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Also known as: Tak-438, 1260141-27-2, 881681-01-2, Vonoprazan fumurate, 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine fumarate, Tak 438
Molecular Formula
C21H20FN3O6S
Molecular Weight
461.5  g/mol
InChI Key
ROGSHYHKHPCCJW-WLHGVMLRSA-N
FDA UNII
4QW3X4AMLB

Vonoprazan Fumarate
Vonoprazan Fumarate is the fumarate salt form of vonoprazan, a pyrrole derivative and reversible potassium-competitive acid blocker (P-CAB), with potential antacid activity. Upon administration, vonoprazan specifically and competitively binds to the gastric hydrogen-potassium ATPase (H+/K+ ATPase) proton pump at or, more likely, near its potassium ion (K+) binding site and sterically inhibits K+ binding. This blocks the activation of the H+/K+ ATPase by K+, inhibits the proton pump and prevents gastric acid secretion, thereby lowering gastric acid levels.
1 2D Structure

Vonoprazan Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-N-methylmethanamine
2.1.2 InChI
InChI=1S/C17H16FN3O2S.C4H4O4/c1-19-10-13-9-17(15-6-2-3-7-16(15)18)21(12-13)24(22,23)14-5-4-8-20-11-14;5-3(6)1-2-4(7)8/h2-9,11-12,19H,10H2,1H3;1-2H,(H,5,6)(H,7,8)/b;2-1+
2.1.3 InChI Key
ROGSHYHKHPCCJW-WLHGVMLRSA-N
2.1.4 Canonical SMILES
CNCC1=CN(C(=C1)C2=CC=CC=C2F)S(=O)(=O)C3=CN=CC=C3.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CNCC1=CN(C(=C1)C2=CC=CC=C2F)S(=O)(=O)C3=CN=CC=C3.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
4QW3X4AMLB
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2010-05-17
3 Chemical and Physical Properties
Molecular Weight 461.5 g/mol
Molecular Formula C21H20FN3O6S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass461.10568470 g/mol
Monoisotopic Mass461.10568470 g/mol
Topological Polar Surface Area147 Ų
Heavy Atom Count32
Formal Charge0
Complexity629
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

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Vonoprazan Fumarate

Date of Issue : 2024-01-15

Valid Till : 2027-01-14

Written Confirmation Number : SD240003

Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong, PR China

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Vonoprazan Fumarate IH

Date of Issue : 2022-08-18

Valid Till : 2025-06-26

Written Confirmation Number : WC-0054

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

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Vonoprazan Fumarate IHS

Date of Issue : 2022-08-04

Valid Till : 2025-06-16

Written Confirmation Number : WC-050

Address of the Firm : (Unit-IV), (Morepen Village), Village Malkumajra, Baddi-Nalagarh Road, Baddi, Di...

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Vonoprazan Fumarate IH

Date of Issue : 2022-11-02

Valid Till : 2025-07-02

Written Confirmation Number : WC-0182

Address of the Firm : Sy.No.239&240,Dothigudem Village,Pochampally MandalYadadri-Bhuvanagiri,Dist.-508...

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Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.
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DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.
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Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the Hyderabad-based company has grown from a single manufacturing unit to four, employing over 1,000 people. The manufacturing units are situated in Kazipally, Pashamylaram, Humnabad and Gandhi Nagar. Virupaksha's manufacturing facility holds FDA approval, reflecting its adherence to stringent standards. With a customer base exceeding 300 and a presence spanning over 70 countries, Virupaksha has established itself as a reputable global player in its field.
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03-Feb-2022
26-Apr-2025
KGS
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Drugs in Development

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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: Other Small Molecule

Sponsor: Phathom Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 24, 2022

Evonik company banner

01

Evonik

Germany
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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

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 : Other Small Molecule

Upfront Cash : Undisclosed

October 24, 2022

Evonik company banner

Details:

Voquezna (vonoprazan) is a potassium-competitive acid blocker, indicated for heartburn associated with Non-Erosive GERD.


Lead Product(s): Vonoprazan Fumarate

Therapeutic Area: Gastroenterology Brand Name: Voquezna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 06, 2025

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02

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

Details : Voquezna (vonoprazan) is a potassium-competitive acid blocker, indicated for heartburn associated with Non-Erosive GERD.

