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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
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
Molecular Weight | 387.4 g/mol |
---|---|
Molecular Formula | C20H19F2N3O3 |
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 Ų |
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 |
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
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.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38991
Submission : 2023-12-30
Status : Active
Type : II
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
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2024-01-19
Registration Number : No. 69-17-ND(1)
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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 : Vadodara, Gujarat, India
Registrant Name : Hiple Co., Ltd.
Registration Date : 2023-12-11
Registration Number : Su30-7-ND
Manufacturer Name : Ruyuan HEC Pharm Co., Ltd.
Manufacturer Address : Xiaba Development Zone, Ruyuan County, Shaoguan, Guangdong Province, China
Registrant Name : Hiple Co., Ltd.
Registration Date : 2024-02-23
Registration Number : Su21-25-ND(1)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No.10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, 502319, India
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2024-01-19
Registration Number : Thu21-25-ND
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No.10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, 502319, India
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38991
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39217
Submission : 2023-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39156
Submission : 2023-11-18
Status : Active
Type : II
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2024-01-19
Registration Number : No. 69-17-ND(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
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...
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
Registrant Name : J2H Biotech Co., Ltd.
Registration Date : 2024-07-08
Registration Number : 6169-1-ND
Manufacturer Name : J2H Biotech Co., Ltd. @ Kukj...
Manufacturer Address : Gyeonggi-do Ansan-si Danwon-gu Sandan-ro 349 B-dong, D-dongilbu@Gyeonggi-do Hwaseong-...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2024-07-04
Registration Number : 2520-50-ND
Manufacturer Name : Kukjeon Pharmaceutical Co., ...
Manufacturer Address : 8, Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2024-07-04
Registration Number : Su21-25-ND(3)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-03-19
Registration Number : Su21-25-ND(2)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Sy no. 10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana...
Registrant Name : Hiple Co., Ltd.
Registration Date : 2024-02-23
Registration Number : Su21-25-ND(1)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No.10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telang...
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
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2024-08-26
Registration Number : 1452-9-ND
Manufacturer Name : Pharmacostec Co., Ltd.
Manufacturer Address : Block 35-2, Balan Local Industrial Complex, 47, Pharmaceutical Complex, Hyangnam-eup,...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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
NDC Package Code : 60240-0276
Start Marketing Date : 2024-10-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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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...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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...
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...
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About the Company : Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk...
About the Company : Honour is a leading global Contract Development and Manufacturing Organization (CDMO) as well as a manufacturer of specialty chemicals and ingredients, operating six facilities tha...
About the Company : Kukjeon Pharmaceutical has been contributing towards advancing Korea’s pharmaceutical industry with its active pharmaceutical ingredients (API) based on professional capacity bui...
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...
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...
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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
Lead Product(s) : Tegoprazan
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sebela Reports Positive Phase 3 TRIUMpH Results for Tegoprazan in GERD
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
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
Lead Product(s) : Tegoprazan
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Malaysia Gives Nod to RaQualia’s Tegoprazan for Gastroesophageal Reflux Disease Treatment
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
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
Lead Product(s) : Tegoprazan
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Dr. Reddy's Laboratories
Deal Size : Undisclosed
Deal Type : Partnership
Dr. Reddy’s Laboratories to Commercialise Novel Molecule Tegoprazan in India
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
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
Lead Product(s) : Tegoprazan
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sebela Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Sebela Pharmaceuticals® Acquires Exclusive Licensing Rights to Develop and Commercialize Tegopraz...
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
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
Lead Product(s) : Tegoprazan
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hk Inno.N Publishes P3 Trial Results of Drug on Gastric Ulcers
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
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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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Tegoprazan API and other APIs are published in this directory by the FDA.
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.
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 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.
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).