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Fluoxetine | CAS No: 54910-89-3 | GMP-certified suppliers
A medication that supports treatment of major depression, obsessive compulsive disorder, bulimia, panic disorder, bipolar‑related depression, and premenstrual dysphoric disorder for broad psychiatric care.
Therapeutic categories
Primary indications
- Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa
- However, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present
- Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression
- Fluoxetine is additionally indicated for the treatment of female patients with premenstrual dysphoric disorder (PMDD)
Product Snapshot
- Fluoxetine is an oral small‑molecule API supplied in multiple solid and liquid formulations
- It is used for major depressive disorder, obsessive compulsive disorder, bulimia nervosa, panic disorder, premenstrual dysphoric disorder, and as an adjunct in certain depression subtypes
- It is approved for human use in the US and Canada and also carries veterinary approval
Clinical Overview
Fluoxetine’s pharmacological activity results from inhibition of the presynaptic serotonin transporter, producing sustained elevations of serotonin concentrations in key brain regions. It shows high affinity for serotonin transporters, weak affinity for noradrenaline transporters, and no meaningful affinity for dopamine transporters, supporting its selectivity for serotonergic pathways. Limited interaction with several neurotransmitter receptor classes contributes to its distinct adverse effect profile relative to older antidepressants. Interaction with the 5‑HT2C receptor has been proposed to influence noradrenergic and dopaminergic signaling in the prefrontal cortex.
Fluoxetine is absorbed orally and undergoes extensive hepatic metabolism, involving multiple cytochrome P450 pathways. It is both a substrate and inhibitor of several CYP isoenzymes, including CYP2D6 and CYP2C19, creating potential for clinically relevant drug interactions. The parent compound and its active metabolite exhibit long elimination half‑lives, supporting once‑daily dosing but prolonging washout periods. Distribution is extensive due to high protein binding.
Safety considerations include risks associated with serotonergic excess, potential QTc prolongation, and a lowered seizure threshold. Use requires caution in combination with other centrally acting or CYP‑metabolized agents. Fluoxetine is marketed globally in various formulations, with Prozac being one of the earliest well‑known brands.
For API procurement, sourcing should prioritize verified manufacturers with robust impurity profiling, validated control of organofluorine intermediates, and compliance with relevant pharmacopeial monographs and GMP standards.
Identification & chemistry
| Generic name | Fluoxetine |
|---|---|
| Molecule type | Small molecule |
| CAS | 54910-89-3 |
| UNII | 01K63SUP8D |
| DrugBank ID | DB00472 |
Pharmacology
| Summary | Fluoxetine is a selective serotonin reuptake inhibitor that increases synaptic serotonin by blocking the presynaptic serotonin transporter. Its primary pharmacodynamic effect is sustained elevation of 5‑hydroxytryptamine in key brain regions, with minimal activity at most other monoaminergic and cholinergic receptors. Limited interaction with 5‑HT2C receptors may contribute to secondary modulation of noradrenaline and dopamine signaling in the prefrontal cortex. |
|---|---|
| Mechanism of action | The monoaminergic hypothesis of depression emerged in 1965 and linked depression with dysfunction of neurotransmitters such as noradrenaline and serotonin.Indeed, low levels of serotonin have been observed in the cerebrospinal fluid of patients diagnosed with depression.As a result of this hypothesis, drugs that modulate levels of serotonin such as fluoxetine were developed. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and as the name suggests, it exerts it's therapeutic effect by inhibiting the presynaptic reuptake of the neurotransmitter serotonin.As a result, levels of 5-hydroxytryptamine (5-HT) are increased in various parts of the brain.Further, fluoxetine has high affinity for 5-HT transporters, weak affinity for noradrenaline transporters and no affinity for dopamine transporters indicating that it is 5-HT selective. Fluoxetine interacts to a degree with the 5-HT<sub>2C</sub> receptor and it has been suggested that through this mechanism, it is able to increase noradrenaline and dopamine levels in the prefrontal cortex. |
| Pharmacodynamics | Fluoxetine blocks the serotonin reuptake transporter in the presynaptic terminal, which ultimately results in sustained levels of 5-hydroxytryptamine (5-HT) in certain brain areas.However, fluoxetine binds with relatively poor affinity to 5-HT, dopaminergic, adrenergic, cholinergic, muscarinic, and histamine receptors which explains why it has a far more desirable adverse effect profile compared to earlier developed classes of antidepressants such as tricyclic antidepressants. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent serotonin transporter | Humans | inhibitor |
| 5-hydroxytryptamine receptor 2C | Humans | antagonist |
| Neuronal acetylcholine receptor subunit alpha-2 | Humans | antagonist |
ADME / PK
| Absorption | The oral bioavailability of fluoxetine is <90% as a result of hepatic first pass metabolism. In a bioequivalence study, the Cmax of fluoxetine 20 mg for the established reference formulation was 11.754 ng/mL while the Cmax for the proposed generic formulation was 11.786 ng/ml. Fluoxetine is very lipophilic and highly plasma protein bound, allowing the drug and it's active metabolite, norfluoxetine, to be distributed to the brain. |
|---|---|
| Half-life | The half life of fluoxetine is significant with the elimination half-life of the parent drug averaging 1-3 days after acute administration, and 4-6 days after chronic administration.Further, the elimination half life of it's active metabolite, norfluoxetine, ranges from 4-16 days after both acute and chronic administration.The half-life of fluoxetine should be considered when switching patients from fluoxetine to another antidepressant since marked accumulation occurs after chronic use.Fluoxetine's long half-life may even be beneficial when discontinuing the drug since the risk of withdrawal is minimized. |
| Protein binding | Approximately 94% of fluoxetine is plasma protein bound. |
| Metabolism | Fluoxetine is metabolized to norfluoxetine by CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and CYP3A5 upon ingestion.Although all of the mentioned enzymes contribute to N-demethylation of fluoxetine, CYP2D6, CYP2C9 and CYP3A4 appear to be the major contributing enzymes for phase I metabolism.In addition, there is evidence to suggest that CYP2C19 and CYP3A4 mediate O-dealkylation of fluoxetine and norfluoxetine to produce para-trifluoromethylphenol which is subsequently metabolized to hippuric acid.Both fluoxetine and norfluoxetine undergo glucuronidation to facilitate excretion. Notably, both the parent drug and active metabolite inhibit CYP2D6 isozymes, and as a result patients who are being treated with fluoxetine are susceptible to drug interactions. |
| Route of elimination | Fluoxetine is primarily eliminated in the urine. |
| Volume of distribution | The volume of distribution of fluoxetine and it's metabolite varies between 20 to 42 L/kg. |
| Clearance | The clearance value of fluoxetine in healthy patients is reported to be 9.6 ml/min/kg. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity favor solid oral dosage forms with solubility‑enhancing excipients for reliable dissolution.
