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Venlafaxine | CAS No: 93413-69-5 | GMP-certified suppliers
A medication that supports management of major depressive disorder, generalized and social anxiety disorders, and panic disorder to help address key psychiatric treatment needs.
Therapeutic categories
Primary indications
- Venlafaxine is indicated for the management of major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder
Product Snapshot
- Venlafaxine is an oral small‑molecule API supplied primarily in immediate‑ and extended‑release solid oral formulations
- It is used in products for major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder
- It is approved in major markets including the US and Canada
Clinical Overview
Venlafaxine and its active metabolite O-desmethylvenlafaxine act by selectively inhibiting reuptake of serotonin and norepinephrine at presynaptic sites, increasing neurotransmitter concentrations within the synaptic cleft. Serotonin reuptake inhibition predominates at lower doses, with norepinephrine reuptake inhibition becoming more pronounced at higher exposure levels. Both compounds are weak inhibitors of dopamine reuptake. Venlafaxine exhibits minimal direct activity at muscarinic, histamine, or adrenergic receptors, consistent with its pharmacodynamic profile.
After oral administration, venlafaxine is extensively metabolized, with O-desmethylvenlafaxine formed primarily via CYP2D6. The parent compound and metabolites are substrates for several cytochrome P450 isoenzymes and are subject to renal elimination. Protein binding is modest, and dose proportionality is generally maintained across therapeutic ranges. The extended‑release formulation provides more stable plasma concentrations and supports once‑daily dosing.
Safety considerations include dose‑related increases in blood pressure, potential for tachycardia, and a known risk of serotonin syndrome when combined with other serotonergic agents. Venlafaxine may prolong the QTc interval in susceptible individuals and can lower the seizure threshold. Withdrawal symptoms may occur with abrupt discontinuation. Use should be guided by careful assessment of comorbidities, concomitant medications, and renal function.
For API procurement, suppliers should provide validated control of stereochemistry, impurity profile, and residual solvents, along with evidence of compliance with relevant pharmacopeial specifications and robust change control to support global regulatory submissions.
Identification & chemistry
| Generic name | Venlafaxine |
|---|---|
| Molecule type | Small molecule |
| CAS | 93413-69-5 |
| UNII | GRZ5RCB1QG |
| DrugBank ID | DB00285 |
Pharmacology
| Summary | Venlafaxine and its active metabolite O-desmethylvenlafaxine increase synaptic serotonin and norepinephrine by inhibiting their presynaptic reuptake, with weaker effects on dopamine transport. The drug shows greater functional selectivity for serotonin transport inhibition at lower exposures, expanding to norepinephrine at higher exposures. Its pharmacologic profile supports therapeutic use across depressive and anxiety disorders without significant interaction with muscarinic, histaminergic, or adrenergic receptors. |
|---|---|
| Mechanism of action | The exact mechanism of action of venlafaxine in the treatment of various psychiatric conditions has not been fully elucidated; however, it is understood that venlafaxine and its active metabolite O-desmethylvenlafaxine (ODV) potently and selectively inhibits the reuptake of both serotonin and norepinephrine at the presynaptic terminal.This results in increased levels of neurotransmitters available at the synapse that can stimulate postsynaptic receptors.It is suggested that venlafaxine has a 30-fold selectivity for serotonin compared to norepinephrine: venlafaxine initially inhibits serotonin reuptake at low doses, and with higher doses, it inhibits norepinephrine reuptake in addition to serotonin.Venlafaxine and ODV are also weak inhibitors of dopamine reuptake. |
| Pharmacodynamics | Venlafaxine is an antidepressant agent that works to ameliorate the symptoms of various psychiatric disorders by increasing the level of neurotransmitters in the synapse. Venlafaxine does not mediate muscarinic, histaminergic, or adrenergic effects. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent serotonin transporter | Humans | inhibitor |
| Sodium-dependent noradrenaline transporter | Humans | inhibitor |
| Sodium-dependent dopamine transporter | Humans | inhibitor |
ADME / PK
