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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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LTD","customerCountry":"INDIA","quantity":"409.24","actualQuantity":"409.24","unit":"KGS","unitRateFc":"425","totalValueFC":"179652.2","currency":"USD","unitRateINR":"36658.9","date":"16-Apr-2024","totalValueINR":"15002270.36","totalValueInUsd":"179652.2","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"3049023","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINASDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716489000,"product":"ESCITALOPRAM OXALATE (TL NO: SW\/ND\/CT-17\/2024\/000001254) FORR&D PURPOSE NOT FOR SALE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"670","totalValueFC":"50850.3","currency":"USD","unitRateINR":"56514.5","date":"24-May-2024","totalValueINR":"4238587.5","totalValueInUsd":"50850.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3639489","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO LINHAI ZHEJIANG 317024 CHINA Linhai, , ChinaSDNF China","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"ESCITALOPRAM OXALATE (CAS NO:219861-08-2)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"425","totalValueFC":"34723.8","currency":"USD","unitRateINR":"36373.7","date":"03-Sep-2024","totalValueINR":"2909893.67","totalValueInUsd":"34723.8","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"5393596","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 C HINA SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725388200,"product":"ESCITALOPRAM OXALATE (CAS NO:219861-08-2)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"425","totalValueFC":"166791.6","currency":"USD","unitRateINR":"43679.2","date":"04-Sep-2024","totalValueINR":"13977340.5","totalValueInUsd":"166791.6","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"5424193","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 C HINA SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"ESCITALOPRAM OXALATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"425","totalValueFC":"140606.1","currency":"USD","unitRateINR":"36920.8","date":"23-Oct-2024","totalValueINR":"11814644.5","totalValueInUsd":"140606.1","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"6284258","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"XUNQIAO,LINHAI, ZHEJIANG,317024 Chi na SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"ESCITALOPRAM OXALATE ( USP ) ( IMPORT FOR RE- PROCESS AND REEXPORT VIDE - SB NO 1258464 DT 29-05-2024 )","address":"PLOT NO. 705, ADITYA TRADE CENTRE","city":"HYDERABAD ANDHRA PRADESH","supplier":"MEDIST FZE","supplierCountry":"UNITED ARAB EMIRATES","foreign_port":"DUBAI","customer":"SHODHANA LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"360","totalValueFC":"36798.4","currency":"USD","unitRateINR":"31053.5","date":"19-Nov-2024","totalValueINR":"3105346.5","totalValueInUsd":"36798.4","indian_port":"Hyderabad Air","hs_no":"29321990","bill_no":"6758143","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBAI","supplierAddress":"BLDG 4 EA OFFICE NO : 216 DUBAI AIRPORT FREE ZONE DUBAI UAE AE","customerAddress":"PLOT NO. 705, ADITYA TRADE CENTRE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"ESCITALOPRAM OXALATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"PADANG","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"425","totalValueFC":"138701.8","currency":"USD","unitRateINR":"36577.5","date":"28-Nov-2024","totalValueINR":"11704790.87","totalValueInUsd":"138701.8","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"6938280","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"PADANG","supplierAddress":"XUNQIAO,LINHAI, ZHEJIANG,317024 Chi na SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735929000,"product":"ESCITALOPRAM OXALATE CHEMICAL","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"425","totalValueFC":"136584.8","currency":"USD","unitRateINR":"36805","date":"04-Jan-2025","totalValueINR":"11777600","totalValueInUsd":"136584.8","indian_port":"Madras Sea","hs_no":"29329990","bill_no":"7608425","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"XUNQIAO LINHAI ZHEJIANG CHINA 317 24 SDNF CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
    03-Jan-2022
    30-Apr-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 10MG BASE

    USFDA APPLICATION NUMBER - 21323

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    DOSAGE - TABLET;ORAL - EQ 20MG BASE

    USFDA APPLICATION NUMBER - 21323

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE

    USFDA APPLICATION NUMBER - 21323

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    DOSAGE - SOLUTION;ORAL - EQ 5MG BASE/5ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21365

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    ABOUT THIS PAGE

    Looking for 219861-08-2 / Escitalopram Oxalate API manufacturers, exporters & distributors?

    Escitalopram Oxalate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Escitalopram Oxalate 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 Escitalopram Oxalate manufacturer or Escitalopram Oxalate supplier for your needs.

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

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

    API | Excipient name

    Escitalopram Oxalate

    Synonyms

    219861-08-2, Lexapro, (s)-citalopram oxalate, Cipralex, Escitalopram (oxalate), (s)-(+)citalopram oxalate

    Cas Number

    219861-08-2

    Unique Ingredient Identifier (UNII)

    5U85DBW7LO

    About 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.

