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Producer
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CoA|
WCAll certificates
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Produced in
Slovenia|
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Producer
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Japan|
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Producer
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Produced in
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CoA|
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Mirtazapine | CAS No: 85650-52-8 | GMP-certified suppliers
A medication that helps manage major depressive disorder by addressing core mood and associated symptoms for organizations sourcing reliable antidepressant APIs.
Therapeutic categories
Adrenergic AgentsAdrenergic alpha-2 Receptor AntagonistsAdrenergic alpha-AntagonistsAdrenergic AntagonistsAgents that produce hypertensionAnti-Anxiety Agents
Generic name
Mirtazapine
Molecule type
small molecule
CAS number
85650-52-8
DrugBank ID
DB00370
Approval status
Approved drug
ATC code
N06AX11
Primary indications
- This drug is indicated for the treatment of major depressive disorder and its associated symptoms
- [FDA label]
- Mirtazapine has been used off-label for a variety of conditions including panic disorder, generalized anxiety disorder, dysthymia, tension headaches, hot flushes, post-traumatic stress disorder (PTSD), sleep disorders, substance abuse disorders, and sexual disorders, among others
Product Snapshot
- Oral small‑molecule formulations dominate, with multiple tablet and ODT presentations and limited use of injectable concentrate
- It is primarily used for major depressive disorder, with additional off‑label applications across anxiety and related CNS conditions
- It is approved in the US and Canada
Clinical Overview
Mirtazapine (CAS 85650-52-8) is a tetracyclic piperazino‑azepine antidepressant approved for the treatment of major depressive disorder. It is used clinically to address core depressive symptoms including impaired sleep, reduced appetite, anhedonia, and anxiety. Symptom improvement may begin within the first week of therapy. Off‑label use has been reported in conditions such as panic disorder, generalized anxiety disorder, PTSD, certain sleep disorders, and selected cases of appetite loss or weight decline associated with medical illness.
Mirtazapine’s pharmacological activity involves modulation of central adrenergic and serotonergic pathways. It antagonizes presynaptic alpha2‑adrenergic autoreceptors and heteroreceptors, enhancing norepinephrine and serotonin release. It also blocks 5‑HT2 and 5‑HT3 receptors while indirectly increasing 5‑HT1A signaling. Strong H1‑histamine receptor antagonism contributes to pronounced sedative effects, and peripheral alpha1‑adrenergic blockade may account for orthostatic hypotension. These multimodal actions differentiate mirtazapine from selective serotonin reuptake inhibitors and other second‑generation antidepressants.
Absorption is generally rapid and oral bioavailability is moderate. Mirtazapine is extensively metabolized in the liver, involving CYP1A2, CYP2D6, and CYP3A isoenzymes, and demonstrates high plasma protein binding. Elimination occurs primarily via the kidneys after metabolic conversion. The drug is categorized as a weak CYP3A4 inhibitor and is also a substrate of this pathway.
Safety considerations include dose‑related somnolence, increased appetite, and weight gain. Suicidal ideation and behavioral changes may emerge, particularly in younger adults, and careful monitoring is required during dose adjustments. Other risks include orthostatic hypotension, potential QTc prolongation, and serotonin syndrome when combined with serotonergic agents. Mirtazapine is not recommended for pediatric use.
Common global brand contexts include formulations originally developed by Organon and subsequent generic equivalents.
For API procurement, manufacturers should ensure control of stereochemistry, impurity profiles, and residual solvent levels, supported by full regulatory documentation and compliance with relevant pharmacopoeial standards.
Mirtazapine’s pharmacological activity involves modulation of central adrenergic and serotonergic pathways. It antagonizes presynaptic alpha2‑adrenergic autoreceptors and heteroreceptors, enhancing norepinephrine and serotonin release. It also blocks 5‑HT2 and 5‑HT3 receptors while indirectly increasing 5‑HT1A signaling. Strong H1‑histamine receptor antagonism contributes to pronounced sedative effects, and peripheral alpha1‑adrenergic blockade may account for orthostatic hypotension. These multimodal actions differentiate mirtazapine from selective serotonin reuptake inhibitors and other second‑generation antidepressants.
Absorption is generally rapid and oral bioavailability is moderate. Mirtazapine is extensively metabolized in the liver, involving CYP1A2, CYP2D6, and CYP3A isoenzymes, and demonstrates high plasma protein binding. Elimination occurs primarily via the kidneys after metabolic conversion. The drug is categorized as a weak CYP3A4 inhibitor and is also a substrate of this pathway.
