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    Chemistry

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    Also known as: 181183-52-8, Almotriptan maleate, Axert, Las 31416 d,l-malate acid, Almotriptan (malate), Almogran
    Molecular Formula
    C21H31N3O7S
    Molecular Weight
    469.6  g/mol
    InChI Key
    QHATUKWEVNMHRY-UHFFFAOYSA-N
    FDA UNII
    PJP312605E
    Almotriptan Malate
    Almotriptan Malate is the malate salt of almotriptan, a sulfonamide triptan with vasoconstrictor activity. Almotriptan selectively binds to and activates serotonin 5-HT 1B and 1D receptors in the central nervous system (CNS), thereby causing cerebral blood vessel constriction. This may lead to pain relief from vascular headaches. Almotriptan may also relieve vascular headaches by preventing the release of vasoactive neuropeptides from perivascular trigeminal axons in the dura mater during a migraine, by reducing extravasation of plasma proteins, and by decreasing the release of other mediators of inflammation from the trigeminal nerve.
    1 2D Structure

    Almotriptan Malate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N,N-dimethyl-2-[5-(pyrrolidin-1-ylsulfonylmethyl)-1H-indol-3-yl]ethanamine;2-hydroxybutanedioic acid
    2.1.2 InChI
    InChI=1S/C17H25N3O2S.C4H6O5/c1-19(2)10-7-15-12-18-17-6-5-14(11-16(15)17)13-23(21,22)20-8-3-4-9-20;5-2(4(8)9)1-3(6)7/h5-6,11-12,18H,3-4,7-10,13H2,1-2H3;2,5H,1H2,(H,6,7)(H,8,9)
    2.1.3 InChI Key
    QHATUKWEVNMHRY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(C)CCC1=CNC2=C1C=C(C=C2)CS(=O)(=O)N3CCCC3.C(C(C(=O)O)O)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    PJP312605E
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Almogran

    2. Almotriptan

    3. Axert

    2.3.2 Depositor-Supplied Synonyms

    1. 181183-52-8

    2. Almotriptan Maleate

    3. Axert

    4. Las 31416 D,l-malate Acid

    5. Almotriptan (malate)

    6. Almogran

    7. Pnu-180638e

    8. Almotriptan Malate [usan]

    9. Almotriptan D,l-hydrogenmalate

    10. Chebi:53781

    11. Las-31416 D,l-malate Acid

    12. Pjp312605e

    13. 181183-52-8(almotriptan Malate)

    14. Las-31416-d,l-malate-acid

    15. N,n-dimethyl-2-(5-((pyrrolidin-1-ylsulfonyl)methyl)-1h-indol-3-yl)ethan-1-amine 2-hydroxysuccinate

    16. 1-(((3-(2-(dimethylamino)ethyl)indol-5-yl)methyl)sulfonyl)pyrrolidine Malate (1:1)

    17. 1-(((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)sulfonyl)pyrrolidine, Hydroxybutanedioate (1:1)

    18. N,n-dimethyl-2-[5-(pyrrolidin-1-ylsulfonylmethyl)-1h-indol-3-yl]ethanamine;2-hydroxybutanedioic Acid

    19. Pnu 180638e

    20. Unii-pjp312605e

    21. Sr-05000001986

    22. Axert (tn)

    23. Almotriptan Malate (usp)

    24. 1-[[[2-(dimethyl-amino)ethyl]-1h-indol-5-yl]methyl]sulfonyl]pyrrolidine Malate

    25. Almotriptan Malate (axert)

    26. 1-(((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)sulfonyl)pyrrolidine, Hydroxybutanedionate (1:1)

    27. Mls006010048

    28. Schembl221131

    29. Almotriptan Maleate [mi]

    30. Chembl1200521

    31. Dtxsid1044225

    32. Almotriptan Malate [vandf]

    33. Almotriptan Malate(pnu180638)

    34. Hms3651a12

    35. Hms3884p05

    36. Almotriptan Malate [mart.]

    37. Almotriptan Malate [usp-rs]

    38. Almotriptan Malate [who-dd]

    39. Bcp05632

    40. Hy-b0383

    41. Mfcd08067740

    42. Pnu180638

    43. S2096

    44. (zznon-labelled)almotriptan-d6 Malate

    45. Akos015950790

    46. Bcp9000276

    47. Ccg-269445

    48. Pnu 180638

    49. Almotriptan Malate [orange Book]

    50. Almotriptan Malate [ep Monograph]

    51. Almotriptan Malate [usp Monograph]

    52. As-12142

    53. Butanedioic Acid, Hydroxy-, Compd. With 1-(((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)sulfonyl)pyrrolidine (1:1)

