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    Chemistry

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    Also known as: 219861-08-2, Lexapro, (s)-citalopram oxalate, Cipralex, Escitalopram (oxalate), (s)-(+)citalopram oxalate
    Molecular Formula
    C22H23FN2O5
    Molecular Weight
    414.4  g/mol
    InChI Key
    KTGRHKOEFSJQNS-BDQAORGHSA-N
    FDA UNII
    5U85DBW7LO
    Escitalopram Oxalate
    S-enantiomer of CITALOPRAM. Belongs to a class of drugs known as SELECTIVE SEROTONIN REUPTAKE INHIBITORS, used to treat depression and generalized anxiety disorder.
    1 2D Structure

    Escitalopram Oxalate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3H-2-benzofuran-5-carbonitrile;oxalic acid
    2.1.2 InChI
    InChI=1S/C20H21FN2O.C2H2O4/c1-23(2)11-3-10-20(17-5-7-18(21)8-6-17)19-9-4-15(13-22)12-16(19)14-24-20;3-1(4)2(5)6/h4-9,12H,3,10-11,14H2,1-2H3;(H,3,4)(H,5,6)/t20-;/m0./s1
    2.1.3 InChI Key
    KTGRHKOEFSJQNS-BDQAORGHSA-N
    2.1.4 Canonical SMILES
    CN(C)CCCC1(C2=C(CO1)C=C(C=C2)C#N)C3=CC=C(C=C3)F.C(=O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    CN(C)CCC[C@@]1(C2=C(CO1)C=C(C=C2)C#N)C3=CC=C(C=C3)F.C(=O)(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    5U85DBW7LO
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Escitalopram

    2. Lexapro

    2.3.2 Depositor-Supplied Synonyms

    1. 219861-08-2

    2. Lexapro

    3. (s)-citalopram Oxalate

    4. Cipralex

    5. Escitalopram (oxalate)

    6. (s)-(+)citalopram Oxalate

    7. Lu 26-054-0

    8. Escitalopram (as Oxalate)

    9. Citalopram Oxalate, (s)-

    10. Nsc-758934

    11. 5u85dbw7lo

    12. Lu-26-054-0

    13. (s)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile Oxalate

    14. (1s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3h-2-benzofuran-5-carbonitrile;oxalic Acid

    15. Lu-26-054-o

    16. Ncgc00095903-01

    17. Dsstox_cid_26003

    18. Dsstox_rid_81282

    19. S-(+)-1-(3-(dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile Oxalate

    20. Dsstox_gsid_46003

    21. S-(+)-5-isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, Oxalate

    22. Cas-219861-08-2

    23. Escitalopram Oxalate [usan]

    24. Gaudium

    25. Entact

    26. (s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile Oxalate

    27. Lexapro (tn)

    28. Escitalopram Oxalate Inn

    29. Unii-5u85dbw7lo

    30. Schembl35123

    31. Mls001401408

    32. Spectrum1505216

    33. (+)-(s)-citalopram Oxalate

    34. Mld-55

    35. (s)-citalopram Oxalate- Bio-x

    36. Chembl1200322

    37. Dtxsid1046003

    38. Escitalopram Oxalate (jan/usp)

    39. Escitalopram Oxalate [mi]

    40. C20h21fn2o.c2h2o4

    41. Escitalopram Oxalate [usan:usp]

    42. Escitalopram Oxalate [jan]

    43. Hms2051d11

    44. Hms2231m16

    45. Hms3370i17

    46. Hms3393d11

    47. Hms3713d16

    48. Pharmakon1600-01505216

    49. Bcp05686

    50. Escitalopram Oxalate [vandf]

    51. Tox21_111535

    52. Ccg-39559

    53. Escitalopram Oxalate [mart.]

    54. Hy-14258a

    55. Mfcd06407826

    56. Nsc758934

    57. Escitalopram Oxalate [usp-rs]

    58. Escitalopram Oxalate [who-dd]

    59. Akos016340275

    60. Tox21_111535_1

    61. Ac-6770

    62. Cs-2054

    63. Ks-1263

    64. Nc00194

    65. Nsc 758934

    66. Sb17454

    67. Ncgc00178555-02

    68. 5-isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1s)-, Ethanedioate (1:1)

