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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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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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Sitagliptin HCl Monohydrate IH
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm : CTO-SEZ-Process Unit-01, Sector No 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey...
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Sitagliptin Hydrochloride Monohydrate IH
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Date of Issue : 2023-01-06
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: Pal...
Sitagliptin Hydrochloride Monohydrate IH
Date of Issue : 2022-06-27
Valid Till : 2022-11-27
Written Confirmation Number : WC-0459A3
Address of the Firm : Unit-4, Plot No 25, 25A to 25K, Atchutapuram, Rambilli, Visakhapatnam District-5...
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 212, A, B, C, D, IDA, Phase II, Pashamylaram (V), Patancheru (M), Sanga...
Date of Issue : 2022-07-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0373
Address of the Firm : Unit-VII Kandivalasa (V) Poosapatirega (M) Vizianagaram District, Andhra Pradesh...
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Sitagliptin hydrochloride hydrate
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2017-12-15
Registration Number : No. 574-7-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : Chemical Technical Operations-Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranas...
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Sitagliptin hydrochloride hydrate
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2021-11-30
Registration Number : No. 574-20-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey N...
Sitagliptin hydrochloride hydrate
Registrant Name : Donggu Biopharmaceutical Co., Ltd.
Registration Date : 2022-12-21
Registration Number : Su207-55-ND(1)
Manufacturer Name : Benechim SRL
Manufacturer Address : Rue Rene Magritte 163 Lessines 7860 Belgium
Sitagliptin hydrochloride hydrate
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-26
Registration Number : Su207-55-ND
Manufacturer Name : Benechim SRL
Manufacturer Address : Rue Rene Magritte 163 Lessines 7860 Belgium
Sitagliptin hydrochloride hydrate
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2019-08-12
Registration Number : Su434-10-ND(1)
Manufacturer Name : Biocon Limited
Manufacturer Address : Special Economic Zone Plot No. 2, 3, 4, Phase IV Bommasandra-Jigani Link Road Bommasa...
Sitagliptin hydrochloride hydrate
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-08-08
Registration Number : Su434-10-ND
Manufacturer Name : Biocon Limited
Manufacturer Address : Special Economic Zone Plot No. 2, 3, 4, Phase IV Bommasandra-Jigani Link Road Bommasa...
Registrant Name : Shinil Pharmaceutical Co., Ltd.
Registration Date : 2022-11-18
Registration Number : Su259-7-ND(4)
Manufacturer Name : Honour Lab Limited Unit III
Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N.Narasapuram Village, Nakkapally Mandal, V...
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2019-02-01
Registration Number : Su259-7-ND(3)
Manufacturer Name : Honour Lab Limited
Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure SEZ Ltd, N.Narasapuram Village, Nakkapally...
Sitagliptin hydrochloride hydrate
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-12-24
Registration Number : Number 173-32-ND
Manufacturer Name : MSN Pharmachem Private Limit...
Manufacturer Address : Plot No.: 212/ A,B,C,D, Phase-II, IDA Pashamylaram, Pashamylaram (Village), Patancher...
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2024-09-05
Registration Number : Su579-1-ND
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Manufacturer Address : 19, Pelplinska Street., 83-200 Starogard Gdanski, Poland
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End Marketing Date : 2024-12-31
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NDC Package Code : 66651-923
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End Marketing Date : 2024-12-31
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