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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

3 API Suppliers, 2 USDMF, 1 NDC API, 1 Listed Suppliers, $ API Reference Price

3 API Suppliers
2 USDMF
1 NDC API
1 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers, 5 FDA Orange Book, 5 Europe, 2 Canada

12 FDF Dossiers
5 FDA Orange Book
5 Europe
2 Canada

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 500MG BASE, CAPSULE;ORAL - EQ 100MG BASE, CAPSULE;ORAL - EQ 50MG BASE

drugProductComposition
TABLET;ORAL - EQ 100MG BASE
TABLET;ORAL - EQ 400MG BASE
TABLET;ORAL - EQ 500MG BASE
CAPSULE;ORAL - EQ 100MG BASE
CAPSULE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 DKSH, 1 Jai Radhe Sales, 2 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 5 Corel Pharma Chem, 3 DFE Pharma, 6 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 6 Kerry, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

23 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 15 Disintegrants & Superdisintegrants, 15 Direct Compression, 13 Lubricants & Glidants, 11 Thickeners and Stabilizers, 9 Controlled & Modified Release, 8 Co-Processed Excipients, 8 Granulation, 6 Film Formers & Plasticizers, 3 Parenteral, 3 Taste Masking, 3 Topical, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 2 Coloring Agents, 1 API Stability Enhancers, 1 Solubilizers

DIGITAL CONTENT

11 NEWS #PharmaBuzz

media
11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices

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1 US Medicaid Prescriptions
3 Finished Drug Prices

MARKET PLACE

1 APIs

marketPlace
1 APIs

PATENTS & EXCLUSIVITIES

63 US Patents, 26 US Exclusivities

patents
63 US Patents
26 US Exclusivities

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5,451

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

170,022,055

Annual Reports (USD Million)

Finished Drug Prices

87 RELATED EXCIPIENT COMPANIES

147EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Bosutinib hydrate, 918639-08-4, Ski-606 monohydrate, Bosutinib.h2o, Bosutinib (hydrate), 844zje6i55

Molecular Formula

C₂₆H₃₁Cl₂N₅O₄

Molecular Weight

548.5 g/mol

InChI Key

BXPOSPOKHGNMEP-UHFFFAOYSA-N

FDA UNII

844ZJE6I55

Bosutinib Monohydrate is the monohydrate form of bosutinib, a synthetic quinolone derivative and dual kinase inhibitor that targets both Abl and Src kinases with potential antineoplastic activity. Unlike imatinib, bosutinib inhibits the autophosphorylation of both Abl and Src kinases, resulting in inhibition of cell growth and apoptosis. Because of the dual mechanism of action, this agent may have activity in resistant CML disease, other myeloid malignancies and solid tumors. Abl kinase is upregulated in the presence of the abnormal Bcr-abl fusion protein which is commonly associated with chronic myeloid leukemia (CML). Overexpression of specific Src kinases is also associated with the imatinib-resistant CML phenotype.

1 2D Structure

Bosutinib Monohydrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-(2,4-dichloro-5-methoxyanilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile;hydrate

2.1.2 InChI

InChI=1S/C26H29Cl2N5O3.H2O/c1-32-6-8-33(9-7-32)5-4-10-36-25-13-21-18(11-24(25)35-3)26(17(15-29)16-30-21)31-22-14-23(34-2)20(28)12-19(22)27;/h11-14,16H,4-10H2,1-3H3,(H,30,31);1H2

2.1.3 InChI Key

BXPOSPOKHGNMEP-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN1CCN(CC1)CCCOC2=C(C=C3C(=C2)N=CC(=C3NC4=CC(=C(C=C4Cl)Cl)OC)C#N)OC.O

2.2 Other Identifiers

2.2.1 UNII

844ZJE6I55

2.3 Synonyms

2.3.1 Depositor-Supplied Synonyms

1. Bosutinib Hydrate

2. 918639-08-4

3. Ski-606 Monohydrate

4. Bosutinib.h2o

5. Bosutinib (hydrate)

6. 844zje6i55

7. Bosutinib Hydrate (jan)

8. 3-quinolinecarbonitrile, 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-, Hydrate (1:1)

