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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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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-23
Pay. Date : 2019-09-13
DMF Number : 33551
Submission : 2019-01-31
Status : Active
Type : II
Certificate Number : R0-CEP 2021-155 - Rev 00
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 2778
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 71796-035
Start Marketing Date : 2021-02-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 58175-0620
Start Marketing Date : 2019-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Temad- We think of world-class quality.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-28
Pay. Date : 2024-01-22
DMF Number : 39377
Submission : 2024-02-02
Status : Active
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38931
Submission : 2024-01-31
Status : Active
Type : II
NDC Package Code : 49716-338
Start Marketing Date : 2023-10-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-09-20
DMF Number : 33206
Submission : 2018-09-28
Status : Active
Type : II
NDC Package Code : 71495-0002
Start Marketing Date : 2019-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-23
Pay. Date : 2019-09-13
DMF Number : 33551
Submission : 2019-01-31
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 : 35580
Submission : 2021-02-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-28
Pay. Date : 2024-01-22
DMF Number : 39377
Submission : 2024-02-02
Status : Active
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38931
Submission : 2024-01-31
Status : Active
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-27
Pay. Date : 2023-10-11
DMF Number : 38921
Submission : 2023-09-28
Status : Active
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-09-20
DMF Number : 33206
Submission : 2018-09-28
Status : Active
Type : II
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39354
Submission : 2024-01-20
Status : Active
Type : II
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37030
Submission : 2022-05-02
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-07
Pay. Date : 2018-12-18
DMF Number : 33428
Submission : 2019-01-06
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2012-11-13
DMF Number : 25867
Submission : 2012-03-02
Status : Active
Type : II
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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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Sitagliptin Phosphate Monohydrate, Process II
Certificate Number : CEP 2024-249 - Rev 00
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2778
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Sitagliptin Phosphate Monohydrate
Certificate Number : CEP 2022-340 - Rev 00
Status : Valid
Issue Date : 2024-05-06
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 2021-117 - Rev 00
Status : Valid
Issue Date : 2023-06-22
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2020-215 - Rev 01
Status : Valid
Issue Date : 2023-03-10
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate
Certificate Number : R0-CEP 2019-040 - Rev 00
Status : Valid
Issue Date : 2020-05-12
Type : Chemical
Substance Number : 2778
Sitagliptin Phosphate Monohydrate, Route STP Pro...
Certificate Number : R0-CEP 2020-200 - Rev 00
Status : Valid
Issue Date : 2020-12-16
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
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 21995
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DOSAGE - TABLET;ORAL - 1GM;EQ 50MG BASE
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DOSAGE - TABLET;ORAL - 500MG;EQ 50MG BASE
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ABOUT THIS PAGE
A Janumet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Janumet, including repackagers and relabelers. The FDA regulates Janumet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Janumet 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 Janumet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Janumet supplier is an individual or a company that provides Janumet active pharmaceutical ingredient (API) or Janumet finished formulations upon request. The Janumet suppliers may include Janumet API manufacturers, exporters, distributors and traders.
click here to find a list of Janumet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Janumet DMF (Drug Master File) is a document detailing the whole manufacturing process of Janumet active pharmaceutical ingredient (API) in detail. Different forms of Janumet DMFs exist exist since differing nations have different regulations, such as Janumet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Janumet DMF submitted to regulatory agencies in the US is known as a USDMF. Janumet USDMF includes data on Janumet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Janumet USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Janumet 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 Janumet Drug Master File in Japan (Janumet JDMF) empowers Janumet 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 Janumet JDMF during the approval evaluation for pharmaceutical products. At the time of Janumet 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 Janumet 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 Janumet Drug Master File in Korea (Janumet KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Janumet. The MFDS reviews the Janumet KDMF as part of the drug registration process and uses the information provided in the Janumet KDMF to evaluate the safety and efficacy of the drug.
After submitting a Janumet 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 Janumet API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Janumet suppliers with KDMF on PharmaCompass.
A Janumet CEP of the European Pharmacopoeia monograph is often referred to as a Janumet Certificate of Suitability (COS). The purpose of a Janumet CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Janumet EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Janumet to their clients by showing that a Janumet CEP has been issued for it. The manufacturer submits a Janumet CEP (COS) as part of the market authorization procedure, and it takes on the role of a Janumet CEP holder for the record. Additionally, the data presented in the Janumet CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Janumet DMF.
A Janumet CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Janumet 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 Janumet suppliers with CEP (COS) on PharmaCompass.
A Janumet written confirmation (Janumet WC) is an official document issued by a regulatory agency to a Janumet manufacturer, verifying that the manufacturing facility of a Janumet active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Janumet APIs or Janumet finished pharmaceutical products to another nation, regulatory agencies frequently require a Janumet WC (written confirmation) as part of the regulatory process.
click here to find a list of Janumet 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 Janumet as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Janumet 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 Janumet 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 Janumet and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Janumet NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Janumet suppliers with NDC on PharmaCompass.
Janumet 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 Janumet 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 Janumet GMP manufacturer or Janumet GMP API supplier for your needs.
A Janumet CoA (Certificate of Analysis) is a formal document that attests to Janumet's compliance with Janumet specifications and serves as a tool for batch-level quality control.
Janumet CoA mostly includes findings from lab analyses of a specific batch. For each Janumet 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.
Janumet may be tested according to a variety of international standards, such as European Pharmacopoeia (Janumet EP), Janumet JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Janumet USP).
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