Synopsis
Synopsis
0
CEP/COS
0
KDMF
0
VMF
0
FDF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Ski-606
2. Ski606
1. 380843-75-4
2. Ski-606
3. Bosutinib (ski-606)
4. Ski 606
5. Bosulif
6. Ski606
7. 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile
8. 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methylpiperazin-1-yl)propoxy)quinoline-3-carbonitrile
9. 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
10. Bosutinib (usan)
11. Bosutinib [usan]
12. Sk-606
13. 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-3-quinolinecarbonitrile
14. Bosutinib Isomer 1
15. Chembl288441
16. 4-(2,4-dichloro-5-methoxyanilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
17. 4-(2,4-dichloro-5-methoxyphenylamino)-6-methoxy-7-(3-(4-methylpiperazin-1-yl)propoxy)quinoline-3-carbonitrile
18. Chebi:39112
19. 5018v4aez0
20. Ski-606)
21. Bosutinib (as Monohydrate)
22. Bosutinib [usan:inn]
23. Ncgc00241107-01
24. Unii-5018v4aez0
25. Mfcd07367846
26. Bosutinib,ski-606
27. Bosutinib [inn]
28. Bosutinib (ski606)
29. Bosutinib [mi]
30. Bosutinib [vandf]
31. Pf-5208763
32. Bosutinib - Ski-606
33. Bosutinib [mart.]
34. Ec 700-455-1
35. Bosutinib [who-dd]
36. Mls006011212
37. Schembl158390
38. Amy266
39. Bdbm4552
40. Gtpl5710
41. Bosutinib, >=98% (hplc)
42. Dtxsid10861568
43. Ex-a391
44. Bcpp000318
45. Hms2043a22
46. Hms3244a03
47. Hms3244a04
48. Hms3244b03
49. Hms3651c03
50. Hms3672k11
51. Hms3743e09
52. 2-pyridin-2-ylethylacetate
53. K00615a
54. Bcp01782
55. Nsc765694
56. Nsc799367
57. Sk 606
58. Zinc22448983
59. Akos015902521
60. Ac-2413
61. Bcp9000446
62. Ccg-208129
63. Cs-0118
64. Db06616
65. Nsc-765694
66. Nsc-799367
67. Pb30881
68. Ncgc00241107-03
69. Ncgc00241107-05
70. 4-(2,4-dichloro-5-methoxy-anilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
71. As-11064
72. Hy-10158
73. Smr002530350
74. Ft-0656231
75. S1014
76. Ski606; Ski 606; Sk-i606
77. Sw220197-1
78. A25014
79. D03252
80. Ab01565836_03
81. 843b754
82. Q894611
83. Sr-01000941572
84. J-519931
85. Q-200745
86. Sr-01000941572-1
87. Brd-k99964838-001-01-0
88. Brd-k99964838-001-06-9
89. 3-quinolinecarbonitrile, 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-
90. 3-quinolinecarbonitrile, 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methyl-1-piperazinyl)propoxy)-
91. 4-(2,4-dichloro-5-methoxy-phenylamino)-6-methoxy-7-[3-(4-methyl-piperazin-1-yl)propoxy]quinoline-3-carbonitrile
92. Ski-606;4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile
| Molecular Weight | 530.4 g/mol |
|---|---|
| Molecular Formula | C26H29Cl2N5O3 |
| XLogP3 | 5.4 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 9 |
| Exact Mass | 529.1647452 g/mol |
| Monoisotopic Mass | 529.1647452 g/mol |
| Topological Polar Surface Area | 82.9 Ų |
| Heavy Atom Count | 36 |
| Formal Charge | 0 |
| Complexity | 734 |
| 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 | 1 |
| 1 of 1 | |
|---|---|
| Drug Name | <a class="pubchem-internal-link multiple-CIDs" href="/compound/Bosulif">Bo |
| PubMed Health | <a class="pubchem-internal-link CID-5328940" href="/compound/Bosutinib" |
| Drug Classes | Antineoplastic Agent |
| Active Ingredient | Bosutinib monohydrate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 100mg base; eq 500mg base |
| Market Status | Prescription |
| Company | Wyeth Pharms |
Treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy in adult patients.
