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    Chemistry

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    Also known as: 475207-59-1, Nexavar, Sorafenib tosylate [usan], Sorafenib (tosylate), Sorafenib tosilate, Bay 54-9085
    Molecular Formula
    C28H24ClF3N4O6S
    Molecular Weight
    637.0  g/mol
    InChI Key
    IVDHYUQIDRJSTI-UHFFFAOYSA-N
    FDA UNII
    5T62Q3B36J
    Sorafenib
    A niacinamide and phenylurea derivative that inhibits multiple intracellular and cell surface kinases thought to be involved in ANGIOGENESIS, including RAF KINASES and VEGF RECEPTORS. It is used in the treatment of advanced RENAL CELL CARCINOMA and HEPATOCELLULAR CARCINOMA, and for treatment of THYROID CARCINOMA refractory to radioactive iodine therapy.
    1 2D Structure

    Sorafenib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide;4-methylbenzenesulfonic acid
    2.1.2 InChI
    InChI=1S/C21H16ClF3N4O3.C7H8O3S/c1-26-19(30)18-11-15(8-9-27-18)32-14-5-2-12(3-6-14)28-20(31)29-13-4-7-17(22)16(10-13)21(23,24)25;1-6-2-4-7(5-3-6)11(8,9)10/h2-11H,1H3,(H,26,30)(H2,28,29,31);2-5H,1H3,(H,8,9,10)
    2.1.3 InChI Key
    IVDHYUQIDRJSTI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC=C(C=C1)S(=O)(=O)O.CNC(=O)C1=NC=CC(=C1)OC2=CC=C(C=C2)NC(=O)NC3=CC(=C(C=C3)Cl)C(F)(F)F
    2.2 Other Identifiers
    2.2.1 UNII
    5T62Q3B36J
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-(4-(3-(4-chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxylic Acid Methyamide-4-methylbenzenesulfonate

    2. Bay 43 9006

    3. Bay 43-9006

    4. Bay 439006

    5. Bay 545 9085

    6. Bay 545-9085

    7. Bay 5459085

    8. Bay 673472

    9. Bay-545-9085

    10. Bay-673472

    11. Bay5459085

    12. Nexavar

    13. Sorafenib

    14. Sorafenib N Oxide

    15. Sorafenib N-oxide

    2.3.2 Depositor-Supplied Synonyms

    1. 475207-59-1

    2. Nexavar

    3. Sorafenib Tosylate [usan]

    4. Sorafenib (tosylate)

    5. Sorafenib Tosilate

    6. Bay 54-9085

    7. 475207-59-1 (tosylate)

    8. 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-n-methylpicolinamide 4-methylbenzenesulfonate

    9. Chebi:50928

    10. 5t62q3b36j

    11. Mfcd08235032

    12. Bay-54-9085

    13. Sorafenib Tosilate (jan)

    14. Sorafenib (nexavar)

    15. Sorafenib Tosylate (usan)

    16. Nexavar(r)

    17. Dsstox_cid_27817

    18. Dsstox_rid_82581

    19. Dsstox_gsid_47839

    20. 1-(4-chloro-3-(trifluoromethyl)phenyl)-3-(4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)urea Mono(4-methylbenzenesulfonate)

    21. 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-n2-methylpyridine-2-carboxamide Mono (4-methylbenzenesulfonate)

    22. 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-n-methylpyridine-2-carboxamide;4-methylbenzenesulfonic Acid

    23. Sorafenib Tosilate [jan]

    24. Bay 43-9006 Tosylate

    25. 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-n-methylpicolinamide 4-methylbenzenesulfonate.

