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1. 4-t-butyl-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide
2. Bosentan Anhydrous
3. Bosentan Monohydrate
4. Ro 47 0203
5. Ro 47-0203
6. Ro 470203
7. Ro-47-0203
8. Tracleer
1. 147536-97-8
2. Tracleer
3. Actelion
4. Bosentan Anhydrous
5. Ro 47-0203
6. Ro-47-0203
7. Anhydrous Bosentan
8. Bosentan [usan:inn:ban]
9. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-ylpyrimidin-4-yl]benzenesulfonamide
10. P-tert-butyl-n-(6-(2-hydroxyethoxy)-5-(o-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl)benzenesulfonamide
11. Bosentan (inn)
12. 4-(tert-butyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidin]-4-yl)benzenesulfonamide
13. Chembl957
14. Xul93r30k2
15. N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]-4-tert-butyl-benzenesulfonamide
16. Chebi:51450
17. 147536-97-8 (free)
18. 174227-18-0
19. Benzenesulfonamide, 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)(2,2'-bipyrimidin)-4-yl)-
20. Ncgc00167440-01
21. Bosentan [inn]
22. Dsstox_cid_26627
23. Dsstox_rid_81776
24. Dsstox_gsid_46627
25. 1174918-31-0
26. 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl) Benzenesulfornamide
27. 4-tert-butyl-n-[6-(2-hydroxyethyloxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]benzenesulfonamide
28. Benzenesulfonamide, 4-(1,1-dimethylethyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]-
29. Bosentanum
30. Ro-47-0203/029
31. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl]benzenesulfonamide
32. Cas-147536-97-8
33. Ro 47-0203/039
34. Sr-05000001532
35. Ro-470203029
36. Ro-47-0203-029
37. Unii-xul93r30k2
38. 4-tert-butyl-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide
39. 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl)benzenesulfornamide
40. Ks-5062
41. Starbld0043886
42. Bosentan [mi]
43. Ro-47-0203/039
44. Bosentan [who-dd]
45. Schembl4218
46. Gtpl3494
47. Dtxsid7046627
48. Hms2090n14
49. Hms3652f15
50. Hms3715n05
51. Hms3750a13
52. Bcp05202
53. Hy-a0013
54. Zinc1538857
55. Tox21_112444
56. Ac-148
57. Bdbm50061101
58. Pdsp1_001731
59. Pdsp2_001714
60. S4220
61. Akos015852063
62. Tox21_112444_1
63. Am84442
64. Bcp9000445
65. Ccg-221182
66. Cs-0381
67. Db00559
68. Sb17356
69. Ncgc00167440-02
70. Bb164259
71. B5118
72. Ft-0658809
73. Sw199648-3
74. D07538
75. W18800
76. Ab01275536-01
77. 212b550
78. A808658
79. L001086
80. Q419769
81. J-008366
82. Sr-05000001532-1
83. Sr-05000001532-2
84. Sr-05000001532-4
85. Z1541632805
86. 4-(1,1-dimethylethyl)-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2''-bipyrimidin)-4-yl) Benzenesulfornamide
87. 4-(1,1-dimethylethyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide
88. 4-(tert-butyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide
89. 4-tert Butyl-n-[4-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)pyrimidin-6-yl]benzenesulphonamide
90. 4-tert-butyl-n-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide
91. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidine]-4-yl]benzene-1-sulfonamide
92. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2''-bipyrimidin-4-yl]benzenesulfonamide
93. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide
94. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzene-1-sulfonamide
95. 4-tert-butyl-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide
96. K86
| Molecular Weight | 551.6 g/mol |
|---|---|
| Molecular Formula | C27H29N5O6S |
| XLogP3 | 3.8 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 11 |
| Exact Mass | 551.18385484 g/mol |
| Monoisotopic Mass | 551.18385484 g/mol |
| Topological Polar Surface Area | 154 Ų |
| Heavy Atom Count | 39 |
| Formal Charge | 0 |
| Complexity | 839 |
| 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 |
| 1 of 2 | |
|---|---|
| Drug Name | Tracleer |
| PubMed Health | Bosentan (By mouth) |
| Drug Classes | Antihypertensive |
| Drug Label | Tracleer is the proprietary name for bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-me... |
| Active Ingredient | Bosentan |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 125mg; 62.5mg |
| Market Status | Prescription |
| Company | Actelion Pharms |
| 2 of 2 | |
|---|---|
| Drug Name | Tracleer |
| PubMed Health | Bosentan (By mouth) |
| Drug Classes | Antihypertensive |
| Drug Label | Tracleer is the proprietary name for bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-me... |
| Active Ingredient | Bosentan |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 125mg; 62.5mg |
| Market Status | Prescription |
| Company | Actelion Pharms |
Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).
