Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
Europe
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
US Medicaid
NA
Regulatory FDF Prices
NA
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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 |
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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
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...
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...
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...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : 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 ...
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
About the Company : 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 g...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
About the Company : 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...
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...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
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
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 : Other Small Molecule
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
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
Lead Product(s) : Vonoprazan Fumarate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
June 06, 2025
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
Lead Product(s) : Vonoprazan Fumarate
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 : Other Small Molecule
Upfront Cash : Undisclosed
September 18, 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
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
Lead Product(s) : Vonoprazan Fumarate
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 : Other Small Molecule
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
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
Lead Product(s) : Vonoprazan Fumarate
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 : Other Small Molecule
Upfront Cash : Undisclosed
July 19, 2024
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
Lead Product(s) : Vonoprazan Fumarate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® for Non-Erosive GERD
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
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
Lead Product(s) : Vonoprazan Fumarate
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 : Other Small Molecule
Upfront Cash : Undisclosed
July 18, 2024
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
Lead Product(s) : Vonoprazan Fumarate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Mankind Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Mankind Pharma signs agreement with Takeda to commercialize Vonoprazan in India
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
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
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
Sun Pharma Signs Patent License with Takeda for Voltapraz in India
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
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
Lead Product(s) : Vonoprazan Fumarate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Cipla
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Cipla Signs Agreement With Takeda To Commercialize Vonoprazan in India
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
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
71
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 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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Vonoprazan 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 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 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 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.
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).