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ACTIVE PHARMA INGREDIENTS

5 API Suppliers, 1 USDMF, 5 Listed Suppliers

5 API Suppliers
1 USDMF
5 Listed Suppliers

DEVELOPMENTS

48 Drugs in Development

48 Drugs in Development

FINISHED DOSAGE FORMULATIONS

4 FDF Dossiers, 3 Europe, 1 Canada

4 FDF Dossiers
3 Europe
1 Canada

DIGITAL CONTENT

1 STOCK RECAP #PipelineProspector, 28 NEWS #PharmaBuzz

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1 STOCK RECAP #PipelineProspector
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 Finished Drug Prices

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3 Finished Drug Prices

MARKET PLACE

3 APIs

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3 APIs

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

48DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

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Chemistry

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Also known as: 14605-22-2, Tudca, Ursodeoxycholyltaurine, Tauroursodeoxycholate, Taurursodiol, Taurolite

Molecular Formula

C₂₆H₄₅NO₆S

Molecular Weight

499.7 g/mol

InChI Key

BHTRKEVKTKCXOH-LBSADWJPSA-N

FDA UNII

60EUX8MN5X

tauroursodeoxycholic acid is a natural product found in Homo sapiens with data available.

1 2D Structure

Tauroursodeoxycholic Acid

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[[(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoyl]amino]ethanesulfonic acid

2.1.2 InChI

InChI=1S/C26H45NO6S/c1-16(4-7-23(30)27-12-13-34(31,32)33)19-5-6-20-24-21(9-11-26(19,20)3)25(2)10-8-18(28)14-17(25)15-22(24)29/h16-22,24,28-29H,4-15H2,1-3H3,(H,27,30)(H,31,32,33)/t16-,17+,18-,19-,20+,21+,22+,24+,25+,26-/m1/s1

2.1.3 InChI Key

BHTRKEVKTKCXOH-LBSADWJPSA-N

2.1.4 Canonical SMILES

CC(CCC(=O)NCCS(=O)(=O)O)C1CCC2C1(CCC3C2C(CC4C3(CCC(C4)O)C)O)C

2.1.5 Isomeric SMILES

C[C@H](CCC(=O)NCCS(=O)(=O)O)[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2[C@H](C[C@H]4[C@@]3(CC[C@H](C4)O)C)O)C

2.2 Other Identifiers

2.2.1 UNII

60EUX8MN5X

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Chenyl Taurine Sodium

2. Tauroursodeoxycholate

3. Tauroursodeoxycholate Sodium Salt

4. Tauroursodeoxycholic Acid, (3alpha,5alpha,7alpha)-isomer

5. Tauroursodeoxycholic Acid, Monosodium Salt, (3alpha,5beta,7alpha)-isomer

6. Taurursodiol

7. Tudca

8. Ursodoxicoltaurine

2.3.2 Depositor-Supplied Synonyms

1. 14605-22-2

2. Tudca

3. Ursodeoxycholyltaurine

4. Tauroursodeoxycholate

5. Taurursodiol

6. Taurolite

7. Ursodoxicoltaurine

8. Ur 906

9. Sodium Tauroursodeoxycholate

10. Tauroursodesoxycholic Acid

11. Ursodeoxy Cholic Acid

12. Taurursodiol [usan]

13. 60eux8mn5x

14. Chembl272427

15. Chebi:80774

16. Ur-906

17. Taurursodiol (usan)

18. Ursodoxicoltaurine (inn)

19. Ursodoxicoltaurine [inn]

20. N-(3alpha,7beta-dihydroxy-5beta-cholan-24-oyl)-taurine

21. Tauroursodeoxycholate Sodium

22. 2-[(4r)-4-[(1s,2s,5r,7s,9s,10r,11s,14r,15r)-5,9-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanamido]ethane-1-sulfonic Acid

23. 2-{[(3alpha,5beta,7alpha,8alpha,14beta,17alpha)-3,7-dihydroxy-24-oxocholan-24-yl]amino}ethanesulfonic Acid

24. Unii-60eux8mn5x

25. N-(3alpha,7beta-dihydroxy-5beta-cholan-24-oyl)taurine

26. Mfcd00065451

27. Tuda

28. N-ursodeoxycholoyltaurine

29. Tauroursodeoxycholic Acid, Sodium Salt

30. Schembl40764

31. Gtpl4746

32. Tauroursodeoxycholic Acid;tudca

33. Dtxsid80932754

34. Ex-a730

35. 2-(((3-alpha,5-beta,7-beta)-3,7-dihydroxy-24-oxocholan-24-yl) Amino)ethanesulfonic Acid

36. Hms3885c19

37. Ursodoxicoltaurine [who-dd]

38. Taurine, N-(3-alpha,7-beta-dihydroxy-5-beta-cholan-24-oyl)-,

39. Zinc3914813

40. 3alpha,7beta-dihydroxy-5beta-cholan-24-oic Acid N-(2-sulfoethyl)amide

41. Bdbm50236230

42. Lmst05040015

43. S3654

44. Sodium Tauroursodeoxycholate, >=95%

45. Who 11388

46. Ccg-269687

47. Db08834

48. 2-(((3-alpha,5-beta,7-beta)-3,7-dihydroxy-24-oxocholan-24-yl)amino)ethanesulfonic Acid