9. 4-(2,4-dichloro-5-methoxyanilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile;hydrate

10. Bosutinib Hydrate [jan]

11. Bosutinib (as Monohydrate)

12. 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile Monohydrate

13. 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile--water (1/1)

14. Bosutinibhydrate

15. Unii-844zje6i55

16. Bosulif (tn)

17. Schembl2887945

18. Chebi:68533

19. Dtxsid20238722

20. Amy16532

21. Bcp17036

22. Hy-10158a

23. Akos027326604

24. Ac-30573

25. Bosutinib Monohydrate [orange Book]

26. Cs-0019907

27. Bosutinib (as Monohydrate) [ema Epar]

28. D09728

29. A900109

30. Q27137001

31. 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) Propoxy]-3-quinolinecarbonitrile Monohydrate

32. 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile Monohydrate

2.4 Create Date

2007-02-05

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₁Cl₂N₅O₄
Molecular Weight	548.5 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	9
Exact Mass	547.1753099 g/mol
Monoisotopic Mass	547.1753099 g/mol
Topological Polar Surface Area	83.9 Å²
Heavy Atom Count	37
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Bosulif
PubMed Health	Bosutinib (By mouth)
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

2 of 2
Drug Name	Bosulif
PubMed Health	Bosutinib (By mouth)
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

4.2 Drug Indication

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.

5 Pharmacology and Biochemistry

5.1 FDA Pharmacological Classification

5.1.1 Pharmacological Classes

Kinase Inhibitor [EPC]; Bcr-Abl Tyrosine Kinase Inhibitors [MoA]

API SUPPLIERS

01

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma Manufacturing 2024

Not Confirmed

02

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma Manufacturing 2024

Not Confirmed

03

Alembic Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma Manufacturing 2024

Not Confirmed

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USDMF

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NDC API

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Listed Suppliers

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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FDF Dossiers

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FDA Orange Book

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Europe

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 203341

DOSAGE - TABLET;ORAL - EQ 400MG BASE

USFDA APPLICATION NUMBER - 203341

DOSAGE - TABLET;ORAL - EQ 500MG BASE

USFDA APPLICATION NUMBER - 203341

DOSAGE - CAPSULE;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 217729

DOSAGE - CAPSULE;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 217729

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Fillers, Diluents & Binders

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Granulation

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Parenteral

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Topical

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US Medicaid Prescriptions

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ABOUT THIS PAGE

Find Bosutinib Monohydrate manufacturers, exporters & distributors on PharmaCompass

ACCESS ALL DATA

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

3 API Suppliers

2 USDMF

1 NDC API

1 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers

5 FDA Orange Book

5 Europe

2 Canada

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 400MG BASE

TABLET;ORAL - EQ 500MG BASE

CAPSULE;ORAL - EQ 100MG BASE

CAPSULE;ORAL - EQ 50MG BASE

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EXCIPIENTS BY APPLICATIONS

23 Fillers, Diluents & Binders

20 Coating Systems & Additives

15 Disintegrants & Superdisintegrants

15 Direct Compression

13 Lubricants & Glidants

11 Thickeners and Stabilizers

9 Controlled & Modified Release

8 Co-Processed Excipients

8 Granulation

6 Film Formers & Plasticizers

3 Parenteral

3 Taste Masking

3 Topical

2 Rheology Modifiers

2 Emulsifying Agents

2 Chewable & Orodispersible Aids

2 Coloring Agents

1 API Stability Enhancers

1 Solubilizers

DIGITAL CONTENT

11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

3 Finished Drug Prices

MARKET PLACE

1 APIs

PATENTS & EXCLUSIVITIES

63 US Patents

26 US Exclusivities

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)