87%. ABILIFY can be administered with or without food. Administration of a 15 mg ABILIFY tablet with a standard high-fat meal did not significantly affect the C<sub>max</sub> or AUC of aripiprazole or its active metabolite, dehydro-aripiprazole, but delayed T<sub>max</sub> by 3 hours for aripiprazole and 12 hours for dehydro-aripiprazole. Oral Solution: Aripiprazole is well absorbed when administered orally as the solution. At equivalent doses, the plasma concentrations of aripiprazole from the solution were higher than that from the tablet formulation. In a relative bioavailability study comparing the pharmacokinetics of 30 mg aripiprazole as the oral solution to 30 mg aripiprazole tablets in healthy subjects, the solution-to-tablet ratios of geometric mean C<sub>max</sub> and AUC values were 122% and 114%, respectively. The single-dose pharmacokinetics of aripiprazole were linear and dose-proportional between the doses of 5 mg to 30 mg. Extended-release injectable suspension, bimonthly injection: Aripiprazole absorption into the systemic circulation is prolonged following gluteal intramuscular injection due to the low solubility of aripiprazole particles. The release profile of aripiprazole from ABILIFY ASIMTUFII results in sustained plasma concentrations over 2 months following gluteal injection(s). Following multiple doses, the median peak:trough ratio for aripiprazole following an ABILIFY ASIMTUFII dose is 1.3, resulting in a flat plasma concentration profile with T<sub>max</sub> ranging between 1 to 49 days following multiple gluteal administrations of 960 mg. |
|---|---|
| Half-life | The mean elimination half-lives are about 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively.For populations that are poor CYP2D6 metabolizers, the half-life of aripiprazole is 146 hours and these patients should be treated with half the normal dose.Other studies have reported a half-life of 61.03±19.59 hours for aripiprazole and 279±299 hours for the active metabolite. |
| Protein binding | At therapeutic concentrations, aripiprazole and its major metabolite are greater than 99% bound to serum proteins, primarily to albumin. |
| Metabolism | Aripiprazole is metabolized primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for the dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalyzed by CYP3A4. Aripiprazole is the predominant drug moiety in systemic circulation. At steady-state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma. |
| Route of elimination | Following a single oral dose of [14C]-labeled aripiprazole, approximately 25% and 55% of the administered radioactivity was recovered in the urine and feces, respectively. Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% of the oral dose was recovered unchanged in the feces. |
| Volume of distribution | The steady-state volume of distribution of aripiprazole following intravenous administration is high (404 L or 4.9 L/kg), indicating extensive extravascular distribution. |
| Clearance | The clearance of aripiprazole was estimated to be 0.8mL/min/kg.Other studies have also reported a clearance rate of 3297±1042mL/hr. |
Formulation & handling
- Low aqueous solubility and high lipophilicity favor solid‑oral formulations with solubilization strategies and support development of stable intramuscular solutions or suspensions.
- Extended‑release intramuscular products require controlled‑particle or depot‑forming systems with attention to reconstitution and suspension uniformity for lyophilized powders.
- Oral formulations are not food‑sensitive, enabling flexible administration, while buccal and ODT formats require attention to moisture protection and rapid disintegration performance.