| Absorption | Venlafaxine is well absorbed after oral administration with an absolute bioavailability of approximately 45%. In mass balance studies, at least 92% of a single oral dose of venlafaxine was absorbed. After twice-daily oral administration of immediate-release formulation of 150 mg venlafaxine, C<sub>max</sub> was 150 ng/mL and T<sub>max</sub> was 5.5 hours. C<sub>max</sub> and T<sub>max</sub> of ODV were 260 ng/mL and nine hours, respectively. The extended-release formulation of venlafaxine has a slower rate of absorption, but the same extent of absorption as the immediate-release formulation. After once-daily administration of extended-release formulation of 75 mg venlafaxine, C<sub>max</sub> was 225 ng/mL and T<sub>max</sub> was two hours. C<sub>max</sub> and T<sub>max</sub> of ODV were 290 ng/mL and three hours, respectively. Food does not affect the bioavailability of venlafaxine or its active metabolite, O-desmethylvenlafaxine (ODV). |
|---|---|
| Half-life | The apparent elimination half-life is 5 ± 2 hours for venlafaxine and 11 ± 2 hours for ODV. |
| Protein binding | Venlafaxine and ODV is 27% and 30% bound to plasma proteins, respectively. |
| Metabolism | Following absorption, venlafaxine undergoes extensive presystemic metabolism in the liver. It primarily undergoes CYP2D6-mediated demethylation to form its active metabolite O-desmethylvenlafaxine (ODV).Venlafaxine can also undergo N-demethylation mediated by CYP2C9, and CYP2C19, and CYP3A4 to form N-desmethylvenlafaxine (NDV) but this is a minor metabolic pathway.ODV and NDV further metabolized by CYP2C19, CYP2D6 and/or CYP3A4 to form N,O-didesmethylvenlafaxine (NODV) and NODV can be further metabolized to form N, N, O-tridesmethylvenlafaxine, followed by a possible glucuronidation. |
| Route of elimination | Approximately 87% of a venlafaxine dose is recovered in the urine within 48 hours as unchanged venlafaxine (5%), unconjugated ODV (29%), conjugated ODV (26%), or other minor inactive metabolites (27%). |
| Volume of distribution | The apparent volume of distribution at steady-state is 7.5 ± 3.7 L/kg for venlafaxine and 5.7 ± 1.8 L/kg for ODV. |
| Clearance | Mean ± SD plasma apparent clearance at steady-state is 1.3 ± 0.6 L/h/kg for venlafaxine and 0.4 ± 0.2 L/h/kg for ODV. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, often requiring salt forms or modified‑release matrices to control dissolution and mitigate dose‑dumping risks.
- Extended‑release capsules and tablets rely on coated pellets or diffusion‑controlled polymers to manage rapid absorption and reduce peak‑related tolerability issues.
- Co‑administration with food can reduce GI irritation, but it does not materially affect API stability or absorption characteristics relevant to formulation.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patents expired between 2013 and 2017, indicating that the API is well past its primary exclusivity period. With products marketed in both Canada and the United States, the API is in a mature, post‑patent market phase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Venlafaxine originated with Wyeth, but the product is now supplied by a broad set of generic manufacturers and repackagers, indicating a fully mature multi‑source market. Branded and generic versions are established in North American markets, including the US and Canada. Key patents expired between 2013 and 2017, supporting the widespread generic competition currently present. |
|---|
Safety
| Toxicity | Oral LD<sub>50</sub> was 350 mg/kg in female rats and 700 mg/kg in male rats. There are reports of acute overdosage with venlafaxine either alone or in combination with other drugs including alcohol. Doses up to several-fold higher than the usual therapeutic dose have been ingested in these cases of acute overdosage. Somnolence is the most commonly reported symptom, along with other symptoms such as paresthesia of the extremities, moderate dizziness, altered consciousness, nausea, vomiting, numb hands and feet, hot-cold spells (which occur a few days after the overdose event), hypotension, convulsions, sinus and ventricular tachycardia, rhabdomyolysis, vertigo, liver necrosis, electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), serotonin syndrome, and death. There is no known antidote for venlafaxine overdose. Cases of overdose have been managed with or without symptomatic treatment, hospitalization, and activated charcoal. Retrospective studies suggest that the risk of fatal outcomes from venlafaxine overdosage is higher than that of SSRI antidepressants, but lower than that of tricyclic antidepressants. |
|---|
- Oral toxicity is moderate, with rat LD50 values of approximately 350 mg/kg (female) and 700 mg/kg (male)
- Acute overdose has produced CNS depression, cardiovascular conduction abnormalities, serotonin toxicity, and rhabdomyolysis, with documented fatalities
- Retrospective data indicate a higher fatality rate in overdose relative to SSRIs, though lower than tricyclic antidepressants
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Venlafaxine is a type of Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)
Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) belong to a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that have gained significant popularity in the treatment of various medical conditions. SNRIs work by modulating the levels of two essential neurotransmitters in the brain, namely serotonin and norepinephrine.
