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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 |
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 : 35150
Submission : 2020-08-31
Status : Active
Type : II
NDC Package Code : 42765-014
Start Marketing Date : 2020-08-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39107
Submission : 2023-11-02
Status : Active
Type : II
Date of Issue : 2024-01-15
Valid Till : 2027-01-14
Written Confirmation Number : SD240003
Address of the Firm :
Registrant Name : Pampia Co., Ltd.
Registration Date : 2025-01-23
Registration Number : Su719-2-ND
Manufacturer Name : Shandong Chenghui Shuangda Pharmaceutical Co.,Ltd.
Manufacturer Address : Economic Development Zone,Pingyuan County, DezhouCity, Shandong, PRChina
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
NDC Package Code : 52696-0010
Start Marketing Date : 2023-11-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39528
Submission : 2024-02-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36262
Submission : 2021-09-06
Status : Active
Type : II
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2021-12-15
Registration Number : 69-12-ND
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
Available Reg Filing : BR, CN |
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 : 35150
Submission : 2020-08-31
Status : Active
Type : II
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39107
Submission : 2023-11-02
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39528
Submission : 2024-02-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36262
Submission : 2021-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40682
Submission : 2024-10-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32831
Submission : 2018-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39360
Submission : 2024-05-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38701
Submission : 2023-09-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38293
Submission : 2023-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37923
Submission : 2023-01-05
Status : Active
Type : II
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Registrant Name : Pampia Co., Ltd.
Registration Date : 2025-01-23
Registration Number : Su719-2-ND
Manufacturer Name : Shandong Chenghui Shuangda P...
Manufacturer Address : Economic Development Zone,Pingyuan County, DezhouCity, Shandong, PRChina
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2021-12-15
Registration Number : 69-12-ND
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 : H.L.G.Nomics Co., Ltd.
Registration Date : 2024-04-17
Registration Number : 94-10-ND
Manufacturer Name : H.L.G.Nomics Co., Ltd.
Manufacturer Address : 1552 Bogaewonsam-ro, Wonsam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-02-15
Registration Number : Thu21-26-ND(4)
Manufacturer Name : Honour Lab Limited Unit III
Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, ...
Registrant Name : Hoosung Bio Co., Ltd.
Registration Date : 2024-02-15
Registration Number : Thu21-26-ND(3)
Manufacturer Name : Honour Lab Limited(Unit-III)
Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, ...
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2024-02-15
Registration Number : Thu21-26-ND(5)
Manufacturer Name : Honour Lab Limited(Unit-III)
Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, ...
Registrant Name : Parmarine Co., Ltd.
Registration Date : 2025-03-11
Registration Number : Number 97-5-ND
Manufacturer Name : Maithri Drugs Private Limite...
Manufacturer Address : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally(Village), Gummadidala(Mandal), ...
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2024-07-30
Registration Number : 207-62-ND(1)
Manufacturer Name : Morepen Laboratories Limited
Manufacturer Address : (Morepen Village)Vill. Malkumajra, Baddi-Nalagarh Road, Baddi. District-Solan (Himach...
Registrant Name : Klasia Co., Ltd.
Registration Date : 2024-06-03
Registration Number : No. 758-12-ND
Manufacturer Name : Optimus Drugs Private Limite...
Manufacturer Address : Unit-I, Sy.No.239 & 240, Dothigudem(V), Pochampally(M), Yadari-Bhuvanagiri(D), Telang...
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2019-03-22
Registration Number : 108-8-ND
Manufacturer Name : Takeda Pharmaceutical Compan...
Manufacturer Address : 4720, Takeda, Mitsui, Hikari, Yamaguchi 743-8502, Japan
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...
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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 Takecab (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Takecab (TN), including repackagers and relabelers. The FDA regulates Takecab (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Takecab (TN) 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 Takecab (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Takecab (TN) supplier is an individual or a company that provides Takecab (TN) active pharmaceutical ingredient (API) or Takecab (TN) finished formulations upon request. The Takecab (TN) suppliers may include Takecab (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Takecab (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Takecab (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Takecab (TN) active pharmaceutical ingredient (API) in detail. Different forms of Takecab (TN) DMFs exist exist since differing nations have different regulations, such as Takecab (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Takecab (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Takecab (TN) USDMF includes data on Takecab (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Takecab (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Takecab (TN) 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 Takecab (TN) Drug Master File in Korea (Takecab (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Takecab (TN). The MFDS reviews the Takecab (TN) KDMF as part of the drug registration process and uses the information provided in the Takecab (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Takecab (TN) 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 Takecab (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Takecab (TN) suppliers with KDMF on PharmaCompass.
A Takecab (TN) written confirmation (Takecab (TN) WC) is an official document issued by a regulatory agency to a Takecab (TN) manufacturer, verifying that the manufacturing facility of a Takecab (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Takecab (TN) APIs or Takecab (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Takecab (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Takecab (TN) 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 Takecab (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Takecab (TN) 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 Takecab (TN) 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 Takecab (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Takecab (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Takecab (TN) suppliers with NDC on PharmaCompass.
Takecab (TN) 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 Takecab (TN) 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 Takecab (TN) GMP manufacturer or Takecab (TN) GMP API supplier for your needs.
A Takecab (TN) CoA (Certificate of Analysis) is a formal document that attests to Takecab (TN)'s compliance with Takecab (TN) specifications and serves as a tool for batch-level quality control.
Takecab (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Takecab (TN) 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.
Takecab (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Takecab (TN) EP), Takecab (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Takecab (TN) USP).