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1. 202189-78-4
2. Bilaxten
3. Ilaxten
4. Bilastine [inn]
5. 2-[4-[2-[4-[1-(2-ethoxyethyl)benzimidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic Acid
6. 2-(4-(2-(4-(1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic Acid
7. Pa1123n395
8. Bilastinum
9. Bilatex
10. Unii-pa1123n395
11. 2-[4-[2-[4-[1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic Acid
12. Bilanoa (tn)
13. Bilastine (jan/inn)
14. Bilastine [jan]
15. Bilastine [mi]
16. Bilastine [who-dd]
17. Dsstox_cid_31467
18. Dsstox_rid_97352
19. Dsstox_gsid_57678
20. Benzeneacetic Acid,4-[2-[4-[1-(2-ethoxyethyl)-1h-benzimidazol-2-yl]-1-piperidinyl]ethyl]-a,a-dimethyl-
21. Schembl991810
22. Chembl1742423
23. Dtxsid5057678
24. Gtpl11579
25. Chebi:135954
26. Hms3887o17
27. Amy16470
28. Bcp02576
29. Ex-a2962
30. Zinc3822702
31. Tox21_113905
32. Mfcd09837814
33. S3721
34. Akos030241723
35. Bcp9000412
36. Ccg-269384
37. Db11591
38. F-96221-bm
39. Sb17508
40. Ncgc00262907-01
41. Ac-29231
42. Bs-15792
43. Hy-14447
44. B5392
45. Cas-202189-78-4
46. Ft-0700542
47. D09570
48. 189b784
49. A856214
50. Q2902977
51. P-(2-(4-(1-(2-ethoxyethyl)-2-benzimidazolyl)piperidino)ethyl)-alpha-methylhydratropic Acid
52. 2-[4-(2-{4-[1-(2-ethoxy-ethyl)-1h-benzoimidazol-2-yl]-piperidin-1-yl}-ethyl)-phenyl]-2-methyl-propionic Acid
53. 2-[4-(2-{4-[1-(2-ethoxy-ethyl)-1h-benzoimidazol-2-yl]-piperidin-1-yl}ethyl)-phenyl]-2-methyl-propionic Acid
54. 2-[4-[2-[4-[1-(2-ethoxyethyl)-1h-benzoimidazole-2-yl]piperidine-1-yl]ethyl]phenyl]-2-methylpropanoic Acid
55. 2-[4-[2-[4-[1-(2-ethoxyethyl)benzoimidazol-2-yl]-1-piperidyl]ethyl]phenyl]-2-methyl-propanoic Acid
56. Benzeneacetic Acid, 4-(2-(4-(1-(2-ethoxyethyl)-1h-benzimidazol-2-yl)-1-piperidinyl)ethyl-alpha, Alpha-dimethyl-
57. Benzeneacetic Acid, 4-[2-[4-[1-(2-ethoxyethyl)-1h-benzimidazol-2-yl]-1-piperidinyl]ethyl]-alpha,alpha-dimethyl-
58. Benzeneaceticacid,4-(2-(4-(1-(2-ethoxyethyl)-1h-benzimidazol-2-yl)-1-piperidinyl)ethyl-alpha,alpha-dimethyl-
59. Bilastine; 2-(4-(2-(4-(1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic Acid
60. P-(2-(4-(1-(2-ethoxyethyl)-2-benzimidazolyl)piperidino)ethyl)-.alpha.-methylhydratropic Acid
| Molecular Weight | 463.6 g/mol |
|---|---|
| Molecular Formula | C28H37N3O3 |
| XLogP3 | 2.3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 10 |
| Exact Mass | 463.28349205 g/mol |
| Monoisotopic Mass | 463.28349205 g/mol |
| Topological Polar Surface Area | 67.6 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 641 |
| 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 |
For symptomatic relief of nasal and non-nasal symptoms of seasonal rhinitis in patients 12 years of age and older and for symptomatic relief in chronic spontaneous urticaria in patients 18 years of age and older.
FDA Label
Treatment of allergic rhinoconjunctivitis, Treatment of urticaria
Treatment of urticaria, Treatment of allergic rhinoconjunctivitis
Treatment of acute type I hypersensitivity reactions
Treatment of allergic conjunctivitis
Bilastine is an antiallergenic and acts to reduce allergic symptoms such as nasal congestion and urticaria.
R06AX29
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
R06AX29 - Bilastine
S - Sensory organs
S01 - Ophthalmologicals
S01G - Decongestants and antiallergics
S01GX - Other antiallergics
S01GX13 - Bilastine
Absorption
Bilastine has a Tmax of 1.13 h. The absolute bioavailability is 61%. No accumulation observed with daily dosing of 20-100 mg after 14 days. Cmax decreased by 25 % and 33% when taken with a low fat and high fat meal compared to fasted state. Administration with grapefruit juice decreased Cmax by 30%.
Route of Elimination
Bilastine is mainly excreted in the feces (66.5%) with some excreted in the urine (28.3%). Nearly all is excreted as the parent compound.
