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Atomoxetine | CAS No: 83015-26-3 | GMP-certified suppliers
A medication that supports reliable management of attention deficit hyperactivity disorder in children and adults, providing consistent symptom control for diverse therapeutic and manufacturing needs.
Therapeutic categories
Adrenergic AgentsAgents producing tachycardiaAgents that produce hypertensionAminesCytochrome P-450 CYP2C19 SubstratesCytochrome P-450 CYP2D6 Substrates
Generic name
Atomoxetine
Molecule type
small molecule
CAS number
83015-26-3
DrugBank ID
DB00289
Approval status
Approved drug
ATC code
N06BA09
Primary indications
- Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults
Product Snapshot
- Oral small-molecule product supplied mainly as film‑coated tablets and hard capsules
- Used for management of attention deficit hyperactivity disorder in pediatric and adult populations
- Approved in the US and Canada with established regulatory registrations
Clinical Overview
Atomoxetine (CAS 83015-26-3) is a selective norepinephrine reuptake inhibitor approved for the treatment of attention deficit hyperactivity disorder in children and adults. It is widely known under the brand Strattera and is used as part of a multimodal therapeutic approach. Its clinical utility derives from modulation of noradrenergic and dopaminergic signaling in the prefrontal cortex, a region critical for attention and executive regulation.
Atomoxetine increases extracellular norepinephrine and dopamine in the prefrontal cortex by inhibiting the norepinephrine transporter. This regionally selective effect avoids substantial dopaminergic elevation in the nucleus accumbens or striatum, reducing the reinforcing effects commonly associated with stimulant therapies. Additional interactions include measurable binding to the serotonin transporter and inhibition of the NMDA receptor, indicating involvement of serotonergic and glutamatergic pathways in symptom control.
Absorption is rapid after oral administration. Atomoxetine is metabolized mainly by CYP2D6, with CYP2C19 contributing in poor metabolizers. Clearance and systemic exposure vary significantly according to CYP2D6 phenotype. The drug and metabolites are principally excreted renally.
Key safety considerations include dose‑related increases in heart rate and blood pressure. Serious cardiovascular events, although uncommon, have been reported. Atomoxetine can precipitate psychotic or manic symptoms in susceptible individuals and has been associated with increased suicidal ideation in pediatric patients. Rare but severe liver injury, including liver failure, has occurred in postmarketing experience, warranting prompt discontinuation if hepatic dysfunction is suspected.
Atomoxetine is supplied globally in capsule formulations. For API procurement, sourcing should ensure compliance with regional pharmacopoeial standards, validated control of isomeric and impurity profiles, and reliable documentation of manufacturing consistency to support regulatory submissions and finished product quality.
Atomoxetine increases extracellular norepinephrine and dopamine in the prefrontal cortex by inhibiting the norepinephrine transporter. This regionally selective effect avoids substantial dopaminergic elevation in the nucleus accumbens or striatum, reducing the reinforcing effects commonly associated with stimulant therapies. Additional interactions include measurable binding to the serotonin transporter and inhibition of the NMDA receptor, indicating involvement of serotonergic and glutamatergic pathways in symptom control.
Absorption is rapid after oral administration. Atomoxetine is metabolized mainly by CYP2D6, with CYP2C19 contributing in poor metabolizers. Clearance and systemic exposure vary significantly according to CYP2D6 phenotype. The drug and metabolites are principally excreted renally.
Key safety considerations include dose‑related increases in heart rate and blood pressure. Serious cardiovascular events, although uncommon, have been reported. Atomoxetine can precipitate psychotic or manic symptoms in susceptible individuals and has been associated with increased suicidal ideation in pediatric patients. Rare but severe liver injury, including liver failure, has occurred in postmarketing experience, warranting prompt discontinuation if hepatic dysfunction is suspected.
Atomoxetine is supplied globally in capsule formulations. For API procurement, sourcing should ensure compliance with regional pharmacopoeial standards, validated control of isomeric and impurity profiles, and reliable documentation of manufacturing consistency to support regulatory submissions and finished product quality.
