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Also known as: 202189-78-4, Bilaxten, Ilaxten, Bilastine [inn], 2-[4-[2-[4-[1-(2-ethoxyethyl)benzimidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic acid, 2-(4-(2-(4-(1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid
Molecular Formula
C28H37N3O3
Molecular Weight
463.6  g/mol
InChI Key
ACCMWZWAEFYUGZ-UHFFFAOYSA-N
FDA UNII
PA1123N395

Bilastine
Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.
1 2D Structure

Bilastine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4-[2-[4-[1-(2-ethoxyethyl)benzimidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic acid
2.1.2 InChI
InChI=1S/C28H37N3O3/c1-4-34-20-19-31-25-8-6-5-7-24(25)29-26(31)22-14-17-30(18-15-22)16-13-21-9-11-23(12-10-21)28(2,3)27(32)33/h5-12,22H,4,13-20H2,1-3H3,(H,32,33)
2.1.3 InChI Key
ACCMWZWAEFYUGZ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCOCCN1C2=CC=CC=C2N=C1C3CCN(CC3)CCC4=CC=C(C=C4)C(C)(C)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
PA1123N395
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 463.6 g/mol
Molecular Formula C28H37N3O3
XLogP32.3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count10
Exact Mass463.28349205 g/mol
Monoisotopic Mass463.28349205 g/mol
Topological Polar Surface Area67.6 Ų
Heavy Atom Count34
Formal Charge0
Complexity641
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

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


5 Pharmacology and Biochemistry
5.1 Pharmacology

Bilastine is an antiallergenic and acts to reduce allergic symptoms such as nasal congestion and urticaria.


5.2 ATC Code

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


5.3 Absorption, Distribution and Excretion

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.


5.4 Metabolism/Metabolites

Bilastine does not interact with the cytochrome P450 system and does not undergo significant metabolism in humans.


5.5 Biological Half-Life

The mean half life of elimination is 14.5h.


5.6 Mechanism of Action

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.


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02-Jan-2021
27-Feb-2025
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ABOUT THIS PAGE

Looking for 202189-78-4 / Bilastine API manufacturers, exporters & distributors?

Bilastine manufacturers, exporters & distributors 1

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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.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bilastine manufacturer or Bilastine supplier.

PharmaCompass also assists you with knowing the Bilastine API Price utilized in the formulation of products. Bilastine API Price is not always fixed or binding as the Bilastine Price is obtained through a variety of data sources. The Bilastine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Bilastine

Synonyms

202189-78-4, Bilaxten, Ilaxten, Bilastine [inn], 2-[4-[2-[4-[1-(2-ethoxyethyl)benzimidazol-2-yl]piperidin-1-yl]ethyl]phenyl]-2-methylpropanoic acid, 2-(4-(2-(4-(1-(2-ethoxyethyl)-1h-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid

Cas Number

202189-78-4

Unique Ingredient Identifier (UNII)

PA1123N395

About Bilastine

Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.

Bilastine Manufacturers

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

Bilastine Suppliers

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

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

Bilastine USDMF

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

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

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

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

Bilastine WC

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

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

Bilastine 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 Bilastine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Bilastine GMP

Bilastine 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 Bilastine 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 Bilastine GMP manufacturer or Bilastine GMP API supplier for your needs.

Bilastine CoA

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

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

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