Escitalopram API Manufacturers & Suppliers
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Escitalopram | CAS No: 128196-01-0 | GMP-certified suppliers
A medication that provides reliable treatment for major depressive disorder, generalized anxiety disorder, and, where approved, obsessive‑compulsive disorder for diverse patient populations.
Therapeutic categories
Primary indications
- Escitalopram is indicated for the acute and maintenance treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years old and older and for the acute treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years old and older
- It is additionally indicated for symptomatic relief of obsessive-compulsive disorder (OCD) in Canada
Product Snapshot
- Oral small‑molecule formulations supplied mainly as tablets and oral solutions
- Used for major depressive disorder, generalized anxiety disorder, and in Canada for obsessive‑compulsive disorder
- Approved in the US and Canada with established regulatory acceptance for commercial supply
Clinical Overview
Escitalopram enhances serotonergic neurotransmission through high‑affinity binding to the primary site of the serotonin transporter, inhibiting reuptake of serotonin into presynaptic neurons. It also exhibits allosteric binding to a secondary site on the transporter, which reinforces inhibition and contributes to rapid engagement of the target. Sustained elevations in synaptic serotonin lead to desensitization of 5‑HT1A autoreceptors, a process associated with clinical response.
Pharmacologically, escitalopram displays minimal activity at histaminergic and muscarinic receptors and limited off‑target interactions relative to other SSRIs. This high selectivity is a defining characteristic of the molecule. Its potency also exceeds that of the R‑enantiomer of citalopram, which may counteract its activity in the racemate.
Absorption is rapid, and the compound is metabolized primarily by cytochrome P450 enzymes including CYP2C19, CYP2D6, and CYP3A4. It is a weak inhibitor of CYP2D6 and is also a substrate for P‑glycoprotein. Elimination pathways include hepatic metabolism followed by renal excretion of metabolites.
Safety considerations include risks common to SSRIs such as serotonin syndrome, abnormal bleeding in patients with co‑administered agents affecting hemostasis, QTc prolongation, and discontinuation symptoms with abrupt cessation. Caution is warranted with serotonergic drugs and in patients with elevated bleeding risk.
Escitalopram is available globally under multiple brand and generic products. For API procurement, sourcing should prioritize suppliers with validated control of enantiomeric purity, consistent polymorphic form, and compliance with ICH and pharmacopeial quality standards.
Identification & chemistry
| Generic name | Escitalopram |
|---|---|
| Molecule type | Small molecule |
| CAS | 128196-01-0 |
| UNII | 4O4S742ANY |
| DrugBank ID | DB01175 |
Pharmacology
| Summary | Escitalopram is a selective serotonin reuptake inhibitor that increases synaptic serotonin by binding to both the primary and an allosteric site on the serotonin transporter. This dual interaction enhances transporter inhibition and contributes to its characteristic pharmacodynamic profile, including sustained elevation of extracellular serotonin and downstream 5‑HT1A autoreceptor desensitization. It shows minimal affinity for most off‑target receptors, with limited activity at histamine and muscarinic receptors. |
|---|---|
| Mechanism of action | Escitalopram, like other selective serotonin re-uptake inhibitors, enhances serotonergic activity by binding to the orthosteric (i.e. primary) binding site on the serotonin transporter (SERT), the same site to which endogenous 5-HT binds, and thus prevents the re-uptake of serotonin into the presynaptic neuron.Escitalopram, along with [paroxetine], is also considered an allosteric serotonin re-uptake inhibitor - it binds to a secondary allosteric site on the SERT molecule to more strongly inhibit 5-HT re-uptake. Its combination of orthosteric and allosteric activity on SERT allows for greater extracellular 5-HT levels, a faster onset of action, and greater efficacy as compared to other SSRIs. The sustained elevation of synaptic 5-HT eventually causes desensitization of 5-HT<sub>1A</sub> auto-receptors, which normally shut down endogenous 5-HT release in the presence of excess 5-HT - this desensitization may be necessary for the full clinical effect of SSRIs and may be responsible for their typically prolonged onset of action. Escitalopram has shown little-to-no binding affinity at a number of other receptors, such as histamine and muscarinic receptors, and minor activity at these off-targets may explain some of its adverse effects. |
