Synopsis
Synopsis
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USDMF
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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Stock Recap #PipelineProspector
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1. 3-pyridinecarboxamide, N-((1,3-dimethyl-1h-pyrazol-4-yl)sulfonyl)-6-(3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1h-pyrazol-1-yl)-2-((4s)-2,2,4-trimethyl-1-pyrrolidinyl)-
2. Vx-445
3. Vx445
1. 2216712-66-0
2. Vx-445
3. Elexacaftor [usan]
4. Rrn67gmb0v
5. Elexacaftor (usan)
6. (s)-n-((1,3-dimethyl-1h-pyrazol-4-yl)sulfonyl)-6-(3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1h-pyrazol-1-yl)-2-(2,2,4-trimethylpyrrolidin-1-yl)nicotinamide
7. 3-pyridinecarboxamide, N-((1,3-dimethyl-1h-pyrazol-4-yl)sulfonyl)-6-(3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1h-pyrazol-1-yl)-2-((4s)-2,2,4-trimethyl-1-pyrrolidinyl)-
8. N-(1,3-dimethylpyrazol-4-yl)sulfonyl-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)pyrazol-1-yl]-2-[(4s)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide
9. (6p)-n-(1,3-dimethyl-1h-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1h-pyrazol-1-yl]-2-[(4s)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide
10. Wjx
11. Elexacaftor [mi]
12. Unii-rrn67gmb0v
13. Elexacaftor [inn]
14. Elexacaftor (vx-445)
15. Elexacaftor [who-dd]
16. Elexacaftor/ivacaftor/tezacaftor
17. Chembl4298128
18. Schembl20239811
19. Gtpl10552
20. Elexacaftor [orange Book]
21. Dtxsid901027907
22. Ex-a3637
23. S8851
24. Trikafta Component Elexacaftor
25. Vx-445vx-445
26. Who 11180
27. At16051
28. Db15444
29. Elexacaftor Component Of Trikafta
30. Compound 1 [wo2018107100a1]
31. Ac-36746
32. Hy-111772
33. Cs-0090942
34. D11507
35. A930250
Molecular Weight | 597.7 g/mol |
---|---|
Molecular Formula | C26H34F3N7O4S |
XLogP3 | 4.9 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 8 |
Exact Mass | 597.23450825 g/mol |
Monoisotopic Mass | 597.23450825 g/mol |
Topological Polar Surface Area | 133 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 1050 |
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 | 1 |
Elexacaftor, in combination with [ivacaftor] and [tezacaftor] as the combination product TrikaftaTM, is indicated for the treatment of cystic fibrosis (CF) in patients 12 years of age and older who have at least one _F508del_ mutation in the CTFR gene.
As a CFTR corrector, elexacaftor works to increase the amount of mature CFTR proteins present on the surface of cells. When used in combination with CFTR potentiators, which enhance the function of cell-surface CFTR proteins, drugs like elexacaftor help to improve a variety of multi-organ cystic fibrosis symptoms, including lung function, nutritional status, and overall quality of life. TrikaftaTM, the triple combination product containing elexacaftor, may cause elevations in liver transaminases. Liver function testing should be conducted prior to beginning Trikafta, every 3 months for the first year of treatment, and annually thereafter.
Chloride Channel Agonists
A class of drugs that stimulate chloride ion influx through cell membrane channels. (See all compounds classified as Chloride Channel Agonists.)
Absorption
The absolute oral bioavailability of elexacaftor is approximately 80%. The steady-state AUC0-24h and Cmax following once daily dosing with elexacaftor 200mg are 162 mcgh/mL and 8.7 mcg/mL, respectively, and the median Tmax is 6 hours. The AUC of elexacaftor is increased 1.9-2.5-fold following a moderate-fat meal - for this reason, it is recommended to give TrikaftaTM with fat-containing food.
Route of Elimination
Approximately 87.3% of an administered radio-labeled dose of elexacaftor was found in the feces, mostly as metabolites, while only 0.23% of that same dose was found excreted in the urine.
Volume of Distribution
The apparent volume of distribution of elexacaftor is 53.7 L.
Clearance
The mean apparent clearance of elexacaftor is 1.18 L/h.
The metabolism of elexacaftor is extensive and primarily catalyzed via CYP3A4/5. Its main active metabolite, M23-ELX, carries a similar potency as the parent drug. The precise metabolic pathway of elexacaftor has not yet been elucidated in published research.
The mean terminal half-life of elexacaftor is approximately 24.7 hours.
