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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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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 207-43-ND
Manufacturer Name : Moehs BCN, SL
Manufacturer Address : Polígono Industrial Aquiberia, c/Zenc, 12 08755 Castellbisbal (Barcelona) Spain
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registration Number : 305MF10086
Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Vadodara-390 020, Gujarat, India
Initial Date of Registration : 2023-07-19
Latest Date of Registration : --
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 434-39-ND
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, Gujarat, India
| Available Reg Filing : BR, CN, MX |
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Vildagliptin 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 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.
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 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.
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).
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