Synopsis
Synopsis
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USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
NA
Regulatory FDF Prices
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FDF
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1. (1z)-6-fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo(13.5.2.04,9.018,22)docosa-1,4,6,8,15,19,21-heptaen-14-one
2. 1,15-etheno-1h-pyrazolo(4,3-f)(1,4,8,10)benzoxatriazacyclotridecin-4(5h)-one, 11-fluoro-2,6,7,13-tetrahydro-7,13-dimethyl-, (14z)-
1. Tpx-0005
2. 1802220-02-5
3. Ropotrectinib
4. 08o3fq4unp
5. Repotrectinib [usan]
6. Tpx0005
7. (3r,11s)-6-fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentazatetracyclo[13.5.2.04,9.018,22]docosa-1(21),4(9),5,7,15(22),16,19-heptaen-14-one
8. Trx-0005
9. Repotrectinib (usan)
10. 1,15-etheno-1h-pyrazolo(4,3-f)(1,4,8,10)benzoxatriazacyclotridecin-4(5h)-one, 11-fluoro-6,7,13,14-tetrahydro-7,13-dimethyl-, (7s,13r)-
11. Repotrectinib(tpx-005)
12. Unii-08o3fq4unp
13. Repotrectinib [inn]
14. Repotrectinib [who-dd]
15. Chembl4298138
16. Schembl16946804
17. Gtpl10316
18. Tpx 0005 [who-dd]
19. Bdbm374727
20. Ex-a2572
21. Tpx 0005
22. Us10246466, Example 93
23. Nsc800522
24. S8583
25. Akos037648789
26. Ccg-268096
27. Cs-7628
28. Nsc-800522
29. Ac-31283
30. Bs-15622
31. Example 93 [us20170334929a1]
32. Hy-103022
33. C73438
34. D11454
35. A910911
36. (13e,14e,3r,6s)-45-fluoro-3,6-dimethyl-5-oxa-2,8-diaza-1(5,3)-pyrazolo[1,5-a]pyrimidina-4(1,2)-benzenacyclononaphan-9-one
37. (13e,14e,3r,6s)-45-fluoro-3,6-dimethyl-5-oxa-2,8-diaza-1(5,3)pyrazolo[1,5-a]pyrimidina-4(1,2)-benzenacyclononaphan-9-one
38. (1z)-6-fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo(13.5.2.04,9.018,22)docosa-1,4,6,8,15,19,21-heptaen-14-one
39. (3r,11s)-6-fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo[13.5.2.04,9.018,22]docosa-1(21),4,6,8,15(22),16,19-heptaen-14-one
40. (3r,6s,)-45-fluoro-3,6-dimethyl-5-oxa-2,8-diaza-1(5,3)-pyrazolo(1,5-a)pyrimidina-4(1,2)-benzenanonaphan-9-one
41. (7s,13r)-11-fluoro-6,7,13,14-tetrahydro-7,13-dimethyl-1,15-etheno-1h-pyrazolo[4,3-f][1,4,8,10]benzoxatriazacyclotridecin-4(5h)-one
42. (7s,13r)-11-fluoro-7,13-dimethyl-6,7,13,14- Tetrahydro-1,15-ethenopyrazolo[4,3- F][1,4,8,10]benzoxatriazacyclotridecin-4(5h)- One
43. 1,15-etheno-1h-pyrazolo(4,3-f)(1,4,8,10)benzoxatriazacyclotridecin-4(5h)-one, 11-fluoro-2,6,7,13-tetrahydro-7,13-dimethyl-, (14z)-
44. 1,15-etheno-1h-pyrazolo[4,3-f][1,4,8,10]benzoxatriazacyclotridecin-4(5h)-one,11-fluoro-6,7,13,14-tetrahydro-7,13-dimethyl-, (7s,13r)-
| Molecular Weight | 355.4 g/mol |
|---|---|
| Molecular Formula | C18H18FN5O2 |
| XLogP3 | 2.1 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 0 |
| Exact Mass | 355.14445300 g/mol |
| Monoisotopic Mass | 355.14445300 g/mol |
| Topological Polar Surface Area | 80.6 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 524 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

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Repotrectinib, a miscellaneous product, shows promise in treating solid tumors with NTRK gene fusion by targeting ROS1, TrkA, TrkB, and TrkC.
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Augtyro
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2026