- Chemical stability is generally robust for a small molecule, allowing conventional solid formulations and standard handling of the API powder.
- Oral solutions or syrups require solubilizers or co-solvents due to very low water solubility of the free base.
Regulatory status
| Lifecycle | U.S. patents for the API expired in 2017, indicating that the product is now in a mature, post‑exclusivity phase. With availability in the United States and Canada, the market is characterized by established competition and stable generic presence. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Fluoxetine’s supply chain is dominated by a single originator, Eli Lilly, with a large and diverse group of generic manufacturers now producing the active ingredient and finished products. Branded and generic formulations are widely established in the US and Canada, with substantial participation from global manufacturers and repackagers. All listed US patents expired in 2017, indicating that generic competition is fully established. |
|---|
Safety
| Toxicity | In a report that included 234 fluoxetine overdose cases, it was concluded that symptoms resulting from fluoxetine overdose were generally minor and short in duration.The most common overdose adverse effects included drowsiness, tremor, tachycardia, nausea and vomiting, and providing the patient with aggressive supportive care was the recommended intervention. Despite this evidence, more severe adverse effects have been linked to fluoxetine ingestion although most of these reports involved co-ingestion with other substances or drugs as well as other factors.For example, there is a case report that details a patient who ingested 1400 mg of fluoxetine in a suicide attempt and as a result, experienced a generalized seizure three hours later.In a separate case, a 14 year old patient ingested 1.2 g of fluoxetine and subsequently experienced tonic/clonic seizures, symptoms consistent with serotonin syndrome, and rhabdomyolysis, although the patient did not experience sustained renal injury. |
|---|
- Overdose exposures have predominantly produced transient CNS and autonomic effects, including drowsiness, tremor, tachycardia, and gastrointestinal disturbance
- High‑level ingestion has been associated with seizure activity and serotonin‑syndrome–like presentations, particularly in cases involving co‑ingestants
- Severe events such as rhabdomyolysis have been reported at gram‑level doses
Fluoxetine is a type of Serotonin reuptake inhibitors
Serotonin reuptake inhibitors (SRIs) are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various mental health conditions. These medications work by specifically targeting the serotonin transporter protein, inhibiting its function and thereby increasing the concentration of serotonin in the synaptic cleft.
SRIs are commonly prescribed for the management of depression, anxiety disorders, obsessive-compulsive disorder (OCD), and other related conditions. By blocking the reuptake of serotonin, SRIs enhance serotonin neurotransmission, which plays a crucial role in regulating mood, emotions, and cognition.
This class of API includes well-known drugs such as fluoxetine, sertraline, paroxetine, and escitalopram, among others. They are typically administered orally and exhibit good bioavailability, allowing for effective systemic distribution.
The therapeutic effects of SRIs are achieved by modulating the delicate balance of serotonin in the brain. By preventing its reuptake, SRIs ensure that serotonin remains available for longer periods, leading to increased activation of postsynaptic serotonin receptors. This neurochemical modulation results in improved mood, reduced anxiety, and alleviation of related symptoms.
Serotonin reuptake inhibitors are generally well-tolerated, but they may have potential side effects such as nausea, gastrointestinal disturbances, sexual dysfunction, and sleep disturbances. However, these effects are often manageable and vary among individuals.
Overall, serotonin reuptake inhibitors are a crucial class of pharmaceutical APIs widely utilized in the treatment of mental health disorders. Their ability to modulate serotonin levels effectively makes them valuable tools in improving patients' quality of life and well-being.
Fluoxetine (Serotonin reuptake inhibitors), classified under 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.
Fluoxetine API manufacturers & distributors
Compare qualified Fluoxetine API suppliers worldwide. We currently have 9 companies offering Fluoxetine API, with manufacturing taking place in 6 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. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Erregierre | Producer | Italy | Italy | CoA, USDMF | 44 products |
| Fermion | Producer | Finland | Finland | BSE/TSE, CEP, CoA, GDP, GMP, KDMF, MSDS, USDMF | 29 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP | 35 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, USDMF | 51 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 762 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Fluoxetine 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 Fluoxetine 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 Fluoxetine API
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Technical
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Regulatory
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