Safety considerations include dose‑related somnolence, increased appetite, and weight gain. Suicidal ideation and behavioral changes may emerge, particularly in younger adults, and careful monitoring is required during dose adjustments. Other risks include orthostatic hypotension, potential QTc prolongation, and serotonin syndrome when combined with serotonergic agents. Mirtazapine is not recommended for pediatric use.
Common global brand contexts include formulations originally developed by Organon and subsequent generic equivalents.
For API procurement, manufacturers should ensure control of stereochemistry, impurity profiles, and residual solvent levels, supported by full regulatory documentation and compliance with relevant pharmacopoeial standards.
Identification & chemistry
| Generic name | Mirtazapine |
|---|---|
| Molecule type | Small molecule |
| CAS | 85650-52-8 |
| UNII | A051Q2099Q |
| DrugBank ID | DB00370 |
Pharmacology
| Summary | Mirtazapine modulates central noradrenergic and serotonergic signaling primarily through antagonism of presynaptic alpha‑2 adrenergic receptors, which enhances norepinephrine release and indirectly increases 5‑HT1A–mediated transmission. It also blocks 5‑HT2 and 5‑HT3 receptors, histamine H1 receptors, and peripheral alpha‑1 receptors, shaping its sedative, appetite‑stimulating, and autonomic effects. Additional activity at opioid receptors may contribute to its analgesic properties. |
|---|---|
| Mechanism of action | **Summary** The mechanism of action of mirtazapine is not fully understood[FDA label] but may be explained by its effects on central adrenergic and serotonergic activity. This drug exhibits a fast onset of action, a high level of response, a manageable side-effect profile, and dual noradrenergic and serotonergic effects that are unique from the effects of other antidepressants. **Effects on various receptors** It has been shown that both noradrenergic and serotonergic activity increase following mirtazapine administration. The results of these studies demonstrate mirtazapine exerts antagonist activity at presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors in the central nervous system. This is thought to lead to enhanced noradrenergic and serotonergic activity [FDA label], which are known to improve the symptoms of depression and form the basis of antidepressant therapy. Mirtazapine is a strong antagonist of serotonin 5-HT2 and 5-HT3 receptors. It has not been found to bind significantly to the serotonin 5-HT1A and 5-HT1B receptors [FDA label] but indirectly increases 5-HT1A transmission. In addition to the above effects, mirtazapine is a peripheral α1-adrenergic antagonist. This action may explain episodes of orthostatic hypotension that have been reported after mirtazapine use.[FDA label] Mirtazapine is a potent histamine (H1) receptor antagonist, which may contribute to its powerful sedating effects.[FDA label] The pain-relieving effects of mirtazapine may be explained by its effects on opioid receptors. |
| Pharmacodynamics | **General effects and a note on suicidality** Mirtazapine is effective in treating moderate to severe depression and treats many symptoms normally associated with this condition. These symptoms may include disturbed sleep, lack of appetite, and anhedonia, in addition to anxiety.. It is important to note that suicidal ideation and behavior may emerge or increase during treatment with mirtazapine, as with any other antidepressant. This risk is especially pronounced in younger individuals. Patients, medical professionals, and families should monitor for suicidal thoughts, worsening depression, anxiety, agitation, sleep changes, irritable behavior, aggression, impulsivity, restlessness, and other unusual behavior when this drug is taken or the dose is adjusted.[FDA label] Do not administer mirtazapine to children. When deciding to prescribe this drug, carefully consider the increased risk of suicidal thoughts and behavior, especially in young adults.