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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
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
Molecular Weight | 637.0 g/mol |
---|---|
Molecular Formula | C28H24ClF3N4O6S |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 6 |
Exact Mass | 636.1057179 g/mol |
Monoisotopic Mass | 636.1057179 g/mol |
Topological Polar Surface Area | 155 Ų |
Heavy Atom Count | 43 |
Formal Charge | 0 |
Complexity | 853 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Nexavar |
PubMed Health | Sorafenib (By mouth) |
Drug Classes | Antineoplastic Agent |
Drug Label | NEXAVAR, 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 Ingredient | Sorafenib tosylate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 200mg base |
Market Status | Prescription |
Company | Bayer Hlthcare |
2 of 2 | |
---|---|
Drug Name | Nexavar |
PubMed Health | Sorafenib (By mouth) |
Drug Classes | Antineoplastic Agent |
Drug Label | NEXAVAR, 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 Ingredient | Sorafenib tosylate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 200mg base |
Market Status | Prescription |
Company | Bayer Hlthcare |
* 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.
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.)
L01EX02
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Nexavar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexavar, including repackagers and relabelers. The FDA regulates Nexavar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexavar 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 Nexavar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexavar supplier is an individual or a company that provides Nexavar active pharmaceutical ingredient (API) or Nexavar finished formulations upon request. The Nexavar suppliers may include Nexavar API manufacturers, exporters, distributors and traders.
click here to find a list of Nexavar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nexavar DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexavar active pharmaceutical ingredient (API) in detail. Different forms of Nexavar DMFs exist exist since differing nations have different regulations, such as Nexavar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexavar DMF submitted to regulatory agencies in the US is known as a USDMF. Nexavar USDMF includes data on Nexavar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexavar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexavar suppliers with USDMF on PharmaCompass.
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 Nexavar Drug Master File in Japan (Nexavar JDMF) empowers Nexavar 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 Nexavar JDMF during the approval evaluation for pharmaceutical products. At the time of Nexavar 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 Nexavar suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nexavar Drug Master File in Korea (Nexavar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nexavar. The MFDS reviews the Nexavar KDMF as part of the drug registration process and uses the information provided in the Nexavar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nexavar 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 Nexavar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nexavar suppliers with KDMF on PharmaCompass.
A Nexavar CEP of the European Pharmacopoeia monograph is often referred to as a Nexavar Certificate of Suitability (COS). The purpose of a Nexavar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nexavar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nexavar to their clients by showing that a Nexavar CEP has been issued for it. The manufacturer submits a Nexavar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nexavar CEP holder for the record. Additionally, the data presented in the Nexavar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nexavar DMF.
A Nexavar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nexavar 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 Nexavar suppliers with CEP (COS) on PharmaCompass.
A Nexavar written confirmation (Nexavar WC) is an official document issued by a regulatory agency to a Nexavar manufacturer, verifying that the manufacturing facility of a Nexavar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nexavar APIs or Nexavar finished pharmaceutical products to another nation, regulatory agencies frequently require a Nexavar WC (written confirmation) as part of the regulatory process.
click here to find a list of Nexavar suppliers with Written Confirmation (WC) 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 Nexavar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nexavar 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 Nexavar 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 Nexavar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nexavar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nexavar suppliers with NDC on PharmaCompass.
Nexavar 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 Nexavar 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 Nexavar GMP manufacturer or Nexavar GMP API supplier for your needs.
A Nexavar CoA (Certificate of Analysis) is a formal document that attests to Nexavar's compliance with Nexavar specifications and serves as a tool for batch-level quality control.
Nexavar CoA mostly includes findings from lab analyses of a specific batch. For each Nexavar 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.
Nexavar may be tested according to a variety of international standards, such as European Pharmacopoeia (Nexavar EP), Nexavar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nexavar USP).
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