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Also known as: 1140909-48-3, Cabozantinib malate, Cabozantinib (s)-malate, Cabometyx, Cabozantinib malate (xl184), Xl184
Molecular Formula
C32H30FN3O10
Molecular Weight
635.6  g/mol
InChI Key
HFCFMRYTXDINDK-WNQIDUERSA-N
FDA UNII
DR7ST46X58

Cabozantinib
Cabozantinib S-malate is the s-malate salt form of cabozantinib, an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Cabozantinib strongly binds to and inhibits several RTKs, which are often overexpressed in a variety of cancer cell types, including hepatocyte growth factor receptor (MET), RET (rearranged during transfection), vascular endothelial growth factor receptor types 1 (VEGFR-1), 2 (VEGFR-2), and 3 (VEGFR-3), mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (FLT-3), TIE-2 (TEK tyrosine kinase, endothelial), tropomyosin-related kinase B (TRKB) and AXL. This may result in an inhibition of both tumor growth and angiogenesis, and eventually lead to tumor regression.
1 2D Structure

Cabozantinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-N-[4-(6,7-dimethoxyquinolin-4-yl)oxyphenyl]-1-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide;(2S)-2-hydroxybutanedioic acid
2.1.2 InChI
InChI=1S/C28H24FN3O5.C4H6O5/c1-35-24-15-21-22(16-25(24)36-2)30-14-11-23(21)37-20-9-7-19(8-10-20)32-27(34)28(12-13-28)26(33)31-18-5-3-17(29)4-6-18;5-2(4(8)9)1-3(6)7/h3-11,14-16H,12-13H2,1-2H3,(H,31,33)(H,32,34);2,5H,1H2,(H,6,7)(H,8,9)/t;2-/m.0/s1
2.1.3 InChI Key
HFCFMRYTXDINDK-WNQIDUERSA-N
2.1.4 Canonical SMILES
COC1=CC2=C(C=CN=C2C=C1OC)OC3=CC=C(C=C3)NC(=O)C4(CC4)C(=O)NC5=CC=C(C=C5)F.C(C(C(=O)O)O)C(=O)O
2.1.5 Isomeric SMILES
COC1=CC2=C(C=CN=C2C=C1OC)OC3=CC=C(C=C3)NC(=O)C4(CC4)C(=O)NC5=CC=C(C=C5)F.C([C@@H](C(=O)O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
DR7ST46X58
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bms 907351

2. Bms-907351

3. Bms907351

4. Cabozantinib

5. Cometriq

6. Xl 184

7. Xl-184

8. Xl184 Cpd

2.3.2 Depositor-Supplied Synonyms

1. 1140909-48-3

2. Cabozantinib Malate

3. Cabozantinib (s)-malate

4. Cabometyx

5. Cabozantinib Malate (xl184)

6. Xl184

7. Cabozantinib (s-malate)

8. Cometriq

9. Cabozantinib S-malate [usan]

10. Dr7st46x58

11. Bms907351

12. Chebi:72319

13. N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-n-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (s)-2-hydroxysuccinate

14. Cabometyx (tn)

15. Cometriq (tn)

16. Cabozantinib Malate (jan)

17. 1-n-[4-(6,7-dimethoxyquinolin-4-yl)oxyphenyl]-1-n'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide;(2s)-2-hydroxybutanedioic Acid

18. Cabozantinib S-malate (usan)

19. Cabozantinib Malate [jan]

20. Unii-dr7st46x58

21. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-(4-((6,7-dimethoxy-4-quinolinyl)oxy)phenyl)-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

22. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

23. Xl184 Malate

24. Cabozantinib L-malate

25. Bms907351 Malate

26. Xl184(cabozantinib Malate)

27. Mls006010951

28. Chembl2103868

29. Dtxsid60915949

30. Ex-a2819

31. Mfcd20923480

32. S4001

33. 1140909-48-3 (malate)

34. Akos025401945

35. Cabozantinib S-malate [who-dd]

36. Ccg-270301

37. Cs-0201

38. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluor

39. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

40. Ac-27471

41. As-75255

42. Hy-12044

43. Smr004702755

44. Cabozantinib S-malate [orange Book]

45. Sw218093-2

46. D10095

47. Q27139901

48. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide

49. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

50. (2s)-2-hydroxybutanedioic Acid; N'1-{4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-n1-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide

51. 1,1-cyclopropanedicarboxamide, N'-(4-((6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n-(4- Fluorophenyl)- Mono((2s)-2-hydroxybutanedioate)

52. Cyclopropane-1,1-dicarboxylic Acid [4-(6,7-dimethoxy-quinoline-4-yloxy)-phenyl]-amide(4-fluoro-phenyl)-amide, (s) Malate Salt

53. N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-n'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide Mono((2s)-2-hydroxybutanedioate)

54. N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-n-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (s)-2-hydroxysuccinate

55. N-{4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-n'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (2s)-2-hydroxybutanedioate

2.4 Create Date
2008-12-22
3 Chemical and Physical Properties
Molecular Weight 635.6 g/mol
Molecular Formula C32H30FN3O10
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count12
Rotatable Bond Count11
Exact Mass635.19152232 g/mol
Monoisotopic Mass635.19152232 g/mol
Topological Polar Surface Area194 Ų
Heavy Atom Count46
Formal Charge0
Complexity924
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

* Renal Cell Carcinoma (RCC):

Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):

- in treatment-nave adults with intermediate or poor risk,

- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

* Hepatocellular Carcinoma (HCC):

Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.