Cystic fibrosis (CF) is the result of a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The CFTR proteins produced by this gene are transmembrane ion channels that move sodium and chloride across cell membranes - water follows the flow of chloride ions to the cell surface, which consequently helps to hydrate the surface of the cell and thin the secretions (i.e. mucous) around the cell. Mutations in the CFTR gene produce CFTR proteins of insufficient quantity and/or function, leading to defective ion transport and a build-up of thick mucous throughout the body that causes multi-organ disease involving the pulmonary, gastrointestinal, and pancreatic systems (amongst others). The most common CFTR mutation, the _F508del_ mutation, is estimated to account for 70 to 90% of all CFTR mutations and results in severe processing and trafficking defects of the CFTR protein. Elexacaftor is a CFTR corrector that modulates CFTR proteins to facilitate trafficking to the cell surface for incorporation into the cell membrane. The end result is an increase in the number of mature CFTR proteins present at the cell surface and, therefore, improved ion transport and CF symptomatology. Elexacaftor is used in combination with tezacaftor, another CFTR corrector with a different mechanism of action, and ivacaftor, a CFTR potentiator that improves the function of CFTR proteins on the cell surface - this multi-faceted, triple-drug approach confers a synergistic effect beyond that seen in typical corrector/potentiator dual therapy regimens.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC Package Code : 57572-0717
Start Marketing Date : 2020-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 24538-445
Start Marketing Date : 2019-10-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...
About the Company : Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Ph...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
About the Company : SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a sin...
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface.
Lead Product(s): Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Kaftrio
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 07, 2025
Lead Product(s) : Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EC Expands KAFTRIO Label with Ivacaftor for Cystic Fibrosis Patients
Details : Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface.
Product Name : Kaftrio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 07, 2025
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to bind on CFTR protein, which is investigated for cystic fibrosis in patients aged 2 years & above.
Lead Product(s): Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Kaftrio
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 28, 2025
Lead Product(s) : Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Gets CHMP Positive Opinion for KAFTRIO® Label Expansion in Cystic Fibrosis
Details : Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to bind on CFTR protein, which is investigated for cystic fibrosis in patients aged 2 years & above.
Product Name : Kaftrio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 28, 2025
Details:
Trikafta (ivacaftor/tezacaftor/elexacaftor) is an oral drug designed to binding to different sites on the CFTR protein, indicated for F508del-mutated cystic fibrosis in patients aged 2 years & above.
Lead Product(s): Elexacaftor,Ivacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Trikafta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2024
Lead Product(s) : Elexacaftor,Ivacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Announces U.S. FDA Approval for TRIKAFTA Including Non-F508del Variants
Details : Trikafta (ivacaftor/tezacaftor/elexacaftor) is an oral drug designed to binding to different sites on the CFTR protein, indicated for F508del-mutated cystic fibrosis in patients aged 2 years & above.
Product Name : Trikafta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 20, 2024
Details:
Undisclosed
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 14, 2024
Lead Product(s) : Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 14, 2024
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of cystic fibrosis in patients aged 2 years & above.
Lead Product(s): Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Kaftrio
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 24, 2023
Lead Product(s) : Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of cystic fibrosis in patients aged 2 years & above.
Product Name : Kaftrio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 24, 2023
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of cystic fibrosis in patients aged 2 years & above.
Lead Product(s): Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Kaftrio
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 23, 2023
Lead Product(s) : Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves KAFTRIO® in Combination With Ivacaftor for the Treatment of Children...
Details : Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of cystic fibrosis in patients aged 2 years & above.
Product Name : Kaftrio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 23, 2023
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of children With cystic fibrosis ages 2 through 5.
Lead Product(s): Elexacaftor,Ivacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Trikafta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 15, 2023
Lead Product(s) : Elexacaftor,Ivacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Receives CHMP Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combinat...
Details : Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of children With cystic fibrosis ages 2 through 5.
Product Name : Trikafta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 15, 2023
Details:
Undisclosed
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 31, 2023
Lead Product(s) : Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 31, 2023
Details:
Trikafta is a combination drug where elexacaftor and tezacaftor bind to different sites of CFTR and additionally facilitates the cellular processing and trafficking of mutated CFTR. Ivacaftor potentiates the channel open probability of the CFTR protein at the cell surface.
Lead Product(s): Elexacaftor,Ivacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Trikafta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 26, 2023
Lead Product(s) : Elexacaftor,Ivacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vertex Announces U.S. FDA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)...
Details : Trikafta is a combination drug where elexacaftor and tezacaftor bind to different sites of CFTR and additionally facilitates the cellular processing and trafficking of mutated CFTR. Ivacaftor potentiates the channel open probability of the CFTR protein a...
Product Name : Trikafta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 26, 2023
Details:
EC approval for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor has shown clinical benefit for people with CF ages 12 and above. This medicine is also approved in the regulatory authorities of New Zealand and Switzerland, where it is known as TRIKAFTA.
