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1. 486459-71-6
2. Sitagliptin Monohydrochloride
3. Iel0a0os7e
4. (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;hydrochloride
5. (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 Hydrochloride
6. 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)-, Monohydrochloride
7. 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)-, Hydrochloride (1:1), (3r)-
8. Sitagliptin Hcl
9. Unii-iel0a0os7e
10. Chembl539077
11. Schembl1533793
12. Q27280690
13. 1000153-09-2
| Molecular Weight | 443.77 g/mol |
|---|---|
| Molecular Formula | C16H16ClF6N5O |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 4 |
| Exact Mass | 443.0947568 g/mol |
| Monoisotopic Mass | 443.0947568 g/mol |
| Topological Polar Surface Area | 77 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 566 |
| 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 |
For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control:
as monotherapy:
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i. e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with:
- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
A10BH01
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NDC Package Code : 71796-016
Start Marketing Date : 2019-12-30
End Marketing Date : 2025-12-31
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Registration Date : 2021-11-30
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Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No.'s 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District 532409, Andhra Pradesh, India
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Submission : 2019-12-30
Status : Active
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Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 71796-016
Start Marketing Date : 2019-12-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2021-11-30
Registration Number : No. 574-20-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No.'s 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District 532409, Andhra Pradesh, India
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