49. Ac-34539

50. Hy-19696

51. Cs-0016289

52. T1567

53. 3alpha,7beta-dihydroxy-5beta-cholanoyltaurine

54. D11836

55. 605t222

56. A808445

57. Q7688907

58. 3,7-dihydroxy-n-(2-sulfoethyl)cholan-24-imidic Acid

59. 3.alpha.,7.beta.-dihydroxy-5.beta.-cholanoyltaurine

60. 2-[(3alpha,7beta-dihydroxy-24-oxo-5beta-cholan-24-yl)amino]ethanesulfonic Acid

61. 2-{[(3alpha,5beta,7beta)-3,7-dihydroxy-24-oxocholan-24-yl]amino}ethane-1-sulfonic Acid

62. Ethanesulfonic Acid,2-[[(3a,5b,7b)-3,7-dihydroxy-24-oxocholan-24-yl]amino]-

63. 2-((r)-4-((3r,5s,7s,8r,9s,10s,13r,14s,17r)-3,7-dihydroxy-10,13-dimethyl-hexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)pentanamido)ethanesulfonic Acid

64. 2-[[(4r)-4-[(3r,5s,7s,8r,9s,10s,13r,14s,17r)-10,13-dimethyl-3,7-bis(oxidanyl)-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]pentanoyl]amino]ethanesulfonic Acid

65. 2-[[(4r)-4-[(3r,5s,7s,8r,9s,10s,13r,14s,17r)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]-1-oxopentyl]amino]ethanesulfonic Acid

66. Ethanesulfonic Acid, 2-(((3-alpha,5-beta,7-beta)-3,7-dihydroxy-24-oxocholan-24-yl)amino)-

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₄₅NO₆S
Molecular Weight	499.7 g/mol
XLogP3	3.6
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	7
Exact Mass	499.29675933 g/mol
Monoisotopic Mass	499.29675933 g/mol
Topological Polar Surface Area	132 Å²
Heavy Atom Count	34
Formal Charge	0
Complexity	858
Isotope Atom Count	0
Defined Atom Stereocenter Count	10
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

Used in the treatment of cholesterol gallstones. Tauroursodeoxycholic acid is also being investigated for use in several conditions such as Primary Biliary Cirrhosis (PBC), insulin resistance, amyloidosis, Cystic Fibrosis, Cholestasis, and Amyotrophic Lateral Sclerosis.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antiviral Agents

Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

Cholagogues and Choleretics

Gastrointestinal agents that stimulate the flow of bile into the duodenum (cholagogues) or stimulate the production of bile by the liver (choleretic). (See all compounds classified as Cholagogues and Choleretics.)

5.2 Mechanism of Action

Tauroursodeoxycholic acid is the more hydrophilic form of ursodeoxycholic acid, which is naturally produced in the body. In patients with properly functioning gallbladders, both of these bile acids inhibit liver cholesterol secretion and synthesis as well as intestinal cholesterol absorption allowing for the promotion of cholesterol gallstone dissolution. The mechanism of action of tauroursodeoxycholic acid in the other conditions is still being investigated.

API SUPPLIERS

01

Axplora

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east

Not Confirmed

Axplora- The partner of choice for complex APIs.

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Germany

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east

Not Confirmed

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

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

ICE Pharma

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east

Not Confirmed

ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Italy

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USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

05

Dipharma

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east

Not Confirmed

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USDMF

01

Ice Spa

Italy

CPHI Middle east

Not Confirmed

ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Italy

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Tauroursodeoxycholic Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31049

Submission : 2016-09-30

Status : Active

Type : II

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Listed Suppliers

01

Axplora

Germany

CPHI Middle east

Not Confirmed

Axplora- The partner of choice for complex APIs.

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Germany

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Digital Content

Tauroursodeoxycholic Acid

About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

02

Metrochem API Private Limited

India

CPHI Middle east

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Contact Supplier

India

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Tauroursodeoxycholic Acid

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

03

Nuray Chemicals Private Limited

India

CPHI Middle east

Not Confirmed

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

Contact Supplier

India

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Digital Content

Tauroursodeoxycholic Acid

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.

04

ICE Pharma

Italy

CPHI Middle east

Not Confirmed

ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Italy

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Ursodoxicoltaurine

About the Company : ICE Pharma's core business includes the manufacture of active pharmaceutical ingredients, the most important of which is Ursodeoxycholic Acid (UDCA), used to treat liver diseases a...

ICE Pharma's core business includes the manufacture of active pharmaceutical ingredients, the most important of which is Ursodeoxycholic Acid (UDCA), used to treat liver diseases and gallstones. The company develops and manufactures a range of bile acid derivatives that are used as excipients, nutraceutical ingredients, cell culture media, and intermediates. ICE Pharma also provides contract manufacturing services for liquid and solid finished dosage forms for branded and generic products. Since October 2019, ICE Pharma has been owned by Advent International, one of the largest and most experienced global private equity investors.