Lead Product(s): Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area: Genetic Disease Brand Name: Kaftrio
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 01, 2022
Lead Product(s) : Ivacaftor,Elexacaftor,Tezacaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivac...
Details : EC approval for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor has shown clinical benefit for people with CF ages 12 and above. This medicine is also approved in the regulatory authorities of New Zealand and Switzerland, where i...
Product Name : Kaftrio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 01, 2022
Global Sales Information
Market Place
Reply
03 Oct 2023
Reply
31 Jan 2023
Patents & EXCLUSIVITIES
Patent Expiration Date : 2035-10-06
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 11426407
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 212273
Patent Use Code : U-3425
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-10-06
Patent Expiration Date : 2027-04-09
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 11639347
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 212273
Patent Use Code : U-3587
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-04-09
Patent Expiration Date : 2033-07-15
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 9012496
Drug Substance Claim :
Drug Product Claim :
Application Number : 212273
Patent Use Code : U-3154
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-07-15
Patent Expiration Date : 2038-07-17
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 12350262
Drug Substance Claim :
Drug Product Claim :
Application Number : 217660
Patent Use Code : U-4220
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-07-17
Patent Expiration Date : 2033-02-27
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 11752106
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217660
Patent Use Code : U-3696
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-02-27
Patent Expiration Date : 2037-12-08
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 10793547
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217660
Patent Use Code : U-4066
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-12-08
Patent Expiration Date : 2037-12-08
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 11179367
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217660
Patent Use Code : U-3597
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-12-08
Patent Expiration Date : 2037-12-08
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 11179367
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 212273
Patent Use Code : U-3253
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-12-08
Patent Expiration Date : 2027-08-05
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 8324242
Drug Substance Claim :
Drug Product Claim :
Application Number : 217660
Patent Use Code : U-3589
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-08-05
Patent Expiration Date : 2027-04-09
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US Patent Number : 10022352
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 212273
Patent Use Code : U-3156
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-04-09
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : M-313
Exclusivity Expiration Date : 2027-12-20
Application Number : 212273
Product Number : 1
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE-275
Exclusivity Expiration Date : 2026-10-21
Application Number : 212273
Product Number : 1
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE-323
Exclusivity Expiration Date : 2027-12-21
Application Number : 212273
Product Number : 1
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE-357
Exclusivity Expiration Date : 2028-06-08
Application Number : 212273
Product Number : 1
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE-512
Exclusivity Expiration Date : 2031-12-20
Application Number : 212273
Product Number : 1
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : M-313
Exclusivity Expiration Date : 2027-12-20
Application Number : 212273
Product Number : 2
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE*
Exclusivity Expiration Date : 2026-10-21
Application Number : 212273
Product Number : 2
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE*
Exclusivity Expiration Date : 2027-12-21
Application Number : 212273
Product Number : 2
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE-357
Exclusivity Expiration Date : 2028-06-08
Application Number : 212273
Product Number : 2
Exclusivity Details :
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Exclusivity Code : ODE-512
Exclusivity Expiration Date : 2031-12-20
Application Number : 212273
Product Number : 2
Exclusivity Details :
ABOUT THIS PAGE
12
PharmaCompass offers a list of Elexacaftor 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 Elexacaftor manufacturer or Elexacaftor supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Elexacaftor manufacturer or Elexacaftor supplier.
PharmaCompass also assists you with knowing the Elexacaftor API Price utilized in the formulation of products. Elexacaftor API Price is not always fixed or binding as the Elexacaftor Price is obtained through a variety of data sources. The Elexacaftor Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Elexacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elexacaftor, including repackagers and relabelers. The FDA regulates Elexacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elexacaftor 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 Elexacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elexacaftor supplier is an individual or a company that provides Elexacaftor active pharmaceutical ingredient (API) or Elexacaftor finished formulations upon request. The Elexacaftor suppliers may include Elexacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of Elexacaftor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Elexacaftor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elexacaftor 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 Elexacaftor 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 Elexacaftor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elexacaftor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elexacaftor suppliers with NDC on PharmaCompass.
Elexacaftor 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 Elexacaftor 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 Elexacaftor GMP manufacturer or Elexacaftor GMP API supplier for your needs.
A Elexacaftor CoA (Certificate of Analysis) is a formal document that attests to Elexacaftor's compliance with Elexacaftor specifications and serves as a tool for batch-level quality control.
Elexacaftor CoA mostly includes findings from lab analyses of a specific batch. For each Elexacaftor 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.
Elexacaftor may be tested according to a variety of international standards, such as European Pharmacopoeia (Elexacaftor EP), Elexacaftor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elexacaftor USP).