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Tegoprazan

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 3 USDMF, 3 KDMF, 1 NDC API, 7 Listed Suppliers

9 API Suppliers
3 USDMF
3 KDMF
1 NDC API
7 Listed Suppliers

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

DIGITAL CONTENT

5 NEWS #PharmaBuzz

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5 NEWS #PharmaBuzz

Synopsis

ACTIVE PHARMA INGREDIENTS

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4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

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Chemistry

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Also known as: 942195-55-3, Tegoprazan [inn], W017g7if4s, Lxi-15028, (s)-4-((5,7-difluorochroman-4-yl)oxy)-n,n,2-trimethyl-1h-benzo[d]imidazole-6-carboxamide, 1h-benzimidazole-5-carboxamide, 7-(((4s)-5,7-difluoro-3,4-dihydro-2h-1-benzopyran-4-yl)oxy)-n,n,2-trimethyl-

Molecular Formula

C₂₀H₁₉F₂N₃O₃

Molecular Weight

387.4 g/mol

InChI Key

CLIQCDHNPDMGSL-HNNXBMFYSA-N

FDA UNII

W017G7IF4S

Tegoprazan (also known as CJ-12420) is a novel therapeutic developed by CJ Healthcare Corp for treating acid-related gastrointestinal diseases. This drug is a potent and high-selective potassium-competitive acid blocker (P-CAB) with a fast onset of action and the ability to control gastric pH for a prolonged period of time. Tegoprazans strong and sustained effect is due to its ability to be slowly cleared from the gastric glands and exertion of effects independent of acid levels. It has also been observed to be efficacious independent of food intake.

1 2D Structure

Tegoprazan

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

7-[[(4S)-5,7-difluoro-3,4-dihydro-2H-chromen-4-yl]oxy]-N,N,2-trimethyl-3H-benzimidazole-5-carboxamide

2.1.2 InChI

InChI=1S/C20H19F2N3O3/c1-10-23-14-6-11(20(26)25(2)3)7-17(19(14)24-10)28-15-4-5-27-16-9-12(21)8-13(22)18(15)16/h6-9,15H,4-5H2,1-3H3,(H,23,24)/t15-/m0/s1

2.1.3 InChI Key

CLIQCDHNPDMGSL-HNNXBMFYSA-N

2.1.4 Canonical SMILES

CC1=NC2=C(N1)C=C(C=C2OC3CCOC4=C3C(=CC(=C4)F)F)C(=O)N(C)C

2.1.5 Isomeric SMILES

CC1=NC2=C(N1)C=C(C=C2O[C@H]3CCOC4=C3C(=CC(=C4)F)F)C(=O)N(C)C

2.2 Other Identifiers

2.2.1 UNII

W017G7IF4S

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (s)-4-((5,7-difluorochroman-4-yl)oxy)-n,n,2-trimethyl-1h-benzo(d)imidazole-6-carboxamide

2. 1h-benzimidazole-5-carboxamide, 7-(((4s)-5,7-difluoro-3,4-dihydro-2h-1-benzopyran-4-yl)oxy)-n,n,2-trimethyl-

3. 7-(((4s)-5,7-difluoro-3,4-dihydro-2h-chromen-4-yl)oxy)-n,n,2-trimethyl-1h-benzimidazole-5-carboxamide

2.3.2 Depositor-Supplied Synonyms

1. 942195-55-3

2. Tegoprazan [inn]

3. W017g7if4s

4. Lxi-15028

5. (s)-4-((5,7-difluorochroman-4-yl)oxy)-n,n,2-trimethyl-1h-benzo[d]imidazole-6-carboxamide

6. 1h-benzimidazole-5-carboxamide, 7-(((4s)-5,7-difluoro-3,4-dihydro-2h-1-benzopyran-4-yl)oxy)-n,n,2-trimethyl-

7. Unii-w017g7if4s

8. Emixustat Hcl

9. (s)-4-((5,7-difluorochroman-4-yl)oxy)-n,n,2-trimethyl-1h-benzo(d)imidazole-6-carboxamide

10. 7-[[(4s)-5,7-difluoro-3,4-dihydro-2h-chromen-4-yl]oxy]-n,n,2-trimethyl-3h-benzimidazole-5-carboxamide

