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1. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine
2. Tak 438
3. Tak-438
4. Tak438
5. Vonoprazan
1. Tak-438
2. 1260141-27-2
3. 881681-01-2
4. Vonoprazan Fumurate
5. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Fumarate
6. Tak 438
7. Tak-438 Monofumarate
8. Vonoprazan Monofumarate
9. Vonoprazan Fumarate (tak-438)
10. 4qw3x4amlb
11. Tak438
12. Unii-4qw3x4amlb
13. Takecab
14. Vocinti
15. (e)-but-2-enedioic Acid;1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-n-methylmethanamine
16. 1h-pyrrole-3-methanamine, 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-, (2e)-2-butenedioate (1:1)
17. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Xfumarate
18. 1h-pyrrole-3-methanamine, 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-, 2-butenedioate (1:1)
19. Mfcd18633280
20. Vonoprazan Monofumurate
21. 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl]-n-methylmethanamine Fumarate
22. Takecab (tn)
23. Vonoprazan Fumarate [usan]
24. Schembl194394
25. Schembl194396
26. Chembl2064032
27. Vonoprazan Fumarate [mi]
28. Vonoprazan Fumarate (jan/usan)
29. Ex-a097
30. Vonoprazan Fumarate [jan]
31. Bcp05635
32. Bcp13238
33. Ex-a4001
34. S8016
35. Vonoprazan Fumarate [who-dd]
36. Akos027251052
37. Ccg-269350
38. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Monofumarate
39. 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-1h-pyrrole-3-methanamine (2e)-2-butenedioate
40. Ac-29287
41. Ac-29309
42. Ds-12234
43. Ls-14849
44. Cs-0164592
45. Sw220126-1
46. D10466
47. A854789
48. A900258
49. J-524312
50. Q25104163
51. Tak438 Fumarate;tak-438 Fumarate;tak 438 Fumarate;1260141-27-2
52. 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine Fumarate? (vonoprazan Impurity Pound(c)
53. 2098974-13-9
54. 5-(2-fluorophenyl)-n-methyl-1-(3-pyridinylsulfonyl)-1h-pyrrole-3-methanamine 2-butenedioate
Molecular Weight | 461.5 g/mol |
---|---|
Molecular Formula | C21H20FN3O6S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 7 |
Exact Mass | 461.10568470 g/mol |
Monoisotopic Mass | 461.10568470 g/mol |
Topological Polar Surface Area | 147 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 629 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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Details:
Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna Triple Pack
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Phathom Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 24, 2022
Lead Product(s) : Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Phathom Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Evonik and Phathom Pharmaceuticals Partner to Produce Novel Acid-Blocker Vonoprazan
Details : Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.
Product Name : Voquezna Triple Pack
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 24, 2022
Details:
Voquezna (vonoprazan) is a potassium-competitive acid blocker, indicated for heartburn associated with Non-Erosive GERD.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Voquezna
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 06, 2025
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phathom Gets FDA Nod for 10 Years of Regulatory Exclusivity for Voquezna
Details : Voquezna (vonoprazan) is a potassium-competitive acid blocker, indicated for heartburn associated with Non-Erosive GERD.
Product Name : Voquezna
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 06, 2025
Details:
Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Eosinophilic Esophagitis.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 28, 2025
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Eosinophilic Esophagitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 28, 2025
Details:
Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 18, 2025
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 18, 2025
Details:
Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Stomach Ulcer.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 15, 2024
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vonoprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Stomach Ulcer.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 15, 2024
Details:
Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Lupivon (vonoprazan), a novel potassium-competitive acid blocker, in India.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Lupivon
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 18, 2024
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lupin Partners with Takeda to Commercialise Vonoprazan
Details : Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Lupivon (vonoprazan), a novel potassium-competitive acid blocker, in India.
Product Name : Lupivon
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 18, 2024
Details:
The licensing deal will enhance Alkem's offerings in the gastrointestinal segment by including Vonzai (vonoprazan), a first-in-class potassium-competitive acid blocker.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Vonzai
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Alkem Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 03, 2024
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Alkem Laboratories
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Alkem Inks Licensing Pact with Takeda to Introduce Vonoprazan in India
Details : The licensing deal will enhance Alkem's offerings in the gastrointestinal segment by including Vonzai (vonoprazan), a first-in-class potassium-competitive acid blocker.
