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Inke Tafamidis

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Farmak Tafamidis

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xyz-pharma-m-2024-10-07

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Nuray Tafamidis

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-10-07

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 13 USDMF, 1 EU WC, 11 NDC API, 13 Listed Suppliers, $ API Reference Price

24 API Suppliers
13 USDMF
1 EU WC
11 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

6 FDF Dossiers, 1 FDA Orange Book, 1 Europe, 1 Canada, 1 Australia, 2 Listed Dossiers

6 FDF Dossiers
1 FDA Orange Book
1 Europe
1 Canada
1 Australia
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 6 DKSH, 1 Jai Radhe Sales, 1 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Actylis, 2 BASF, 1 Clariant, 5 Gangwal Chemicals, 1 Kerry, 3 Lonza Capsugel, 1 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pluviaendo, 1 Qualicaps, 11 Roquette, 8 Seppic, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

14 Solubilizers, 13 Film Formers & Plasticizers, 12 Parenteral, 9 Topical, 9 Fillers, Diluents & Binders, 9 Coating Systems & Additives, 8 Thickeners and Stabilizers, 8 Empty Capsules, 7 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 Taste Masking, 2 Direct Compression, 2 Rheology Modifiers, 2 Coloring Agents, 2 Co-Processed Excipients, 2 Chewable & Orodispersible Aids, 1 Controlled & Modified Release, 1 API Stability Enhancers, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 44 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
44 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Finished Drug Prices, 5 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
1 Finished Drug Prices
5 Annual Reports

MARKET PLACE

2 APIs, 2 FDF Dossiers

marketPlace
2 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents, 2 US Exclusivities

patents
3 US Patents
2 US Exclusivities

Inke Tafamidis

Synopsis

ACTIVE PHARMA INGREDIENTS

24

API Suppliers

13

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

1

EU WC

0

KDMF

11

NDC API

0

VMF

13

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 18,932

MARKET PLACE

2

API

2

FDF

7INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

6

FDF Dossiers

1

FDA Orange Book

FDA (Orange Book)

1

Europe

1

Canada

1

Australia

0

South Africa

2

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

3

US Patents

2

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

3

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

44

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

845,100,487

Annual Reports (USD Million)

9,544

Finished Drug Prices

61 RELATED EXCIPIENT COMPANIES

112EXCIPIENTS BY APPLICATIONS

Chemistry

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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 Formula	C₁₄H₇Cl₂NO₃
Molecular Weight	308.1 g/mol
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 Å²
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

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 C_max of 1430.93ng/mL with a T_max 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 SUPPLIERS

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USDMF

01

Ss Pharma Llc

India

CPhI India 2024

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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India

Digital Content

Tafamidis (cc)

GDUFA

DMF Review : Complete

Rev. Date : 2023-03-28

Pay. Date : 2023-02-08

DMF Number : 36953

Submission : 2023-02-08

Status : Active

Type : II

Nuray Chemicals

Product Web Link

Digital Content

02

Ss Pharma Llc

India

CPhI India 2024

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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India

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-01

Pay. Date : 2020-09-15

DMF Number : 35067

Submission : 2020-09-18

Status : Active

Type : II

Nuray Chemicals

Product Web Link

Digital Content

03

Biophore India Pharmaceuticals Pvt L...

India

CPhI India 2024

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2023-03-31

Pay. Date : 2023-03-21

DMF Number : 37694

Submission : 2022-11-30

Status : Active

Type : II

Product Web Link

Digital Content

04

Neuland Laboratories Ltd

India

TIDES Europe 2024

Neuland Laboratories- A dedicated 100% API provider.

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India

Digital Content

Tafamidis (form-4)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38240

Submission : 2023-03-31

Status : Active

Type : II

Product Web Link

Digital Content

05

Apitoria Pharma Private Ltd

India

World Vaccine Congress

Not Confirmed

06

Aurore Life Sciences Private Ltd

India

World Vaccine Congress

Not Confirmed

07

Cipla Ltd

India

World Vaccine Congress

Not Confirmed

08

Cipla Ltd

India

World Vaccine Congress

Not Confirmed

09

Glenmark Life Sciences Ltd

India

World Vaccine Congress

Not Confirmed

10

Msn Laboratories Private Ltd

India

World Vaccine Congress

Not Confirmed

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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