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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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DMF Review : Reviewed
Rev. Date : 2024-12-26
Pay. Date : 2024-12-11
DMF Number : 40524
Submission : 2024-09-27
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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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 :
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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 : 71495-0004
Start Marketing Date : 2023-09-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
AMI Lifesciences is Driven by Chemistry. Powered by People.
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Rev. Date :
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DMF Number : 37030
Submission : 2022-05-02
Status : Active
Type : II
Certificate Number : CEP 2024-249 - Rev 00
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2778
Status : Valid
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Registration Number : 303MF10124
Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.
Initial Date of Registration : 2021-08-16
Latest Date of Registration : 2021-08-16
Registration Number : 306MF10105
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2024-07-24
Latest Date of Registration : 2024-07-24
Registration Number : 226MF10001
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2014-01-08
Latest Date of Registration : 2014-01-08
Sitagliptin phosphate hydrate (containing propyl gallate)
Registration Number : 305MF10116
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2023-10-12
Latest Date of Registration : 2023-10-12
Registration Number : 231MF10016
Registrant's Address : 50 Tuas West Drive Singapore 638408
Initial Date of Registration : 2019-01-23
Latest Date of Registration : 2019-01-23
Sitagliptin phosphate hydrate (containing propyl gallate)
Registration Number : 305MF10105
Registrant's Address : 50 Tuas West Drive Singapore 638408
Initial Date of Registration : 2023-08-30
Latest Date of Registration : 2023-08-30
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Sitagliptin Phosphate Anhydrous IH
Date of Issue : 2022-08-24
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit ?IV, MIDC, Tarapur?401506, Taluka: Palghar, Di...
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...
Sitagliptin Phosphate Monohydrate IH
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...
Sitagliptin Phosphate Anhydrous IH
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Survey no. 52,53,58,59,61 to 78,127&128, Pydibhimanvaram Village &Sy.No. 1,2,4t0...
Date of Issue : 2022-06-03
Valid Till : 2025-06-16
Written Confirmation Number : WC-0030n
Address of the Firm : UNIT-II, Annavaram (Post), Chippada Village, Bheemunipatnam Mandai, Visakhapatna...
Sitagliptin Phosphate Monohydrate
Date of Issue : 2022-08-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045nA2
Address of the Firm : Plot No. E-7, E-8, E-9, MIDC Industrial Area, Chikalthana, Aurangabad-431006
Sitagliptin Phosphate Anhydrous IH
Date of Issue : 2022-07-11
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 182 to 186, 192-A and 193 to 197 & 212/A,B,C,D Phase-ll, IDA, Pashamyla...
Sitagliptin Phosphate Monohydrate IH/USP/Ph. Eur
Date of Issue : 2022-07-11
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 182 to 186, 192-A and 193 to 197 & 212/A,B,C,D Phase-ll, IDA, Pashamyla...
Sitagliptin Phosphate Monohydrate Ph. Eur
Date of Issue : 2022-05-02
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027A2
Address of the Firm : Unit-ll, Sy. No. 14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, San...
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
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Dosage Form : Oral Solid Dosage Form
Dosage Strength : 25MG
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Sitagliptin Phosphate; Metformin
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 50MG; 500MG
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Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Sitagliptin Phosphate; Metformin
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Registration Country : Italy
Brand Name : SITAGLIPTIN AND METFORMIN DR. REDDY'S
Dosage Form : Film-Coated Tablets
Dosage Strength : 50 mg/1,000 mg
Packaging : 56 UNITS (50+1000) MG - ORAL USE
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Brand Name : SITAGLIPTIN AND METFORMIN DR. REDDY'S
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Dosage Strength : 50 mg/850 mg
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Metformin hydrochloride; Sitagliptin
Brand Name : Sitagliptin Metformin Zentiva
Dosage Form : Filmtabl
Dosage Strength : 50/1000mg
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Metformin hydrochloride; Sitagliptin
Brand Name : Sitagliptin Metformin Zentiva
Dosage Form : Filmtabl
Dosage Strength : 50/500mg
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RLD :
TE Code :
Brand Name : SITAGLIPTIN
Dosage Form : TABLET; FILM COATED
Dosage Strength : 25MG
Approval Date :
Application Number : 216919
RX/OTC/DISCN :
RLD :
TE Code :
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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TE Code :
Brand Name : SITAGLIPTIN
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Dosage Strength : 50MG
Approval Date :
Application Number : 216919
RX/OTC/DISCN :
RLD :
TE Code :
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RLD :
TE Code :
Brand Name : SITAGLIPTIN
Dosage Form : TABLET; FILM COATED
Dosage Strength : 100MG
Approval Date :
Application Number : 216919
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SITAGLIPTIN PHOSPHATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date :
Application Number : 215155
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SITAGLIPTIN PHOSPHATE
Dosage Form : TABLET; ORAL
Dosage Strength : 100MG
Approval Date :
Application Number : 202425
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Brand Name : SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 1GM;EQ 100MG BASE
Approval Date : 2025-06-04
Application Number : 204144
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : JANUVIA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 25MG BASE
Approval Date : 2006-10-16
Application Number : 21995
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Brand Name : JUVISYNC
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2011-10-07
Application Number : 202343
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
Brand Name : STEGLUJAN
Dosage Form : TABLET;ORAL
Dosage Strength : 15MG;EQ 100MG BASE
Approval Date : 2017-12-19
Application Number : 209805
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : SITAGLIPTIN PHOSPHATE
Dosage Form : TABLET; ORAL
Dosage Strength : EQ 25MG BASE
Approval Date :