Identification & chemistry
| Generic name | Atomoxetine |
|---|---|
| Molecule type | Small molecule |
| CAS | 83015-26-3 |
| UNII | ASW034S0B8 |
| DrugBank ID | DB00289 |
Pharmacology
| Summary | Atomoxetine is a selective inhibitor of the norepinephrine transporter, increasing norepinephrine and related dopaminergic signaling in the prefrontal cortex to support control of attention and impulse regulation. It also shows ancillary binding to the serotonin transporter and NMDA receptors, suggesting secondary effects on serotonergic and glutamatergic pathways. Its pharmacologic profile is centered on modulation of catecholaminergic tone in circuits relevant to ADHD. |
|---|---|
| Mechanism of action | Atomoxetine is known to be a potent and selective inhibitor of the norepinephrine transporter (NET),which prevents cellular reuptake of norepinephrine throughout the brain, which is thought to improve the symptoms of ADHD. More recently, positron emission tomography (PET) imaging studies in rhesus monkeys have shown that atomoxetine also binds to the serotonin transporter (SERT),and blocks the N-methyl-d-aspartate (NMDA) receptor,indicating a role for the glutamatergic system in the pathophysiology of ADHD. |
| Pharmacodynamics | Atomoxetine is a selective norepinephrine (NE) reuptake inhibitor used for the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine has been shown to specifically increase norepinephrine and dopamine within the prefrontal cortex, which results in improved ADHD symptoms. Due to atomoxetine's noradrenergic activity, it also has effects on the cardiovascular system such as increased blood pressure and tachycardia.Sudden deaths, stroke, and myocardial infarction have been reported in patients taking atomoxetine at usual doses for ADHD. Atomoxetine should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure or heart rate such as certain patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. It should not be used in patients with severe cardiac or vascular disorders whose condition would be expected to deteriorate if they experienced clinically important increases in blood pressure or heart rate. Although the role of atomoxetine in these cases is unknown, consideration should be given to not treating patients with clinically significant cardiac abnormalities. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt cardiac evaluation. In general, particular care should be taken in treating ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in patients at risk for bipolar disorder. Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by atomoxetine at usual doses. If such symptoms occur, consideration should be given to a possible causal role of atomoxetine, and discontinuation of treatment should be considered. Atomoxetine capsules increased the risk of suicidal ideation in short-term studies in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). All pediatric patients being treated with atomoxetine should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Postmarketing reports indicate that atomoxetine can cause severe liver injury. Although no evidence of liver injury was detected in clinical trials of about 6000 patients, there have been rare cases of clinically significant liver injury that were considered probably or possibly related to atomoxetine use in postmarketing experience. Rare cases of liver failure have also been reported, including a case that resulted in a liver transplant. Atomoxetine should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. Laboratory testing to determine liver enzyme levels should be done upon the first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu like” symptoms). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent noradrenaline transporter | Humans | inhibitor |
| Sodium-dependent serotonin transporter | Humans | binder |
| NMDA receptor | Humans | blocker |
ADME / PK
| Absorption | The pharmacokinetic profile of atomoxetine is highly dependent on cytochrome P450 2D6 genetic polymorphisms of the individual.A large fraction of the population (up to 10% of Caucasians and 2% of people of African descent and 1% of Asians) are poor metabolizers (PMs) of CYP2D6 metabolized drugs. These individuals have reduced activity in this pathway resulting in 10-fold higher AUCs, 5-fold higher peak plasma concentrations, and slower elimination (plasma half-life of 21.6 hours) of atomoxetine compared with people with normal CYP2D6 activity. Atomoxetine is rapidly absorbed after oral administration, with absolute bioavailability of about 63% in extensive metabolizers (EMs) and 94% in poor metabolizers (PMs). Mean maximal plasma concentrations (Cmax) are reached approximately 1 to 2 hours after dosing with a maximal concentration of 350 ng/ml with an AUC of 2 mcg.h/ml. |
|---|---|
| Half-life | The reported half-life depends on the CYP2D6 genetic polymorphisms of the individual and can range from 3 to 5.6 hours. |
| Protein binding | At therapeutic concentrations, 98.7% of plasma atomoxetine is bound to protein, with 97.5% of that being bound to albumin, followed by alpha-1-acid glycoprotein and immunoglobulin G. |
