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Chemistry

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Also known as: 302962-49-8, Sprycel, Bms-354825, Dasatinib anhydrous, Bms 354825, Bms354825
Molecular Formula
C22H26ClN7O2S
Molecular Weight
488.0  g/mol
InChI Key
ZBNZXTGUTAYRHI-UHFFFAOYSA-N
FDA UNII
X78UG0A0RN

Dasatinib
A pyrimidine and thiazole derived ANTINEOPLASTIC AGENT and PROTEIN KINASE INHIBITOR of BCR-ABL KINASE. It is used in the treatment of patients with CHRONIC MYELOID LEUKEMIA who are resistant or intolerant to IMATINIB.
Dasatinib anhydrous is a Kinase Inhibitor. The mechanism of action of dasatinib anhydrous is as a Protein Kinase Inhibitor, and Cytochrome P450 3A4 Inhibitor.
1 2D Structure

Dasatinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide
2.1.2 InChI
InChI=1S/C22H26ClN7O2S/c1-14-4-3-5-16(23)20(14)28-21(32)17-13-24-22(33-17)27-18-12-19(26-15(2)25-18)30-8-6-29(7-9-30)10-11-31/h3-5,12-13,31H,6-11H2,1-2H3,(H,28,32)(H,24,25,26,27)
2.1.3 InChI Key
ZBNZXTGUTAYRHI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C(=CC=C1)Cl)NC(=O)C2=CN=C(S2)NC3=CC(=NC(=N3)C)N4CCN(CC4)CCO
2.2 Other Identifiers
2.2.1 UNII
X78UG0A0RN
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (18f)-n-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide

2. 354825, Bms

3. Bms 354825

4. Bms-354825

5. Bms354825

6. N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide

7. Sprycel

2.3.2 Depositor-Supplied Synonyms

1. 302962-49-8

2. Sprycel

3. Bms-354825

4. Dasatinib Anhydrous

5. Bms 354825

6. Bms354825

7. Dasatinib (bms-354825)

8. Dasatinib (anhydrous)

9. N-(2-chloro-6-methylphenyl)-2-({6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl}amino)-1,3-thiazole-5-carboxamide

10. N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide

11. N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)thiazole-5-carboxamide

12. N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide

13. Anh. Dasatinib

14. Anhydrous Dasatinib

15. Dasatinib (anh.)

16. Chembl1421

17. X78ug0a0rn

18. Chebi:49375

19. Dasatinib D8

20. Nsc732517

21. Nsc-732517

22. Nsc-759877

23. Ncgc00181129-01

24. Dsstox_cid_20979

25. Dsstox_rid_79608

26. Dsstox_gsid_40979

27. 5-thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)-1-piperazinyl)-2-methyl-4-pyrimidinyl)amino)-

28. Dasatinibum

29. Bms-354825 Hydrate

30. 5-thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-

31. Smr002529551

32. Cas-302962-49-8

33. 302962-49-8 Pound Not863127-77-9

34. Dasatinib [usan:inn]

35. Unii-x78ug0a0rn

36. Bms Dasatinib

37. 1n1

38. Kinome_3650

39. Dasatinib (jan/inn)

40. Dasatinib [inn]

41. Dasatinib [mi]

42. N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide

43. Sprycel (bristol Meyers)

44. Dasatinib [who-dd]

45. Schembl8226

46. Dasatinib,bms-354825

47. Mls003915609

48. Mls004774145

49. Mls006010904

50. Dasatinib - Bms-354825

51. Gtpl5678

52. Dtxsid4040979

53. Bdbm13216

54. Cid_3062316

55. Ex-a401

56. 5-thiazolecarboxamide, Monohydrate

57. Bcpp000263

58. Hms2043n05

59. Hms3244a05

60. Hms3244a06

61. Hms3244b05

62. Hms3265c19

63. Hms3265c20

64. Hms3265d19

65. Hms3265d20

66. Hms3654k05

67. Hms3744c11

68. Pharmakon1600-01502275

69. Bcp01797

70. Zinc3986735

71. Tox21_112736

72. Mfcd11046566

73. Nsc759877

74. Nsc800087

75. S1021

76. Akos015902363

77. Tox21_112736_1

78. Bcp9000589

79. Bms 345825

80. Ccg-264779

81. Cs-0100

82. Db01254

83. Gs-6548

84. Nsc-800087

85. Sb17284

86. Ncgc00181129-02

87. Ncgc00181129-03

88. Ncgc00181129-05

89. Ncgc00181129-06

90. Ncgc00181129-07

91. Ncgc00181129-12

92. Ncgc00181129-14

93. Ncgc00181129-22

94. Ncgc00481571-01

95. 2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)-n-(2-chloro-6-methylphenyl)thiazole-5-carboxamide

96. Ac-22749

97. Bcb03_000715

98. Bms 35482513

99. Hy-10181

100. N-(2-chloro-6-methyl-phenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methyl-pyrimidin-4-yl]amino]thiazole-5-carboxamide

101. Am20080877

102. D5949

103. Ft-0650671

104. Sw208076-5

105. Ec-000.2122

106. D-3307

107. D03658

108. Ab01273956-01

109. Ab01273956-02

110. Ab01273956_03

111. Ar-270/43507994

112. Q419940

113. Sr-00000000554

114. Q-101345

115. Sr-00000000554-5

116. Brd-k49328571-001-05-1

117. Brd-k49328571-001-07-7

118. Bms-354825;bms354825;bms 354825

119. Z2786158251

120. N-(2-chloro-6-methylphenyl)-2-({6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl}amino)-1,3-thiazole-5-carboxamide

