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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]

API Reference Price

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HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"470","totalValueFC":"242506.3","currency":"USD","unitRateINR":"40260","date":"21-Sep-2023","totalValueINR":"20130019.38","totalValueInUsd":"242506.3","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"7920409","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":"2023","qtr":"Q4","strtotime":1701887400,"product":"ESCITALOPRAM OXALATE USP, LOT NO: EL22080028(EXP VIDE SB NO:6048266 DT:09-12-2022,EXP.INV NO:SI3622226624,DT:07-12-2022)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"LIBBS 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PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"210.00","actualQuantity":"210","unit":"KGS","unitRateFc":"425","totalValueFC":"91346.2","currency":"USD","unitRateINR":"36152.1","date":"19-Jan-2024","totalValueINR":"7591939.17","totalValueInUsd":"91346.2","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"9741201","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":"Q1","strtotime":1710095400,"product":"ESCITALOPRAM OXALATE USP, BATCH NO: EL22080028(EXP VIDE SB NO:6048266, DT:09-12-2022,INV NO:SI3622226624,DT:07-12-2022)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"LIBBS 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PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"PADANG","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"425","totalValueFC":"130473","currency":"USD","unitRateINR":"36318.2","date":"12-Apr-2024","totalValueINR":"10895447.89","totalValueInUsd":"130473","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"2992880","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"PADANG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINASDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713205800,"product":"ESCITALOPRAM OXALATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA 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LIFESCIENCES","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","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA 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LIMITED","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":1732732200,"product":"ESCITALOPRAM OXALATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"PADANG","customer":"AUROBINDO PHARMA LIMITED","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","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA 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LIMITED","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,"}]
04-Jan-2021
31-Mar-2025
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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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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.

Escitalopram Oxalate Manufacturers

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

Escitalopram Oxalate Suppliers

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

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

Escitalopram Oxalate USDMF

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

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

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

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

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

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

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

Escitalopram Oxalate CEP

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

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

Escitalopram Oxalate WC

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

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

Escitalopram 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 Escitalopram Oxalate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Escitalopram Oxalate GMP

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

Escitalopram Oxalate CoA

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

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

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