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Fluvoxamine | CAS No: 54739-18-3 | GMP-certified suppliers
A medication that manages depression and obsessive-compulsive disorder by enhancing serotonin availability, with additional use in anxiety and bulimia nervosa treatment.
Therapeutic categories
Primary indications
- Indicated predominantly for the management of depression and for Obsessive Compulsive Disorder (OCD)
- Has also been used in the management of bulimia nervosa
Product Snapshot
- Fluvoxamine is available primarily as oral tablets and extended-release capsules
- It is used mainly for the management of depression and Obsessive Compulsive Disorder, with additional application in bulimia nervosa
- Fluvoxamine is approved for use in the US and Canada, with FDA approval and investigational status in some indications
Clinical Overview
Pharmacologically, fluvoxamine acts by inhibiting the neuronal reuptake of serotonin (5-HT) in the central nervous system, thereby increasing serotonin availability in the synaptic cleft. This selective inhibition underlies its antidepressant and anti-obsessive effects. The compound exhibits minimal affinity for other neurotransmitter receptors, including adrenergic, dopaminergic, cholinergic, GABA-benzodiazepine, histaminergic, and various serotonin receptor subtypes, except for notable binding to the sigma-1 receptor. This receptor profile differentiates fluvoxamine from other SSRIs and is thought to influence its clinical effects and side effect profile.
The precise mechanism of action remains incompletely characterized but centers on serotonin transporter blockade, enhancing serotonergic neurotransmission and modulating 5-HT1A autoreceptor activity. Some variability in norepinephrine receptor modulation has been reported with chronic administration, but findings are inconclusive.
Pharmacokinetic data show that fluvoxamine is a substrate and inhibitor of multiple cytochrome P450 enzymes, notably CYP1A2, CYP2C19, CYP2D6, and CYP3A4, which warrants consideration for potential drug-drug interactions. The compound is primarily cleared renally, and metabolism involves hepatic biotransformation.
Safety considerations include monitoring for serotonin syndrome, especially in polypharmacy contexts. Common adverse effects relate to its serotonergic activity and may include gastrointestinal disturbances, sleep alterations, and CNS effects. Cardiovascular and anticholinergic side effects are uncommon due to receptor selectivity.
Fluvoxamine has been marketed under various brand names globally, with regulatory approvals dating back to the 1990s in the United States and Japan.
For API sourcing, quality control should emphasize compliance with pharmacopeial standards for purity, residual solvents, and polymorphic form. Given its involvement in cytochrome P450 interactions, consistent batch quality is critical to ensure predictable pharmacokinetic and safety profiles. Suppliers should provide comprehensive certificates of analysis and demonstrate adherence to Good Manufacturing Practice (GMP) for pharmaceutical-grade material.
Identification & chemistry
| Generic name | Fluvoxamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 54739-18-3 |
| UNII | O4L1XPO44W |
| DrugBank ID | DB00176 |
Pharmacology
| Summary | Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that primarily acts by inhibiting the neuronal reuptake of serotonin in the central nervous system, enhancing serotonergic neurotransmission. Its pharmacological effects are mainly mediated through the serotonin transporter, with minimal affinity for other neurotransmitter receptors. Therapeutically, fluvoxamine is used in the management of depression, obsessive-compulsive disorder, and related mood disorders. |
|---|---|
| Mechanism of action | The exact mechanism of action of fluvoxamine has not been fully determined, but appears to be linked to its inhibition of CNS neuronal uptake of serotonin [FDA Label, A249, A250]. Fluvoxamine blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT<sub>1A</sub> autoreceptors [FDA Label, A249, A250]. Studies have also demonstrated that fluvoxamine has virtually no affinity for α<sub>1</sub>- or α<sub>2</sub>-adrenergic, β-adrenergic, muscarinic, dopamine D<sub>2</sub>, histamine H<sub>1</sub>, GABA-benzodiazepine, opiate, 5-HT<sub>1</sub>, or 5-HT<sub>2</sub> receptors, despite having an affinity for binding to σ1 receptors . |
