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1. Ivacaftor - Lumacaftor
2. Ivacaftor, Lumacaftor Drug Combination
3. Lumacaftor, Ivacaftor Drug Combination
1. Lumacaftor / Ivacaftor
2. Lumacaftor And Ivacaftor
3. Lumacaftor And Ivacaftor Tablet
4. Schembl19410545
5. Vx 700-vx 809 Combination
6. Vx 809-vx 770 Combination
7. Ivacaftor Mixture With Lumacaftor
8. Lumacaftor, Ivacaftor Drug Combination
9. S900006790
10. 1815566-23-4
| Molecular Weight | 844.9 g/mol |
|---|---|
| Molecular Formula | C48H46F2N4O8 |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 9 |
| Exact Mass | 844.32837076 g/mol |
| Monoisotopic Mass | 844.32837076 g/mol |
| Topological Polar Surface Area | 176 Ų |
| Heavy Atom Count | 62 |
| Formal Charge | 0 |
| Complexity | 1450 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 1 | |
|---|---|
| Drug Name | ORKAMBI |
| Active Ingredient | IVACAFTOR; LUMACAFTOR |
| Company | VERTEX PHARMS INC (Application Number: N206038. Patents: 7495103, 7973038, 8324242, 8410274, 8507534, 8653103, 8716338, 8741933, 8754224, 8846718, 8993600, 9150552, 9192606, 9216969, 9670163, 9931334) |
Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.
Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene.
R07AX30
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ABOUT THIS PAGE
A Orkambi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orkambi, including repackagers and relabelers. The FDA regulates Orkambi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orkambi 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 Orkambi supplier is an individual or a company that provides Orkambi active pharmaceutical ingredient (API) or Orkambi finished formulations upon request. The Orkambi suppliers may include Orkambi API manufacturers, exporters, distributors and traders.
Orkambi 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 Orkambi 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 Orkambi GMP manufacturer or Orkambi GMP API supplier for your needs.
A Orkambi CoA (Certificate of Analysis) is a formal document that attests to Orkambi's compliance with Orkambi specifications and serves as a tool for batch-level quality control.
Orkambi CoA mostly includes findings from lab analyses of a specific batch. For each Orkambi 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.
Orkambi may be tested according to a variety of international standards, such as European Pharmacopoeia (Orkambi EP), Orkambi JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orkambi USP).
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