Product Name : Vonzai
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 03, 2024
Details:
Phathom intends to use the net proceeds from the offering to fund commercialization expenses and further clinical development of Voquezna (vonoprazan) for the treatment of Erosive GERD.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Voquezna
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Evercore ISI
Deal Size: $130.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 19, 2024
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Evercore ISI
Deal Size : $130.0 million
Deal Type : Public Offering
Phathom Pharmaceuticals Prices $130M Offering of Common Stock, Pre-Funded Warrants
Details : Phathom intends to use the net proceeds from the offering to fund commercialization expenses and further clinical development of Voquezna (vonoprazan) for the treatment of Erosive GERD.
Product Name : Voquezna
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 19, 2024
Details:
Under the terms of this agreement, Takeda has granted Zydus non-exclusive patent licensing rights for the commercialization of Vault (vonoprazan) in India.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Vault
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Zydus Lifesciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 19, 2024
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Zydus Lifesciences
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Zydus signs patent licensing agreement with Takeda for 'VaultA’ in India
Details : Under the terms of this agreement, Takeda has granted Zydus non-exclusive patent licensing rights for the commercialization of Vault (vonoprazan) in India.
Product Name : Vault
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 19, 2024
Details:
Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.
Lead Product(s): Vonoprazan Fumarate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Vault
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Dr. Reddy\'s Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 18, 2024
Lead Product(s) : Vonoprazan Fumarate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Dr. Reddy\'s Laboratories
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Dr. Reddy's Signs Patent Licensing Agreement with Takeda to Commercialize Vonoprazan
Details : Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.
Product Name : Vault
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 18, 2024
5-(2-fluorophenyl)-1H-pyrrole-3- carbonitrile
CAS Number : 1240948-77-9
End Use API : Vonoprazan Fumarate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...
5-(2-fluorophenyl)-1H-Pyrrole-3- carboxaldehyde
CAS Number : 881674-56-2
End Use API : Vonoprazan Fumarate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...
Pyridine-3-sulfonyl chloride hydrochloride
CAS Number : 16133-25-8
End Use API : Vonoprazan Fumarate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...
Pyridine-3-Sulfonyl Chloride Hydrochloride
CAS Number : 16133-25-8
End Use API : Vonoprazan Fumarate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
5-(2-Fluorophenyl)-1H-pyrrole-3-carbaldehyde
CAS Number : 881674-56-2
End Use API : Vonoprazan Fumarate
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
CAS Number : 16133-25-8
End Use API : Vonoprazan Fumarate
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
5-(2-Fluorophenyl)-1-(pyridine-3-sulfonyl)-1H- pyr...
CAS Number : 807-719-6
End Use API : Vonoprazan Fumarate
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
CAS Number : 16133-25-8
End Use API : Vonoprazan Fumarate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
5-(2-fluorophenyl)-1H- Pyrrole-3-carboxaldehyde
CAS Number : 881674-56-2
End Use API : Vonoprazan Fumarate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
5-(2-Fluorophenyl)-1H-pyrrole-3-carboxaldehyde
CAS Number : 881674-56-2
End Use API : Vonoprazan Fumarate
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...