| Pharmacodynamics | Escitalopram belongs to a class of medications called selective serotonin re-uptake inhibitors (SSRIs). These agents cause an increase in serotonin levels in neuronal synapses by preventing the re-uptake of serotonin (5-HT) into the presynaptic terminals of serotonergic neurons.As compared to other SSRIs, it appears to have a relatively quick onset of effect due to its potency. SSRIs as a class have been associated with abnormal bleeding, particularly in patients receiving concomitant therapy with other medications affecting hemostasis, and with the development of serotonin syndrome. Use escitalopram with caution in patients with a higher-than-baseline risk of bleeding and in patients receiving concomitant therapy with other serotonergic drugs. Escitalopram may also cause a discontinuation syndrome with abrupt removal of the drug, and should be slowly tapered if discontinuation of therapy is warranted. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent serotonin transporter | Humans | inhibitor |
| Muscarinic acetylcholine receptor M1 | Humans | inhibitor |
| Histamine H1 receptor | Humans | inhibitor |
ADME / PK
| Absorption | Absorption of escitalopram following oral administration is expected to be almost complete, with an estimated absolute bioavailability of approximately 80%. T<sub>max</sub> occurs after about 4-5 hours.C<sub>max</sub> and AUC appear to follow dose proportionality - at steady state, patients receiving 10mg of escitalopram daily had a C<sub>max</sub> of 21 ng/mL and a 24h AUC of approximately 360 ng*h/mL, while patients receiving 30mg daily had a roughly 3-fold increase in both C<sub>max</sub> and 24h AUC, comparatively. |
|---|---|
| Half-life | The elimination half-life of escitalopram is 27-32 hours, though this is increased by approximately 50% in the elderly and doubled in patients with reduced hepatic function.The elimination half-life of escitalopram's primary metabolite, S-desmethylcitalopram, is approximately 54 hours at steady state. |
| Protein binding | Escitalopram exhibits relatively low protein binding at approximately 55-56%. |
| Metabolism | The metabolism of escitalopram is mainly hepatic, mediated primarily by CYP2C19 and CYP3A4 and, to a lesser extent, CYP2D6. Oxidative N-demethylation by the CYP enzyme system results in S-desmethylcitalopram (S-DCT) and S-didesmethylcitalopram (S-DDCT) - these metabolites do not contribute to the pharmacologic activity of escitalopram, and exist in the plasma in small quantities relative to the parent compound (28-31% and <5%, respectively). There is also some evidence that escitalopram is metabolized to a propionic acid metabolite by monoamine oxidase A and B in the brain, and that these enzymes constitute the major route of escitalopram metabolism in the brain. |
| Route of elimination | After oral administration of escitalopram, approximately 8% of the total dose is eliminated in the urine as unchanged escitalopram and 10% is eliminated in the urine as S-desmethylcitalopram.The apparent hepatic clearance of escitalopram amounts to approximately 90% of the total dose. |
| Volume of distribution | Escitalopram appears to distribute extensively into tissues, with an apparent volume of distribution of approximately 12-26 L/kg. |
| Clearance | The oral plasma clearance of escitalopram is 600 mL/min, of which approximately 7% is due to renal clearance. |
Formulation & handling
- Oral small‑molecule API suitable for tablets and solutions, with low aqueous solubility that may require solubility‑enhancing excipients for robust dissolution.
- Moderate lipophilicity (LogP ~3.8) supports conventional oral absorption, and food has minimal impact on bioavailability.