Regulatory status
| Lifecycle | Most core U.S. patents have expired, with remaining protection ending between 2026 and 2027, indicating the API is moving into a late‑lifecycle phase. With products already established in the US, Canada, and the EU, the markets appear mature and increasingly open to broader generic participation. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Aripiprazole was introduced by an originator partnership responsible for developing and commercializing the branded product, which is now widely available across the US, Canada, and EU. Numerous repackagers and distributors support broad supply coverage, reflecting a mature branded and generic market. Key U.S. patents have already expired or will expire in the near term, indicating established and expanding generic competition. |
|---|
Safety
| Toxicity | Neonates exposed to antipsychotic drugs, including ABILIFY, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia, bipolar I disorder, or major depressive disorder, and with exposure to antipsychotics, including ABILIFY, during pregnancy. In animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 19 times, respectively, the maximum recommended human dose (MRHD) of 30 mg/day based on mg/m2 body surface area, produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the MRHD based on mg/m2 body surface area, produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. ABILIFY has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of ABILIFY misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). In physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral ABILIFY have been reported worldwide. These include overdoses with oral ABILIFY alone and in combination with other substances. No fatality was reported with ABILIFY alone. The largest known dose with a known outcome involved acute ingestion of 1,260 mg of oral ABILIFY (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 years and younger) involving oral ABILIFY ingestions up to 195 mg with no fatalities. Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral ABILIFY overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with ABILIFY overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia. No specific information is available on the treatment of overdose with ABILIFY. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers. _Charcoal_: In the event of an overdose of ABILIFY, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of ABILIFY, decreased the mean AUC and C<sub>max</sub> of aripiprazole by 50%. _Hemodialysis_: Although there is no information on the effect of hemodialysis in treating an overdose with ABILIFY, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins. Lifetime carcinogenicity studies were conducted in ICR mice, F344 rats, and Sprague-Dawley (SD) rats. Aripiprazole was administered for 2 years in the diet at doses of 1, 3, 10, and 30 mg/kg/day to ICR mice and 1, 3, and 10 mg/kg/day to F344 rats (0.2, 0.5, 2 and 5 times and 0.3, 1 and 3 times the MRHD of 30 mg/day based on mg/m2 body surface area, respectively). In addition, SD rats were dosed orally for 2 years at 10, 20, 40, and 60 mg/kg/day, which are 3, 6, 13 and 19 times the MRHD based on mg/m2 body surface area. Aripiprazole did not induce tumors in male mice or male rats. In female mice, the incidences of pituitary gland adenomas and mammary gland adenocarcinomas and adenoacanthomas were increased at dietary doses of 3 to 30 mg/kg/day (0.5 to 5 times the MRHD). In female rats, the incidence of mammary gland fibroadenomas was increased at a dietary dose of 10 mg/kg/day (3 times the MRHD); and the incidences of adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas were increased at an oral dose of 60 mg/kg/day (19 times the MRHD). An increase in mammary, pituitary, and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be mediated by prolonged dopamine D2-receptor antagonism and hyperprolactinemia. Serum prolactin was not measured in the aripiprazole carcinogenicity studies. However, increases in serum prolactin levels were observed in female mice in a 13 week dietary study at the doses associated with mammary gland and pituitary tumors. Serum prolactin was not increased in female rats in 4 week and 13 week dietary studies at the dose associated with mammary gland tumors. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unclear. The mutagenic potential of aripiprazole was tested in the in vitro bacterial reverse-mutation assay, the in vitro bacterial DNA repair assay, the in vitro forward gene mutation assay in mouse lymphoma cells, the in vitro chromosomal aberration assay in Chinese hamster lung (CHL) cells, the in vivo micronucleus assay in mice, and the unscheduled DNA synthesis assay in rats. Aripiprazole and a metabolite (2,3-DCPP) were clastogenic in the in vitro chromosomal aberration assay in CHL cells with and without metabolic activation. The metabolite, 2,3-DCPP, increased numerical aberrations in the in vitro assay in CHL cells in the absence of metabolic activation. A positive response was obtained in the in vivo micronucleus assay in mice; however, the response was due to a mechanism not considered relevant to humans. Female rats were treated orally with aripiprazole from 2 weeks prior to mating through gestation Day 7 at doses of 2, 6, and 20 mg/kg/day, which are 0.6, 2, and 6 times the MRHD of 30 mg/day based on mg/m2 body surface area. Estrus cycle irregularities and increased corpora lutea were seen at all doses, but no impairment of fertility was seen. Increased pre-implantation loss was seen at 2 and 6 times the MRHD, and decreased fetal weight was seen at 6 times the MRHD. Male rats were treated orally with aripiprazole from 9 weeks prior to mating through mating at doses of 20, 40, and 60 mg/kg/day, which are 6, 13, and 19 times the MRHD of 30 mg/day based on mg/m2 body surface area. Disturbances in spermatogenesis were seen at 19 times the MRHD and prostate atrophy was seen at 13 and 19 times the MRHD without impairment of fertility. Pharmacokinetic properties in patients 10-17 years of age are similar to that of adults once body weight has been corrected for. No dosage adjustment is necessary in elderly patients however aripiprazole is not approved for Alzheimer's associated psychosis. Patients classified as CYP2D6 poor metabolizers should be prescribed half the regular dose of aripiprazole. Hepatic and renal function as well as sex, race, and smoking status do not affect dosage requirements for aripiprazole |
|---|
High Level Warnings:
- High‑dose animal studies show embryo‑fetal toxicity, including fetal death, skeletal abnormalities, and impaired postnatal survival
- These effects occurred at exposures multiple times the human dose
- Overdose experience indicates a broad spectrum of CNS and cardiovascular effects (e
Aripiprazole 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.
