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1. Symdeko
2. Tezacaftor - Ivacaftor
3. Tezacaftor And Ivacaftor
4. Tezacaftor, Ivacaftor Drug Combination
5. Tezacaftor; Ivacaftor
1. Ivacaftor Regimen With Tezacaftor
2. 1969264-35-4
3. Ivacaftor / Tezacaftor
4. Tezacaftor / Ivacaftor
5. Tezacaftor And Ivacaftor
6. Ivacaftor And Tezacaftor
7. Tezacaftor Mixture With Ivacaftor
8. Dtxsid401027914
9. 3-quinolinecarboxamide, N-(2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl)-1,4-dihydro-4-oxo-, Mixture With 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-n-(1-((2r)-2,3-dihydroxypropyl)-6-fluoro-2-(2-hydroxy-1,1-dimethylethyl)-1h-indol-5-yl)cyclopropanecarboxamide
| Molecular Weight | 913.0 g/mol |
|---|---|
| Molecular Formula | C50H55F3N4O9 |
| Hydrogen Bond Donor Count | 7 |
| Hydrogen Bond Acceptor Count | 13 |
| Rotatable Bond Count | 12 |
| Exact Mass | 912.39211383 g/mol |
| Monoisotopic Mass | 912.39211383 g/mol |
| Topological Polar Surface Area | 192 Ų |
| Heavy Atom Count | 66 |
| Formal Charge | 0 |
| Complexity | 1530 |
| 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 |
Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3AG, S945L, S977F, R1070W, D1152H, 2789+5GA, 3272 26AG, and 3849+10kbCT.
R07AX31
R - Respiratory system
R07 - Other respiratory system products
R07A - Other respiratory system products
R07AX - Other respiratory system products
R07AX31 - Ivacaftor and tezacaftor
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Ivacaftor/Tezacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivacaftor/Tezacaftor, including repackagers and relabelers. The FDA regulates Ivacaftor/Tezacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivacaftor/Tezacaftor 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 Ivacaftor/Tezacaftor supplier is an individual or a company that provides Ivacaftor/Tezacaftor active pharmaceutical ingredient (API) or Ivacaftor/Tezacaftor finished formulations upon request. The Ivacaftor/Tezacaftor suppliers may include Ivacaftor/Tezacaftor API manufacturers, exporters, distributors and traders.
Ivacaftor/Tezacaftor 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 Ivacaftor/Tezacaftor 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 Ivacaftor/Tezacaftor GMP manufacturer or Ivacaftor/Tezacaftor GMP API supplier for your needs.
A Ivacaftor/Tezacaftor CoA (Certificate of Analysis) is a formal document that attests to Ivacaftor/Tezacaftor's compliance with Ivacaftor/Tezacaftor specifications and serves as a tool for batch-level quality control.
Ivacaftor/Tezacaftor CoA mostly includes findings from lab analyses of a specific batch. For each Ivacaftor/Tezacaftor 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.
Ivacaftor/Tezacaftor may be tested according to a variety of international standards, such as European Pharmacopoeia (Ivacaftor/Tezacaftor EP), Ivacaftor/Tezacaftor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ivacaftor/Tezacaftor USP).
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