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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
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 Weight 387.4 g/mol
Molecular Formula C20H19F2N3O3
XLogP33.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass387.13944780 g/mol
Monoisotopic Mass387.13944780 g/mol
Topological Polar Surface Area67.4 Ų
Heavy Atom Count28
Formal Charge0
Complexity581
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
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.


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DMF Review : N/A

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DMF Number : 40643

Submission : 2024-10-07

Status : Active

Type : II

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Tegoprazan IH

Date of Issue : 2022-06-15

Valid Till : 2025-07-28

Written Confirmation Number : WC-0186

Address of the Firm : Sy No.10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 5023...

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Registrant Name : Iksoo Pharmaceutical Co., Ltd.

Registration Date : 2023-08-18

Registration Number : 69-17-ND

Manufacturer Name : Ami Lifesciences Pvt. Ltd.

Manufacturer Address : Block No. 82/B, ECP Road, At & Post: Karakhadi-391450, Taluka: Padra, District : Vado...

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Registrant Name : Kyungdong Pharmaceutical Co., Ltd.

Registration Date : 2024-01-19

Registration Number : No. 69-17-ND(1)

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Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

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Tegoprazanhemizin chloride

Registrant Name : Inistesti Co., Ltd.

Registration Date : 2025-01-21

Registration Number : 2220-20-ND

Manufacturer Name : Inistesti Co., Ltd.

Manufacturer Address : 54 Osongsaengmyeong 6-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do

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Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

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Registrant Name : Lee Sung International Co., Ltd.

Registration Date : 2025-06-23

Registration Number : Thu21-33-ND

Manufacturer Name : Lee Pharma Limited

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Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2024-03-19

Registration Number : Su21-25-ND(2)

Manufacturer Name : Lee Pharma Limited

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Registrant Name : Hiple Co., Ltd.

Registration Date : 2024-02-23

Registration Number : Su21-25-ND(1)

Manufacturer Name : Lee Pharma Limited

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Registrant Name : Lihu Healthcare Co., Ltd.

Registration Date : 2024-07-04

Registration Number : Su21-25-ND(3)

Manufacturer Name : Lee Pharma Limited

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Tegoprazan maleate

Registrant Name : MFC Corporation

Registration Date : 2024-11-06

Registration Number : 346-7-ND

Manufacturer Name : MFC Corporation

Manufacturer Address : 35 Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do

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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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NDC Package Code : 60240-0276

Start Marketing Date : 2024-10-19

End Marketing Date : 2025-12-31

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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.
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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 gro...

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
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About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
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About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.
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Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standards, we are committed to delivering excellence with innovative, holistic solutions to clients across the globe by leveraging our expertise in chemistry. Operating through our two core verticals - Honour Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our team of over 2,500 professionals collaborates closely with pharmaceutical, biotechnology, and specialty industries worldwide to develop practical, scalable solutions.
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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.
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About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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About the Company : Hy-Gro Chemicals Pharmtek Pvt. Ltd. (Hy-Gro) is a fast growing pharmaceutical company engaged in the manufacture of Active Pharmaceutical Ingredients (APIs), Advanced Intermediates...

Hy-Gro Chemicals Pharmtek Pvt. Ltd. (Hy-Gro) is a fast growing pharmaceutical company engaged in the manufacture of Active Pharmaceutical Ingredients (APIs), Advanced Intermediates, specialized Fine Chemicals and Finished Dosages. Hy-Gro is led by a team of professional and technically proficient individuals enabling a sustainable growth trajectory for the company. We currently have 3 GMP compliant manufacturing facilities located in India. Hy-Gro was established in early 1970's as a trading company and ventured into the manufacture of bulk drugs in an associate company in 1980.
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Lee Pharma

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Lee Pharma

India
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Tegoprazan

About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...

Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affordable and high-quality healthcare solutions. Through advanced research, modern manufacturing, and a strong emphasis on quality, we are dedicated to producing medicines that enhance lives. Lee Pharma is a research-focused company that prioritizes the development, synthesis, and commercialization of high-quality Active Pharmaceutical Ingredients (APIs), intermediate chemicals, and finished formulations.
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Tegoprazan

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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07-Oct-2022
07-May-2025
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Drugs in Development

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Details:

BLI5100 (tegoprazan) is a novel agent and member of a class of oral medications known as P-CABs. It is being evaluated in late-stage clinical trial studies for the treatment of GERD.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: BLI5100

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 23, 2025

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01

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : BLI5100 (tegoprazan) is a novel agent and member of a class of oral medications known as P-CABs. It is being evaluated in late-stage clinical trial studies for the treatment of GERD.