Product Name : Voquezna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 06, 2025

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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

Therapeutic Area: Gastroenterology Brand Name: Lupivon

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Lupin Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 18, 2024

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03

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

September 18, 2024

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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

Therapeutic Area: Gastroenterology Brand Name: Voquezna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Evercore ISI

Deal Size: $130.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering August 19, 2024

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04

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

August 19, 2024

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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

Therapeutic Area: Gastroenterology Brand Name: Vault

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Zydus Lifesciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 19, 2024

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05

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

July 19, 2024

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Details:

Voquezna (vonoprazan) is an oral small molecule potassium-competitive acid blocker (PCAB). It is being developed for the treatment of heartburn due to Non-Erosive Gastroesophageal Reflux Disease.


Lead Product(s): Vonoprazan Fumarate

Therapeutic Area: Gastroenterology Brand Name: Voquezna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 18, 2024

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06

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

Details : Voquezna (vonoprazan) is an oral small molecule potassium-competitive acid blocker (PCAB). It is being developed for the treatment of heartburn due to Non-Erosive Gastroesophageal Reflux Disease.

Product Name : Voquezna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 18, 2024

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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

Therapeutic Area: Gastroenterology Brand Name: Vault

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Dr. Reddy's Laboratories

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 18, 2024

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07

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

July 18, 2024

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Details:

Under the terms of this agreement, Takeda has granted Mankind Pharma non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.


Lead Product(s): Vonoprazan Fumarate

Therapeutic Area: Gastroenterology Brand Name: Voquezna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Mankind Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 16, 2024

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08

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

Details : Under the terms of this agreement, Takeda has granted Mankind Pharma non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.

Product Name : Voquezna

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

July 16, 2024

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Details:

Under the terms of this agreement, Takeda has granted Sun Pharma non-exclusive patent licensing rights for the commercialization of Voltapraz (vonoprazan) in India.


Lead Product(s): Vonoprazan Fumarate

Therapeutic Area: Gastroenterology Brand Name: Voltapraz

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Sun Pharmaceutical Industries Limited

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 21, 2024

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09

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

Lead Product(s) : Vonoprazan Fumarate

Therapeutic Area : Gastroenterology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Sun Pharmaceutical Industries Limited

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Under the terms of this agreement, Takeda has granted Sun Pharma non-exclusive patent licensing rights for the commercialization of Voltapraz (vonoprazan) in India.

Product Name : Voltapraz

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

June 21, 2024

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Details:

Under the terms of this agreement, Takeda has granted Cipla non-exclusive patent licensing rights for the commercialization of Voltapraz (vonoprazan) in India.


Lead Product(s): Vonoprazan Fumarate

Therapeutic Area: Gastroenterology Brand Name: Voltapraz

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Cipla

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 20, 2024

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10

FCE Pharma
Not Confirmed
FCE Pharma
Not Confirmed

Details : Under the terms of this agreement, Takeda has granted Cipla non-exclusive patent licensing rights for the commercialization of Voltapraz (vonoprazan) in India.

Product Name : Voltapraz

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

June 20, 2024

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ABOUT THIS PAGE

Looking for 1260141-27-2 / Vonoprazan Fumarate API manufacturers, exporters & distributors?

Vonoprazan Fumarate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Vonoprazan Fumarate

Synonyms

Tak-438, 1260141-27-2, 881681-01-2, Vonoprazan fumurate, 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine fumarate, Tak 438

Cas Number

1260141-27-2

Unique Ingredient Identifier (UNII)

4QW3X4AMLB

About Vonoprazan Fumarate

Vonoprazan Fumarate is the fumarate salt form of vonoprazan, a pyrrole derivative and reversible potassium-competitive acid blocker (P-CAB), with potential antacid activity. Upon administration, vonoprazan specifically and competitively binds to the gastric hydrogen-potassium ATPase (H+/K+ ATPase) proton pump at or, more likely, near its potassium ion (K+) binding site and sterically inhibits K+ binding. This blocks the activation of the H+/K+ ATPase by K+, inhibits the proton pump and prevents gastric acid secretion, thereby lowering gastric acid levels.

Vonoprazan Manufacturers

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

Vonoprazan Suppliers

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

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

Vonoprazan USDMF

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

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

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

Vonoprazan KDMF

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

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

After submitting a Vonoprazan 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 API can apply through the Korea Drug Master File (KDMF).

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

Vonoprazan WC

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

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

Vonoprazan 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 Vonoprazan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vonoprazan GMP

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

Vonoprazan CoA

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

Vonoprazan CoA mostly includes findings from lab analyses of a specific batch. For each Vonoprazan 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vonoprazan EP), Vonoprazan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vonoprazan 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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