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    Chemistry

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    Also known as: 85650-52-8, Remeron, 61337-67-5, 6-azamianserin, Zispin, Mepirzepine
    Molecular Formula
    C17H19N3
    Molecular Weight
    265.35  g/mol
    InChI Key
    RONZAEMNMFQXRA-UHFFFAOYSA-N
    FDA UNII
    A051Q2099Q
    Mirtazapine
    A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.
    1 2D Structure

    Mirtazapine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-methyl-2,5,19-triazatetracyclo[13.4.0.02,7.08,13]nonadeca-1(15),8,10,12,16,18-hexaene
    2.1.2 InChI
    InChI=1S/C17H19N3/c1-19-9-10-20-16(12-19)15-7-3-2-5-13(15)11-14-6-4-8-18-17(14)20/h2-8,16H,9-12H2,1H3
    2.1.3 InChI Key
    RONZAEMNMFQXRA-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1CCN2C(C1)C3=CC=CC=C3CC4=C2N=CC=C4
    2.2 Other Identifiers
    2.2.1 UNII
    A051Q2099Q
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (n-methyl-11c)mirtazapine

    2. (s)-mirtazapine

    3. 6 Azamianserin

    4. 6-azamianserin

    5. Esmirtazapine

    6. Norset

    7. Org 3770

    8. Org 50081

    9. Org-3770

    10. Org3770

    11. Remergil

    12. Remeron

    13. Rexer

    14. Zispin

    2.3.2 Depositor-Supplied Synonyms

    1. 85650-52-8

    2. Remeron

    3. 61337-67-5

    4. 6-azamianserin

    5. Zispin

    6. Mepirzepine

    7. Remergil

    8. Rexer

    9. Promyrtil

    10. Remergon

    11. Norset

    12. Mirtazepine

    13. Avanza

    14. Remeron Soltab

    15. Mepirzapin

    16. Mirtazipine

    17. Org 3770

    18. Mirtazapina

    19. Mirtazapinum

    20. Mirtazapinum [inn-latin]

    21. Mirtazapina [inn-spanish]

    22. Mirtazapin

    23. Org-3770

    24. 2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine

    25. Mirataz

    26. 2-methyl-1,2,3,4,10,14b-hexahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepine

    27. Org3770

    28. Mirtazapine Anhydrous

    29. 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine

    30. 1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)benzazepine

    31. Chembl654

    32. Mirtazapine (remeron, Avanza)

    33. Chebi:6950

    34. (r)-org3770;(r)-6-azamianserin

    35. (s)-org3770;(s)-6-azamianserin

    36. Pyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-

    37. A051q2099q

    38. Ncgc00025346-02

    39. Pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-

    40. Azamianserin

    41. Mirtazapine [usan:ban:inn]

    42. Smilon

    43. 2-methyl-1,2,3,4,9,13b-hexahydro-2,4a,5-triaza-tribenzo[a,c,e]cycloheptene

    44. 5-methyl-2,5,19-triazatetracyclo[13.4.0.02,7.08,13]nonadeca-1(15),8,10,12,16,18-hexaene

    45. Smr000466347

    46. Remeron (tn)

    47. Sr-01000597530

    48. Einecs 288-060-6

    49. Mepirzapine

    50. Unii-a051q2099q

    51. 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c](2)benzazepine

    52. Mirtazapine [usan:usp:inn:ban]

    53. Mirtazapine Solution

    54. Mirtazapine- Bio-x

    55. Mfcd00865427

    56. Reflex (tn)

    57. (1)-1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine

    58. Mianserin, 6-aza-

    59. 5-methyl-2,5,19-triazatetracyclo[13.4.0.0^{2,7}.0^{8,13}]nonadeca-1(15),8(13),9,11,16,18-hexaene

