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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 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.


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Inke S.A

Spain
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Tafamidis

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
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Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Tafamidis

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
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FARMAK, a.s

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Virtual BoothFarmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Tafamidis

About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...

Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingredients (APIs), intermediates and specialized chemicals. The company primarily focuses on exporting its products, with the main markets being the EU, USA, India, Japan and Latin America. Additionally, Farmak offers contract manufacturing and custom synthesis services through its R&D department to support the clients.
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Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Tafamidis

About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...

Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata-Pharmasynthèse offers a wide range of services, including sourcing, manufacturing, and the development of raw materials for the pharmaceutical and cosmetic industries. It supplies these ingredients to Europe, Japan, and other countries. With expertise in fine chemical production, Inabata-Pharmasynthèse conducts manufacturing operations, ranging from pilot to commercial quantities, at its GMP-certified facility at St. Pierre-Les-Elbeuf in France.
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Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

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Tafamidis

About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...

Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the Hyderabad-based company has grown from a single manufacturing unit to four, employing over 1,000 people. The manufacturing units are situated in Kazipally, Pashamylaram, Humnabad and Gandhi Nagar. Virupaksha's manufacturing facility holds FDA approval, reflecting its adherence to stringent standards. With a customer base exceeding 300 and a presence spanning over 70 countries, Virupaksha has established itself as a reputable global player in its field.
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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Tafamidis

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Tafamidis

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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08

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About the Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 years of development, ...

Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 years of development, Nanfang Pharmaceutical has grown into a major domestic manufacturer of anti-tumor raw materials and intermediates, and has expanded to non-anti-tumor drugs. Using the company's accumulated rich experience and first-class technology in plant extraction, the company's product line has been expanded to the field of plant-derived products.
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Tafamidis

About the Company : Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated mar...

Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated markets of USA, Europe, Russia, Canada and also for non-regulated markets. The first Morepen manufacturing plant was set up on the foothills of the Himalayas in the idyllic surroundings of Parwanoo. The large and spread-out facility is USDFA approved for manufacture of Loratadine, an anti-allergy drug- internationally known as Claritin.
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Natco Pharma

India
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Natco Pharma

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About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...

NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, NATCO today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc.NATCO family currently consists of more than 2500 employees, we are consistently ranked among fastest growing pharmaceutical companies in India. NATCO is well recognized for its innovation in Pharmaceutical R&D.
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MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"WORLD MEDICINE","customerCountry":"TURKEY","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"15","totalValueFC":"4328.8","currency":"USD","unitRateINR":1204.5533333333333,"date":"07-Jun-2024","totalValueINR":"361366","totalValueInUsd":"4328.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"1508164","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720377000,"product":"TAFAMIDIS MEGLUMINE","address":"PLOT NO. 193, HOUSE NO. 5-35\/50,","city":"HYDERABAD, AP","supplier":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"RENATA LIMITED","customerCountry":"BANGLADESH","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"20000","totalValueFC":"39510.2","currency":"USD","unitRateINR":1651350,"date":"08-Jul-2024","totalValueINR":"3302700","totalValueInUsd":"39510.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2248361","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. 193, HOUSE NO. 5-35\/50,, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"TAFAMIDIS","address":"JUBILEE HEIGHTS PLOT NO 68 & 69,2N","city":"HYDERABAD,TELANGANA","supplier":"AURORE LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"ACTAVIS INC","customerCountry":"TAIWAN","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"7000","totalValueFC":"13760.8","currency":"USD","unitRateINR":580625,"date":"19-Nov-2024","totalValueINR":"1161250","totalValueInUsd":"13760.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5714974","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"JUBILEE HEIGHTS PLOT NO 68 & 69,2N, HYDERABAD,TELANGANA","customerAddress":""},{"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":"2023","qtr":"Q4","strtotime":1700073000,"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":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"39000","totalValueFC":"38321.1","currency":"EUR","unitRateINR":"3545590.8","date":"16-Nov-2023","totalValueINR":"3191031.74","totalValueInUsd":"38321.1","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"8793046","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"CARRER SANT GABRIEL 50 08950, ESPLUGUES DE LLOBREHAT-SPAIN CIF ES B63078075 ES","customerAddress":"206, DEVAVRATA,"},{"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,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"TAFAMIDIS","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"4708.7","totalValueFC":"9480","currency":"USD","unitRateINR":"400000","date":"07-Nov-2024","totalValueINR":"800000","totalValueInUsd":"9480","indian_port":"Vizag-HIPL SEZ","hs_no":"29189990","bill_no":"6536691","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD N.NARASAPURAM VILLAGE,NAKKAPALLY MA SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"}]
22-Feb-2021
19-Nov-2024
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Drugs in Development

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Details:

NICE is willing to conduct a rapid review of Vyndaqel (tafamidis) used for treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM).


Lead Product(s): Tafamidis

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vyndaqel

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2021

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Pfizer Inc

U.S.A
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Biotech Digital Meet
Not Confirmed

Pfizer Inc

U.S.A
arrow
Biotech Digital Meet
Not Confirmed

Details : NICE is willing to conduct a rapid review of Vyndaqel (tafamidis) used for treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

Product Name : Vyndaqel

Product Type : Small molecule

Upfront Cash : Not Applicable

May 12, 2021

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Details:

VYNDAQEL® (tafamidis meglumine) 80 mg/VYNDAMAX® (tafamidis) 61 mg were associated with a statistically significant improvement in long-term survival in patients with transthyretin amyloid cardiomyopathy.


Lead Product(s): Tafamidis

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vyndamax

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 12, 2020

blank

02

Pfizer Inc

U.S.A
arrow
Biotech Digital Meet
Not Confirmed

Pfizer Inc

U.S.A
arrow
Biotech Digital Meet
Not Confirmed

Details : VYNDAQEL® (tafamidis meglumine) 80 mg/VYNDAMAX® (tafamidis) 61 mg were associated with a statistically significant improvement in long-term survival in patients with transthyretin amyloid cardiomyopathy.

Product Name : Vyndamax

Product Type : Small molecule

Upfront Cash : Not Applicable

November 12, 2020

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ABOUT THIS PAGE

Looking for 594839-88-0 / Tafamidis API manufacturers, exporters & distributors?

Tafamidis manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Tafamidis API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tafamidis manufacturer or Tafamidis supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tafamidis manufacturer or Tafamidis supplier.

PharmaCompass also assists you with knowing the Tafamidis API Price utilized in the formulation of products. Tafamidis API Price is not always fixed or binding as the Tafamidis Price is obtained through a variety of data sources. The Tafamidis Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Tafamidis

Synonyms

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

Cas Number

594839-88-0

Unique Ingredient Identifier (UNII)

8FG9H9D31J

About 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.

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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