Aripiprazole (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.
Aripiprazole API manufacturers & distributors
Compare qualified Aripiprazole API suppliers worldwide. We currently have 32 companies offering Aripiprazole API, with manufacturing taking place in 14 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 |
|---|---|---|---|---|---|
| Alkem Labs. | Producer | India | India | CoA, USDMF, WC | 22 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Centaur Pharma | Producer | India | India | CoA, GMP, WC | 40 products |
| Chinoin | Producer | Hungary | Hungary | CoA, GMP | 21 products |
| Chr. Olesen Group | Distributor | Denmark | Denmark, India | CoA | 252 products |
| Daewoong Bio | Producer | South Korea | South Korea | CoA, JDMF | 12 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Erregierre | Producer | Italy | Italy | CoA, GMP, USDMF | 44 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Harman Finochem | Producer | India | India | CoA, GMP, WC | 34 products |
| HEC Pharm | Producer | Germany | Unknown | CoA, USDMF | 31 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 90 products |
| Ind-Swift Labs. | Producer | India | India | CoA, GMP, WC | 27 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Medichem | Producer | Spain | Malta | CoA, GMP | 39 products |
| MSN Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 31 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| Pharmaceutical Solutions ... | Producer | United Arab Emirates | United Arab Emirates | CEP, CoA | 1 products |
| Polpharma | Producer | Poland | Poland | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, MSDS, USDMF | 64 products |
| Sandoz | Producer | Austria | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 58 products |
| Sharon Bio-Medicine | Producer | India | India | CoA, GMP, WC | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 764 products |
| Solfyn International LLP | Distributor | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 24 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
| Unichem Labs. | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 62 products |
| ZCL Chemicals | Producer | India | India | CEP, CoA, Other, FDA, ISO9001, KDMF, USDMF, WC | 30 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
| Zhejiang Jinhua Conba | Producer | China | China | CoA, USDMF | 6 products |
When sending a request, specify which Aripiprazole 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 Aripiprazole 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 Aripiprazole API
Sourcing
What matters most when sourcing GMP-grade Aripiprazole?
Key considerations include confirming GMP compliance and ensuring the API meets regulatory requirements for the US, Canada, and EU. Supplier qualification is important in a mature market with many repackagers and distributors. Attention to documentation, traceability, and consistent quality helps manage variability across multiple generic sources. Continuous supply assurance is also relevant given broad but diverse distribution channels.
Which documents are typically required when sourcing Aripiprazole API?
Request the core API documentation set: CoA (32 companies), GMP (23 companies), USDMF (17 companies), WC (14 companies), CEP (13 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Aripiprazole API?
Known or reported manufacturers for Aripiprazole: Duchefa Farma B.V., Polpharma, Sinoway industrial Co.,Ltd, Chr. Olesen Group, Global Pharma Tek, Apollo Healthcare Resources (Singapore), LGM Pharma, Gonane Pharma, Jubilant Pharmova. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Aripiprazole 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 Aripiprazole manufacturers?
Audit reports may be requested for Aripiprazole: 13 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Aripiprazole API on Pharmaoffer?
Reported supplier count for Aripiprazole: 32 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Aripiprazole API?
Production countries reported for Aripiprazole: India (17 producers), China (3 producers), Poland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Aripiprazole usually hold?
Common certifications for Aripiprazole suppliers: CoA (32 companies), GMP (23 companies), USDMF (17 companies), WC (14 companies), CEP (13 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Aripiprazole (CAS 129722-12-9) used for?
