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Chemistry

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Also known as: Vyndaqel, 951395-08-7, Fx-1006a, Fx1006a, Fx 1006a, Zu7cf08a1a
Molecular Formula
C21H24Cl2N2O8
Molecular Weight
503.3  g/mol
InChI Key
DQJDBUPLRMRBAB-WZTVWXICSA-N
FDA UNII
ZU7CF08A1A

Tafamidis Meglumine
Tafamidis Meglumine is a soft gelatin capsule formulation containing the meglumine salt form of tafamidis, a small molecule and pharmacological chaperone with potential disease-modifying activity. Tafamidis binds to and stabilizes wild-type and variant (V122I) transthyretin (TTR), thereby preventing tetramer dissociation into monomers; this prevents misfolding of the TTR protein and inhibits the formation of TTR amyloid fibrils and the subsequent deposition of these insoluble protein clusters in peripheral nerve tissues and organs. TTR is a 127 amino acid transport protein for thyroxine and retinol and is secreted by the liver.
1 2D Structure

Tafamidis Meglumine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
2.1.2 InChI
InChI=1S/C14H7Cl2NO3.C7H17NO5/c15-9-3-8(4-10(16)6-9)13-17-11-2-1-7(14(18)19)5-12(11)20-13;1-8-2-4(10)6(12)7(13)5(11)3-9/h1-6H,(H,18,19);4-13H,2-3H2,1H3/t;4-,5+,6+,7+/m.0/s1
2.1.3 InChI Key
DQJDBUPLRMRBAB-WZTVWXICSA-N
2.1.4 Canonical SMILES
CNCC(C(C(C(CO)O)O)O)O.C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl
2.1.5 Isomeric SMILES
CNC[C@@H]([C@H]([C@@H]([C@@H](CO)O)O)O)O.C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
ZU7CF08A1A
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fx 1006a

2. Fx-1006a

3. Fx1006a

4. Tafamidis

5. Vyndamax

6. Vyndaqel

2.3.2 Depositor-Supplied Synonyms

1. Vyndaqel

2. 951395-08-7

3. Fx-1006a

4. Fx1006a

5. Fx 1006a

6. Zu7cf08a1a

7. Chebi:79345

8. 951395-08-7 (meglumine)

9. (2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol 2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylate

10. (2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol 2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylic Acid

11. Unii-zu7cf08a1a

12. Tafamidis Meglumine [usan]

13. Tafamidis Meglumine [usan:inn]

14. Vyndaqel (tn)

15. Chembl2105675

16. Schembl14783506

17. Tafamidis Meglumine [mi]

18. Tafamidis Meglumine (jan/usan)

19. Dtxsid50915094

20. Tafamidis Meglumine [jan]

21. Ex-a3550

22. Hy-14852a

23. Mfcd28502032

24. Tafamidis Meglumine [who-dd]

25. Akos037649321

26. At18247

27. D-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate

28. Tafamidis Meglumine [orange Book]

29. Bs-18043

30. Cs-0045567

31. Pf-06291826

32. D09674

33. Q27148396

34. 1-deoxy-1-(methylazaniumyl)-d-glucitol 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylate

35. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid--1-deoxy-1-(methylamino)-d-glucitol (1/1)

36. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid--1-deoxy-1-(methylamino)hexitol (1/1)

37. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid;(2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentol

38. D-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)

39. D-gluco-2,3,4,5,6-pentahydroxy-n-methylhexan-1-aminium 2-(3,5-dichlorophenyl)benzoxazole-6-carboxylate

2.4 Create Date
2008-10-20
3 Chemical and Physical Properties
Molecular Weight 503.3 g/mol
Molecular Formula C21H24Cl2N2O8
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count10
Rotatable Bond Count8
Exact Mass502.0909711 g/mol
Monoisotopic Mass502.0909711 g/mol
Topological Polar Surface Area177 Ų
Heavy Atom Count33
Formal Charge0
Complexity506
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Investigated for use/treatment in amyloidosis.


Neuropathic heredofamilial amyloidosis


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

Fx-1006A is a first-in-class, disease-modifying compound that is designed to inhibit the formation of amyloid deposits by preventing the misfolding and deposition of the transthyretin protein (TTR), which is associated with amyloidosis.


API Reference Price

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25-May-2021
08-Jul-2024
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Tafamidis Meglumine manufacturers, exporters & distributors 1

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API | Excipient name

Tafamidis Meglumine

Synonyms

Vyndaqel, 951395-08-7, Fx-1006a, Fx1006a, Fx 1006a, Zu7cf08a1a

Cas Number

951395-08-7

Unique Ingredient Identifier (UNII)

ZU7CF08A1A

About Tafamidis Meglumine

Tafamidis Meglumine is a soft gelatin capsule formulation containing the meglumine salt form of tafamidis, a small molecule and pharmacological chaperone with potential disease-modifying activity. Tafamidis binds to and stabilizes wild-type and variant (V122I) transthyretin (TTR), thereby preventing tetramer dissociation into monomers; this prevents misfolding of the TTR protein and inhibits the formation of TTR amyloid fibrils and the subsequent deposition of these insoluble protein clusters in peripheral nerve tissues and organs. TTR is a 127 amino acid transport protein for thyroxine and retinol and is secreted by the liver.

Tafamidis Meglumine Manufacturers

A Tafamidis Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tafamidis Meglumine, including repackagers and relabelers. The FDA regulates Tafamidis Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tafamidis Meglumine 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 Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tafamidis Meglumine Suppliers

A Tafamidis Meglumine supplier is an individual or a company that provides Tafamidis Meglumine active pharmaceutical ingredient (API) or Tafamidis Meglumine finished formulations upon request. The Tafamidis Meglumine suppliers may include Tafamidis Meglumine API manufacturers, exporters, distributors and traders.

click here to find a list of Tafamidis Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tafamidis Meglumine USDMF

A Tafamidis Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tafamidis Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Tafamidis Meglumine DMFs exist exist since differing nations have different regulations, such as Tafamidis Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tafamidis Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Tafamidis Meglumine USDMF includes data on Tafamidis Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tafamidis Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Tafamidis Meglumine suppliers with USDMF on PharmaCompass.

Tafamidis Meglumine WC

A Tafamidis Meglumine written confirmation (Tafamidis Meglumine WC) is an official document issued by a regulatory agency to a Tafamidis Meglumine manufacturer, verifying that the manufacturing facility of a Tafamidis Meglumine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tafamidis Meglumine APIs or Tafamidis Meglumine finished pharmaceutical products to another nation, regulatory agencies frequently require a Tafamidis Meglumine WC (written confirmation) as part of the regulatory process.

click here to find a list of Tafamidis Meglumine suppliers with Written Confirmation (WC) on PharmaCompass.

Tafamidis Meglumine 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 Meglumine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tafamidis Meglumine 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 Meglumine 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 Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tafamidis Meglumine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tafamidis Meglumine suppliers with NDC on PharmaCompass.

Tafamidis Meglumine GMP

Tafamidis Meglumine 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 Meglumine 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 Meglumine GMP manufacturer or Tafamidis Meglumine GMP API supplier for your needs.

Tafamidis Meglumine CoA

A Tafamidis Meglumine CoA (Certificate of Analysis) is a formal document that attests to Tafamidis Meglumine's compliance with Tafamidis Meglumine specifications and serves as a tool for batch-level quality control.

Tafamidis Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Tafamidis Meglumine 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 Meglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tafamidis Meglumine EP), Tafamidis Meglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tafamidis Meglumine 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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