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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.
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GDUFA
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Rev. Date :
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DMF Number : 39332
Submission : 2023-12-29
Status : Active
Type : II
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DMF Number : 36965
Submission : 2022-04-30
Status : Active
Type : II
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
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Submission : 2025-02-28
Status : Active
Type : II
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38752
Submission : 2024-02-14
Status : Active
Type : II
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
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
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Date of Issue : 2022-08-18
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Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Date of Issue : 2022-06-15
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy No.10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 5023...
Date of Issue : 2023-11-28
Valid Till : 2026-11-28
Written Confirmation Number : WC-0310
Address of the Firm : Plot No. Z-103/l, Dahej SEZ, Phase II, Dahej, Dist-Bharuch, Gujarat, India
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Survey no. 52,53,58,59,61 to 78,127&128, Pydibhimanvaram Village &Sy.No. 1,2,4t0...
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
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Date of Issue : 2024-03-01
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Date of Issue : 2022-08-08
Valid Till : 2025-08-08
Written Confirmation Number : WC-0383
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Date of Issue : 2022-04-13
Valid Till : 2025-04-12
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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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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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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.
A Bilaxten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilaxten, including repackagers and relabelers. The FDA regulates Bilaxten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilaxten 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 Bilaxten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bilaxten supplier is an individual or a company that provides Bilaxten active pharmaceutical ingredient (API) or Bilaxten finished formulations upon request. The Bilaxten suppliers may include Bilaxten API manufacturers, exporters, distributors and traders.
click here to find a list of Bilaxten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bilaxten DMF (Drug Master File) is a document detailing the whole manufacturing process of Bilaxten active pharmaceutical ingredient (API) in detail. Different forms of Bilaxten DMFs exist exist since differing nations have different regulations, such as Bilaxten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bilaxten DMF submitted to regulatory agencies in the US is known as a USDMF. Bilaxten USDMF includes data on Bilaxten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bilaxten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bilaxten 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 Bilaxten Drug Master File in Japan (Bilaxten JDMF) empowers Bilaxten 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 Bilaxten JDMF during the approval evaluation for pharmaceutical products. At the time of Bilaxten 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 Bilaxten suppliers with JDMF on PharmaCompass.
A Bilaxten written confirmation (Bilaxten WC) is an official document issued by a regulatory agency to a Bilaxten manufacturer, verifying that the manufacturing facility of a Bilaxten active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bilaxten APIs or Bilaxten finished pharmaceutical products to another nation, regulatory agencies frequently require a Bilaxten WC (written confirmation) as part of the regulatory process.
click here to find a list of Bilaxten 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 Bilaxten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bilaxten 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 Bilaxten 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 Bilaxten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bilaxten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bilaxten suppliers with NDC on PharmaCompass.
Bilaxten 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 Bilaxten 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 Bilaxten GMP manufacturer or Bilaxten GMP API supplier for your needs.
A Bilaxten CoA (Certificate of Analysis) is a formal document that attests to Bilaxten's compliance with Bilaxten specifications and serves as a tool for batch-level quality control.
Bilaxten CoA mostly includes findings from lab analyses of a specific batch. For each Bilaxten 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.
Bilaxten may be tested according to a variety of international standards, such as European Pharmacopoeia (Bilaxten EP), Bilaxten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bilaxten USP).