5 Pharmacology and Biochemistry
5.1 ATC Code

L01EX07


API Reference Price

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15-Jan-2021
10-Dec-2024
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DOSAGE - CAPSULE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 203756

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USFDA APPLICATION NUMBER - 203756

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ABOUT THIS PAGE

Looking for 1140909-48-3 / Cabozantinib S-Malate API manufacturers, exporters & distributors?

Cabozantinib S-Malate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cabozantinib S-Malate 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 Cabozantinib S-Malate manufacturer or Cabozantinib S-Malate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cabozantinib S-Malate manufacturer or Cabozantinib S-Malate supplier.

PharmaCompass also assists you with knowing the Cabozantinib S-Malate API Price utilized in the formulation of products. Cabozantinib S-Malate API Price is not always fixed or binding as the Cabozantinib S-Malate Price is obtained through a variety of data sources. The Cabozantinib S-Malate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cabozantinib S-Malate

Synonyms

1140909-48-3, Cabozantinib malate, Cabozantinib (s)-malate, Cabometyx, Cabozantinib malate (xl184), Xl184

Cas Number

1140909-48-3

Unique Ingredient Identifier (UNII)

DR7ST46X58

About Cabozantinib S-Malate

Cabozantinib S-malate is the s-malate salt form of cabozantinib, an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Cabozantinib strongly binds to and inhibits several RTKs, which are often overexpressed in a variety of cancer cell types, including hepatocyte growth factor receptor (MET), RET (rearranged during transfection), vascular endothelial growth factor receptor types 1 (VEGFR-1), 2 (VEGFR-2), and 3 (VEGFR-3), mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (FLT-3), TIE-2 (TEK tyrosine kinase, endothelial), tropomyosin-related kinase B (TRKB) and AXL. This may result in an inhibition of both tumor growth and angiogenesis, and eventually lead to tumor regression.

Cabozantinib Manufacturers

A Cabozantinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabozantinib, including repackagers and relabelers. The FDA regulates Cabozantinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabozantinib 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 Cabozantinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cabozantinib Suppliers

A Cabozantinib supplier is an individual or a company that provides Cabozantinib active pharmaceutical ingredient (API) or Cabozantinib finished formulations upon request. The Cabozantinib suppliers may include Cabozantinib API manufacturers, exporters, distributors and traders.

click here to find a list of Cabozantinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cabozantinib USDMF

A Cabozantinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabozantinib active pharmaceutical ingredient (API) in detail. Different forms of Cabozantinib DMFs exist exist since differing nations have different regulations, such as Cabozantinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cabozantinib DMF submitted to regulatory agencies in the US is known as a USDMF. Cabozantinib USDMF includes data on Cabozantinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabozantinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cabozantinib suppliers with USDMF on PharmaCompass.

Cabozantinib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Cabozantinib Drug Master File in Korea (Cabozantinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cabozantinib. The MFDS reviews the Cabozantinib KDMF as part of the drug registration process and uses the information provided in the Cabozantinib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Cabozantinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Cabozantinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cabozantinib suppliers with KDMF on PharmaCompass.

Cabozantinib WC

A Cabozantinib written confirmation (Cabozantinib WC) is an official document issued by a regulatory agency to a Cabozantinib manufacturer, verifying that the manufacturing facility of a Cabozantinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cabozantinib APIs or Cabozantinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Cabozantinib WC (written confirmation) as part of the regulatory process.

click here to find a list of Cabozantinib suppliers with Written Confirmation (WC) on PharmaCompass.

Cabozantinib 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 Cabozantinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cabozantinib 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 Cabozantinib 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 Cabozantinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cabozantinib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cabozantinib suppliers with NDC on PharmaCompass.

Cabozantinib GMP

Cabozantinib 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 Cabozantinib 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 Cabozantinib GMP manufacturer or Cabozantinib GMP API supplier for your needs.

Cabozantinib CoA

A Cabozantinib CoA (Certificate of Analysis) is a formal document that attests to Cabozantinib's compliance with Cabozantinib specifications and serves as a tool for batch-level quality control.

Cabozantinib CoA mostly includes findings from lab analyses of a specific batch. For each Cabozantinib 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.

Cabozantinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Cabozantinib EP), Cabozantinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cabozantinib 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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