Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.)
API SUPPLIERS
With Virupaksha, you get a quality product with on-time delivery.
Click Us!
GDUFA
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.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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 : R0-CEP 2019-096 - Rev 03
Issue Date : 2023-03-24
Type : Chemical
Substance Number : 2733
Status : Withdrawn by Holder
Date of Issue : 2022-06-07
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.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Venkar Chemicals – WHO-GMP & ISO Certified API Experts Delivering Global Standards.
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.
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
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
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14103
Submission : 1999-04-29
Status : Active
Type : II
GDUFA
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21323
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21323
DOSAGE - TABLET;ORAL - EQ 5MG BASE
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
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Thickeners and Stabilizers
Controlled & Modified Release
Direct Compression
Solubilizers
Film Formers & Plasticizers
Disintegrants & Superdisintegrants
Granulation
Parenteral
Co-Processed Excipients
Taste Masking
Topical
Chewable & Orodispersible Aids
Lubricants & Glidants
Rheology Modifiers
Emulsifying Agents
API Stability Enhancers
Empty Capsules
Vegetarian Capsules
Surfactant & Foaming Agents
Coloring Agents
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory FDF Prices
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Annual Reports
Main Therapeutic Indication : CNS & Anesthesia
Currency : USD
2020 Revenue in Millions : 387
2019 Revenue in Millions : 376
Growth (%) : 3
Main Therapeutic Indication : CNS & Anesthesia
Currency : USD
2020 Revenue in Millions : 139
2019 Revenue in Millions : 137
Growth (%) : 1
Main Therapeutic Indication : Neurology
Currency : USD
2021 Revenue in Millions : 358
2020 Revenue in Millions : 381
Growth (%) : -1
Main Therapeutic Indication : Neurology
Currency : USD
2021 Revenue in Millions : 130
2020 Revenue in Millions : 137
Growth (%) : 2
Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 89
2021 Revenue in Millions : 130
Growth (%) : -31
Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 340
2021 Revenue in Millions : 358
Growth (%) : -5
Main Therapeutic Indication : Neurology
Currency : USD
2023 Revenue in Millions : 308
2022 Revenue in Millions : 340
Growth (%) : -10
Main Therapeutic Indication : Neurology
Currency : USD
2023 Revenue in Millions : 3
2022 Revenue in Millions : 89
Growth (%) : -97
Main Therapeutic Indication : Neurology
Currency : USD
2024 Revenue in Millions : 284
2023 Revenue in Millions : 308
Growth (%) : -8
Main Therapeutic Indication : Neurological/Mental Disorders
Currency : USD
2017 Revenue in Millions : 403
2016 Revenue in Millions : 428
Growth (%) : -6
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
13 May 2025
Reply
23 Apr 2025
Reply
12 Apr 2025
Reply
10 Jan 2025
Reply
27 Mar 2023
Reply
05 Nov 2022
Reply
09 Sep 2022
Reply
26 Jul 2022
Reply
13 Jul 2022
Reply
09 Apr 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
51
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 Gaudium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gaudium, including repackagers and relabelers. The FDA regulates Gaudium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gaudium 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 Gaudium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gaudium supplier is an individual or a company that provides Gaudium active pharmaceutical ingredient (API) or Gaudium finished formulations upon request. The Gaudium suppliers may include Gaudium API manufacturers, exporters, distributors and traders.
click here to find a list of Gaudium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gaudium DMF (Drug Master File) is a document detailing the whole manufacturing process of Gaudium active pharmaceutical ingredient (API) in detail. Different forms of Gaudium DMFs exist exist since differing nations have different regulations, such as Gaudium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gaudium DMF submitted to regulatory agencies in the US is known as a USDMF. Gaudium USDMF includes data on Gaudium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gaudium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gaudium suppliers with USDMF on PharmaCompass.
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 Gaudium Drug Master File in Japan (Gaudium JDMF) empowers Gaudium 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 Gaudium JDMF during the approval evaluation for pharmaceutical products. At the time of Gaudium 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 Gaudium 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 Gaudium Drug Master File in Korea (Gaudium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gaudium. The MFDS reviews the Gaudium KDMF as part of the drug registration process and uses the information provided in the Gaudium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gaudium 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 Gaudium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gaudium suppliers with KDMF on PharmaCompass.
A Gaudium CEP of the European Pharmacopoeia monograph is often referred to as a Gaudium Certificate of Suitability (COS). The purpose of a Gaudium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gaudium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gaudium to their clients by showing that a Gaudium CEP has been issued for it. The manufacturer submits a Gaudium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gaudium CEP holder for the record. Additionally, the data presented in the Gaudium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gaudium DMF.
A Gaudium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gaudium 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 Gaudium suppliers with CEP (COS) on PharmaCompass.
A Gaudium written confirmation (Gaudium WC) is an official document issued by a regulatory agency to a Gaudium manufacturer, verifying that the manufacturing facility of a Gaudium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gaudium APIs or Gaudium finished pharmaceutical products to another nation, regulatory agencies frequently require a Gaudium WC (written confirmation) as part of the regulatory process.
click here to find a list of Gaudium 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 Gaudium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gaudium 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 Gaudium 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 Gaudium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gaudium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gaudium suppliers with NDC on PharmaCompass.
Gaudium 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 Gaudium 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 Gaudium GMP manufacturer or Gaudium GMP API supplier for your needs.
A Gaudium CoA (Certificate of Analysis) is a formal document that attests to Gaudium's compliance with Gaudium specifications and serves as a tool for batch-level quality control.
Gaudium CoA mostly includes findings from lab analyses of a specific batch. For each Gaudium 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.
Gaudium may be tested according to a variety of international standards, such as European Pharmacopoeia (Gaudium EP), Gaudium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gaudium USP).
Comment (3)