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonacidan
Dosage Form : Film-Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonacidan
Dosage Form : Film-Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Arromaprazan
Dosage Form : FC Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Arromaprazan
Dosage Form : FC Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Leurovendin
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Regulatory Info : RX
Registration Country : USA
Brand Name : VOQUEZNA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2023-11-01
Application Number : 215151
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VOQUEZNA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Packaging :
Approval Date : 2023-11-01
Application Number : 215151
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VOQUEZNA
Dosage Form : TABLET; ORAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date :
Application Number : 218710
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VOQUEZNA
Dosage Form : TABLET; ORAL
Dosage Strength : EQ 20MG BASE
Packaging :
Approval Date :
Application Number : 218710
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonopravin
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
RLD : Yes
TE Code :
Brand Name : VOQUEZNA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2023-11-01
Application Number : 215151
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : VOQUEZNA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2023-11-01
Application Number : 215151
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : VOQUEZNA
Dosage Form : TABLET; ORAL
Dosage Strength : EQ 10MG BASE
Approval Date :
Application Number : 218710
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : VOQUEZNA
Dosage Form : TABLET; ORAL
Dosage Strength : EQ 20MG BASE
Approval Date :
Application Number : 218710
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonacidan
Dosage Form : Film-Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : Film-Coated Tablet
Dosage Strength : 10MG
Brand Name : Vonacidan
Approval Date :
Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonacidan
Dosage Form : Film-Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : Film-Coated Tablet
Dosage Strength : 20MG
Brand Name : Vonacidan
Approval Date :
Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Arromaprazan
Dosage Form : FC Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : FC Tablet
Dosage Strength : 20MG
Brand Name : Arromaprazan
Approval Date :
Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Arromaprazan
Dosage Form : FC Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : FC Tablet
Dosage Strength : 10MG
Brand Name : Arromaprazan
Approval Date :
Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Leurovendin
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 20MG
Brand Name : Leurovendin
Approval Date :
Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonopravin
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 10MG
Brand Name : Vonopravin
Approval Date :
Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : Egypt
Brand Name : Vonopravin
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 20MG
Brand Name : Vonopravin
Approval Date :
Application Number :
Registration Country : Egypt
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
Exclusivity Code : I-948
Exclusivity Expiration Date : 2027-07-17
Application Number : 215151
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2027-05-03
Application Number : 215151
Product Number : 1
Exclusivity Details :
Exclusivity Code : NP
Exclusivity Expiration Date : 2026-11-01
Application Number : 215151
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2027-05-03
Application Number : 215151
Product Number : 2
Exclusivity Details :
Exclusivity Code : NP
Exclusivity Expiration Date : 2026-11-01
Application Number : 215151
Product Number : 2
Exclusivity Details :
Exclusivity Code : GAIN
Exclusivity Expiration Date : 2032-05-03
Application Number : 215151
Product Number : 1
Exclusivity Details :
Exclusivity Code : GAIN
Exclusivity Expiration Date : 2032-05-03
Application Number : 215151
Product Number : 2
Exclusivity Details :
REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Vonoprazan Fumarate 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 Vonoprazan Fumarate manufacturer or Vonoprazan Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vonoprazan Fumarate manufacturer or Vonoprazan Fumarate supplier.
PharmaCompass also assists you with knowing the Vonoprazan Fumarate API Price utilized in the formulation of products. Vonoprazan Fumarate API Price is not always fixed or binding as the Vonoprazan Fumarate Price is obtained through a variety of data sources. The Vonoprazan Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vonoprazan Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan Fumarate, including repackagers and relabelers. The FDA regulates Vonoprazan Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan Fumarate 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 Vonoprazan Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan Fumarate supplier is an individual or a company that provides Vonoprazan Fumarate active pharmaceutical ingredient (API) or Vonoprazan Fumarate finished formulations upon request. The Vonoprazan Fumarate suppliers may include Vonoprazan Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vonoprazan Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Vonoprazan Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Vonoprazan Fumarate DMFs exist exist since differing nations have different regulations, such as Vonoprazan Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vonoprazan Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Vonoprazan Fumarate USDMF includes data on Vonoprazan Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vonoprazan Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vonoprazan Fumarate 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 Vonoprazan Fumarate Drug Master File in Korea (Vonoprazan Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan Fumarate. The MFDS reviews the Vonoprazan Fumarate KDMF as part of the drug registration process and uses the information provided in the Vonoprazan Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vonoprazan Fumarate 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 Vonoprazan Fumarate API can apply through the Korea Drug Master File (KDMF).
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A Vonoprazan Fumarate written confirmation (Vonoprazan Fumarate WC) is an official document issued by a regulatory agency to a Vonoprazan Fumarate manufacturer, verifying that the manufacturing facility of a Vonoprazan Fumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan Fumarate APIs or Vonoprazan Fumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan Fumarate WC (written confirmation) as part of the regulatory process.
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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 Vonoprazan Fumarate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vonoprazan Fumarate 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 Vonoprazan Fumarate 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 Vonoprazan Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vonoprazan Fumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vonoprazan Fumarate suppliers with NDC on PharmaCompass.
Vonoprazan Fumarate 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 Vonoprazan Fumarate 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 Vonoprazan Fumarate GMP manufacturer or Vonoprazan Fumarate GMP API supplier for your needs.
A Vonoprazan Fumarate CoA (Certificate of Analysis) is a formal document that attests to Vonoprazan Fumarate's compliance with Vonoprazan Fumarate specifications and serves as a tool for batch-level quality control.
Vonoprazan Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Vonoprazan Fumarate 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.
Vonoprazan Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Vonoprazan Fumarate EP), Vonoprazan Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vonoprazan Fumarate USP).