11. K-cab

12. Tegoprazan [who-dd]

13. Schembl2687723

14. Chembl4297583

15. Schembl19236298

16. Gtpl12008

17. (s)-7-((5,7-difluorochroman-4-yl)oxy)-n,n,2-trimethyl-1h-benzo(d)imidazole-5-carboxamide

18. Ex-a4304

19. Cj12420

20. Ac-36576

21. As-84160

22. Cj-12420

23. Hy-17623

24. Cs-0014702

25. E83739

26. Cj-12420; In-a001; Lxi-15028

27. Q27292116

28. (-)-4-[((4s)-5,7-difluoro-3,4-dihydro-2h-chromen-4-yl)oxy]-n,n,2-trimethyl-1h-benzimidazole-6-carboxamide

29. 7-(((4s)-5,7-difluoro-3,4-dihydro-2h-chromen-4-yl)oxy)-n,n,2-trimethyl-1h-benzimidazole-5-carboxamide

30. 7-[[(4s)-5,7-difluoro-3,4-dihydro-2h-1-benzopyran-4-yl]oxy]-n,n,2-trimethyl-1h-benzimidazole-5-carboxamide

31. 8bn

2.4 Create Date

2007-12-10

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₁₉F₂N₃O₃
Molecular Weight	387.4 g/mol
XLogP3	3.2
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	3
Exact Mass	387.13944780 g/mol
Monoisotopic Mass	387.13944780 g/mol
Topological Polar Surface Area	67.4 Å²
Heavy Atom Count	28
Formal Charge	0
Complexity	581
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Pharmacology and Biochemistry

4.1 ATC Code

A - Alimentary tract and metabolism

A02 - Drugs for acid related disorders

A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

A02BC - Proton pump inhibitors

A02BC09 - Tegoprazan

4.2 Mechanism of Action

Tegoprazan works as a potassium-competitive acid blocker that is potent and highly selective. Its mechanism of action is different from that of the proton-pump inhibitors as this drug does not require conversion into an active form and can directly inhibit H+/K+ATPase in a reversible and K+competitive way. This is because it is an acid-resistant weak base with the ability to remain in the highly acidic canaliculi of gastric parietal cells.

API SUPPLIERS

01

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.

Contact Supplier

India

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USDMF

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CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

02

Ami Lifesciences Private Limited

India

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

CPHI Middle east

Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

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India

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Digital Content

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

03

Aptra Synthesis

India

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

CPHI Middle east

Not Confirmed

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

Contact Supplier

India

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Digital Content

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

04

Lee Pharma

India

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

CPHI Middle east

Not Confirmed

05

Lee Pharma

India

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

CPHI Middle east

Not Confirmed

06

Beijing Sjar Technology Developmen...

China

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

CPHI Middle east

Not Confirmed

07

Saurav Chemicals

India

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

CPHI Middle east

Not Confirmed

08

Kukjeon Pharmaceutical

South Korea

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

CPHI Middle east

Not Confirmed

09

Maithri Drugs

India

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

CPHI Middle east

Not Confirmed

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USDMF

01

Metrochem Api Private Ltd

India

AES 2024

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

Tegoprazan

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38991

Submission : 2023-12-30

Status : Active

Type : II

02

Lee Pharma Ltd

India

AES 2024

Not Confirmed

03

Lee Pharma Ltd

India

AES 2024

Not Confirmed

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KDMF

01

Dasan Pharmaceutical

South Korea

AES 2024

Not Confirmed

02

HK inno.N

South Korea

AES 2024

Not Confirmed

03

HK inno.N

South Korea

AES 2024

Not Confirmed

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NDC API

01

Metrochem API Private Limited

India

AES 2024

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

TEGOPRAZAN

NDC Package Code : 42765-065

Start Marketing Date : 2023-08-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

01

Metrochem API Private Limited

India

Antibody Engineering

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

Tegoprazan

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

02

Ami Lifesciences Private Limited

India

Antibody Engineering

Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

Contact Supplier

India

Virtual Booth

Digital Content

Tegoprazan

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

03

Aptra Synthesis

India

Antibody Engineering

Not Confirmed

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

Contact Supplier

India

Virtual Booth

Digital Content

Tegoprazan

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.