| Metabolism | Atomoxetine undergoes biotransformation primarily through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway. People with reduced activity in the CYP2D6 pathway (also known as poor metabolizers or PMs) have higher plasma concentrations of atomoxetine compared with people with normal activity (also known as extensive metabolizers, or EMs). For PMs, the AUC of atomoxetine at steady-state is approximately 10-fold higher and Cmax is about 5-fold greater than for EMs. The major oxidative metabolite formed regardless of CYP2D6 status is 4-hydroxy-atomoxetine, which is rapidly glucuronidated. 4-Hydroxyatomoxetine is equipotent to atomoxetine as an inhibitor of the norepinephrine transporter, but circulates in plasma at much lower concentrations (1% of atomoxetine concentration in EMs and 0.1% of atomoxetine concentration in PMs). In individuals that lack CYP2D6 activity, 4-hydroxyatomoxetine is still the primary metabolite, but is formed by several other cytochrome P450 enzymes and at a slower rate. Another minor metabolite, N-Desmethyl-atomoxetine is formed by CYP2C19 and other cytochrome P450 enzymes, but has much less pharmacological activity than atomoxetine and lower plasma concentrations (5% of atomoxetine concentration in EMs and 45% of atomoxetine concentration in PMs). |
| Route of elimination | Atomoxetine is excreted primarily as 4-hydroxyatomoxetine-O-glucuronide, mainly in the urine (greater than 80% of the dose) and to a lesser extent in the feces (less than 17% of the dose). Only a small fraction (less than 3%) of the atomoxetine dose is excreted as unchanged atomoxetine, indicating extensive biotransformation. |
| Volume of distribution | The reported volume of distribution of oral atomoxetine was 1.6-2.6 L/kg. The steady-state volume of distribution of intravenous atomoxetine was approximately 0.85 L/kg. |
| Clearance | The clearance rate of atomoxetine depends the CYP2D6 genetic polymorphisms of the individual and can range of 0.27-0.67 L.h/kg. |
Formulation & handling
- Atomoxetine is an oral small‑molecule API with very low aqueous solubility, so solid‑oral formulations typically rely on salt forms or solubility‑enhancing excipients.
- Its moderate lipophilicity (logP ~3.8) supports conventional capsule or tablet manufacturing without special protection from moisture.
- Food has minimal impact on absorption, allowing flexible administration without specific food‑related formulation constraints.
Regulatory status
| Lifecycle | The API’s core patents in Canada and the United States expired between 2016 and 2017, indicating that it has been off‑patent in both markets for several years. Its presence in Canada and the US reflects a mature lifecycle with established generic competition expected. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Atomoxetine is supplied primarily by a single originator company, with distribution supported by multiple U.S. repackagers and packagers. Branded products are established mainly in the U.S. and Canada, with limited presence noted elsewhere. Key patents in both markets have expired, indicating that generic competition is already possible and likely established. |
|---|
Safety
| Toxicity | There is limited clinical trial experience with atomoxetine overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of atomoxetine capsules and at least one other drug. There have been no reports of death involving overdose of atomoxetine capsules alone, including intentional overdoses at amounts up to 1400 mg. In some cases of overdose involving atomoxetine, seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of atomoxetine capsules were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations. If symptoms of overdose are suspected, a Certified Poison Control Center should be consulted for up to date guidance and advice. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose. |
|---|
High Level Warnings:
- Overdose profiles note predominantly mild to moderate sympathetic activation (tachycardia, hypertension, mydriasis) alongside CNS effects such as somnolence, tremor, agitation, or abnormal behavior
- Seizures, QT‑interval prolongation, and hallucinations have been reported less frequently, generally in mixed‑ingestion scenarios
- Fatal outcomes have involved co‑administered agents rather than atomoxetine alone
Atomoxetine is a type of Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Atomoxetine API manufacturers & distributors
Compare qualified Atomoxetine API suppliers worldwide. We currently have 12 companies offering Atomoxetine API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 90 products |
| MSN Organics | Producer | India | India | CoA, GMP, USDMF, WC | 21 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 201 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sharon Bio-Medicine | Producer | India | India | CoA, GMP, WC | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 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 |
| Unichem Labs. | Producer | India | India | CoA, USDMF | 62 products |
| ZCL Chemicals | Producer | India | India | CEP, CoA, Other, FDA, ISO9001, USDMF, WC | 30 products |
When sending a request, specify which Atomoxetine 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 Atomoxetine 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 Atomoxetine API
Sourcing
What matters most when sourcing GMP-grade Atomoxetine?