Aripiprazole is used to treat schizophrenia and bipolar I disorder, including agitation associated with these conditions. It is also used as adjunctive therapy for major depressive disorder, and for irritability in autism spectrum disorder and Tourette’s disorder. Oral and injectable forms support both chronic management and acute agitation.
Which therapeutic class does Aripiprazole fall into?
Aripiprazole belongs to the following therapeutic categories: Adrenergic alpha-1 Receptor Antagonists, Adrenergic alpha-Antagonists, Adrenergic Antagonists, Agents producing tachycardia, Agents that produce hypertension. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Aripiprazole mainly prescribed for?
The primary indications for Aripiprazole: Aripiprazole is indicated for the treatment of acute manic and mixed episodes associated with bipolar I disorder, irritability associated with autism spectrum disorder, schizophrenia, and Tourette's disorder, It is also used as an adjunctive treatment of major depressive disorder, [L45859 An injectable formulation of Aripiprazole is indicated for agitation associated with schizophrenia or bipolar mania, Finally, an extended-release, bimonthly injection formulation of Aripiprazole is indicated for the treatment of adult schizophrenia and maintenance therapy for adult bipolar I disorder. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Aripiprazole work?
The antipsychotic action of Aripiprazole is likely due to its partial agonist activity on D2 and 5-HT1A receptors as well as its antagonist activity at 5-HT2A receptors; however, the exact mechanism has not been fully elucidated.One of the mechanisms that have been proposed is that Aripiprazole both stimulates and inhibits dopamine as it engages the D2 receptor. It lowers dopamine neuronal firing at high dopamine concentrations and increases dopamine firing at low concentrations. Its partial agonist activity gives Aripiprazole an intermediate level of dopaminergic neuronal tone between full agonist and antagonist of the D2 receptor.In addition, some adverse effects may be due to action on other receptors.For example, orthostatic hypotension may be explained by antagonism of the adrenergic alpha-1 receptors.
What should someone know about the safety or toxicity profile of Aripiprazole?
Aripiprazole’s safety profile reflects its broad receptor activity, with known risks that include akathisia, other extrapyramidal symptoms, metabolic effects, orthostatic hypotension, and possible QTc effects. It can also contribute to serotonin syndrome when used with serotonergic agents. High‑dose animal studies showed embryo‑fetal toxicity at exposures several‑fold above human levels. Overdose experience indicates diverse central nervous system and cardiovascular effects.
What are important formulation and handling considerations for Aripiprazole as an API?
Aripiprazole’s low aqueous solubility and high lipophilicity require solubilization or dispersion strategies for solid‑oral products and controlled particle design for injectable suspensions. Extended‑release intramuscular formulations depend on maintaining consistent particle size and suspension uniformity to ensure prolonged absorption. Oral products are not food‑sensitive, while ODT and buccal forms need protection from moisture to preserve rapid disintegration performance. Handling should maintain uniformity of suspensions and prevent moisture uptake in sensitive dosage forms.
Is Aripiprazole a small molecule?
Aripiprazole is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Aripiprazole?
Oral Aripiprazole has low aqueous solubility and high lipophilicity, so solid‑oral formulations rely on solubilization strategies to maintain consistent performance. These products are not food‑sensitive, reducing risk of variability related to administration conditions. Buccal and ODT forms require moisture protection to preserve disintegration behavior. No additional stability concerns are noted beyond these formulation‑specific considerations.
Regulatory
Where is Aripiprazole approved or in use globally?
Aripiprazole is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Aripiprazole right now?
Aripiprazole is subject to established regulatory oversight in the United States, Canada, and the European Union for its manufacture and use as an active pharmaceutical ingredient. Patent considerations are jurisdiction‑dependent and tied to the specific filings and exclusivities applicable to individual products and manufacturers.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Aripiprazole procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Aripiprazole. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Aripiprazole included in the PRO Data Insights coverage?
PRO Data Insights coverage for Aripiprazole: 2127 verified transactions across 590 suppliers and 297 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Aripiprazole?
Market report availability for Aripiprazole: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