Product Name : BLI5100

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 23, 2025

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Details:

K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: K-CAB

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 27, 2024

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02

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : K-CAB (tegoprazan) is a potassium-competitive acid blocker (P-CAB), a new-generation acid suppressant. It is indicated for the treatment of gastroesophageal reflux disease.

Product Name : K-CAB

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 27, 2024

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Details:

Under this partnership, HK inno.N Corporation will be responsible for the manufacture and supply of Tegoprazan (CJ-12420), while Dr. Reddy’s will be responsible for local clinical development, registration, marketing and sales in the licensed territories


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: K-CAB

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Dr. Reddy's Laboratories

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership November 05, 2022

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03

HK inno.N

South Korea
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IFT FIRST
Not Confirmed

HK inno.N

South Korea
arrow
IFT FIRST
Not Confirmed

Details : Under this partnership, HK inno.N Corporation will be responsible for the manufacture and supply of Tegoprazan (CJ-12420), while Dr. Reddy’s will be responsible for local clinical development, registration, marketing and sales in the licensed territori...

Product Name : K-CAB

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

November 05, 2022

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Details:

Tegoprazan (CJ-12420) is a novel agent in development for the treatment of acid-related gastrointestinal diseases. Tegoprazan has already received marketing authorization in multiple territories, including South Korea and China.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: CJ-12420

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Sebela Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 19, 2022

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04

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : Tegoprazan (CJ-12420) is a novel agent in development for the treatment of acid-related gastrointestinal diseases. Tegoprazan has already received marketing authorization in multiple territories, including South Korea and China.

Product Name : CJ-12420

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

October 19, 2022

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Details:

In the study, cohorts with 50 and 100 milligrams of K-CAB tablets showed superior therapeutic effect and safety in treating gastric ulcers than the group administered with 30 milligrams of Lansoprazole.


Lead Product(s): Tegoprazan

Therapeutic Area: Gastroenterology Brand Name: K-CAB

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 24, 2020

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05

HK inno.N

South Korea
arrow
IFT FIRST
Not Confirmed

HK inno.N

South Korea
arrow
IFT FIRST
Not Confirmed

Details : In the study, cohorts with 50 and 100 milligrams of K-CAB tablets showed superior therapeutic effect and safety in treating gastric ulcers than the group administered with 30 milligrams of Lansoprazole.

Product Name : K-CAB

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 24, 2020

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ABOUT THIS PAGE

Looking for 942195-55-3 / Tegoprazan API manufacturers, exporters & distributors?

Tegoprazan manufacturers, exporters & distributors 1

49

PharmaCompass offers a list of Tegoprazan 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 Tegoprazan manufacturer or Tegoprazan supplier for your needs.

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

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

API | Excipient name

Tegoprazan

Synonyms

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-

Cas Number

942195-55-3

Unique Ingredient Identifier (UNII)

W017G7IF4S

About Tegoprazan

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.

Tegoprazan Manufacturers

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

Tegoprazan Suppliers

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

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

Tegoprazan USDMF

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

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

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

Tegoprazan KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Tegoprazan Drug Master File in Korea (Tegoprazan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tegoprazan. The MFDS reviews the Tegoprazan KDMF as part of the drug registration process and uses the information provided in the Tegoprazan KDMF to evaluate the safety and efficacy of the drug.

After submitting a Tegoprazan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tegoprazan API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tegoprazan suppliers with KDMF on PharmaCompass.

Tegoprazan WC

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

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

Tegoprazan 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 Tegoprazan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tegoprazan GMP

Tegoprazan 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 Tegoprazan 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 Tegoprazan GMP manufacturer or Tegoprazan GMP API supplier for your needs.

Tegoprazan CoA

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

Tegoprazan CoA mostly includes findings from lab analyses of a specific batch. For each Tegoprazan 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.

Tegoprazan may be tested according to a variety of international standards, such as European Pharmacopoeia (Tegoprazan EP), Tegoprazan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tegoprazan 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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