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South Africa
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1. Fx 1006a
2. Fx-1006a
3. Fx1006a
4. Tafamidis Meglumine
5. Vyndamax
6. Vyndaqel
1. 594839-88-0
2. Vyndamax
3. Fx-1006
4. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid
5. 2-(3,5-dichlorophenyl)-6-benzoxazole Carboxylic Acid
6. 8fg9h9d31j
7. Chebi:78538
8. 2-(3,5-dichlorophenyl)benzoxazole-6-carboxylic Acid
9. 2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylic Acid
10. 594839-88-0 (free Acid)
11. Fx1006
12. Mfcd16621109
13. Fx-1005
14. 6-benzoxazolecarboxylic Acid, 2-(3,5-dichlorophenyl)-
15. Tafamidis [usan]
16. Tafamidis [usan:inn]
17. Tafamidisum
18. Unii-8fg9h9d31j
19. 4his
20. Tafamidis-meglumine
21. Vyndamax (tn)
22. 3mi
23. Tafamidis [inn]
24. Tafamidis [jan]
25. Tafamidis [mi]
26. Tafamidis [mart.]
27. Tafamidis [who-dd]
28. Tafamidis (jan/usan/inn)
29. Schembl442508
30. Gtpl8378
31. Tafamidis [orange Book]
32. Chembl2103837
33. Pf-06291826(tafamidis)
34. Dtxsid00208185
35. Hms3741e09
36. Bcp29089
37. Ex-a3575
38. Bdbm50197883
39. S6465
40. Zinc43206271
41. Akos017550076
42. Db11644
43. Vs-0125
44. Ncgc00390731-01
45. 137464-18-7
46. Hy-14852
47. Sy217402
48. Db-072645
49. Ft-0674793
50. A14111
51. C75776
52. D09673
53. 839d880
54. A869196
55. Q519447
56. 2-(3,5-dichloro-phenyl)-benzooxazole-6-carboxylic Acid
57. Z2588039578
58. Discontinued Until Pfizer Approves It For Our Agreement""
Molecular Weight | 308.1 g/mol |
---|---|
Molecular Formula | C14H7Cl2NO3 |
XLogP3 | 4.2 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 306.9802985 g/mol |
Monoisotopic Mass | 306.9802985 g/mol |
Topological Polar Surface Area | 63.3 Ų |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 371 |
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 |
Tafamidis is indicated to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults.
FDA Label
Tafamidis stabilizes transthyretin tetramers, reducing the amount of monomers available for amyloidogenesis. It has a long duration of action as it is given once daily, and a wide therapeutic window.
N07XX08
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
N - Nervous system
N07 - Other nervous system drugs
N07X - Other nervous system drugs
N07XX - Other nervous system drugs
N07XX08 - Tafamidis
Absorption
Tafamidis reaches a Cmax of 1430.93ng/mL with a Tmax of 1.75h fasted and 4h fed. The AUC of tafamidis is 47,864.31ng\*h/mL.
Route of Elimination
A 20mg oral dose of tafamidis is approximately 59% recovered in the feces, largely as unchanged drug. Approximately 22% of a 20mg oral dose is recovered in the urine, mostly as the glucuronide metabolite.
Volume of Distribution
The apparent volume of distribution at steady state is 18.5L.
Clearance
The oral clearance of tafamidis is 0.263L/h. The apparent total clearance is 0.44L/h.
Tafamidis is largely not subject to first pass or oxidative metabolism, being 90% unchanged after in in vitro experiments. Preclinical data suggest tafamidis is mainly metabolized through glucuronidation and excreted in bile.
The half life of tafamidis is 49h.
Genetic mutations or natural misfolding of transthyretin destabalizes transthyretin tetramers, leading to their dissociation and aggregation in tissues, and disrupting the normal function of these tissues. Tafamidis binds to transthyretin tetramers at the thyroxin binding sites, stabilizing the tetramer, reducing the availability of monomers for amyloidogenesis.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Tafamidis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tafamidis, including repackagers and relabelers. The FDA regulates Tafamidis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tafamidis 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 Tafamidis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tafamidis supplier is an individual or a company that provides Tafamidis active pharmaceutical ingredient (API) or Tafamidis finished formulations upon request. The Tafamidis suppliers may include Tafamidis API manufacturers, exporters, distributors and traders.
click here to find a list of Tafamidis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tafamidis DMF (Drug Master File) is a document detailing the whole manufacturing process of Tafamidis active pharmaceutical ingredient (API) in detail. Different forms of Tafamidis DMFs exist exist since differing nations have different regulations, such as Tafamidis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tafamidis DMF submitted to regulatory agencies in the US is known as a USDMF. Tafamidis USDMF includes data on Tafamidis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tafamidis USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tafamidis suppliers with USDMF on PharmaCompass.
A Tafamidis written confirmation (Tafamidis WC) is an official document issued by a regulatory agency to a Tafamidis manufacturer, verifying that the manufacturing facility of a Tafamidis active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tafamidis APIs or Tafamidis finished pharmaceutical products to another nation, regulatory agencies frequently require a Tafamidis WC (written confirmation) as part of the regulatory process.
click here to find a list of Tafamidis 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 Tafamidis as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tafamidis 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 Tafamidis 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 Tafamidis and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tafamidis NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tafamidis suppliers with NDC on PharmaCompass.
Tafamidis 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 Tafamidis 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 Tafamidis GMP manufacturer or Tafamidis GMP API supplier for your needs.
A Tafamidis CoA (Certificate of Analysis) is a formal document that attests to Tafamidis's compliance with Tafamidis specifications and serves as a tool for batch-level quality control.
Tafamidis CoA mostly includes findings from lab analyses of a specific batch. For each Tafamidis 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.
Tafamidis may be tested according to a variety of international standards, such as European Pharmacopoeia (Tafamidis EP), Tafamidis JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tafamidis USP).
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