Synopsis
Synopsis
0
USDMF
0
NDC API
0
VMF
0
FDA Orange Book
0
Canada
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 4-diphenylmethoxy-1-(3-(4-tert-butylbenzoyl)propyl)piperidine
2. Bactil
3. Busidril
4. Ebastel
5. Evastel
6. Kestin
7. Kestine
8. Las W-090
1. 90729-43-4
2. Kestine
3. Ebastel
4. Ebastin
5. Kestin
6. Bactil
7. Las W-090
8. Rp 64305
9. 4-(4-benzhydryloxypiperidin-1-yl)-1-(4-tert-butylphenyl)butan-1-one
10. Las-w-090
11. 1-(4-tert-butylphenyl)-4-[4-(diphenylmethoxy)piperidin-1-yl]butan-1-one
12. Las-w 090;rp64305
13. Rp-64305
14. Chembl305660
15. Tqd7q784p1
16. 4-(4-(benzhydryloxy)piperidin-1-yl)-1-(4-(tert-butyl)phenyl)butan-1-one
17. Rp64305
18. Ncgc00164603-01
19. Evastel
20. Dsstox_cid_26472
21. Dsstox_rid_81644
22. Dsstox_gsid_46472
23. Ebastinum [latin]
24. Ebastina [spanish]
25. Ebastina
26. Ebastinum
27. Estivan
28. Bastel
29. Cas-90729-43-4
30. Unii-tqd7q784p1
31. Ebastine [usan:inn:ban]
32. 4-(4-(benzhydryloxy)piperidin-1-yl)-1-(4-tert-butylphenyl)butan-1-one
33. 4-[4-(benzhydryloxy)piperidin-1-yl]-1-(4-tert-butylphenyl)butan-1-one
34. 4-diphenylmethoxy-1-(3-(4-tert-butylbenzoyl)propyl)piperidine
35. Las-w 090
36. No-sedat
37. Kestine (tn)
38. Mfcd00865661
39. 4'-tert-butyl-4-(4-(diphenylmethoxy)piperidino)butyrophenone
40. Ebastine [usan]
41. Ebastine [inn]
42. Ebastine [jan]
43. Ebastine [mi]
44. 4-(4-benzhydryloxy-1-piperidyl)-1-(4-tert-butylphenyl)butan-1-one
45. Ebastine [mart.]
46. Ebastine [who-dd]
47. 1-(4-(1,1-dimethylethyl)phenyl)-4-(4-(diphenylmethoxy)-1-piperidinyl)-1-butanone
48. Schembl18467
49. Ebastine [ep Impurity]
50. Ebastine (jp17/usan/inn)
51. Ebastine [ep Monograph]
52. Dtxsid6046472
53. Bdbm22873
54. Chebi:31528
55. Hms3261i03
56. Hms3887c19
57. Bcp08300
58. Hy-b0674
59. Zinc3781952
60. Tox21_112225
61. Tox21_500361
62. Bbl029069
63. Ebastine, >=98% (hplc), Solid
64. S4262
65. Stk624411
66. Akos005557491
67. Tox21_112225_1
68. Ccg-221665
69. Db11742
70. Ks-1349
71. Lp00361
72. Sdccgsbi-0633701.p001
73. 1-butanone, 1-(4-(1,1-dimethylethyl)phenyl)-4-(4-(diphenylmethoxy)-1-piperidinyl)-
74. Ncgc00164603-02
75. Ncgc00164603-04
76. Ncgc00164603-05
77. Ncgc00164603-11
78. Ncgc00261046-01
79. Ac-15213
80. Ac-30629
81. Be164400
82. Db-057220
83. E0925
84. Ft-0630975
85. W-090
86. A14946
87. C77079
88. D01478
89. Ab01325291-02
90. 729e434
91. A843625
92. Sr-01000883997
93. Q-201053
94. Q2327739
95. Sr-01000883997-1
96. 4-diphenylmethoxy-1[3-(4-tert-butylbenzoyl)propyl]-piperidine
97. Ebastine, United States Pharmacopeia (usp) Reference Standard
| Molecular Weight | 469.7 g/mol |
|---|---|
| Molecular Formula | C32H39NO2 |
| XLogP3 | 7.2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 10 |
| Exact Mass | 469.298079487 g/mol |
| Monoisotopic Mass | 469.298079487 g/mol |
| Topological Polar Surface Area | 29.5 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 594 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Histamine H1 Antagonists
Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)
R06AX22
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
R - Respiratory system
R06 - Antihistamines for systemic use
R06A - Antihistamines for systemic use
R06AX - Other antihistamines for systemic use
R06AX22 - Ebastine
Ebastine has known human metabolites that include 4-(4-tert-butylphenyl)-4-oxobutanal and Deslakylebastine.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
API SUPPLIERS
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Certificate Number : CEP 2013-051 - Rev 02
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 2015
Status : Valid
Registration Number : 227MF10209
Registrant's Address : 5th Floor, Lakshminarayan Complex, 10/1, Palace Road, Bangalore-560052, India
Initial Date of Registration : 2015-08-11
Latest Date of Registration :
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm :
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-02-15
Registration Number : 20120824-156-I-42-01(1)
Manufacturer Name : Bal Pharma Limited
Manufacturer Address : 61-B, Bommasandra Industrial Area Bangalore – 560 099
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2012-08-24
Registration Number : 20120824-156-I-42-01
Manufacturer Name : Bal Pharma Limited
Manufacturer Address : 61-B, Bommasandra Industrial Area Bangalore – 560 099
Certificate Number : CEP 2017-058 - Rev 01
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 2015
Status : Valid
Certificate Number : CEP 2013-243 - Rev 03
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 2015
Status : Valid
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070
Address of the Firm :
Certificate Number : R1-CEP 2009-106 - Rev 03
Issue Date : 2023-07-13
Type : Chemical
Substance Number : 2015
Status : Valid
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225
Address of the Firm :
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070
Address of the Firm :
Certificate Number : CEP 2011-160 - Rev 03
Issue Date : 2024-10-25
