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Also known as: 594839-88-0, Vyndamax, Fx-1006, 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid, 2-(3,5-dichlorophenyl)-6-benzoxazole carboxylic acid, 8fg9h9d31j
Molecular Formula
C14H7Cl2NO3
Molecular Weight
308.1  g/mol
InChI Key
TXEIIPDJKFWEEC-UHFFFAOYSA-N
FDA UNII
8FG9H9D31J

Tafamidis
Tafamidis and tafamidis meglumine (FX-1006A) are benzoxazole derivatives developed by FoldRX. Tafamidis is structurally similar to diflusinal. Tafamidis was granted an EMA market authorisation on 16 November 2011 and FDA approval on 3 May 2019.
1 2D Structure

Tafamidis

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid
2.1.2 InChI
InChI=1S/C14H7Cl2NO3/c15-9-3-8(4-10(16)6-9)13-17-11-2-1-7(14(18)19)5-12(11)20-13/h1-6H,(H,18,19)
2.1.3 InChI Key
TXEIIPDJKFWEEC-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
8FG9H9D31J
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fx 1006a

2. Fx-1006a

3. Fx1006a

4. Tafamidis Meglumine

5. Vyndamax

6. Vyndaqel

2.3.2 Depositor-Supplied Synonyms

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""

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 308.1 g/mol
Molecular Formula C14H7Cl2NO3
XLogP34.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass306.9802985 g/mol
Monoisotopic Mass306.9802985 g/mol
Topological Polar Surface Area63.3 Ų
Heavy Atom Count20
Formal Charge0
Complexity371
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Tafamidis is indicated to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 ATC Code

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


5.3 Absorption, Distribution and Excretion

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.


5.4 Metabolism/Metabolites

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.


5.5 Biological Half-Life

The half life of tafamidis is 49h.


5.6 Mechanism of Action

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 Reference Price

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CS1027)","address":"802, BLOCK-A, ALPINE HEIGHTS GULMOHAR AVENUE, SOMAJIGUDA","city":"HYDERABAD, A.P.","supplier":"ALFRED E TIEFENBACHER GMBH","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"41237.1","totalValueFC":"24844.1","currency":"EUR","unitRateINR":"3703093.4","date":"15-Jul-2021","totalValueINR":"1851546.69","totalValueInUsd":"24844.1","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"4688372","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS GULMOHAR AVENUE, SOMAJIGUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640802600,"product":"TAFAMIDIS MEGLUMINE","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"ALFRED E TIEFENBACHER GMBH","supplierCountry":"SPAIN","foreign_port":"N\/A","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"10530","totalValueFC":"6121.8","currency":"EUR","unitRateINR":"923481","date":"30-Dec-2021","totalValueINR":"461740.5","totalValueInUsd":"6121.8","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"6894002","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654885800,"product":"TAFAMIDIS MEGLUMINE MICRONIZED","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"NA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"10000","totalValueFC":"12959","currency":"EUR","unitRateINR":"842500","date":"11-Jun-2022","totalValueINR":"1011000","totalValueInUsd":"12959","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"9065267","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662748200,"product":"TAFAMIDIS MEGLUMINE ( FOC ITEM) PF-06291826-83","address":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU.","city":"CHENNAI,","supplier":"PFIZER INC","supplierCountry":"IRELAND","foreign_port":"NA","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"26.6","totalValueFC":"270.3","currency":"USD","unitRateINR":"2165.9","date":"10-Sep-2022","totalValueINR":"21659.16","totalValueInUsd":"270.3","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"2376503","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU."},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701455400,"product":"TAFAMIDIS MEGLUMINE(FOC)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"GALENICUM","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"0.97","actualQuantity":"0.966","unit":"KGS","unitRateFc":"39000","totalValueFC":"42013.4","currency":"EUR","unitRateINR":"3620426.3","date":"02-Dec-2023","totalValueINR":"3497331.78","totalValueInUsd":"42013.4","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"9053417","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"CARRER SANT GABRIEL 50 08950, ESPLUGUES DE LLOBREHAT-SPAIN CIF ES B630SDNF ES","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717093800,"product":"FREE SAMPLE - TAFAMIDIS - FOR R AND D PURPOSE","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"GALENICUM","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"39500","totalValueFC":"350672.3","currency":"EUR","unitRateINR":"3653750","date":"31-May-2024","totalValueINR":"29230000","totalValueInUsd":"350672.3","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"3768825","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"Carrer Sant Gabriel 50 08950, Esplugues de Llobrehat Barcelona, , SPAIN SPAIN","customerAddress":"206, DEVAVRATA,"}]
03-Mar-2021
19-Nov-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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ABOUT THIS PAGE

Tafamidis Manufacturers

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.

Tafamidis Suppliers

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.

Tafamidis USDMF

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.

Tafamidis WC

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.

Tafamidis NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tafamidis API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Tafamidis CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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