    60. Me-2040

    61. Mirtazapine [mi]

    62. Mirtazapine [inn]

    63. Mirtazapine [jan]

    64. Dsstox_cid_3325

    65. Mirtazapine [usan]

    66. Mirtazapine [vandf]

    67. Dsstox_rid_76979

    68. Dsstox_gsid_23325

    69. Schembl35408

    70. Mirtazapine [usp-rs]

    71. Mirtazapine [who-dd]

    72. Mls000759460

    73. Mls001076676

    74. Mls001424294

    75. Mls006011449

    76. Mirtazapine (jan/usp/inn)

    77. Gtpl7241

    78. Dtxsid0023325

    79. Mirtazapine [green Book]

    80. Mirtazapine, (+/-)-

    81. Mirtazapine, >=98% (hplc)

    82. Mirtazapine [orange Book]

    83. Hms2052h03

    84. Hms2233k03

    85. Hms3268f21

    86. Hms3370b05

    87. Hms3374j01

    88. Hms3394h03

    89. Hms3413c11

    90. Hms3657m13

    91. Hms3677c11

    92. Hms3713p13

    93. Hms3884o18

    94. Mirtazapine [ep Monograph]

    95. Mirtazapine [usp Monograph]

    96. Bcp14560

    97. Bcp22244

    98. Hy-b0352

    99. Mirtazapine 1.0 Mg/ml In Methanol

    100. Tox21_110965

    101. Bdbm50115644

    102. Pdsp1_001529

    103. Pdsp2_001513

    104. S2016

    105. Stk711107

    106. Akos005530681

    107. Bcp9000930

    108. Ccg-101154

    109. Ccg-220556

    110. Db00370

    111. Ks-1086

    112. Nc00404

    113. (14br)-2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine

    114. Ncgc00025346-01

    115. Ncgc00025346-08

    116. 5-methyl-2,5,19-triazatetracyclo[13.4.0.0^{2,7}.0^{8,13}]nonadeca-1(19),8(13),9,11,15,17-hexaene

    117. Ac-15480

    118. Bm164672

    119. Cas-61337-67-5

    120. Ft-0601544

    121. Ft-0628951

    122. Ft-0672414

    123. M-130

    124. M2151

    125. Sw197784-4

    126. En300-49851

    127. C07570

    128. D00563

    129. Ab00698265_08

    130. 337m675

    131. A914630

    132. L001294

    133. Q421930

    134. Sr-01000597530-1

    135. Sr-01000597530-4

    136. Brd-a64977602-001-01-9

    137. Brd-a64977602-001-04-3

    138. Z2327131613

    139. Mirtazapine, European Pharmacopoeia (ep) Reference Standard

    140. Mirtazapine, United States Pharmacopeia (usp) Reference Standard

    141. (+/-)-12-methyl-1,2,3,4,9,13b-hexahydro-2,4a,5-triaza-tribenzo[a,c,e]cycloheptene

    142. 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.

    143. 2-methyl-1,2,3,4,10,14b-hexahydrobenzo-[c]pyrazino[1,2-a]pyrido[3,2-f]azepine

    144. Mirtazapine For System Suitability, European Pharmacopoeia (ep) Reference Standard

    145. Mirtazapine Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    146. 5-methyl-2,5,19-triazatetracyclo[13.4.0.0?,?.0?,??]nonadeca-1(15),8,10,12,16,18-hexaene

    147. Pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-, (.+/-.)-

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 265.35 g/mol
    Molecular Formula C17H19N3
    XLogP33.3
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count0
    Exact Mass265.157897619 g/mol
    Monoisotopic Mass265.157897619 g/mol
    Topological Polar Surface Area19.4 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity345
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameMirtazapine
    PubMed HealthMirtazapine (By mouth)
    Drug ClassesAntidepressant
    Drug LabelMirtazapine Tablets USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazep...
    Active IngredientMirtazapine
    Dosage FormTablet; Tablet, orally disintegrating
    RouteOral
    Strength7.5mg; 30mg; 15mg; 45mg
    Market StatusPrescription
    CompanyMylan Pharms; Actavis Labs Fl; Teva; Apotex; Aurobindo; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Watson Labs; Mylan

    2 of 6  
    Drug NameRemeron
    PubMed HealthMirtazapine (By mouth)
    Drug ClassesAntidepressant
    Drug LabelREMERON (mirtazapine) Tablets are an orally administered drug. Mirtazapine has a tetra-cyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,...
    Active IngredientMirtazapine
    Dosage FormTablet
    RouteOral
    Strength30mg; 15mg; 45mg
    Market StatusPrescription
    CompanyOrganon Usa