[FDA label] **Effects on appetite and weight gain** In addition to the above effects, mirtazapine exerts stimulating effects on appetite, and has been used for increasing appetite and decreasing nausea in cancer patients.Some studies and case reports have shown that this drug improves eating habits and weight gain in patients suffering from anorexia nervosa when administered in conjunction with psychotherapy and/or other psychotropic drugs.In a clinical trial, women with depression experienced a clinically significant mean increase in body weight, fat mass, and concentrations of leptin when treated with mirtazapine for a 6-week period, with a lack of effect on glucose homeostasis. **Effects on sleep** The use of mirtazapine to treat disordered sleep has been leveraged from its tendency to cause somnolence, which is a frequently experienced adverse effect by patients taking this drug.[A177808,A177994,FDA label] Mirtazapine has been shown to exert beneficial effects on sleep latency, duration, and quality due to its sedating properties.Insomnia is a common occurrence in patients with depression, and mirtazapine has been found to be efficacious in treating this condition. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| 5HT3 serotonin receptor | Humans | antagonist |
| Alpha-2A adrenergic receptor | Humans | antagonist |
ADME / PK
| Absorption | The absorption of this drug is rapid and complete.[A177826, FDA label] Due to first pass metabolism in the liver and metabolism in the gut wall, absolute bioavailability is about 50%.[FDA label,A177826] Peak blood concentrations are attained within about 2 hours after an oral dose. Food has little effect on the absorption of mirtazapine, and no dose adjustment is required if it is taken with food.[FDA label] Steady-state levels are achieved by about 5 days after the initial dose.[FDA label, A177826] Mirtazapine pharmacokinetics vary across gender and age range. Females and the elderly population have been shown to have higher blood concentrations in comparison to males and younger adults. |
|---|---|
| Half-life | 20-40 hours [FDA label, A177826] |
| Protein binding | Mirtazapine is about 85% bound to plasma proteins.[A177826,FDA label] |
| Metabolism | Mirtazapine is heavily metabolized in humans.[FDA label] Demethylation and hydroxylation and subsequent glucuronide conjugation are the major pathways by which mirtazapine is metabolized.[A177826,FDA label] Data from in vitro studies on human liver microsomes show that cytochrome 2D6 and 1A2 lead to the formation of the _8-hydroxy metabolite_ of mirtazapine. The CYP3A enzyme metabolizes this drug into its _N-desmethyl and N-oxide_ metabolites. There are various other unconjugated metabolites of this drug that are pharmacologically active, but are measured in the blood at limited concentrations.[FDA label, A177826] |
| Route of elimination | This drug is mainly excreted by the kidney. It is 75% eliminated in the urine and 15% eliminated in the feces. |
| Volume of distribution | The volume of distribution after an oral steady-state dose was measured to be 107 ± 42L in a pharmacokinetic study. |
| Clearance | Total body clearance in males was found to be 31 L/h in a clinical pharmacokinetics study after intravenous administration. **Clearance in elderly patients** Mirtazapine clearance is slower in the elderly than in younger subjects. Exercise caution when this drug is given to elderly patients. In a clinical trial, elderly males showed a marked decrease in mirtazapine clearance when compared to young males taking the same dose. This difference was less significant when clearance was compared between elderly females and younger females taking mirtazapine.[FDA label] **Clearance in hepatic and renal impairment** Patients with hepatic and renal impairment have decreased rates of clearance and dosage adjustments may be necessary for these patients.[FDA label] Moderate renal impairment and hepatic impairment cause about a 30% decrease in mirtazapine clearance. Severe renal impairment leads to a 50% decrease in mirtazapine clearance. |
Formulation & handling
- Oral solid and ODT formulations leverage its small‑molecule, lipophilic profile, with adequate aqueous solubility for conventional tablet processing.
- IV concentrate forms require protection from light and control of pH to maintain solution stability.
- Absorption is not food‑sensitive, allowing flexible administration and minimal need for food‑effect mitigation in formulation design.
