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1. 0431, Mk
2. 4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine
3. Anhydrous, Sitagliptin Phosphate
4. Januvia
5. Mk 0431
6. Mk-0431
7. Mk0431
8. Monohydrate, Sitagliptin Monophosphate
9. Monohydrate, Sitagliptin Phosphate
10. Monophosphate Monohydrate, Sitagliptin
11. Phosphate Anhydrous, Sitagliptin
12. Phosphate Monohydrate, Sitagliptin
13. Phosphate, Sitagliptin
14. Sitagliptin
15. Sitagliptin Monophosphate Monohydrate
16. Sitagliptin Phosphate Anhydrous
17. Sitagliptin Phosphate Monohydrate
1. 654671-78-0
2. Sitagliptin (phosphate)
3. Mk-0431
4. Chembl393336
5. 494p4635i6
6. Mk0431
7. (2r)-4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine Phosphate Salt
8. (3r)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric Acid
9. (r)-3-amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one Phosphate
10. 1-butanone, 3-amino-1-[5,6-dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8h)-yl]-4-(2,4,5-trifluorophenyl)-, (3r)-, Phosphate (1:1)
11. Sitagliptin Monophosphate
12. Sitagliptin Phosphate Anhydrous
13. (3r)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)-1-butanone; Phosphoric Acid
14. Mk 0431
15. Sr-05000001748
16. Unii-494p4635i6
17. (2r)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine Phosphate Salt
18. Mk 431
19. Mk-0431 Phosphate
20. Schembl877069
21. Dtxsid10215789
22. Hy-13749a
23. Mfcd09952339
24. Akos015896098
25. Sitagliptin Phosphate [who-dd]
26. Ks-1214
27. 4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine Phosphate
28. Sitagliptin Monophosphate Anhydrous [mi]
29. 671s780
30. A835125
31. Sr-05000001748-2
32. Q27259224
33. Sitagliptin Phosphate Anhydrous Component Of Janumet
34. (3r)-3-amino-1-[5,6-dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8h)-yl]-4-(2,4,5-trifluorophenyl)-1-butanone Phosphate
35. (3r)-3-azanyl-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-[2,4,5-tris(fluoranyl)phenyl]butan-1-one; Phosphoric Acid
36. 1,2,4-triazolo(4,3-a)pyrazine, 7-((3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydro-3-(trifluoromethyl)-, Phosphate (1:1)
37. 1269630-53-6
38. 7-((3r)-3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo(4,3-a)pyrazinemonophosphate
39. 7-(3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine Phosphate
| Molecular Weight | 505.31 g/mol |
|---|---|
| Molecular Formula | C16H18F6N5O5P |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 14 |
| Rotatable Bond Count | 4 |
| Exact Mass | 505.09497466 g/mol |
| Monoisotopic Mass | 505.09497466 g/mol |
| Topological Polar Surface Area | 155 Ų |
| Heavy Atom Count | 33 |
| Formal Charge | 0 |
| Complexity | 616 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Januvia |
| PubMed Health | Sitagliptin (By mouth) |
| Drug Classes | Antidiabetic |
| Drug Label | JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahy... |
| Active Ingredient | Sitagliptin phosphate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 25mg base |
| Market Status | Prescription |
| Company | Merck Sharp Dohme |
| 2 of 4 | |
|---|---|
| Drug Name | Sitagliptin phosphate |
| Active Ingredient | Sitagliptin phosphate |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | eq 100mg base; 25mg; eq 50mg base; 100mg; 50mg; eq 25mg base |
| Market Status | Tentative Approval |
| Company | Mylan Pharms; Apotex; Sandoz; Sun Pharma Global; Watson Labs |
| 3 of 4 | |
|---|---|
| Drug Name | Januvia |
| PubMed Health | Sitagliptin (By mouth) |
| Drug Classes | Antidiabetic |
| Drug Label | JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahy... |
| Active Ingredient | Sitagliptin phosphate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 25mg base |
| Market Status | Prescription |
| Company | Merck Sharp Dohme |
| 4 of 4 | |
|---|---|
| Drug Name | Sitagliptin phosphate |
| Active Ingredient | Sitagliptin phosphate |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | eq 100mg base; 25mg; eq 50mg base; 100mg; 50mg; eq 25mg base |
| Market Status | Tentative Approval |
| Company | Mylan Pharms; Apotex; Sandoz; Sun Pharma Global; Watson Labs |
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
Incretins
Peptides which stimulate INSULIN release from the PANCREATIC BETA CELLS following oral nutrient ingestion, or postprandially. (See all compounds classified as Incretins.)
Dipeptidyl-Peptidase IV Inhibitors
Compounds that suppress the degradation of INCRETINS by blocking the action of DIPEPTIDYL-PEPTIDASE IV. This helps to correct the defective INSULIN and GLUCAGON secretion characteristic of TYPE 2 DIABETES MELLITUS by stimulating insulin secretion and suppressing glucagon release. (See all compounds classified as Dipeptidyl-Peptidase IV Inhibitors.)