    54. Smr004701216

    55. Ft-0661519

    56. Sw219418-1

    57. D02825

    58. F14758

    59. J-011571

    60. Sr-05000001986-2

    61. Q27124206

    62. 1-(((3-(2-(dimethylamino)ethyl)indol-5-yl)methyl)sulfonyl)pyrrolidine Malate

    63. 3-[2-(dimethylamino)ethyl]-5-(pyrrolidin-1-ylsulfonylmethyl )-1h-indole Malate

    64. 1-(((3-(2-(dimethylamino)ethyl)-1h-indol-5-yl)methyl)sulfonyl)pyrrolidine Hydroxybutanedioate

    65. Butanedioic Acid, 2-hydroxy-, Compd. With N,n-dimethyl-5-[(1-pyrrolidinylsulfonyl)methyl]-1h-indole-3-ethanamine (1:1)

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 469.6 g/mol
    Molecular Formula C21H31N3O7S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count9
    Exact Mass469.18827151 g/mol
    Monoisotopic Mass469.18827151 g/mol
    Topological Polar Surface Area160 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity612
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameAlmotriptan malate
    Drug LabelAXERT (almotriptan malate) Tablets contain almotriptan malate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidi...
    Active IngredientAlmotriptan malate
    Dosage FormTablet
    Routeoral
    Strength6.25mg; 12.5mg
    Market StatusTentative Approval
    CompanyTeva Pharms

    2 of 2  
    Drug NameAlmotriptan malate
    Drug LabelAXERT (almotriptan malate) Tablets contain almotriptan malate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidi...
    Active IngredientAlmotriptan malate
    Dosage FormTablet
    Routeoral
    Strength6.25mg; 12.5mg
    Market StatusTentative Approval
    CompanyTeva Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Serotonin Receptor Agonists

    Endogenous compounds and drugs that bind to and activate SEROTONIN RECEPTORS. Many serotonin receptor agonists are used as ANTIDEPRESSANTS; ANXIOLYTICS; and in the treatment of MIGRAINE DISORDERS. (See all compounds classified as Serotonin Receptor Agonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin 1d Receptor Agonists [MoA]; Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]; Serotonin 1b Receptor Agonists [MoA]

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    08-Jan-2021
    27-Sep-2024
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    DOSAGE - TABLET;ORAL - EQ 12.5MG BASE **Feder...DOSAGE - TABLET;ORAL - EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21001

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    DOSAGE - TABLET;ORAL - EQ 6.25MG BASE **Feder...DOSAGE - TABLET;ORAL - EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21001

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    ABOUT THIS PAGE

    Almotriptan Malate Manufacturers

    A Almotriptan Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Almotriptan Malate, including repackagers and relabelers. The FDA regulates Almotriptan Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Almotriptan Malate 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 Almotriptan Malate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Almotriptan Malate Suppliers

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

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

    Almotriptan Malate USDMF

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

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

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

    Almotriptan Malate CEP

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

    A Almotriptan Malate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Almotriptan Malate 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 Almotriptan Malate suppliers with CEP (COS) on PharmaCompass.

    Almotriptan Malate WC

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

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

    Almotriptan Malate 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 Almotriptan Malate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Almotriptan Malate 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 Almotriptan Malate 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 Almotriptan Malate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Almotriptan Malate NDC to their finished compounded human drug products, they may choose to do so.

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

    Almotriptan Malate GMP

    Almotriptan Malate 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 Almotriptan Malate 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 Almotriptan Malate GMP manufacturer or Almotriptan Malate GMP API supplier for your needs.

    Almotriptan Malate CoA

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

    Almotriptan Malate CoA mostly includes findings from lab analyses of a specific batch. For each Almotriptan Malate 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.

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