FDA Label
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:
- Primary (idiopathic and familial) PAH;
- PAH secondary to scleroderma without significant interstitial pulmonary disease;
- PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology.
Some improvements have also been shown in patients with PAH WHO functional class II.
Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Bosentan belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Patients with PAH have elevated levels of endothelin, a potent blood vessel constrictor, in their plasma and lung tissue. Bosentan blocks the binding of endothelin to its receptors, thereby negating endothelin's deleterious effects.
Antihypertensive Agents
Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)
Endothelin Receptor Antagonists
Compounds and drugs that bind to and inhibit or block the activation of ENDOTHELIN RECECPTORS. (See all compounds classified as Endothelin Receptor Antagonists.)
C02KX01
C02KX01
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
C - Cardiovascular system
C02 - Antihypertensives
C02K - Other antihypertensives
C02KX - Antihypertensives for pulmonary arterial hypertension
C02KX01 - Bosentan
Absorption
Absolute bioavailability is approximately 50% and food does not affect absorption.
Route of Elimination
Bosentan is eliminated by biliary excretion following metabolism in the liver.
Volume of Distribution
18 L
Clearance
4 L/h [patients with pulmonary arterial hypertension]
Bosentan is metabolized in the liver by the cytochrome P450 enzymes CYP2C9 and CYP3A4 (and possibly CYP2C19), producing three metabolites, one of which, Ro 48-5033, is pharmacologically active and may contribute 10 to 20% to the total activity of the parent compound.
Bosentan has known human metabolites that include 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-hydroxyphenoxy)-[2,2-]bipyrimidinyl-4-yl]-benzenesulfonamide and Hydroxy Bosentan.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
Terminal elimination half-life is about 5 hours in healthy adult subjects.
Endothelin-1 (ET-1) is a neurohormone, the effects of which are mediated by binding to ETA and ETB receptors in the endothelium and vascular smooth muscle. It displays a slightly higher affinity towards ETA receptors than ETB receptors. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension, suggesting a pathogenic role for ET-1 in this disease. Bosentan is a specific and competitive antagonist at endothelin receptor types ETA and ETB.
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DOSAGE - TABLET;ORAL - 125MG
USFDA APPLICATION NUMBER - 21290
DOSAGE - TABLET;ORAL - 62.5MG
USFDA APPLICATION NUMBER - 21290
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ABOUT THIS PAGE
A Bosentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosentan, including repackagers and relabelers. The FDA regulates Bosentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosentan 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 Bosentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosentan supplier is an individual or a company that provides Bosentan active pharmaceutical ingredient (API) or Bosentan finished formulations upon request. The Bosentan suppliers may include Bosentan API manufacturers, exporters, distributors and traders.
click here to find a list of Bosentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bosentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Bosentan active pharmaceutical ingredient (API) in detail. Different forms of Bosentan DMFs exist exist since differing nations have different regulations, such as Bosentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bosentan DMF submitted to regulatory agencies in the US is known as a USDMF. Bosentan USDMF includes data on Bosentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bosentan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bosentan 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 Bosentan Drug Master File in Japan (Bosentan JDMF) empowers Bosentan 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 Bosentan JDMF during the approval evaluation for pharmaceutical products. At the time of Bosentan 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 Bosentan suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bosentan Drug Master File in Korea (Bosentan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bosentan. The MFDS reviews the Bosentan KDMF as part of the drug registration process and uses the information provided in the Bosentan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bosentan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bosentan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bosentan suppliers with KDMF on PharmaCompass.
A Bosentan written confirmation (Bosentan WC) is an official document issued by a regulatory agency to a Bosentan manufacturer, verifying that the manufacturing facility of a Bosentan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bosentan APIs or Bosentan finished pharmaceutical products to another nation, regulatory agencies frequently require a Bosentan WC (written confirmation) as part of the regulatory process.
click here to find a list of Bosentan 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 Bosentan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bosentan 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 Bosentan 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 Bosentan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bosentan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bosentan suppliers with NDC on PharmaCompass.
Bosentan 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 Bosentan 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 Bosentan GMP manufacturer or Bosentan GMP API supplier for your needs.
A Bosentan CoA (Certificate of Analysis) is a formal document that attests to Bosentan's compliance with Bosentan specifications and serves as a tool for batch-level quality control.
Bosentan CoA mostly includes findings from lab analyses of a specific batch. For each Bosentan 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.
Bosentan may be tested according to a variety of international standards, such as European Pharmacopoeia (Bosentan EP), Bosentan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bosentan USP).
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