FDA Label
Bosulif is indicated for the treatment of adult patients with:
- newlydiagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
- CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01E - Protein kinase inhibitors
L01EA - Bcr-abl tyrosine kinase inhibitors
L01EA04 - Bosutinib
Absorption
Food increase the exposure of bosutinib. Tmax, single dose, cancer patients, fed-state = 4-6 hours; After 15 daily doses of bosutinib 500 mg with food in CML patients, the pharmacokinetic parameters are as follows: Cmax = 200 ng/mL; AUC = 3650 ngh/mL
Route of Elimination
When given a single oral dose, 91.3% of the dose was recovered in feces and 3% of the dose recovered in urine.
Volume of Distribution
Apparent volume of distribution = 6080 1230 L.
Clearance
Mean clearance (CL/F), single oral dose, fed-state = 189 L/h
Bosutinib is primarily metabolized by CYP3A4. The major circulating metabolites identified in plasma are oxydechlorinated (M2) bosutinib (19% of parent exposure) and N-desmethylated (M5) bosutinib (25% of parent exposure), with bosutinib N-oxide (M6) as a minor circulating metabolite. All the metabolites were deemed inactive.
Terminal phase elimination half-life, single oral dose, fed-state = 22.5 hours
Bosutinib is a tyrosine kinase inhibitor. Although it is able to inhibit several tyrosine kinases such as Src, Lyn, and Hck, which are members of the Src-family of kinases, its primary target is the Bcr-Abl kinase. The Bcr-Abl gene is a chimeric oncogene created from the fusion of the breakpoint-cluster (Bcr) gene and Abelson (Abl) tyrosine gene. This chromosomal abnormality results in the formation of what is commonly known as the Philadelphia chromosome or Philadelphia translocation. The Bcr-Abl gene expresses a particular kinase that promotes the progression of CML. A decrease in the growth and size of the CML tumour has been observed following administration of bosutinib. Bosutinib did not inhibit the T315I and V299L mutant cells.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Bosutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosutinib, including repackagers and relabelers. The FDA regulates Bosutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosutinib 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 Bosutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosutinib supplier is an individual or a company that provides Bosutinib active pharmaceutical ingredient (API) or Bosutinib finished formulations upon request. The Bosutinib suppliers may include Bosutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Bosutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bosutinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Bosutinib active pharmaceutical ingredient (API) in detail. Different forms of Bosutinib DMFs exist exist since differing nations have different regulations, such as Bosutinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bosutinib DMF submitted to regulatory agencies in the US is known as a USDMF. Bosutinib USDMF includes data on Bosutinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bosutinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bosutinib 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 Bosutinib Drug Master File in Japan (Bosutinib JDMF) empowers Bosutinib 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 Bosutinib JDMF during the approval evaluation for pharmaceutical products. At the time of Bosutinib 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 Bosutinib suppliers with JDMF on PharmaCompass.
A Bosutinib written confirmation (Bosutinib WC) is an official document issued by a regulatory agency to a Bosutinib manufacturer, verifying that the manufacturing facility of a Bosutinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bosutinib APIs or Bosutinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Bosutinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Bosutinib 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 Bosutinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bosutinib 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 Bosutinib 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 Bosutinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bosutinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bosutinib suppliers with NDC on PharmaCompass.
Bosutinib 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 Bosutinib 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 Bosutinib GMP manufacturer or Bosutinib GMP API supplier for your needs.
A Bosutinib CoA (Certificate of Analysis) is a formal document that attests to Bosutinib's compliance with Bosutinib specifications and serves as a tool for batch-level quality control.
Bosutinib CoA mostly includes findings from lab analyses of a specific batch. For each Bosutinib 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.
Bosutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Bosutinib EP), Bosutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bosutinib USP).
LOOKING FOR A SUPPLIER?
