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1. (2s)-(((3-hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile
2. Galvus
3. Nvp Laf237
4. Nvp-laf237
5. Vildagliptin
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
1. Jalra
2. Equa
| Molecular Weight | 303.4 g/mol |
|---|---|
| Molecular Formula | C17H25N3O2 |
| XLogP3 | 0.9 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 3 |
| Exact Mass | 303.19467705 g/mol |
| Monoisotopic Mass | 303.19467705 g/mol |
| Topological Polar Surface Area | 76.4 Ų |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 523 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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
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.)
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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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.
A Galvus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galvus, including repackagers and relabelers. The FDA regulates Galvus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galvus 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 Galvus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Galvus supplier is an individual or a company that provides Galvus active pharmaceutical ingredient (API) or Galvus finished formulations upon request. The Galvus suppliers may include Galvus API manufacturers, exporters, distributors and traders.
click here to find a list of Galvus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Galvus DMF (Drug Master File) is a document detailing the whole manufacturing process of Galvus active pharmaceutical ingredient (API) in detail. Different forms of Galvus DMFs exist exist since differing nations have different regulations, such as Galvus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galvus DMF submitted to regulatory agencies in the US is known as a USDMF. Galvus USDMF includes data on Galvus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galvus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galvus 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 Galvus Drug Master File in Japan (Galvus JDMF) empowers Galvus 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 Galvus JDMF during the approval evaluation for pharmaceutical products. At the time of Galvus 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 Galvus 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 Galvus Drug Master File in Korea (Galvus KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Galvus. The MFDS reviews the Galvus KDMF as part of the drug registration process and uses the information provided in the Galvus KDMF to evaluate the safety and efficacy of the drug.
After submitting a Galvus 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 Galvus API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Galvus suppliers with KDMF on PharmaCompass.
A Galvus written confirmation (Galvus WC) is an official document issued by a regulatory agency to a Galvus manufacturer, verifying that the manufacturing facility of a Galvus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Galvus APIs or Galvus finished pharmaceutical products to another nation, regulatory agencies frequently require a Galvus WC (written confirmation) as part of the regulatory process.
click here to find a list of Galvus 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 Galvus as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Galvus 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 Galvus 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 Galvus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galvus NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Galvus suppliers with NDC on PharmaCompass.
Galvus 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 Galvus 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 Galvus GMP manufacturer or Galvus GMP API supplier for your needs.
A Galvus CoA (Certificate of Analysis) is a formal document that attests to Galvus's compliance with Galvus specifications and serves as a tool for batch-level quality control.
Galvus CoA mostly includes findings from lab analyses of a specific batch. For each Galvus 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.
Galvus may be tested according to a variety of international standards, such as European Pharmacopoeia (Galvus EP), Galvus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Galvus USP).