    26. 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-n-methylpyridine-2-carboxamide; 4-methylbenzene-1-sulfonic Acid

    27. Cas-475207-59-1

    28. Nsc-724772

    29. Ncgc00167488-01

    30. Unii-5t62q3b36j

    31. Sr-00000000529

    32. Orafenib Tosylate

    33. Bay43-9006 Mono-p-tosylate

    34. Bay 43-9006 Mono-p-tosylate

    35. 4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl)amino)phenoxy)-n-methylpyridine-2-carboxamide 4-methylbenzenesulfonate

    36. 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-n-methylpyridine-2-carboxamide 4-methylbenzenesulfonate

    37. Nexavar (tn)

    38. Nsc724772

    39. Sorafenib - Nexavar

    40. Sorafenib Tsoh Salt

    41. Mls002415564

    42. Sorafenib Tosylate [mi]

    43. Chembl1200485

    44. Dtxsid9047839

    45. Sorafenib (bay-43-9006)

    46. Hms2219e08

    47. Hms3654i09

    48. Sorafenib, P-toluenesulfonate Salt

    49. Sorafenib Tosilate [mart.]

    50. Sorafenib Tosilate [who-dd]

    51. Sorafenib Tosylate [usp-rs]

    52. Tox21_112489

    53. Hy-10201a

    54. S1040

    55. Akos015924650

    56. Akos027469919

    57. Tox21_112489_1

    58. Ac-6799

    59. Ccg-208000

    60. Cs-0164

    61. Nd-0228

    62. Sorafenib Tosylate [orange Book]

    63. Ncgc00167488-08

    64. Sorafenib Tosilate [ep Monograph]

    65. 2-pyridinecarboxamide, 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-n-methyl-, Mono(4-methylbenzenesulfonate)

    66. Bs164414

    67. Smr001339079

    68. Sorafenib Tosylate [usp Monograph]

    69. Sy012324

    70. Bcp0726000112

    71. Am20090612

    72. Ft-0650737

    73. Ft-0698449

    74. Sw202562-3

    75. Ec-000.2356

    76. A25518

    77. D06272

    78. S-8502

    79. 207s591

    80. Q-201729

    81. Sr-00000000529-5

    82. 2,5-dioxo-1,4-cyclohexanedicarboxylicaciddimethylester

    83. Q27122250

    84. 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-n-methylpicolinamide Tosylate

    85. 2-pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-n-methyl-, 4-methylbenzenesulfonate (1:1)

    86. 4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl)amino)phenoxy)-n-methylpyridine-2-carboxamide 4-methylbenzenesulphonate

    87. 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-n-methylpicolinamide4-methylbenzenesulfonate

    88. 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-n-methyl-2-pyridinecarboxamide Tosylate

    89. 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-n-methylpyridine-2-carboxamide;hydron;4-methylbenzenesulfonate

    90. 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-n-methylpyridine-2-carboxamide Tosylate

    91. 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-n -methylpyridine-2-carboxamide Tosylate

    92. 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-n-methylpyridine-2-carboxamide Tosylate

    93. 4-{4-[3-(4-chloro-3-trifluoromethyl-phenyl)-ureido]-phenoxy} -pyridine-2-carboxylic Acid Methylamide-4-methylbenzenesulfonate

    94. 4-{4-[3-(4-cl-3-trifluoromethyl-phenyl)-ureido]-phenoxy}-pyridine-2-carboxylic Acid Methylamide 4-methylbenzenesulfonate

    95. 4-methyl-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-n-(5-(4-methyl-1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl)benzamide Monomethanesulfonate

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 637.0 g/mol
    Molecular Formula C28H24ClF3N4O6S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count6
    Exact Mass636.1057179 g/mol
    Monoisotopic Mass636.1057179 g/mol
    Topological Polar Surface Area155 Ų
    Heavy Atom Count43
    Formal Charge0
    Complexity853
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameNexavar
    PubMed HealthSorafenib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelNEXAVAR, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4-methylbenzenesulfonate and its structural formula is...
    Active IngredientSorafenib tosylate
    Dosage FormTablet
    RouteOral
    Strengtheq 200mg base
    Market StatusPrescription
    CompanyBayer Hlthcare

    2 of 2  
    Drug NameNexavar
    PubMed HealthSorafenib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelNEXAVAR, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4-methylbenzenesulfonate and its structural formula is...
    Active IngredientSorafenib tosylate
    Dosage FormTablet
    RouteOral
    Strengtheq 200mg base
    Market StatusPrescription
    CompanyBayer Hlthcare

    4.2 Drug Indication

    * Hepatocellular carcinoma:

    Nexavar is indicated for the treatment of hepatocellular carcinoma.