Regulatory status
| Lifecycle | Patent protection ended in the United States in 2010 and in Canada in 2020, indicating that the API is now in a mature, post‑expiry phase in both markets. These conditions suggest widespread generic availability and limited remaining exclusivity. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The originator for mirtazapine appears to be Organon, with subsequent brand ownership transitions reflected in the listed packagers, while the current manufacturing landscape is dominated by numerous generic producers across the US and Canada. Branded products show presence mainly in North America, with market activity largely driven by generic formulations. Patent expiry in the US (2010) and Canada (2020) indicates that generic competition is long‑established in the US and fully open in Canada. |
|---|
Safety
| Toxicity | **LD50** Oral LD50 was 830 mg/kg in male Swiss mice 24 hours after being administered mirtazapine. **Overdose information** Activated charcoal should be administered during an overdose to absorb excess mirtazapine. General supportive therapy should be employed, including maintenance of an adequate airway, oxygen therapy, and ventilation therapy. Vital signs and cardiac rhythm must be monitored. It is not advisable to induce vomiting. Gastric lavage with a large-bore orogastric tube with proper protection of the airway is recommended [FDA label]. There is no antidote for mirtazapine available currently.[FDA label] Consider the possibility of mirtazapine combined with other drugs in an overdose and ensure to contact the local poison control center for guidance on management.[FDA label] **Carcinogenesis** At higher than normal doses, mirtazapine increased the incidence of hepatocellular adenomas and carcinomas in male mice. The highest doses administered to the mice were about 20 and 12 times the maximum recommended human dose (MRHD).[FDA label] Hepatocellular tumors and thyroid follicular adenoma/cystadenomas in male rats occurred at an increased rate at a higher mirtazapine dose (60 mg/kg/day). In female rats, both the medium (20 mg/kg/day) and higher (60 mg/kg/day) doses of mirtazapine increased the rate of hepatocellular adenomas.[FDA label] The relevance of these findings in humans is not known at this time.[FDA label] **Impairment of Fertility** Mirtazapine was administered to rats at doses reaching 100 mg/kg (equivalent to 20 times the maximum recommended human dose) in a fertility study. There was no impact on mating and conception, however, there was a disturbance of reproductive (estrous) cycling at higher doses. These doses were measured to be at least 3 times the maximum recommended human dose. Loss of fetus before implantation in the uterus occurred when doses equivalent to 20 times the maximum recommended dose were administered.[FDA label] **Use in pregnancy** This drug is categorized as a pregnancy category C drug. No adequate studies in pregnant women have been conducted. In rats, an increased rate of post-implantation demise occurred with mirtazapine administration. Additionally, an increase in deaths of rat pups during the first 3 days of lactation with a decrease in pup birth weight was noted. Studies on animals are not always relevant to human response. Mirtazapine should be used during pregnancy only if the clinical need outweighs the possible risks to the fetus.[FDA label] **Use in nursing** Whether this drug is excreted in human milk is unknown.[FDA label] Many drugs are found excreted in human breast milk, therefore caution is advised if this drug is used during nursing.[FDA label] |
|---|
High Level Warnings:
- Oral LD50 in male Swiss mice was 830 mg/kg, indicating moderate acute toxicity at high exposures
- Chronic high‑dose studies in rodents produced increased rates of hepatocellular and thyroid tumors, with uncertain relevance to humans
- High repeat‑dose levels in animal models disrupted reproductive cycling and increased pre‑implantation loss, demonstrating potential reproductive and developmental toxicity at supratherapeutic exposures
Mirtazapine is a type of 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.
Mirtazapine API manufacturers & distributors
Compare qualified Mirtazapine API suppliers worldwide. We currently have 15 companies offering Mirtazapine API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| 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 |
| Hetero Drugs | Producer | India | India | CoA, JDMF | 98 products |
| Kolon Life Science | Producer | South Korea | South Korea | CoA, JDMF | 32 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Maithri Drugs | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 12 products |
| Medichem | Producer | Spain | Unknown | CEP, CoA, FDA, GMP, USDMF | 39 products |
| Menovo | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 27 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 762 products |
| Sumitomo Chemical | Producer | Japan | Japan | CoA, JDMF | 28 products |
| Sun Pharma | Producer | India | India | CEP, CoA, USDMF, WC | 219 products |
| Syn-tech Chem | Producer | Taiwan | Taiwan | CoA, USDMF | 22 products |
| Zhejiang Liaoyuan | Producer | China | China | CEP, CoA, FDA, GMP, WC | 5 products |
When sending a request, specify which Mirtazapine 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 Mirtazapine 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 Mirtazapine API
Sourcing
What matters most when sourcing GMP-grade Mirtazapine?
Key considerations include confirming U.S. and Canadian regulatory compliance and ensuring the supplier maintains verifiable GMP standards. Given long‑standing generic competition in both markets, assessing the reliability and consistency of established generic manufacturers is essential. Suppliers should demonstrate clear traceability and alignment with current regulatory expectations for these regions.
Which documents are typically required when sourcing Mirtazapine API?
Request the core API documentation set: CoA (15 companies), GMP (8 companies), CEP (8 companies), USDMF (7 companies), WC (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Mirtazapine API?
Known or reported manufacturers for Mirtazapine: Duchefa Farma B.V., Atilus Pharma, Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore). Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Mirtazapine 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 Mirtazapine manufacturers?
Audit reports may be requested for Mirtazapine: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Mirtazapine API on Pharmaoffer?
Reported supplier count for Mirtazapine: 15 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Mirtazapine API?
Production countries reported for Mirtazapine: India (6 producers), China (3 producers), Singapore (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Mirtazapine usually hold?
