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1. Escitalopram
2. Lexapro
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)
| Molecular Weight | 414.4 g/mol |
|---|---|
| Molecular Formula | C22H23FN2O5 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 6 |
| Exact Mass | 414.15910000 g/mol |
| Monoisotopic Mass | 414.15910000 g/mol |
| Topological Polar Surface Area | 111 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 537 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Escitalopram oxalate |
| PubMed Health | Escitalopram (By mouth) |
| Drug Classes | Antianxiety, Antidepressant |
| Drug Label | Escitalopramoxalate 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 Ingredient | Escitalopram oxalate |
| Dosage Form | Tablet; Solution |
| Route | oral; Oral |
| Strength | 5mg; eq 5mg base; eq 5mg base/5ml; 10mg; eq 20mg base; eq 10mg base; 20mg |
| Market Status | Tentative Approval; Prescription |
| Company | Watson 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 Name | Lexapro |
| Drug Label | Lexapro (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 Ingredient | Escitalopram oxalate |
| Dosage Form | Tablet; Solution |
| Route | oral; Oral |
| Strength | eq 5mg base; eq 5mg base/5ml; eq 20mg base; eq 10mg base |
| Market Status | Prescription |
| Company | Forest Labs |
| 3 of 4 | |
|---|---|
| Drug Name | Escitalopram oxalate |
| PubMed Health | Escitalopram (By mouth) |
| Drug Classes | Antianxiety, Antidepressant |
| Drug Label | Escitalopramoxalate 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 Ingredient | Escitalopram oxalate |
| Dosage Form | Tablet; Solution |
| Route | oral; Oral |
| Strength | 5mg; eq 5mg base; eq 5mg base/5ml; 10mg; eq 20mg base; eq 10mg base; 20mg |
| Market Status | Tentative Approval; Prescription |
| Company | Watson 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 Name | Lexapro |
| Drug Label | Lexapro (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 Ingredient | Escitalopram oxalate |
| Dosage Form | Tablet; Solution |
| Route | oral; Oral |
| Strength | eq 5mg base; eq 5mg base/5ml; eq 20mg base; eq 10mg base |
| Market Status | Prescription |
| Company | Forest Labs |
Selective Serotonin Reuptake Inhibitors
Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)
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DMF Review : Reviewed
Rev. Date : 2022-05-17
Pay. Date : 2022-04-13
DMF Number : 36632
Submission : 2022-01-06
Status : Active
Type : II
Certificate Number : CEP 2022-032 - Rev 00
Issue Date : 2024-05-13
Type : Chemical
Substance Number : 2733
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-02
Written Confirmation Number : WC-0191
Address of the Firm :
NDC Package Code : 51686-0011
Start Marketing Date : 2022-01-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Toru Corporation
Registration Date : 2023-08-23
Registration Number : 20230823-209-J-1539
Manufacturer Name : Virupaksha Organics Ltd, Unit-I
Manufacturer Address : 502 319, Sy.No.10, Gaddapotharam Village, Jinnaram Mandal, Medak District, Andhra Pradesh, lndia.
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Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-22
Pay. Date : 2021-09-17
DMF Number : 19662
Submission : 2006-08-07
Status : Active
Type : II
Certificate Number : CEP 2021-161 - Rev 02
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 2733
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0134
Start Marketing Date : 2017-11-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-09-19
Registration Number : 20230919-209-J-1546
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No. 347, 473, 474, 490/2, Bonthapally Village, Veerabhadraswamy Temple Road, Gummadidala Mandal, Sangareddy District - 502313, Telangana State, India.
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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Certificate Number : CEP 2022-163 - Rev 00
Issue Date : 2024-06-25
Type : Chemical
Substance Number : 2733
Status : Valid
Neuland Laboratories- A dedicated 100% API provider.
Certificate Number : R0-CEP 2019-096 - Rev 03
Issue Date : 2023-03-24
Type : Chemical
Substance Number : 2733
Status : Withdrawn by Holder
Neuland Laboratories- A dedicated 100% API provider.