    3 of 6  
    Drug NameRemeron soltab
    Active IngredientMirtazapine
    Dosage FormTablet, orally disintegrating
    RouteOral
    Strength30mg; 15mg; 45mg
    Market StatusPrescription
    CompanyOrganon Usa

    4 of 6  
    Drug NameMirtazapine
    PubMed HealthMirtazapine (By mouth)
    Drug ClassesAntidepressant
    Drug LabelMirtazapine Tablets USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazep...
    Active IngredientMirtazapine
    Dosage FormTablet; Tablet, orally disintegrating
    RouteOral
    Strength7.5mg; 30mg; 15mg; 45mg
    Market StatusPrescription
    CompanyMylan Pharms; Actavis Labs Fl; Teva; Apotex; Aurobindo; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Watson Labs; Mylan

    5 of 6  
    Drug NameRemeron
    PubMed HealthMirtazapine (By mouth)
    Drug ClassesAntidepressant
    Drug LabelREMERON (mirtazapine) Tablets are an orally administered drug. Mirtazapine has a tetra-cyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,...
    Active IngredientMirtazapine
    Dosage FormTablet
    RouteOral
    Strength30mg; 15mg; 45mg
    Market StatusPrescription
    CompanyOrganon Usa

    6 of 6  
    Drug NameRemeron soltab
    Active IngredientMirtazapine
    Dosage FormTablet, orally disintegrating
    RouteOral
    Strength30mg; 15mg; 45mg
    Market StatusPrescription
    CompanyOrganon Usa

    4.2 Drug Indication

    This drug is indicated for the treatment of major depressive disorder and its associated symptoms. 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.

    FDA Label

    For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    **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. 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. **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. 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.

    5.2 MeSH Pharmacological Classification

    Anti-Anxiety Agents

    Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

    Serotonin 5-HT2 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. (See all compounds classified as Serotonin 5-HT2 Receptor Antagonists.)

    Adrenergic alpha-2 Receptor Antagonists

    Drugs that bind to and block the activation of ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Antagonists.)

    Antidepressive Agents

    Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)

    Histamine H1 Antagonists

    Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

    Serotonin 5-HT3 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)

    5.3 ATC Code

    QN06AX11

    N06AX11

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N06 - Psychoanaleptics

    N06A - Antidepressants

    N06AX - Other antidepressants

    N06AX11 - Mirtazapine

    5.4 Absorption, Distribution and Excretion

    Absorption

    The absorption of this drug is rapid and complete. Due to first pass metabolism in the liver and metabolism in the gut wall, absolute bioavailability is about 50%. 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. Steady-state levels are achieved by about 5 days after the initial dose. 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.

    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. **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. 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.

    5.5 Metabolism/Metabolites

    Mirtazapine is heavily metabolized in humans. Demethylation and hydroxylation and subsequent glucuronide conjugation are the major pathways by which mirtazapine is metabolized. 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.

    Mirtazapine has known human metabolites that include 8-hydroxy-mirtazapine, Mirtazapine N-oxide, and N-Desmethylmirtazapine.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.6 Biological Half-Life

    20-40 hours

    5.7 Mechanism of Action

    **Summary** The mechanism of action of mirtazapine is not fully understood 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 2-adrenergic inhibitory autoreceptors and heteroreceptors in the central nervous system. This is thought to lead to enhanced noradrenergic and serotonergic activity, 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 but indirectly increases 5-HT1A transmission. In addition to the above effects, mirtazapine is a peripheral 1-adrenergic antagonist. This action may explain episodes of orthostatic hypotension that have been reported after mirtazapine use. Mirtazapine is a potent histamine (H1) receptor antagonist, which may contribute to its powerful sedating effects. The pain-relieving effects of mirtazapine may be explained by its effects on opioid receptors.