Common certifications for Mirtazapine suppliers: CoA (15 companies), GMP (8 companies), CEP (8 companies), USDMF (7 companies), WC (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Mirtazapine (CAS 85650-52-8) used for?
Mirtazapine is used for the treatment of major depressive disorder, helping improve mood, sleep, appetite, and anxiety symptoms. Clinically, it may also be used off‑label for conditions such as panic disorder, generalized anxiety disorder, PTSD, certain sleep disturbances, and appetite or weight loss related to medical illness. Its therapeutic effects stem from enhancing central norepinephrine and serotonin signaling and blocking 5‑HT2, 5‑HT3, and H1 receptors.
Which therapeutic class does Mirtazapine fall into?
Mirtazapine belongs to the following therapeutic categories: Adrenergic Agents, Adrenergic alpha-2 Receptor Antagonists, Adrenergic alpha-Antagonists, Adrenergic Antagonists, Agents that produce hypertension. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Mirtazapine mainly prescribed for?
The primary indications for Mirtazapine: This drug is indicated for the treatment of major depressive disorder and its associated symptoms, [FDA label], Mirtazapine has been used off-label for a variety of conditions including panic disorder, generalized anxiety disorder, dysthymia, tension headaches, hot flushes, post-traumatic stress disorder (PTSD), sleep disorders, substance abuse disorders, and sexual disorders, among others. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Mirtazapine work?
**Summary**
The mechanism of action of Mirtazapine is not fully understood[FDA label] but may be explained by its effects on central adrenergic and serotonergic activity. This drug exhibits a fast onset of action, a high level of response, a manageable side-effect profile, and dual noradrenergic and serotonergic effects that are unique from the effects of other antidepressants.
**Effects on various receptors**
It has been shown that both noradrenergic and serotonergic activity increase following Mirtazapine administration. The results of these studies demonstrate Mirtazapine exerts antagonist activity at presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors in the central nervous system. This is thought to lead to enhanced noradrenergic and serotonergic activity [FDA label], which are known to improve the symptoms of depression and form the basis of antidepressant therapy.
Mirtazapine is a strong antagonist of serotonin 5-HT2 and 5-HT3 receptors. It has not been found to bind significantly to the serotonin 5-HT1A and 5-HT1B receptors [FDA label] but indirectly increases 5-HT1A transmission.
In addition to the above effects, Mirtazapine is a peripheral α1-adrenergic antagonist. This action may explain episodes of orthostatic hypotension that have been reported after Mirtazapine use.[FDA label] Mirtazapine is a potent histamine (H1) receptor antagonist, which may contribute to its powerful sedating effects.[FDA label] The pain-relieving effects of Mirtazapine may be explained by its effects on opioid receptors.
What should someone know about the safety or toxicity profile of Mirtazapine?
Mirtazapine shows moderate acute toxicity in animal models, with an oral LD50 of 830 mg/kg in male mice. Chronic high‑dose rodent studies identified increased hepatocellular and thyroid tumors, and supratherapeutic exposures disrupted reproductive cycling and increased pre‑implantation loss. Clinically, key safety concerns include dose‑related somnolence, weight gain, orthostatic hypotension, potential QTc prolongation, and risk of serotonin syndrome when combined with serotonergic agents. Suicidal ideation may emerge in younger adults, and the drug is not recommended for pediatric use.
What are important formulation and handling considerations for Mirtazapine as an API?
Mirtazapine’s small‑molecule, lipophilic profile with adequate aqueous solubility supports conventional tablet and orally disintegrating tablet manufacturing. Its food‑independent absorption permits flexible administration without food‑effect controls in formulation. For IV concentrate forms, maintenance of solution stability requires protection from light and appropriate pH control.
Is Mirtazapine a small molecule?
Mirtazapine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Mirtazapine?
Oral Mirtazapine tablets and ODTs are stable under standard solid‑dose manufacturing and storage conditions, supported by its lipophilic small‑molecule profile and adequate aqueous solubility. These formulations do not require light protection or pH control measures described for IV solutions. Absorption is not food‑sensitive, so no food‑related stability mitigation is needed.
Regulatory
Where is Mirtazapine approved or in use globally?
Mirtazapine 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.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Mirtazapine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Mirtazapine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Mirtazapine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Mirtazapine: 2264 verified transactions across 487 suppliers and 245 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Mirtazapine?
Market report availability for Mirtazapine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
