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Chemistry

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Also known as: Tpx-0005, 1802220-02-5, Ropotrectinib, 08o3fq4unp, Repotrectinib [usan], Tpx0005
Molecular Formula
C18H18FN5O2
Molecular Weight
355.4  g/mol
InChI Key
FIKPXCOQUIZNHB-WDEREUQCSA-N
FDA UNII
08O3FQ4UNP

Repotrectinib
Repotrectinib is an orally available inhibitor of multiple kinases, including the receptor tyrosine kinase anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), the neurotrophic tyrosine receptor kinase (NTRK) types 1, 2 and 3, the proto-oncogene SRC, and focal adhesion kinase (FAK), with potential antineoplastic activity. Upon oral administration, repotrectinib binds to and inhibits wild-type, point mutants and fusion proteins of ALK, ROS1, NTRK1-3, SRC, FAK and, to a lesser extent, other kinases. Inhibition of these kinases leads to the disruption of downstream signaling pathways and the inhibition of cell growth of tumors in which these kinases are overexpressed, rearranged or mutated.
1 2D Structure

Repotrectinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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
2.1.2 InChI
InChI=1S/C18H18FN5O2/c1-10-8-20-18(25)14-9-21-24-6-5-16(23-17(14)24)22-11(2)13-7-12(19)3-4-15(13)26-10/h3-7,9-11H,8H2,1-2H3,(H,20,25)(H,22,23)/t10-,11+/m0/s1
2.1.3 InChI Key
FIKPXCOQUIZNHB-WDEREUQCSA-N
2.1.4 Canonical SMILES
CC1CNC(=O)C2=C3N=C(C=CN3N=C2)NC(C4=C(O1)C=CC(=C4)F)C
2.1.5 Isomeric SMILES
C[C@H]1CNC(=O)C2=C3N=C(C=CN3N=C2)N[C@@H](C4=C(O1)C=CC(=C4)F)C
2.2 Other Identifiers
2.2.1 UNII
08O3FQ4UNP
2.3 Synonyms
2.3.1 MeSH Synonyms

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)-

2.3.2 Depositor-Supplied Synonyms

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)-

2.4 Create Date
2019-01-15
3 Chemical and Physical Properties
Molecular Weight 355.4 g/mol
Molecular Formula C18H18FN5O2
XLogP32.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count0
Exact Mass355.14445300 g/mol
Monoisotopic Mass355.14445300 g/mol
Topological Polar Surface Area80.6 Ų
Heavy Atom Count26
Formal Charge0
Complexity524
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

Listed Suppliers

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34th NZW-Hamburg
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Repotrectinib

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...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
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Drugs in Development

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Details:

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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01

Zai Lab

China
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34th NZW-Hamburg
Not Confirmed

Zai Lab

China
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34th NZW-Hamburg
Not Confirmed

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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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.


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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02

34th NZW-Hamburg
Not Confirmed
34th NZW-Hamburg
Not Confirmed

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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03

Zai Lab

China
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34th NZW-Hamburg
Not Confirmed

Zai Lab

China
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34th NZW-Hamburg
Not Confirmed

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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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: 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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04

34th NZW-Hamburg
Not Confirmed
34th NZW-Hamburg
Not Confirmed

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

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  • Development Update

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

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05

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country
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34th NZW-Hamburg
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country
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34th NZW-Hamburg
Not Confirmed

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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06

34th NZW-Hamburg
Not Confirmed
34th NZW-Hamburg
Not Confirmed

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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07

34th NZW-Hamburg
Not Confirmed
34th NZW-Hamburg
Not Confirmed

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

blank

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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08

Zai Lab

China
arrow
34th NZW-Hamburg
Not Confirmed

Zai Lab

China
arrow
34th NZW-Hamburg
Not Confirmed

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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09

34th NZW-Hamburg
Not Confirmed
34th NZW-Hamburg
Not Confirmed

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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10

MEDSIR

Spain
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34th NZW-Hamburg
Not Confirmed

MEDSIR

Spain
arrow
34th NZW-Hamburg
Not Confirmed

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

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

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INTERMEDIATE SUPPLIERS

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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...

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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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ABOUT THIS PAGE

Looking for 1802220-02-5 / Repotrectinib API manufacturers, exporters & distributors?

Repotrectinib manufacturers, exporters & distributors 1

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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.

API | Excipient name

Repotrectinib

Synonyms

Tpx-0005, 1802220-02-5, Ropotrectinib, 08o3fq4unp, Repotrectinib [usan], Tpx0005

Cas Number

1802220-02-5

Unique Ingredient Identifier (UNII)

08O3FQ4UNP

About Repotrectinib

Repotrectinib is an orally available inhibitor of multiple kinases, including the receptor tyrosine kinase anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), the neurotrophic tyrosine receptor kinase (NTRK) types 1, 2 and 3, the proto-oncogene SRC, and focal adhesion kinase (FAK), with potential antineoplastic activity. Upon oral administration, repotrectinib binds to and inhibits wild-type, point mutants and fusion proteins of ALK, ROS1, NTRK1-3, SRC, FAK and, to a lesser extent, other kinases. Inhibition of these kinases leads to the disruption of downstream signaling pathways and the inhibition of cell growth of tumors in which these kinases are overexpressed, rearranged or mutated.

Repotrectinib Manufacturers

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.

Repotrectinib Suppliers

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.

Repotrectinib NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Repotrectinib API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Repotrectinib CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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