Clearance
Bilastine has a total clearance is 9.20 L/h and a renal clearance of 8.7 L/h.
Bilastine does not interact with the cytochrome P450 system and does not undergo significant metabolism in humans.
The mean half life of elimination is 14.5h.
Bilastine is a selective histamine H1 receptor antagonist (Ki = 64nM). During allergic response mast cells undergo degranulation which releases histamine and other subastances. By binding to and preventing activation of the H1 receptor, bilastine reduces the development of allergic symptoms due to the release of histamine from mast cells.
API SUPPLIERS
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DMF Number : 36965
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Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-045
Start Marketing Date : 2022-05-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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With Virupaksha, you get a quality product with on-time delivery.
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Registration Number : 307MF10032
Registrant's Address : Plot No. : B1 and B2, IDA, Gandhinagar, Kukatpally, Medchal Malkajgiri, Hyderabad, Telangana 500037, India.
Initial Date of Registration : 2025-02-07
Latest Date of Registration :
NDC Package Code : 51686-0013
Start Marketing Date : 2024-12-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
AMI Lifesciences is Driven by Chemistry. Powered by People.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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DMF Number : 39332
Submission : 2023-12-29
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Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36965
Submission : 2022-04-30
Status : Active
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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DMF Review : N/A
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DMF Number : 37151
Submission : 2025-02-28
Status : Active
Type : II
With Virupaksha, you get a quality product with on-time delivery.
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DMF Number : 38752
Submission : 2024-02-14
Status : Active
Type : II
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Submission : 2023-10-10
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DMF Number : 36288
Submission : 2021-09-16
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DMF Number : 33720
Submission : 2019-03-28
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Drugs in Development
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
2-Piperidin-4-yl-1H-benzoimidazole
CAS Number : 38385-95-4
End Use API : Bilastine
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
tert-butyl 4-(1H-benzo[d]iMidazol-2-yl)piperidine-...
CAS Number : 953071-73-3
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About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
1-(2-Ethoxy-ethyl)-2-piperidine-4-yl-1H-benzimidaz...
CAS Number : 1841081-72-8
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropano...
CAS Number : 1181267-33-3
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Ethoxyethyl-4-methylbenzenesulfonate
CAS Number : 17178-11-9
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
2-Piperidin-4-yl-1H-benzoimidazole
CAS Number : 38385-95-4
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 1126-09-6
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Isonipecotic acid/4-Piperidinecarboxylic acid
CAS Number : 498-94-2
End Use API : Bilastine
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
2-(PIPERIDIN-4-YL)-1H—BENZIMIDAZOLE
CAS Number : 38385-95-4
End Use API : Bilastine
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
1-(2-ETHOXYETHYL)-2-(PIPERIDIN-4-YL)-1H-BENZO[D] I...
CAS Number : 1841081-72-8
End Use API : Bilastine
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
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PharmaCompass offers a list of Bilastine 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 Bilastine manufacturer or Bilastine supplier for your needs.
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A CAS-202189-78-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-202189-78-4, including repackagers and relabelers. The FDA regulates CAS-202189-78-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-202189-78-4 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CAS-202189-78-4 supplier is an individual or a company that provides CAS-202189-78-4 active pharmaceutical ingredient (API) or CAS-202189-78-4 finished formulations upon request. The CAS-202189-78-4 suppliers may include CAS-202189-78-4 API manufacturers, exporters, distributors and traders.
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A CAS-202189-78-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-202189-78-4 active pharmaceutical ingredient (API) in detail. Different forms of CAS-202189-78-4 DMFs exist exist since differing nations have different regulations, such as CAS-202189-78-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-202189-78-4 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-202189-78-4 USDMF includes data on CAS-202189-78-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-202189-78-4 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 CAS-202189-78-4 Drug Master File in Japan (CAS-202189-78-4 JDMF) empowers CAS-202189-78-4 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 CAS-202189-78-4 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-202189-78-4 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A CAS-202189-78-4 written confirmation (CAS-202189-78-4 WC) is an official document issued by a regulatory agency to a CAS-202189-78-4 manufacturer, verifying that the manufacturing facility of a CAS-202189-78-4 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-202189-78-4 APIs or CAS-202189-78-4 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-202189-78-4 WC (written confirmation) as part of the regulatory process.
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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 CAS-202189-78-4 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CAS-202189-78-4 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 CAS-202189-78-4 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 CAS-202189-78-4 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-202189-78-4 NDC to their finished compounded human drug products, they may choose to do so.
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CAS-202189-78-4 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 CAS-202189-78-4 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 CAS-202189-78-4 GMP manufacturer or CAS-202189-78-4 GMP API supplier for your needs.
A CAS-202189-78-4 CoA (Certificate of Analysis) is a formal document that attests to CAS-202189-78-4's compliance with CAS-202189-78-4 specifications and serves as a tool for batch-level quality control.
CAS-202189-78-4 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-202189-78-4 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.
CAS-202189-78-4 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-202189-78-4 EP), CAS-202189-78-4 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-202189-78-4 USP).
