Synopsis
Synopsis
0
CEP/COS
0
KDMF
0
VMF
0
FDA Orange Book
0
Australia
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 38752
Submission : 2024-02-14
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39332
Submission : 2023-12-29
Status : Active
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 : 43373
Submission : 2025-12-31
Status : Active
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37151
Submission : 2025-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39005
Submission : 2023-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42411
Submission : 2025-08-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33720
Submission : 2019-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40112
Submission : 2024-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38966
Submission : 2023-10-09
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
With Virupaksha, you get a quality product with on-time delivery.
Registration Number : 307MF10032
Registrant's Address : Plot No. : B1 and B2, IDA, Gandhinagar, Kukatpally, Medchal Malkajgiri, Hyderabad, Te...
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-11-13
Registration Number : 307MF10027
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-11-18
Registration Number : 306MF10049
Registrant's Address : Ma(´)ximo Aguirre, 14, 48940 Leioa, SPAIN
Initial Date of Registration : 2024-04-03
Latest Date of Registration : 2024-04-03
Registration Number : 307MF10026
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-02-07
Registration Number : 227MF10243
Registrant's Address : Plot No. DS-7, IKP Knowledge Pk, Turkapally Village, Shameerpet Mandal, Medchal Malka...
Initial Date of Registration : 2015-10-07
Latest Date of Registration : 2023-04-05
Registration Number : 306MF10158
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2024-12-11
Latest Date of Registration : 2024-12-11
Registration Number : 307MF10015
Registrant's Address : 8-2-293/174/3, Beside BN Reddy colony, Road No. 14, Banjara Hills, Hyderabad-500 034,...
Initial Date of Registration : 2025-01-23
Latest Date of Registration : 2025-01-23
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]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]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
35
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.
A Bilatex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilatex, including repackagers and relabelers. The FDA regulates Bilatex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilatex 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 Bilatex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bilatex supplier is an individual or a company that provides Bilatex active pharmaceutical ingredient (API) or Bilatex finished formulations upon request. The Bilatex suppliers may include Bilatex API manufacturers, exporters, distributors and traders.
click here to find a list of Bilatex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bilatex DMF (Drug Master File) is a document detailing the whole manufacturing process of Bilatex active pharmaceutical ingredient (API) in detail. Different forms of Bilatex DMFs exist exist since differing nations have different regulations, such as Bilatex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bilatex DMF submitted to regulatory agencies in the US is known as a USDMF. Bilatex USDMF includes data on Bilatex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bilatex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bilatex 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 Bilatex Drug Master File in Japan (Bilatex JDMF) empowers Bilatex 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 Bilatex JDMF during the approval evaluation for pharmaceutical products. At the time of Bilatex 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 Bilatex suppliers with JDMF on PharmaCompass.
A Bilatex written confirmation (Bilatex WC) is an official document issued by a regulatory agency to a Bilatex manufacturer, verifying that the manufacturing facility of a Bilatex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bilatex APIs or Bilatex finished pharmaceutical products to another nation, regulatory agencies frequently require a Bilatex WC (written confirmation) as part of the regulatory process.
click here to find a list of Bilatex 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 Bilatex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bilatex 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 Bilatex 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 Bilatex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bilatex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bilatex suppliers with NDC on PharmaCompass.
Bilatex 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 Bilatex 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 Bilatex GMP manufacturer or Bilatex GMP API supplier for your needs.
A Bilatex CoA (Certificate of Analysis) is a formal document that attests to Bilatex's compliance with Bilatex specifications and serves as a tool for batch-level quality control.
Bilatex CoA mostly includes findings from lab analyses of a specific batch. For each Bilatex 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.
Bilatex may be tested according to a variety of international standards, such as European Pharmacopoeia (Bilatex EP), Bilatex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bilatex USP).
