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Chemistry

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Also known as: Vildagliptin, 274901-16-5, (2r)-1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile, Vildagliptin (2r)-isomer, Schembl671629, Dtxsid301119534
Molecular Formula
C17H25N3O2
Molecular Weight
303.4  g/mol
InChI Key
SYOKIDBDQMKNDQ-JULPFRMLSA-N

Vildagliptin
A pyrrolidine-carbonitrile derivative and potent inhibitor of DIPEPTIDYL PEPTIDASE 4 that is used in the treatment of TYPE 2 DIABETES MELLITUS.
1 2D Structure

Vildagliptin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile
2.1.2 InChI
InChI=1S/C17H25N3O2/c18-9-14-2-1-3-20(14)15(21)10-19-16-5-12-4-13(6-16)8-17(22,7-12)11-16/h12-14,19,22H,1-8,10-11H2/t12?,13?,14-,16?,17?/m1/s1
2.1.3 InChI Key
SYOKIDBDQMKNDQ-JULPFRMLSA-N
2.1.4 Canonical SMILES
C1CC(N(C1)C(=O)CNC23CC4CC(C2)CC(C4)(C3)O)C#N
2.1.5 Isomeric SMILES
C1C[C@@H](N(C1)C(=O)CNC23CC4CC(C2)CC(C4)(C3)O)C#N
2.2 Synonyms
2.2.1 MeSH Synonyms

1. (2s)-(((3-hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile

2. Galvus

3. Nvp Laf237

4. Nvp-laf237

5. Vildagliptin

2.2.2 Depositor-Supplied Synonyms

1. Vildagliptin

2. 274901-16-5

3. (2r)-1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile

4. Vildagliptin (2r)-isomer

5. Schembl671629

6. Dtxsid301119534

7. Akos015969326

8. F78360

9. A819091

10. (2r)-1-[2-[(3-hydroxy-1-adamantyl)amino]-1-oxoethyl]-2-pyrrolidinecarbonitrile

11. (2r)-1-[2-[(3-oxidanyl-1-adamantyl)amino]ethanoyl]pyrrolidine-2-carbonitrile

12. (2r)-1-[2-[(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)amino]acetyl]-2-pyrrolidine Carbonitrile; (r)-1-(2-(((1r,3s,5r,7s)-3-hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile

13. Rel-(2r)-1-[2-[(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)amino]acetyl]-2-pyrrolidinecarbonitrile

2.2.3 Other Synonyms

1. Jalra

2. Equa

2.3 Create Date
2008-07-11
3 Chemical and Physical Properties
Molecular Weight 303.4 g/mol
Molecular Formula C17H25N3O2
XLogP30.9
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count3
Exact Mass303.19467705 g/mol
Monoisotopic Mass303.19467705 g/mol
Topological Polar Surface Area76.4 Ų
Heavy Atom Count22
Formal Charge0
Complexity523
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:

as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control


Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:

- as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance.

- in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 and 5. 1 for available data on different combinations).


Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:

- as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance.

- in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 and 5. 1 for available data on different combinations).


Treatment of type II diabetes mellitus


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


Hypoglycemic Agents

Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)


5.2 ATC Code

A10BH02


A10BH02


A10BH02


A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BH - Dipeptidyl peptidase 4 (dpp-4) inhibitors

A10BH02 - Vildagliptin


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05-Jan-2022
28-May-2025
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ABOUT THIS PAGE

Looking for 274901-16-5 / Vildagliptin API manufacturers, exporters & distributors?

Vildagliptin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Vildagliptin 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 Vildagliptin manufacturer or Vildagliptin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vildagliptin manufacturer or Vildagliptin supplier.

PharmaCompass also assists you with knowing the Vildagliptin API Price utilized in the formulation of products. Vildagliptin API Price is not always fixed or binding as the Vildagliptin Price is obtained through a variety of data sources. The Vildagliptin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vildagliptin

Synonyms

274901-16-5, (2r)-1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile, Vildagliptin (2r)-isomer, Schembl671629, Dtxsid301119534, Akos015969326

Cas Number

274901-16-5

About Vildagliptin

A pyrrolidine-carbonitrile derivative and potent inhibitor of DIPEPTIDYL PEPTIDASE 4 that is used in the treatment of TYPE 2 DIABETES MELLITUS.

Vildagliptin Manufacturers

A Vildagliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vildagliptin, including repackagers and relabelers. The FDA regulates Vildagliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vildagliptin 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 Vildagliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vildagliptin Suppliers

A Vildagliptin supplier is an individual or a company that provides Vildagliptin active pharmaceutical ingredient (API) or Vildagliptin finished formulations upon request. The Vildagliptin suppliers may include Vildagliptin API manufacturers, exporters, distributors and traders.

click here to find a list of Vildagliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vildagliptin USDMF

A Vildagliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Vildagliptin active pharmaceutical ingredient (API) in detail. Different forms of Vildagliptin DMFs exist exist since differing nations have different regulations, such as Vildagliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vildagliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Vildagliptin USDMF includes data on Vildagliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vildagliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vildagliptin suppliers with USDMF on PharmaCompass.

Vildagliptin JDMF

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 Vildagliptin Drug Master File in Japan (Vildagliptin JDMF) empowers Vildagliptin 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 Vildagliptin JDMF during the approval evaluation for pharmaceutical products. At the time of Vildagliptin 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 Vildagliptin suppliers with JDMF on PharmaCompass.

Vildagliptin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Vildagliptin Drug Master File in Korea (Vildagliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vildagliptin. The MFDS reviews the Vildagliptin KDMF as part of the drug registration process and uses the information provided in the Vildagliptin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Vildagliptin 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 Vildagliptin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Vildagliptin suppliers with KDMF on PharmaCompass.

Vildagliptin WC

A Vildagliptin written confirmation (Vildagliptin WC) is an official document issued by a regulatory agency to a Vildagliptin manufacturer, verifying that the manufacturing facility of a Vildagliptin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vildagliptin APIs or Vildagliptin finished pharmaceutical products to another nation, regulatory agencies frequently require a Vildagliptin WC (written confirmation) as part of the regulatory process.

click here to find a list of Vildagliptin suppliers with Written Confirmation (WC) on PharmaCompass.

Vildagliptin NDC

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 Vildagliptin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Vildagliptin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Vildagliptin 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Vildagliptin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vildagliptin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Vildagliptin suppliers with NDC on PharmaCompass.

Vildagliptin GMP

Vildagliptin 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 Vildagliptin 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 Vildagliptin GMP manufacturer or Vildagliptin GMP API supplier for your needs.

Vildagliptin CoA

A Vildagliptin CoA (Certificate of Analysis) is a formal document that attests to Vildagliptin's compliance with Vildagliptin specifications and serves as a tool for batch-level quality control.

Vildagliptin CoA mostly includes findings from lab analyses of a specific batch. For each Vildagliptin 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.

Vildagliptin may be tested according to a variety of international standards, such as European Pharmacopoeia (Vildagliptin EP), Vildagliptin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vildagliptin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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