When sourcing GMP‑grade Atomoxetine, confirm compliance with U.S. and Canadian regulatory requirements and verify that manufacturing follows recognized GMP standards. Assess supply chain transparency, especially since originator production is concentrated and distribution relies on multiple U.S. repackagers. Ensure the supplier can document quality, traceability, and consistency in the context of established generic availability.
Which documents are typically required when sourcing Atomoxetine API?
Request the core API documentation set: CoA (12 companies), GMP (10 companies), USDMF (8 companies), FDA (7 companies), WC (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Atomoxetine API?
Known or reported manufacturers for Atomoxetine: Global Pharma Tek, SETV Global, Sinoway industrial Co.,Ltd, Tenatra Exports Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Atomoxetine 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 Atomoxetine manufacturers?
Audit reports may be requested for Atomoxetine: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Atomoxetine API on Pharmaoffer?
Reported supplier count for Atomoxetine: 12 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Atomoxetine API?
Production countries reported for Atomoxetine: India (11 producers), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Atomoxetine usually hold?
Common certifications for Atomoxetine suppliers: CoA (12 companies), GMP (10 companies), USDMF (8 companies), FDA (7 companies), WC (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Atomoxetine (CAS 83015-26-3) used for?
Atomoxetine is used for the treatment of attention deficit hyperactivity disorder in children and adults. It works by inhibiting the norepinephrine transporter, increasing norepinephrine and dopamine levels in the prefrontal cortex to improve attention and executive control.
Which therapeutic class does Atomoxetine fall into?
Atomoxetine belongs to the following therapeutic categories: Adrenergic Agents, Agents producing tachycardia, Agents that produce hypertension, Amines, Cytochrome P-450 CYP2C19 Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Atomoxetine mainly prescribed for?
The primary indications for Atomoxetine: Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Atomoxetine work?
Atomoxetine is known to be a potent and selective inhibitor of the norepinephrine transporter (NET),which prevents cellular reuptake of norepinephrine throughout the brain, which is thought to improve the symptoms of ADHD. More recently, positron emission tomography (PET) imaging studies in rhesus monkeys have shown that Atomoxetine also binds to the serotonin transporter (SERT),and blocks the N-methyl-d-aspartate (NMDA) receptor,indicating a role for the glutamatergic system in the pathophysiology of ADHD.
What should someone know about the safety or toxicity profile of Atomoxetine?
Atomoxetine can cause dose‑related increases in heart rate and blood pressure and may precipitate psychotic or manic symptoms in susceptible individuals. Pediatric patients have shown an increased risk of suicidal ideation, and rare cases of severe liver injury have been reported. Overdose typically produces mild to moderate sympathetic and CNS activation, while seizures, QT prolongation, and hallucinations occur less often, usually with mixed ingestions. Fatalities have involved co‑administered substances rather than Atomoxetine alone.
What are important formulation and handling considerations for Atomoxetine as an API?
Atomoxetine has very low aqueous solubility, so formulations commonly use salt forms or solubility‑enhancing excipients to ensure adequate dissolution. Its moderate lipophilicity supports standard capsule or tablet manufacturing without special moisture‑protection requirements. Because food has minimal effect on absorption, no food‑related formulation adjustments are typically needed.
Is Atomoxetine a small molecule?
Atomoxetine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Atomoxetine?
Oral Atomoxetine is a low‑solubility small molecule, so formulations commonly use salt forms or solubility‑enhancing excipients to maintain consistent performance. Its moderate lipophilicity supports conventional tablet or capsule manufacturing without special moisture protection. No food‑related stability constraints are noted, as food has minimal impact on absorption.
Regulatory
Where is Atomoxetine approved or in use globally?
Atomoxetine is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Atomoxetine right now?
Atomoxetine is currently authorized for use in both the United States and Canada. Regulatory oversight in these jurisdictions includes standard requirements for quality, safety, and efficacy of the active pharmaceutical ingredient. Patent landscapes are jurisdiction‑specific and typically evolve over time as protections expire and generics enter the market.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Atomoxetine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Atomoxetine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Atomoxetine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Atomoxetine: 1097 verified transactions across 251 suppliers and 117 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Atomoxetine?
Market report availability for Atomoxetine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