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2021-155 - Rev 00
Status : Valid
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 2778
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Sitagliptin Phosphate Monohydrate, Process II
Certificate Number : CEP 2024-249 - Rev 00
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2778
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Sitagliptin Phosphate Monohydrate
Certificate Number : CEP 2022-340 - Rev 00
Status : Valid
Issue Date : 2024-05-06
Type : Chemical
Substance Number : 2778
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Sitagliptin Phosphate Monohydrate
Certificate Number : CEP 2016-324 - Rev 01
Status : Valid
Issue Date : 2024-12-16
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2020-197 - Rev 00
Status : Valid
Issue Date : 2023-08-11
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2021-295 - Rev 00
Status : Valid
Issue Date : 2023-08-25
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2021-175 - Rev 00
Status : Valid
Issue Date : 2023-08-31
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate, Crystalline F...
Certificate Number : CEP 2016-262 - Rev 01
Status : Valid
Issue Date : 2024-01-12
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2017-252 - Rev 00
Status : Valid
Issue Date : 2021-01-28
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2021-228 - Rev 00
Status : Valid
Issue Date : 2023-07-12
Type : Chemical
Substance Number : 2778
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 21995
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 21995
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 21995
DOSAGE - TABLET;ORAL - 1GM;EQ 50MG BASE
USFDA APPLICATION NUMBER - 22044
DOSAGE - TABLET;ORAL - 500MG;EQ 50MG BASE
USFDA APPLICATION NUMBER - 22044
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PharmaCompass offers a list of Sitagliptin Phosphate 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 Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier.
PharmaCompass also assists you with knowing the Sitagliptin Phosphate API Price utilized in the formulation of products. Sitagliptin Phosphate API Price is not always fixed or binding as the Sitagliptin Phosphate Price is obtained through a variety of data sources. The Sitagliptin Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MK 0431 phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MK 0431 phosphate, including repackagers and relabelers. The FDA regulates MK 0431 phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MK 0431 phosphate 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 MK 0431 phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MK 0431 phosphate supplier is an individual or a company that provides MK 0431 phosphate active pharmaceutical ingredient (API) or MK 0431 phosphate finished formulations upon request. The MK 0431 phosphate suppliers may include MK 0431 phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of MK 0431 phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MK 0431 phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of MK 0431 phosphate active pharmaceutical ingredient (API) in detail. Different forms of MK 0431 phosphate DMFs exist exist since differing nations have different regulations, such as MK 0431 phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MK 0431 phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. MK 0431 phosphate USDMF includes data on MK 0431 phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MK 0431 phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MK 0431 phosphate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The MK 0431 phosphate Drug Master File in Japan (MK 0431 phosphate JDMF) empowers MK 0431 phosphate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the MK 0431 phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of MK 0431 phosphate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of MK 0431 phosphate suppliers with JDMF 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 MK 0431 phosphate Drug Master File in Korea (MK 0431 phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MK 0431 phosphate. The MFDS reviews the MK 0431 phosphate KDMF as part of the drug registration process and uses the information provided in the MK 0431 phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a MK 0431 phosphate 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 MK 0431 phosphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MK 0431 phosphate suppliers with KDMF on PharmaCompass.
A MK 0431 phosphate CEP of the European Pharmacopoeia monograph is often referred to as a MK 0431 phosphate Certificate of Suitability (COS). The purpose of a MK 0431 phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MK 0431 phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MK 0431 phosphate to their clients by showing that a MK 0431 phosphate CEP has been issued for it. The manufacturer submits a MK 0431 phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a MK 0431 phosphate CEP holder for the record. Additionally, the data presented in the MK 0431 phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MK 0431 phosphate DMF.
A MK 0431 phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MK 0431 phosphate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of MK 0431 phosphate suppliers with CEP (COS) on PharmaCompass.
A MK 0431 phosphate written confirmation (MK 0431 phosphate WC) is an official document issued by a regulatory agency to a MK 0431 phosphate manufacturer, verifying that the manufacturing facility of a MK 0431 phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MK 0431 phosphate APIs or MK 0431 phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a MK 0431 phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of MK 0431 phosphate 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 MK 0431 phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MK 0431 phosphate 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 MK 0431 phosphate 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 MK 0431 phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MK 0431 phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MK 0431 phosphate suppliers with NDC on PharmaCompass.
MK 0431 phosphate 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 MK 0431 phosphate 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 MK 0431 phosphate GMP manufacturer or MK 0431 phosphate GMP API supplier for your needs.
A MK 0431 phosphate CoA (Certificate of Analysis) is a formal document that attests to MK 0431 phosphate's compliance with MK 0431 phosphate specifications and serves as a tool for batch-level quality control.
MK 0431 phosphate CoA mostly includes findings from lab analyses of a specific batch. For each MK 0431 phosphate 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.
MK 0431 phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (MK 0431 phosphate EP), MK 0431 phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MK 0431 phosphate USP).
