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    Chemistry

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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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    12-Nov-2021
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    Cabozantinib

    Brand Name : Cabometyx

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    Registration Country : Switzerland

    Cabozantinib

    Brand Name : Cabometyx

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 20mg

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    Registration Country : Switzerland

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    Ipsen Pharma Switzerland GmbH

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    Ipsen Pharma Switzerland GmbH

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    Regulatory Info :

    Registration Country : Switzerland

    Cabozantinib

    Brand Name : Cabometyx

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 40mg

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    Regulatory Info :

    Registration Country : Switzerland

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    Ipsen Pharma Switzerland GmbH

    France
    Arab Health
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    Registration Country : Switzerland

    Cabozantinib

    Brand Name : Cabometyx

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 60mg

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    Registration Country : Switzerland

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    TMC Pharma Services Ltd.,

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    Registration Country : Sweden

    kabozantinib S-malate

    Brand Name : Cometriq

    Dosage Form : HARD CAPSULES

    Dosage Strength : 20 MG

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    Registration Country : Sweden

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - EQ 20MG BASE

    USFDA APPLICATION NUMBER - 203756

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    DOSAGE - CAPSULE;ORAL - EQ 80MG BASE

    USFDA APPLICATION NUMBER - 203756

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    ABOUT THIS PAGE

    Cabozantinib S-Malate Manufacturers

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

    Cabozantinib S-Malate Suppliers

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

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

    Cabozantinib S-Malate USDMF

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

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

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

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

    After submitting a Cabozantinib S-Malate 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 S-Malate API can apply through the Korea Drug Master File (KDMF).

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

    Cabozantinib S-Malate WC

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

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

    Cabozantinib S-Malate 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 S-Malate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Cabozantinib S-Malate GMP

    Cabozantinib S-Malate 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 S-Malate 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 S-Malate GMP manufacturer or Cabozantinib S-Malate GMP API supplier for your needs.

    Cabozantinib S-Malate CoA

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

    Cabozantinib S-Malate CoA mostly includes findings from lab analyses of a specific batch. For each Cabozantinib S-Malate 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 S-Malate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cabozantinib S-Malate EP), Cabozantinib S-Malate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cabozantinib S-Malate 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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