Type : Chemical
Substance Number : 2015
Status : Valid
Certificate Number : R1-CEP 2017-287 - Rev 00
Issue Date : 2023-04-05
Type : Chemical
Substance Number : 2015
Status : Valid
Registration Number : 221MF10107
Registrant's Address : General Miter, 151, 08022 Barcelona, Spain
Initial Date of Registration : 2009-06-02
Latest Date of Registration :
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2013-08-21
Registration Number : 20130821-156-I-323-05
Manufacturer Name : Almirall Farmaceuticas Industries, SA@Ranke Quimica, SA_x000D_ (Micronized Ebastin Manufacturing Plant)
Manufacturer Address : Ctra. de Martorell 41-61 08740 Sant Andreu de la Barca (Barcelona), Spain@Ctra. C-35, Km 58.85, Sant Celoni 08470 Barcelona, Spain
Certificate Number : R0-CEP 2020-139 - Rev 00
Issue Date : 2021-09-28
Type : Chemical
Substance Number : 2015
Status : Valid
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]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 
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]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
89
PharmaCompass offers a list of Ebastine 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 Ebastine manufacturer or Ebastine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ebastine manufacturer or Ebastine supplier.
PharmaCompass also assists you with knowing the Ebastine API Price utilized in the formulation of products. Ebastine API Price is not always fixed or binding as the Ebastine Price is obtained through a variety of data sources. The Ebastine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Kestin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kestin, including repackagers and relabelers. The FDA regulates Kestin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kestin 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 Kestin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Kestin supplier is an individual or a company that provides Kestin active pharmaceutical ingredient (API) or Kestin finished formulations upon request. The Kestin suppliers may include Kestin API manufacturers, exporters, distributors and traders.
click here to find a list of Kestin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Kestin Drug Master File in Japan (Kestin JDMF) empowers Kestin 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 Kestin JDMF during the approval evaluation for pharmaceutical products. At the time of Kestin 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 Kestin 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 Kestin Drug Master File in Korea (Kestin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kestin. The MFDS reviews the Kestin KDMF as part of the drug registration process and uses the information provided in the Kestin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kestin 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 Kestin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Kestin suppliers with KDMF on PharmaCompass.
A Kestin CEP of the European Pharmacopoeia monograph is often referred to as a Kestin Certificate of Suitability (COS). The purpose of a Kestin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Kestin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Kestin to their clients by showing that a Kestin CEP has been issued for it. The manufacturer submits a Kestin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Kestin CEP holder for the record. Additionally, the data presented in the Kestin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Kestin DMF.
A Kestin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Kestin 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 Kestin suppliers with CEP (COS) on PharmaCompass.
A Kestin written confirmation (Kestin WC) is an official document issued by a regulatory agency to a Kestin manufacturer, verifying that the manufacturing facility of a Kestin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Kestin APIs or Kestin finished pharmaceutical products to another nation, regulatory agencies frequently require a Kestin WC (written confirmation) as part of the regulatory process.
click here to find a list of Kestin suppliers with Written Confirmation (WC) on PharmaCompass.
Kestin 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 Kestin 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 Kestin GMP manufacturer or Kestin GMP API supplier for your needs.
A Kestin CoA (Certificate of Analysis) is a formal document that attests to Kestin's compliance with Kestin specifications and serves as a tool for batch-level quality control.
Kestin CoA mostly includes findings from lab analyses of a specific batch. For each Kestin 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.
Kestin may be tested according to a variety of international standards, such as European Pharmacopoeia (Kestin EP), Kestin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Kestin USP).
