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1. D9-ivacaftor
2. Ivacaftor D9
3. Ivacaftor-d9
4. Sha6u5fjzl
5. 1413431-07-8
6. Deutivacaftor [usan]
7. Ctp-656
8. Vx-561
9. N-[2-tert-butyl-4-[1,1,1,3,3,3-hexadeuterio-2-(trideuteriomethyl)propan-2-yl]-5-hydroxyphenyl]-4-oxo-1h-quinoline-3-carboxamide
10. Unii-sha6u5fjzl
11. Deutivacaftor [inn]
12. Deutivacaftor (usan/inn)
13. Deutivacaftor [who-dd]
14. Chembl4297603
15. Schembl15504743
16. Hy-13017s
17. Who 10704
18. Db15141
19. Cs-0068247
20. D11423
21. 3-quinolinecarboxamide, N-(2-(1,1-dimethylethyl)-4-(1,1-di(methyl-d3)ethyl- 2,2,2-d3)-5-hydroxyphenyl)-1,4-dihydro-4-oxo-
22. N-(2-tert-butyl-5-hydroxy-4-(2-(2h3)methyl(1,1,1,3,3,3-2h6)propan-2-yl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
| Molecular Weight | 401.5 g/mol |
|---|---|
| Molecular Formula | C24H28N2O3 |
| XLogP3 | 5.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 401.26648347 g/mol |
| Monoisotopic Mass | 401.26648347 g/mol |
| Topological Polar Surface Area | 78.4 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 671 |
| Isotope Atom Count | 9 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
NDC API
NDC Package Code : 57572-0722
Start Marketing Date : 2022-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
21 Dec 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-vertex-pharmas-triple-combo-cystic-fibrosis-treatment-2024-12-20/
26 Sep 2024
// BUSINESSWIRE
ABOUT THIS PAGE
A Deutivacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deutivacaftor, including repackagers and relabelers. The FDA regulates Deutivacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deutivacaftor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Deutivacaftor supplier is an individual or a company that provides Deutivacaftor active pharmaceutical ingredient (API) or Deutivacaftor finished formulations upon request. The Deutivacaftor suppliers may include Deutivacaftor API manufacturers, exporters, distributors and traders.
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 Deutivacaftor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deutivacaftor 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 Deutivacaftor 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 Deutivacaftor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deutivacaftor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deutivacaftor suppliers with NDC on PharmaCompass.
Deutivacaftor 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 Deutivacaftor 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 Deutivacaftor GMP manufacturer or Deutivacaftor GMP API supplier for your needs.
A Deutivacaftor CoA (Certificate of Analysis) is a formal document that attests to Deutivacaftor's compliance with Deutivacaftor specifications and serves as a tool for batch-level quality control.
Deutivacaftor CoA mostly includes findings from lab analyses of a specific batch. For each Deutivacaftor 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.
Deutivacaftor may be tested according to a variety of international standards, such as European Pharmacopoeia (Deutivacaftor EP), Deutivacaftor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deutivacaftor USP).
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