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 15MG

    USFDA APPLICATION NUMBER - 20415

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    DOSAGE - TABLET;ORAL - 30MG

    USFDA APPLICATION NUMBER - 20415

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    DOSAGE - TABLET;ORAL - 45MG **Federal Registe...DOSAGE - TABLET;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20415

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 15MG

    USFDA APPLICATION NUMBER - 21208

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 30MG

    USFDA APPLICATION NUMBER - 21208

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 45MG

    USFDA APPLICATION NUMBER - 21208

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    Looking for 61337-67-5 / Mirtazapine API manufacturers, exporters & distributors?

    Mirtazapine manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Mirtazapine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mirtazapine manufacturer or Mirtazapine supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirtazapine manufacturer or Mirtazapine supplier.

    PharmaCompass also assists you with knowing the Mirtazapine API Price utilized in the formulation of products. Mirtazapine API Price is not always fixed or binding as the Mirtazapine Price is obtained through a variety of data sources. The Mirtazapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Mirtazapine

    Synonyms

    85650-52-8, Remeron, 61337-67-5, 6-azamianserin, Zispin, Mepirzepine

    Cas Number

    61337-67-5

    Unique Ingredient Identifier (UNII)

    A051Q2099Q

    About Mirtazapine

    A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.

    Remergon Manufacturers

    A Remergon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remergon, including repackagers and relabelers. The FDA regulates Remergon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remergon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Remergon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Remergon Suppliers

    A Remergon supplier is an individual or a company that provides Remergon active pharmaceutical ingredient (API) or Remergon finished formulations upon request. The Remergon suppliers may include Remergon API manufacturers, exporters, distributors and traders.

    click here to find a list of Remergon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Remergon USDMF

    A Remergon DMF (Drug Master File) is a document detailing the whole manufacturing process of Remergon active pharmaceutical ingredient (API) in detail. Different forms of Remergon DMFs exist exist since differing nations have different regulations, such as Remergon USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Remergon DMF submitted to regulatory agencies in the US is known as a USDMF. Remergon USDMF includes data on Remergon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Remergon USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Remergon suppliers with USDMF on PharmaCompass.

    Remergon JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Remergon Drug Master File in Japan (Remergon JDMF) empowers Remergon API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Remergon JDMF during the approval evaluation for pharmaceutical products. At the time of Remergon JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Remergon suppliers with JDMF on PharmaCompass.

    Remergon KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Remergon Drug Master File in Korea (Remergon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remergon. The MFDS reviews the Remergon KDMF as part of the drug registration process and uses the information provided in the Remergon KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Remergon KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Remergon API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Remergon suppliers with KDMF on PharmaCompass.

    Remergon CEP

    A Remergon CEP of the European Pharmacopoeia monograph is often referred to as a Remergon Certificate of Suitability (COS). The purpose of a Remergon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Remergon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Remergon to their clients by showing that a Remergon CEP has been issued for it. The manufacturer submits a Remergon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Remergon CEP holder for the record. Additionally, the data presented in the Remergon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Remergon DMF.

    A Remergon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Remergon CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Remergon suppliers with CEP (COS) on PharmaCompass.

    Remergon WC

    A Remergon written confirmation (Remergon WC) is an official document issued by a regulatory agency to a Remergon manufacturer, verifying that the manufacturing facility of a Remergon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Remergon APIs or Remergon finished pharmaceutical products to another nation, regulatory agencies frequently require a Remergon WC (written confirmation) as part of the regulatory process.

    click here to find a list of Remergon suppliers with Written Confirmation (WC) on PharmaCompass.

    Remergon NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Remergon as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Remergon API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Remergon as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Remergon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Remergon NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Remergon suppliers with NDC on PharmaCompass.

    Remergon GMP

    Remergon Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Remergon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Remergon GMP manufacturer or Remergon GMP API supplier for your needs.

    Remergon CoA

    A Remergon CoA (Certificate of Analysis) is a formal document that attests to Remergon's compliance with Remergon specifications and serves as a tool for batch-level quality control.

    Remergon CoA mostly includes findings from lab analyses of a specific batch. For each Remergon CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Remergon may be tested according to a variety of international standards, such as European Pharmacopoeia (Remergon EP), Remergon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Remergon USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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