Application Number : 202387
RX/OTC/DISCN :
RLD :
TE Code :
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Regulatory Info : Lead Market Dossiers- Filed
Dosage : Oral Solid Dosage Form
Dosage Strength : 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Dosage : Oral Solid Dosage Form
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Dosage : Oral Solid Dosage Form
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Sitagliptin Phosphate; Metformin
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 50MG; 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Sitagliptin Phosphate; Metformin
Dosage : Oral Solid Dosage Form
Dosage Strength : 50MG; 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Sitagliptin Phosphate; Metformin
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 50MG; 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Sitagliptin Phosphate; Metformin
Dosage : Oral Solid Dosage Form
Dosage Strength : 50MG; 1000MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Regulatory Info :
Registration Country : India
Brand Name : Sitagliptin
Dosage Form : Granules
Dosage Strength : 25%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Packaging :
Regulatory Info :
Dosage : Granules
Dosage Strength : 25%
Brand Name : Sitagliptin
Approval Date :
Application Number :
Registration Country : India
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q4 2024
Registration Country : Poland
Brand Name :
Dosage Form : Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q4 2024
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q4 2024
Dosage : Coated Tablet
Dosage Strength : 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q4 2024
Registration Country : Poland
Brand Name :
Dosage Form : Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q4 2024
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q4 2024
Dosage : Coated Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q4 2024
Registration Country : Poland
Brand Name :
Dosage Form : Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q4 2024
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q4 2024
Dosage : Coated Tablet
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q4 2018
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q4 2018
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Packaging :
Regulatory Info : EU Dossier Readiness-Q4 2018
Dosage : Film Coated Tablet
Dosage Strength : 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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ABOUT THIS PAGE
94
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 JANUMET-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JANUMET-1, including repackagers and relabelers. The FDA regulates JANUMET-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JANUMET-1 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-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A JANUMET-1 supplier is an individual or a company that provides JANUMET-1 active pharmaceutical ingredient (API) or JANUMET-1 finished formulations upon request. The JANUMET-1 suppliers may include JANUMET-1 API manufacturers, exporters, distributors and traders.
click here to find a list of JANUMET-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A JANUMET-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of JANUMET-1 active pharmaceutical ingredient (API) in detail. Different forms of JANUMET-1 DMFs exist exist since differing nations have different regulations, such as JANUMET-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A JANUMET-1 DMF submitted to regulatory agencies in the US is known as a USDMF. JANUMET-1 USDMF includes data on JANUMET-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The JANUMET-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of JANUMET-1 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-1 Drug Master File in Japan (JANUMET-1 JDMF) empowers JANUMET-1 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-1 JDMF during the approval evaluation for pharmaceutical products. At the time of JANUMET-1 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-1 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-1 Drug Master File in Korea (JANUMET-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of JANUMET-1. The MFDS reviews the JANUMET-1 KDMF as part of the drug registration process and uses the information provided in the JANUMET-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a JANUMET-1 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-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of JANUMET-1 suppliers with KDMF on PharmaCompass.
A JANUMET-1 CEP of the European Pharmacopoeia monograph is often referred to as a JANUMET-1 Certificate of Suitability (COS). The purpose of a JANUMET-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of JANUMET-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of JANUMET-1 to their clients by showing that a JANUMET-1 CEP has been issued for it. The manufacturer submits a JANUMET-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a JANUMET-1 CEP holder for the record. Additionally, the data presented in the JANUMET-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the JANUMET-1 DMF.
A JANUMET-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. JANUMET-1 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-1 suppliers with CEP (COS) on PharmaCompass.
A JANUMET-1 written confirmation (JANUMET-1 WC) is an official document issued by a regulatory agency to a JANUMET-1 manufacturer, verifying that the manufacturing facility of a JANUMET-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting JANUMET-1 APIs or JANUMET-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a JANUMET-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of JANUMET-1 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-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for JANUMET-1 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-1 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-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a JANUMET-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of JANUMET-1 suppliers with NDC on PharmaCompass.
JANUMET-1 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-1 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-1 GMP manufacturer or JANUMET-1 GMP API supplier for your needs.
A JANUMET-1 CoA (Certificate of Analysis) is a formal document that attests to JANUMET-1's compliance with JANUMET-1 specifications and serves as a tool for batch-level quality control.
JANUMET-1 CoA mostly includes findings from lab analyses of a specific batch. For each JANUMET-1 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-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (JANUMET-1 EP), JANUMET-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (JANUMET-1 USP).
