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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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Drugs in Development
Details:
Bilastine Tiefenbacher (Bilastine) is a histamine H1 receptor inverse agonist, small molecule drug candidate which is indicated for the treatment of allergic rhino-conjunctivitis & urticaria.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Immunology Brand Name: Bilastine Tiefenbacher
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 14, 2023
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bilastine Tiefenbacher (Bilastine) is a histamine H1 receptor inverse agonist, small molecule drug candidate which is indicated for the treatment of allergic rhino-conjunctivitis & urticaria.
Product Name : Bilastine Tiefenbacher
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 14, 2023
Details:
Bilastine is an innovative anti-allergy medicine improving the life of patients suffering from allergic symptoms also a second-generation antihistamine product helps to relieve nasal and non-nasal symptoms of seasonal rhinitis as well as urticaria caused symptoms.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Immunology Brand Name: Bilastine Tiefenbacher
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 20, 2021
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bilastine is an innovative anti-allergy medicine improving the life of patients suffering from allergic symptoms also a second-generation antihistamine product helps to relieve nasal and non-nasal symptoms of seasonal rhinitis as well as urticaria caused...
Product Name : Bilastine Tiefenbacher
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 20, 2021
Details:
Bilastine is a small molecule drug, which is currently being evaluated in clinical studies for the treatment of chronic urticaria.
Lead Product(s): Bilastine,Levocetirizine Dihydrochloride
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 26, 2026
Lead Product(s) : Bilastine,Levocetirizine Dihydrochloride
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bilastine is a small molecule drug, which is currently being evaluated in clinical studies for the treatment of chronic urticaria.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 26, 2026
Details:
Bilastine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Rhinoconjunctivitis, Allergic.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 29, 2025
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bilastine 20 mg ODT vs Bilaxten 20 mg ODT Bioavailability Under Fasting In Healthy Adults
Details : Bilastine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Rhinoconjunctivitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 29, 2025
Details:
Blexten-Generic (bilastine) is a histamine H1 receptor inhibitor, which is indicated for the treatment of seasonal allergic rhinitis & chronic spontaneous urticaria.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Immunology Brand Name: Blexten-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2024
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Sunshine Biopharma Launches a New Generic Prescription Drug
Details : Blexten-Generic (bilastine) is a histamine H1 receptor inhibitor, which is indicated for the treatment of seasonal allergic rhinitis & chronic spontaneous urticaria.
Product Name : Blexten-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 05, 2024
Details:
Blexten (bilastine) is a second-generation antihistamine drug, exerts its effect through its highly selective inhibition of peripheral histamine H1 receptors for the symptomatic relief of allergic rhinitis and chronic spontaneous urticaria.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Immunology Brand Name: Blexten
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Miravo Healthcare
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 01, 2022
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Miravo Healthcare
Deal Size : Inapplicable
Deal Type : Inapplicable
Miravo Healthcare™ Announces the Canadian Commercial Launch of Blexten® for Patients 4 Years of...
Details : Blexten (bilastine) is a second-generation antihistamine drug, exerts its effect through its highly selective inhibition of peripheral histamine H1 receptors for the symptomatic relief of allergic rhinitis and chronic spontaneous urticaria.
Product Name : Blexten
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 01, 2022
Details:
Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Immunology Brand Name: Bilaxten
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 20, 2021
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the terms of the agreement, Hikma will be responsible for obtaining regulatory approval of Bilastine by the US Food and Drug Administration (FDA) and for the commercialisation of the product in the US following approval.
Product Name : Bilaxten
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 20, 2021
Details:
Bilastine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Conjunctivitis, Allergic.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Dynamic Science
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 23, 2021
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Dynamic Science
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bilastine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Conjunctivitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 23, 2021
Details:
The company has received approval for Bilastin tablets, which are used for the treatment of allergic Rhino conjunctivitis and Urticaria, the Hyderabad-based company said in a regulatory filing.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 08, 2021
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Vivimed Labs Gets Approval from Uzbekistan Govt for Two Products
Details : The company has received approval for Bilastin tablets, which are used for the treatment of allergic Rhino conjunctivitis and Urticaria, the Hyderabad-based company said in a regulatory filing.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 08, 2021
Details:
Bilastine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Bilastine,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 16, 2018
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Different Level of Single-dose and Multiple-dose Bilastine PK Study in Chinese Population
Details : Bilastine is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 16, 2018
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1-(2-Ethoxyethyl)-2-(piperidin-4-yl)-1H-benzol[d]i...
CAS Number : 110963-63-8
End Use API : Bilastine
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
With Virupaksha, you get a quality product with on-time delivery.
2-[4-(2-{4-[1(2-ethoxyethyl)-1H-1,3-benzodiazol-2-...
CAS Number : 202189-78-4
End Use API : Bilastine
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
2-Piperidin-4-yl-1H-benzoimidazole
CAS Number : 38385-95-4
End Use API : Bilastine
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
tert-butyl 4-(1H-benzo[d]iMidazol-2-yl)piperidine-...
CAS Number : 953071-73-3
End Use API : Bilastine
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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Bilastine Impurity 10 (BLB-04)
CAS Number : 1841081-72-8
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Code/Batch No : B0092.12
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Code/Batch No : B0092.16
CAS Number : 1181267-33-3
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Code/Batch No : B0092.17
Bilastine Impurity 17 (BSN-02)
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Code/Batch No : B0092.19
Bilastine N-Oxide (BS-02-Impurity-01)
CAS Number : 2069238-47-5
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Code/Batch No : B0092.03
CAS Number : 2069238-47-5
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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 Bilastin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilastin, including repackagers and relabelers. The FDA regulates Bilastin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilastin 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 Bilastin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bilastin supplier is an individual or a company that provides Bilastin active pharmaceutical ingredient (API) or Bilastin finished formulations upon request. The Bilastin suppliers may include Bilastin API manufacturers, exporters, distributors and traders.
click here to find a list of Bilastin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bilastin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bilastin active pharmaceutical ingredient (API) in detail. Different forms of Bilastin DMFs exist exist since differing nations have different regulations, such as Bilastin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bilastin DMF submitted to regulatory agencies in the US is known as a USDMF. Bilastin USDMF includes data on Bilastin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bilastin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bilastin 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 Bilastin Drug Master File in Japan (Bilastin JDMF) empowers Bilastin 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 Bilastin JDMF during the approval evaluation for pharmaceutical products. At the time of Bilastin 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 Bilastin suppliers with JDMF on PharmaCompass.
A Bilastin written confirmation (Bilastin WC) is an official document issued by a regulatory agency to a Bilastin manufacturer, verifying that the manufacturing facility of a Bilastin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bilastin APIs or Bilastin finished pharmaceutical products to another nation, regulatory agencies frequently require a Bilastin WC (written confirmation) as part of the regulatory process.
click here to find a list of Bilastin 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 Bilastin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bilastin 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 Bilastin 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 Bilastin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bilastin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bilastin suppliers with NDC on PharmaCompass.
Bilastin 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 Bilastin 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 Bilastin GMP manufacturer or Bilastin GMP API supplier for your needs.
A Bilastin CoA (Certificate of Analysis) is a formal document that attests to Bilastin's compliance with Bilastin specifications and serves as a tool for batch-level quality control.
Bilastin CoA mostly includes findings from lab analyses of a specific batch. For each Bilastin 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.
Bilastin may be tested according to a variety of international standards, such as European Pharmacopoeia (Bilastin EP), Bilastin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bilastin USP).
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