    69. Bc164423

    70. Escitalopram Oxalate [orange Book]

    71. Smr000469191

    72. Escitalopram Oxalate [ep Monograph]

    73. Escitalopram Oxalate [usp Monograph]

    74. E0958

    75. D02567

    76. Escitalopram Oxalate, >=98% (hplc), Powder

    77. 861e082

    78. A852070

    79. Sr-01000763053

    80. Sr-01000763053-3

    81. Q27262882

    82. Escitalopram Oxalate, Europepharmacopoeia (ep) Reference Standard

    83. Escitalopram Oxalate, United States Pharmacopeia (usp) Reference Standard

    84. Escitalopram For System Suitability, Europepharmacopoeia (ep) Reference Standard

    85. Escitalopram Oxalate, Pharmaceutical Secondary Standard; Certified Reference Material

    86. (+)-(s)-1-[3-(dimethylamino)propyl] -1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancar Bonitrile Oxalate

    87. (+)-(s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile Oxalate

    88. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran-carbonitrile Oxalate

    89. 5-isobenzofurancarbonitrile,1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-, (1s)-,ethanedioate (1:1)

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 414.4 g/mol
    Molecular Formula C22H23FN2O5
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count6
    Exact Mass414.15910000 g/mol
    Monoisotopic Mass414.15910000 g/mol
    Topological Polar Surface Area111 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity537
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameEscitalopram oxalate
    PubMed HealthEscitalopram (By mouth)
    Drug ClassesAntianxiety, Antidepressant
    Drug LabelEscitalopramoxalate USPis an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+...
    Active IngredientEscitalopram oxalate
    Dosage FormTablet; Solution
    Routeoral; Oral
    Strength5mg; eq 5mg base; eq 5mg base/5ml; 10mg; eq 20mg base; eq 10mg base; 20mg
    Market StatusTentative Approval; Prescription
    CompanyWatson Labs; Amneal Pharms; Mylan Pharma; Teva Pharms; Macleods Pharms; Caraco; Jubilant Generics; Sti Pharma; Apotex; Accord Hlthcare; Hetero Labs Ltd Iii; Aurobindo Pharma; Teva Pharms Usa; Taro; Torrent Pharms; Lupin; Zydus Pharms Usa; Dr Reddys Labs;

    2 of 4  
    Drug NameLexapro
    Drug LabelLexapro (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designate...
    Active IngredientEscitalopram oxalate
    Dosage FormTablet; Solution
    Routeoral; Oral
    Strengtheq 5mg base; eq 5mg base/5ml; eq 20mg base; eq 10mg base
    Market StatusPrescription
    CompanyForest Labs

    3 of 4  
    Drug NameEscitalopram oxalate
    PubMed HealthEscitalopram (By mouth)
    Drug ClassesAntianxiety, Antidepressant
    Drug LabelEscitalopramoxalate USPis an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+...
    Active IngredientEscitalopram oxalate
    Dosage FormTablet; Solution
    Routeoral; Oral
    Strength5mg; eq 5mg base; eq 5mg base/5ml; 10mg; eq 20mg base; eq 10mg base; 20mg
    Market StatusTentative Approval; Prescription
    CompanyWatson Labs; Amneal Pharms; Mylan Pharma; Teva Pharms; Macleods Pharms; Caraco; Jubilant Generics; Sti Pharma; Apotex; Accord Hlthcare; Hetero Labs Ltd Iii; Aurobindo Pharma; Teva Pharms Usa; Taro; Torrent Pharms; Lupin; Zydus Pharms Usa; Dr Reddys Labs;

    4 of 4  
    Drug NameLexapro
    Drug LabelLexapro (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designate...
    Active IngredientEscitalopram oxalate
    Dosage FormTablet; Solution
    Routeoral; Oral
    Strengtheq 5mg base; eq 5mg base/5ml; eq 20mg base; eq 10mg base
    Market StatusPrescription
    CompanyForest Labs

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Selective Serotonin Reuptake Inhibitors

    Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin Uptake Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]

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    02-Jan-2021
    31-Dec-2024
    KGS
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    ABOUT THIS PAGE

    Escitalopram Manufacturers

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

    Escitalopram Suppliers

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

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

    Escitalopram USDMF

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

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

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

    Escitalopram 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 Escitalopram Drug Master File in Japan (Escitalopram JDMF) empowers Escitalopram 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 Escitalopram JDMF during the approval evaluation for pharmaceutical products. At the time of Escitalopram 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 Escitalopram suppliers with JDMF on PharmaCompass.

    Escitalopram KDMF

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

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

    After submitting a Escitalopram 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 Escitalopram API can apply through the Korea Drug Master File (KDMF).

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

    Escitalopram CEP

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

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

    Escitalopram WC

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

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

    Escitalopram 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 Escitalopram as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Escitalopram GMP

    Escitalopram 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 Escitalopram 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 Escitalopram GMP manufacturer or Escitalopram GMP API supplier for your needs.

    Escitalopram CoA

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

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

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