These APIs are commonly prescribed for managing a range of mental health disorders, including depression, anxiety disorders, and certain chronic pain conditions. By inhibiting the reuptake of serotonin and norepinephrine, SNRIs enhance their availability in the brain, leading to improved mood, increased energy levels, and reduced pain perception.
SNRIs exhibit a unique dual mechanism of action, making them distinct from other classes of antidepressant medications. By targeting both serotonin and norepinephrine reuptake, SNRIs provide a broader spectrum of therapeutic effects, making them effective in treating patients who do not respond well to other medications.
Due to their widespread usage and effectiveness, SNRIs have become a preferred choice for healthcare professionals. Some commonly prescribed SNRIs include duloxetine, venlafaxine, and desvenlafaxine. These APIs are typically available in oral formulations and are well-tolerated by most patients, with a favorable side effect profile.
In summary, SNRIs represent a significant subcategory of pharmaceutical APIs that play a crucial role in the management of mental health disorders and chronic pain conditions. Their unique dual mechanism of action and effectiveness make them a valuable treatment option for healthcare providers, ensuring improved patient outcomes and quality of life.
Venlafaxine (Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)), classified under Antidepressants
Antidepressants are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the treatment of depression and other mood disorders. These medications work by balancing the levels of certain chemicals in the brain called neurotransmitters, such as serotonin, norepinephrine, and dopamine.
There are several types of antidepressants available, each with its own mechanism of action and efficacy. Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed as a first-line treatment for depression. They prevent the reabsorption of serotonin, resulting in increased serotonin levels in the brain. Examples of popular SSRIs include fluoxetine, sertraline, and escitalopram.
Tricyclic antidepressants (TCAs) are another class of antidepressants that work by blocking the reuptake of both serotonin and norepinephrine. They are generally used when SSRIs are ineffective or not well-tolerated. Amitriptyline, nortriptyline, and imipramine are commonly prescribed TCAs.
Other antidepressants include serotonin-norepinephrine reuptake inhibitors (SNRIs), atypical antidepressants, and monoamine oxidase inhibitors (MAOIs). SNRIs, such as venlafaxine and duloxetine, inhibit the reuptake of both serotonin and norepinephrine. Atypical antidepressants, including bupropion and mirtazapine, have diverse mechanisms of action, targeting multiple neurotransmitters. MAOIs, such as phenelzine and tranylcypromine, work by inhibiting the enzyme monoamine oxidase, which breaks down neurotransmitters.
It is important to note that antidepressants may have various side effects and require close monitoring by healthcare professionals. Dosages and treatment duration vary based on individual needs and response. Antidepressants are typically prescribed as part of a comprehensive treatment plan that may include psychotherapy and lifestyle modifications.
In conclusion, antidepressants are a vital category of pharmaceutical APIs used to manage depression and related mood disorders. They act on neurotransmitters in the brain to alleviate symptoms and improve overall well-being. It is crucial to consult with a healthcare provider to determine the most suitable antidepressant and monitor its effects.
Venlafaxine API manufacturers & distributors
Compare qualified Venlafaxine API suppliers worldwide. We currently have 24 companies offering Venlafaxine 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Chongqing Carelife | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 8 products |
| Cipla | Producer | India | India | CEP, CoA, WC | 164 products |
| Divis Labs. | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, Other, USDMF, WC | 47 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hikal | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 26 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, GMP, USDMF | 69 products |
| KRKA | Producer | Slovenia | Unknown | CEP, CoA, GMP | 81 products |
| Lee Pharma | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 21 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 155 products |
| Medichem | Producer | Spain | Unknown | CEP, CoA, FDA, GMP | 39 products |
| Menovo | Producer | China | China | CEP, CoA, FDA, GMP | 27 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP | 51 products |
| Sandoz | Producer | Austria | India | CoA, GMP, WC | 58 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 757 products |
| Strides Pharma Science | Producer | India | Unknown | CEP, CoA, GMP | 14 products |
| Sun Pharma | Producer | India | India | CEP, CoA, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Torrent Pharma | Producer | India | India | CoA, USDMF | 34 products |
| Zhejiang Apeloa Tospo-Jia... | Producer | China | China | CoA, USDMF | 15 products |
| Zhejiang Raybow Pharma | Producer | China | China | CEP, CoA, FDA, USDMF | 2 products |
When sending a request, specify which Venlafaxine 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 Venlafaxine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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