Certificate Number : CEP 2017-217 - Rev 01
Issue Date : 2024-08-23
Type : Chemical
Substance Number : 2733
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
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DMF Review : Complete
Rev. Date : 2022-05-17
Pay. Date : 2022-04-13
DMF Number : 36632
Submission : 2022-01-06
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-22
Pay. Date : 2021-09-17
DMF Number : 19662
Submission : 2006-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19088
Submission : 2005-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-05
Pay. Date : 2021-09-30
DMF Number : 16636
Submission : 2003-06-12
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14103
Submission : 1999-04-29
Status : Active
Type : II
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DMF Review : Complete
Rev. Date : 2013-03-17
Pay. Date : 2013-03-07
DMF Number : 17960
Submission : 2004-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19105
Submission : 2005-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17175
Submission : 2004-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18213
Submission : 2005-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18119
Submission : 2005-02-25
Status : Active
Type : II
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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21323
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USFDA APPLICATION NUMBER - 21323
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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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.
A Seroplex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Seroplex, including repackagers and relabelers. The FDA regulates Seroplex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Seroplex 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 Seroplex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Seroplex supplier is an individual or a company that provides Seroplex active pharmaceutical ingredient (API) or Seroplex finished formulations upon request. The Seroplex suppliers may include Seroplex API manufacturers, exporters, distributors and traders.
click here to find a list of Seroplex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Seroplex DMF (Drug Master File) is a document detailing the whole manufacturing process of Seroplex active pharmaceutical ingredient (API) in detail. Different forms of Seroplex DMFs exist exist since differing nations have different regulations, such as Seroplex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Seroplex DMF submitted to regulatory agencies in the US is known as a USDMF. Seroplex USDMF includes data on Seroplex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Seroplex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Seroplex Drug Master File in Japan (Seroplex JDMF) empowers Seroplex 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 Seroplex JDMF during the approval evaluation for pharmaceutical products. At the time of Seroplex 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 Seroplex suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Seroplex Drug Master File in Korea (Seroplex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Seroplex. The MFDS reviews the Seroplex KDMF as part of the drug registration process and uses the information provided in the Seroplex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Seroplex 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 Seroplex API can apply through the Korea Drug Master File (KDMF).
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A Seroplex CEP of the European Pharmacopoeia monograph is often referred to as a Seroplex Certificate of Suitability (COS). The purpose of a Seroplex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Seroplex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Seroplex to their clients by showing that a Seroplex CEP has been issued for it. The manufacturer submits a Seroplex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Seroplex CEP holder for the record. Additionally, the data presented in the Seroplex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Seroplex DMF.
A Seroplex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Seroplex 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 Seroplex suppliers with CEP (COS) on PharmaCompass.
A Seroplex written confirmation (Seroplex WC) is an official document issued by a regulatory agency to a Seroplex manufacturer, verifying that the manufacturing facility of a Seroplex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Seroplex APIs or Seroplex finished pharmaceutical products to another nation, regulatory agencies frequently require a Seroplex WC (written confirmation) as part of the regulatory process.
click here to find a list of Seroplex suppliers with Written Confirmation (WC) on PharmaCompass.
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 Seroplex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Seroplex API and other APIs are published in this directory by the FDA.
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 Seroplex 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.
The NDC directory also contains data on finished compounded human drug products that contain Seroplex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Seroplex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Seroplex suppliers with NDC on PharmaCompass.
Seroplex 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 Seroplex 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 Seroplex GMP manufacturer or Seroplex GMP API supplier for your needs.
A Seroplex CoA (Certificate of Analysis) is a formal document that attests to Seroplex's compliance with Seroplex specifications and serves as a tool for batch-level quality control.
Seroplex CoA mostly includes findings from lab analyses of a specific batch. For each Seroplex 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.
Seroplex may be tested according to a variety of international standards, such as European Pharmacopoeia (Seroplex EP), Seroplex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Seroplex USP).