| Pharmacodynamics | Fluvoxamine, an aralkylketone-derivative agent, is one of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) that differs structurally from other SSRIs . It is used to treat the depression associated with mood disorders. It is also used on occassion in the treatment of body dysmorphic disorder and anxiety . The antidepressant, antiobsessive-compulsive, and antibulimic actions of Fluvoxamine are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin [FDA Label, A249, A250]. <i>In vitro</i> studies show that Fluvoxamine is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake . Moreover, apart from binding to σ1 receptors , fluvoxamine has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT<sub>1A</sub>, 5HT<sub>1B</sub>, 5HT<sub>2</sub>), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs . Furthermore, some studies have demonstrated that the chronic administration of Fluvoxamine was found to downregulate brain norepinephrine receptors (as has been observed with other drugs effective in the treatment of major depressive disorder), while others suggest the opposite . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent serotonin transporter | Humans | inhibitor |
| Potassium voltage-gated channel subfamily H member 2 | Humans |
ADME / PK
| Absorption | Well absorbed, bioavailability of fluvoxamine maleate is 53%. |
|---|---|
| Half-life | 15.6 hours. |
| Protein binding | ~77-80% (plasma protein). |
| Metabolism | Fluvoxamine is metabolized extensively by the liver. |
| Route of elimination | Nine metabolites were identified following a 5 mg radio labelled dose of fluvoxamine maleate, constituting approximately 85% of the urinary excretion products of fluvoxamine. The main human metabolite was fluvoxamine acid which, together with its N-acetylated analog, accounted for about 60% of the urinary excretion products. Approximately 2% of fluvoxamine was excreted in urine unchanged. Following a 14C-labelled oral dose of fluvoxamine maleate (5 mg), an average of 94% of drug-related products was recovered in the urine within 71 hours. |
| Volume of distribution | * 25 L/kg. |
Formulation & handling
- Fluvoxamine is a small molecule API formulated exclusively for oral administration in solid tablet or capsule forms.
- It exhibits low water solubility and moderate lipophilicity (LogP 2.8), necessitating formulation strategies to enhance bioavailability.
- Absorption is unaffected by food, though interaction with alcohol, grapefruit products, and caffeine should be considered during clinical use.
Regulatory status
| Lifecycle | The API’s primary patent in the United States expired in May 2020, indicating market entry for generic versions is permitted in the US and Canada. The product is considered to be in a mature market phase in both regions. |
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| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Fluvoxamine is manufactured by multiple companies including both originators and generic producers, indicating a diverse supply chain. The branded products have a strong presence primarily in the US and Canadian markets. Patent expiry in 2020 suggests that generic competition is currently established within these markets. |
|---|
Safety
| Toxicity | Fluvoxamine is a member of antidepressants that possess an increased risk compared to placebo of suicidal thinking and behaviour (suicidality) in children, adolescents, and young adults (ages including and and below 24) in short-term studies of major depressive disorder and other psychiatric disorders. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). Side effects include anorexia, constipation, dry mouth, headache, nausea, nervousness, skin rash, sleep problems, somnolence, liver toxicity, mania, increase urination, seizures, sweating increase, tremors, or Tourette's syndrome. |
|---|
- Fluvoxamine exhibits a risk of increased suicidal ideation and behaviors in patients under 24 years of age during short-term treatment
- Not approved for pediatric use except in cases of obsessive-compulsive disorder (OCD)
- Potential adverse effects include hepatotoxicity, seizures, and neurological symptoms such as tremors and mania
Fluvoxamine 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.
Fluvoxamine (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.
Fluvoxamine API manufacturers & distributors
Compare qualified Fluvoxamine API suppliers worldwide. We currently have 8 companies offering Fluvoxamine API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Atilus Pharma | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, HALAL, Kosher, MSDS | 11 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | CoA, GMP, ISO9001, MSDS | 170 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Medichem | Producer | Spain | Unknown | CoA, JDMF, USDMF | 39 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 764 products |
| Sun Pharma | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 219 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 146 products |
| ZCL Chemicals | Producer | India | India | CEP, CoA, Other, FDA, ISO9001, USDMF, WC | 30 products |
When sending a request, specify which Fluvoxamine 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 Fluvoxamine 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.