    * Renal cell carcinoma:

    Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

    * Differentiated thyroid carcinoma:

    Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hrthle cell) thyroid carcinoma, refractory to radioactive iodine.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    Protein Kinase Inhibitors

    Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

    5.2 ATC Code

    L01EX02

    API Reference Price

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    21-Mar-2022
    30-May-2025
    KGS
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    01

    DR REDDYS

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    SORAFENIB TOSYLATE

    Brand Name : SORAFENIB TOSYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2022-06-07

    Application Number : 216073

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    SORAFENIB TOSYLATE

    Brand Name : SORAFENIB TOSYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2025-01-27

    Application Number : 212228

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    SORAFENIB TOSYLATE

    Brand Name : NEXAVAR

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2005-12-20

    Application Number : 21923

    RX/OTC/DISCN : RX

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    RLD : No

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    SORAFENIB TOSYLATE

    Brand Name : SORAFENIB TOSYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2020-11-12

    Application Number : 209567

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    SORAFENIB TOSYLATE

    Brand Name : SORAFENIB TOSYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2023-04-12

    Application Number : 217095

    RX/OTC/DISCN : RX

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    SORAFENIB TOSYLATE

    Brand Name : SORAFENIB TOSYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2020-09-10

    Application Number : 207012

    RX/OTC/DISCN : RX

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    SORAFENIB TOSYLATE

    Brand Name : SORAFENIB TOSYLATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 200MG BASE

    Approval Date : 2022-11-09

    Application Number : 209050

    RX/OTC/DISCN : RX

    RLD : No

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    ABOUT THIS PAGE

    Looking for 475207-59-1 / Sorafenib API manufacturers, exporters & distributors?

    Sorafenib manufacturers, exporters & distributors 1

    82

    PharmaCompass offers a list of Sorafenib 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 Sorafenib manufacturer or Sorafenib supplier for your needs.

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

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

    API | Excipient name

    Sorafenib

    Synonyms

    475207-59-1, Nexavar, Sorafenib tosylate [usan], Sorafenib (tosylate), Sorafenib tosilate, Bay 54-9085

    Cas Number

    475207-59-1

    Unique Ingredient Identifier (UNII)

    5T62Q3B36J

    About Sorafenib

    A niacinamide and phenylurea derivative that inhibits multiple intracellular and cell surface kinases thought to be involved in ANGIOGENESIS, including RAF KINASES and VEGF RECEPTORS. It is used in the treatment of advanced RENAL CELL CARCINOMA and HEPATOCELLULAR CARCINOMA, and for treatment of THYROID CARCINOMA refractory to radioactive iodine therapy.

    Sorafenib Manufacturers

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

    Sorafenib Suppliers

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

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

    Sorafenib USDMF

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

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

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

    Sorafenib JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Sorafenib Drug Master File in Japan (Sorafenib JDMF) empowers Sorafenib API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Sorafenib JDMF during the approval evaluation for pharmaceutical products. At the time of Sorafenib JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Sorafenib suppliers with JDMF on PharmaCompass.

    Sorafenib KDMF

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

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

    After submitting a Sorafenib 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 Sorafenib API can apply through the Korea Drug Master File (KDMF).

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

    Sorafenib CEP

    A Sorafenib CEP of the European Pharmacopoeia monograph is often referred to as a Sorafenib Certificate of Suitability (COS). The purpose of a Sorafenib CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sorafenib EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sorafenib to their clients by showing that a Sorafenib CEP has been issued for it. The manufacturer submits a Sorafenib CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sorafenib CEP holder for the record. Additionally, the data presented in the Sorafenib CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sorafenib DMF.

    A Sorafenib CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sorafenib CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Sorafenib suppliers with CEP (COS) on PharmaCompass.

    Sorafenib WC

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

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

    Sorafenib 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 Sorafenib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sorafenib GMP

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

    Sorafenib CoA

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

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

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