- Solid‑state stability is adequate for standard handling; solution formulations should control pH to maintain solubility and prevent precipitation.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patents for the API expired between 2011 and 2023, indicating that key protections have lapsed across both markets. With the API marketed in the United States and Canada, its lifecycle reflects a mature stage with established generic availability. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Escitalopram has a well‑established manufacturing base, with the original developer’s products long supplemented by numerous repackagers and distributors supporting broad commercial supply. Branded products are present mainly in the US and Canada, while patent expirations in both markets indicate that generic competition is already mature. As a result, the supply landscape is characterized by multiple sources and wide availability across North American markets. |
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Safety
| Toxicity | Symptoms of overdose may include CNS effects (dizziness, convulsions, coma, somnolence), gastrointestinal distress (nausea, vomiting), and/or cardiac abnormalities (hypotension, tachycardia, ECG changes).There is no specific antidote for escitalopram overdose. Management of overdose should focus on monitoring for cardiac abnormalities and changes to vital signs as well as treatment with supportive measures as indicated. As escitalopram is highly distributed into tissue following oral administration, forced diuresis, dialysis, and other methods of extracting drug from plasma are unlikely to be beneficial. |
|---|
- Overexposure is associated with CNS depression and excitation (dizziness, somnolence, convulsions, coma) and gastrointestinal distress, along with potential cardiac effects such as hypotension, tachycardia, and ECG alterations
- No specific antidote is known
- The compound’s extensive tissue distribution limits the utility of extracorporeal removal methods
Escitalopram is a type of Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective Serotonin Reuptake Inhibitors (SSRIs) are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used for the treatment of various mental health disorders, particularly depression and anxiety. SSRIs work by inhibiting the reuptake of serotonin, a neurotransmitter that plays a crucial role in regulating mood, emotions, and well-being.
These medications are designed to selectively target the serotonin transporter proteins in the brain, preventing the reabsorption of serotonin into the presynaptic neuron. By blocking the reuptake process, SSRIs increase the concentration of serotonin in the synaptic cleft, enhancing its availability for binding to postsynaptic receptors. This ultimately leads to an improved transmission of serotonin signals between neurons.
The mechanism of action of SSRIs helps to alleviate symptoms of depression and anxiety by stabilizing mood, reducing feelings of sadness, enhancing motivation, and promoting a sense of calmness. The exact therapeutic effects and onset of action may vary depending on the specific SSRIs used.
SSRIs have gained popularity due to their favorable safety profile and efficacy in treating a range of mental health conditions. Common SSRIs include fluoxetine, sertraline, citalopram, and escitalopram. These medications are typically available in oral dosage forms, such as tablets or capsules.
It's important to note that SSRIs should be prescribed and monitored by healthcare professionals, as they can have potential side effects and interactions with other medications. Individuals considering SSRIs should consult with their healthcare provider to determine the most appropriate treatment option for their specific needs.
Escitalopram API manufacturers & distributors
Compare qualified Escitalopram API suppliers worldwide. We currently have 26 companies offering Escitalopram API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Arch Pharmalabs | Producer | India | India | CoA, USDMF | 19 products |
| AXXO GmbH | Distributor | Germany | European Union | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, GMP, MSDS, USDMF | 252 products |
| Cipla | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF, WC | 170 products |
| H. Lundbeck | Producer | Denmark | Denmark | CoA, JDMF, USDMF | 6 products |
| HEC Pharm | Producer | Germany | Unknown | CoA, USDMF | 31 products |
| Hetero Drugs | Producer | India | India | CEP, CoA, GMP | 98 products |
| Hetero Labs | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 90 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Micro Labs | Producer | India | India | CoA, GMP, WC | 38 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CoA, FDA, GMP, WC | 40 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Sandoz | Producer | Austria | India | CoA, GMP, WC | 58 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sichuan Kelun Pharmaceuti... | Producer | China | China | CoA | 6 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Wuxi Jida Pharma | Producer | China | China | CoA, USDMF | 3 products |
| Xellia (Taizhou) | Producer | China | China | CoA, WC | 8 products |
| Zhejiang Haisen Pharma | Producer | China | China | CoA, WC | 7 products |
When sending a request, specify which Escitalopram 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 Escitalopram 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.
