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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
API SUPPLIERS
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-18
Pay. Date : 2020-09-16
DMF Number : 34400
Submission : 2019-12-30
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 71796-016
Start Marketing Date : 2019-12-30
End Marketing Date : 2026-12-31
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
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36129
Submission : 2021-07-19
Status : Active
Type : II
| Available Reg Filing : ASMF |
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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
| Available Reg Filing : ASMF |
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.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-11-14
Registration Number : Number 207-69-ND
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
NDC Package Code : 69037-0021
Start Marketing Date : 2016-12-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Withers Pharmaceutical Co., Ltd.
Registration Date : 2025-04-07
Registration Number : Su259-7-ND(5)
Manufacturer Name : Honour Lab Limited
Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure SEZ Ltd, N.Narasapuram Village, Nakkapally Mandal, Visakhapatnam District, Andhra Pradesh, India
| Available Reg Filing : ASMF |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2017-12-15
Registration Number : No. 574-7-ND
Manufacturer Name : Dr. Reddy\'s Laboratories Limited
Manufacturer Address : Chemical Technical Operations-Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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
| Available Reg Filing : ASMF |
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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, Visakhapatnam District - 531 081, Andhra Pradesh, India
| Available Reg Filing : ASMF |
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PharmaCompass offers a list of Sitagliptin Hydrochloride 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 Hydrochloride manufacturer or Sitagliptin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sitagliptin Hydrochloride manufacturer or Sitagliptin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Sitagliptin Hydrochloride API Price utilized in the formulation of products. Sitagliptin Hydrochloride API Price is not always fixed or binding as the Sitagliptin Hydrochloride Price is obtained through a variety of data sources. The Sitagliptin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sitagliptin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Hydrochloride, including repackagers and relabelers. The FDA regulates Sitagliptin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitagliptin Hydrochloride supplier is an individual or a company that provides Sitagliptin Hydrochloride active pharmaceutical ingredient (API) or Sitagliptin Hydrochloride finished formulations upon request. The Sitagliptin Hydrochloride suppliers may include Sitagliptin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sitagliptin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sitagliptin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sitagliptin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sitagliptin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sitagliptin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sitagliptin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sitagliptin Hydrochloride USDMF includes data on Sitagliptin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sitagliptin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sitagliptin Hydrochloride suppliers with USDMF 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 Sitagliptin Hydrochloride Drug Master File in Korea (Sitagliptin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sitagliptin Hydrochloride. The MFDS reviews the Sitagliptin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Sitagliptin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sitagliptin Hydrochloride suppliers with KDMF on PharmaCompass.
A Sitagliptin Hydrochloride written confirmation (Sitagliptin Hydrochloride WC) is an official document issued by a regulatory agency to a Sitagliptin Hydrochloride manufacturer, verifying that the manufacturing facility of a Sitagliptin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sitagliptin Hydrochloride APIs or Sitagliptin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sitagliptin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sitagliptin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sitagliptin Hydrochloride suppliers with NDC on PharmaCompass.
Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride GMP manufacturer or Sitagliptin Hydrochloride GMP API supplier for your needs.
A Sitagliptin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sitagliptin Hydrochloride's compliance with Sitagliptin Hydrochloride specifications and serves as a tool for batch-level quality control.
Sitagliptin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sitagliptin Hydrochloride 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.
Sitagliptin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sitagliptin Hydrochloride EP), Sitagliptin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sitagliptin Hydrochloride USP).