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zai Lab Gets NMPA Approval for AUGTYRO™ in NTRK-Positive Solid Tumors
Details : Repotrectinib, a miscellaneous product, shows promise in treating solid tumors with NTRK gene fusion by targeting ROS1, TrkA, TrkB, and TrkC.
Product Name : Augtyro
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 06, 2026

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Repotrectinib is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Anemia, Sickle Cell.
Lead Product(s): Repotrectinib,Metformin,Digoxin,Rosuvastatin Calcium,Bupropion Hydrochloride,Flurbiprofen,Omeprazole
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 03, 2025

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Lead Product(s) : Repotrectinib, Metformin, Digoxin, Rosuvastatin Calcium, Bupropion Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Repotrectinib is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Anemia, Sickle Cell.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 03, 2025

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Details:
Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI), which is being evaluated for the treatment of locally advanced or metastatic NTRK-positive solid tumors.
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Augtyro
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 21, 2025

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zai Lab sNDA Accepted for Repotrectinib in NTRK-Positive Solid Tumors
Details : Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI), which is being evaluated for the treatment of locally advanced or metastatic NTRK-positive solid tumors.
Product Name : Augtyro
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 21, 2025

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Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI), for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Augtyro
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 15, 2024

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bristol Myers Receives CHMP Opinion for Repotrectinib in ROS1/NTRK Tumors
Details : Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI), for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Product Name : Augtyro
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 15, 2024

Details:
Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Groupe Francais De Pneumo-Cancerologie | Hospices Civils de Lyon
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 13, 2024

Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Groupe Francais De Pneumo-Cancerologie | Hospices Civils de Lyon
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 13, 2024

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Details:
Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Repotrectinib,Voriconazole,Quinidine
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 10, 2024

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Lead Product(s) : Repotrectinib,Voriconazole,Quinidine
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 10, 2024

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Details:
Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor. It is approved for the treatment of NTRK-positive locally advanced or metastatic solid tumors.
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Augtyro
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 13, 2024

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Augtyro for NTRK-Positive Metastatic Solid Tumors
Details : Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor. It is approved for the treatment of NTRK-positive locally advanced or metastatic solid tumors.
Product Name : Augtyro
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 13, 2024

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Details:
Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI), for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2024

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zai Lab Receives Approval for AUGTYRO™ (repotrectinib) for ROS1-positive NSCLC in China
Details : Augtyro (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI), for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 12, 2024

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Details:
Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Liver Failure.
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2024

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Liver Failure.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 08, 2024

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Details:
Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Lead Product(s): Repotrectinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Medical University of Vienna
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 18, 2024

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Lead Product(s) : Repotrectinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Medical University of Vienna
Deal Size : Inapplicable
Deal Type : Inapplicable
REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis
Details : Repotrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 18, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]5-chloropyrazole [1,5- a] pyrimidine-3-ethyl forma...
CAS Number : 1224944-77-7
End Use API : Repotrectinib
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

Ethyl 5-oxo-4,5-dihydropyrazolo [1,5-a]pyrimidine-...
CAS Number : 926663-00-5
End Use API : Repotrectinib
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

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22 Jan 2024

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PharmaCompass offers a list of Repotrectinib 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 Repotrectinib manufacturer or Repotrectinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Repotrectinib manufacturer or Repotrectinib supplier.
PharmaCompass also assists you with knowing the Repotrectinib API Price utilized in the formulation of products. Repotrectinib API Price is not always fixed or binding as the Repotrectinib Price is obtained through a variety of data sources. The Repotrectinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Repotrectinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Repotrectinib, including repackagers and relabelers. The FDA regulates Repotrectinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Repotrectinib 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 Repotrectinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Repotrectinib supplier is an individual or a company that provides Repotrectinib active pharmaceutical ingredient (API) or Repotrectinib finished formulations upon request. The Repotrectinib suppliers may include Repotrectinib API manufacturers, exporters, distributors and traders.
click here to find a list of Repotrectinib 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 Repotrectinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Repotrectinib 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 Repotrectinib 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 Repotrectinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Repotrectinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Repotrectinib suppliers with NDC on PharmaCompass.
Repotrectinib 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 Repotrectinib 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 Repotrectinib GMP manufacturer or Repotrectinib GMP API supplier for your needs.
A Repotrectinib CoA (Certificate of Analysis) is a formal document that attests to Repotrectinib's compliance with Repotrectinib specifications and serves as a tool for batch-level quality control.
Repotrectinib CoA mostly includes findings from lab analyses of a specific batch. For each Repotrectinib 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.
Repotrectinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Repotrectinib EP), Repotrectinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Repotrectinib USP).