    ECT-12003 (S-CITALOPRAM OXALATE) Manufacturers

    A ECT-12003 (S-CITALOPRAM OXALATE) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ECT-12003 (S-CITALOPRAM OXALATE), including repackagers and relabelers. The FDA regulates ECT-12003 (S-CITALOPRAM OXALATE) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) Suppliers

    A ECT-12003 (S-CITALOPRAM OXALATE) supplier is an individual or a company that provides ECT-12003 (S-CITALOPRAM OXALATE) active pharmaceutical ingredient (API) or ECT-12003 (S-CITALOPRAM OXALATE) finished formulations upon request. The ECT-12003 (S-CITALOPRAM OXALATE) suppliers may include ECT-12003 (S-CITALOPRAM OXALATE) API manufacturers, exporters, distributors and traders.

    click here to find a list of ECT-12003 (S-CITALOPRAM OXALATE) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) USDMF

    A ECT-12003 (S-CITALOPRAM OXALATE) DMF (Drug Master File) is a document detailing the whole manufacturing process of ECT-12003 (S-CITALOPRAM OXALATE) active pharmaceutical ingredient (API) in detail. Different forms of ECT-12003 (S-CITALOPRAM OXALATE) DMFs exist exist since differing nations have different regulations, such as ECT-12003 (S-CITALOPRAM OXALATE) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A ECT-12003 (S-CITALOPRAM OXALATE) DMF submitted to regulatory agencies in the US is known as a USDMF. ECT-12003 (S-CITALOPRAM OXALATE) USDMF includes data on ECT-12003 (S-CITALOPRAM OXALATE)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ECT-12003 (S-CITALOPRAM OXALATE) USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of ECT-12003 (S-CITALOPRAM OXALATE) suppliers with USDMF on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) Drug Master File in Japan (ECT-12003 (S-CITALOPRAM OXALATE) JDMF) empowers ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) JDMF during the approval evaluation for pharmaceutical products. At the time of ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) suppliers with JDMF on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) KDMF

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

    Pharmaceutical companies submit a ECT-12003 (S-CITALOPRAM OXALATE) Drug Master File in Korea (ECT-12003 (S-CITALOPRAM OXALATE) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ECT-12003 (S-CITALOPRAM OXALATE). The MFDS reviews the ECT-12003 (S-CITALOPRAM OXALATE) KDMF as part of the drug registration process and uses the information provided in the ECT-12003 (S-CITALOPRAM OXALATE) KDMF to evaluate the safety and efficacy of the drug.

    After submitting a ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of ECT-12003 (S-CITALOPRAM OXALATE) suppliers with KDMF on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) CEP

    A ECT-12003 (S-CITALOPRAM OXALATE) CEP of the European Pharmacopoeia monograph is often referred to as a ECT-12003 (S-CITALOPRAM OXALATE) Certificate of Suitability (COS). The purpose of a ECT-12003 (S-CITALOPRAM OXALATE) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ECT-12003 (S-CITALOPRAM OXALATE) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ECT-12003 (S-CITALOPRAM OXALATE) to their clients by showing that a ECT-12003 (S-CITALOPRAM OXALATE) CEP has been issued for it. The manufacturer submits a ECT-12003 (S-CITALOPRAM OXALATE) CEP (COS) as part of the market authorization procedure, and it takes on the role of a ECT-12003 (S-CITALOPRAM OXALATE) CEP holder for the record. Additionally, the data presented in the ECT-12003 (S-CITALOPRAM OXALATE) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ECT-12003 (S-CITALOPRAM OXALATE) DMF.

    A ECT-12003 (S-CITALOPRAM OXALATE) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) suppliers with CEP (COS) on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) WC

    A ECT-12003 (S-CITALOPRAM OXALATE) written confirmation (ECT-12003 (S-CITALOPRAM OXALATE) WC) is an official document issued by a regulatory agency to a ECT-12003 (S-CITALOPRAM OXALATE) manufacturer, verifying that the manufacturing facility of a ECT-12003 (S-CITALOPRAM OXALATE) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ECT-12003 (S-CITALOPRAM OXALATE) APIs or ECT-12003 (S-CITALOPRAM OXALATE) finished pharmaceutical products to another nation, regulatory agencies frequently require a ECT-12003 (S-CITALOPRAM OXALATE) WC (written confirmation) as part of the regulatory process.

    click here to find a list of ECT-12003 (S-CITALOPRAM OXALATE) suppliers with Written Confirmation (WC) on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ECT-12003 (S-CITALOPRAM OXALATE) NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of ECT-12003 (S-CITALOPRAM OXALATE) suppliers with NDC on PharmaCompass.

    ECT-12003 (S-CITALOPRAM OXALATE) GMP

    ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) 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 ECT-12003 (S-CITALOPRAM OXALATE) GMP manufacturer or ECT-12003 (S-CITALOPRAM OXALATE) GMP API supplier for your needs.

    ECT-12003 (S-CITALOPRAM OXALATE) CoA

    A ECT-12003 (S-CITALOPRAM OXALATE) CoA (Certificate of Analysis) is a formal document that attests to ECT-12003 (S-CITALOPRAM OXALATE)'s compliance with ECT-12003 (S-CITALOPRAM OXALATE) specifications and serves as a tool for batch-level quality control.

    ECT-12003 (S-CITALOPRAM OXALATE) CoA mostly includes findings from lab analyses of a specific batch. For each ECT-12003 (S-CITALOPRAM OXALATE) 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.

    ECT-12003 (S-CITALOPRAM OXALATE) may be tested according to a variety of international standards, such as European Pharmacopoeia (ECT-12003 (S-CITALOPRAM OXALATE) EP), ECT-12003 (S-CITALOPRAM OXALATE) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ECT-12003 (S-CITALOPRAM OXALATE) 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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