121. N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl)]-2-methyl-4-pyrimidinyl]amino)]-1,3-thiazole-5-carboxamide

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 488.0 g/mol
Molecular Formula C22H26ClN7O2S
XLogP33.6
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass487.1557220 g/mol
Monoisotopic Mass487.1557220 g/mol
Topological Polar Surface Area135 Ų
Heavy Atom Count33
Formal Charge0
Complexity642
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameSprycel
PubMed HealthDasatinib (By mouth)
Drug ClassesAntineoplastic Agent, Immunological Agent
Drug LabelSPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2...
Active IngredientDasatinib
Dosage FormTablet
Routeoral; Oral
Strength140mg; 100mg; 50mg; 80mg; 70mg; 20mg
Market StatusPrescription
CompanyBristol Myers Squibb

2 of 2  
Drug NameSprycel
PubMed HealthDasatinib (By mouth)
Drug ClassesAntineoplastic Agent, Immunological Agent
Drug LabelSPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2...
Active IngredientDasatinib
Dosage FormTablet
Routeoral; Oral
Strength140mg; 100mg; 50mg; 80mg; 70mg; 20mg
Market StatusPrescription
CompanyBristol Myers Squibb

4.2 Drug Indication

For the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy. Also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.


FDA Label


Sprycel is indicated for the treatment of paediatric patients with:

newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.

Sprycel is indicated for the treatment of adult patients with:

- newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase;

- chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate;

- Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Sprycel is indicated for the treatment of paediatric patients with:

- newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.


Treatment of Philadelphia-chromosome (BCR-ABL translocation)-positive acute lymphoblastic leukaemia, Treatment of Philadelphia-chromosome (BCR-ABL translocation)-positive chronic myeloid leukaemia


Dasatinib Accord is indicated for the treatment of adult patients with:

Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.

Dasatinib Accord is indicated for the treatment of paediatric patients with:

newly diagnosed Ph+ ALL in combination with chemotherapy.


Dasatinib Accordpharma is indicated for the treatment of adult patients with:

newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.

chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.

Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Dasatinib Accordpharma is indicated for the treatment of paediatric patients with:

newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

newly diagnosed Ph+ ALL in combination with chemotherapy.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Dasatinib is an oral dual BCR/ABL and Src family tyrosine kinase inhibitor


5.2 MeSH Pharmacological Classification

Protein Kinase Inhibitors

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


Antineoplastic Agents

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


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
DASATINIB ANHYDROUS
5.3.2 FDA UNII
X78UG0A0RN
5.3.3 Pharmacological Classes
Kinase Inhibitor [EPC]; Protein Kinase Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]
5.4 ATC Code

L01EA02


L01EA02


L01EA02


L01XE06

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EA - Bcr-abl tyrosine kinase inhibitors

L01EA02 - Dasatinib


5.5 Absorption, Distribution and Excretion

Route of Elimination

Dasatinib is extensively metabolized in humans, primarily by the cytochrome P450 enzyme 3A4. Elimination is primarily via the feces.


Volume of Distribution

2505 L


5.6 Metabolism/Metabolites

Dasatinib is extensively metabolized in humans, primarily by the cytochrome P450 enzyme 3A4


5.7 Biological Half-Life

The overall mean terminal half-life of dasatinib is 3-5 hours.


5.8 Mechanism of Action

Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro, dasatinib was active in leukemic cell lines representing variants of imatinib mesylate sensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib was able to overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.


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25-Feb-2021
03-Feb-2025
KGS
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Drugs in Development

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Details:

Sprycel-Generic (dasatinib) is an inhibitor of multiple tyrosine kinases, which is indicated for the treatment of in certain types of cancer of bone marroe and blood.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Sprycel-Generic

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Aurobindo Pharma Limited

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 23, 2025

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01

Eugia Pharma

India
arrow
STLE Annual Meeting
Not Confirmed

Eugia Pharma

India
arrow
STLE Annual Meeting
Not Confirmed

Details : Sprycel-Generic (dasatinib) is an inhibitor of multiple tyrosine kinases, which is indicated for the treatment of in certain types of cancer of bone marroe and blood.

Product Name : Sprycel-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 23, 2025

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Details:

Handa Therapeutics has acquired Phyrago (dasatinib) from Nanocopoeia. This FDA-approved product is indicated for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Phyrago

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Handa Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition January 15, 2025

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02

Nanocopoeia

U.S.A
arrow
STLE Annual Meeting
Not Confirmed

Nanocopoeia

U.S.A
arrow
STLE Annual Meeting
Not Confirmed

Details : Handa Therapeutics has acquired Phyrago (dasatinib) from Nanocopoeia. This FDA-approved product is indicated for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia.

Product Name : Phyrago

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

January 15, 2025

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Details:

Dasynoc (dasatinib) is an amorphous solid dispersion form & innovative protein kinase inhibitor, small molecule drug. It is being developed for the treatment of chronic myeloid leukemia.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Dasynoc

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 02, 2024

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03

Xspray Pharma

Sweden
arrow
STLE Annual Meeting
Not Confirmed

Xspray Pharma

Sweden
arrow
STLE Annual Meeting
Not Confirmed

Details : Dasynoc (dasatinib) is an amorphous solid dispersion form & innovative protein kinase inhibitor, small molecule drug. It is being developed for the treatment of chronic myeloid leukemia.

Product Name : Dasynoc

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 02, 2024

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Details:

Xspray Pharma's lead product XS004 (dasatinib) is being evaluated in the late-stage clinical trial studies for treating patients suffering from chronic myeloid leukemia.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Dasynoc

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 19, 2024

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04

Xspray Pharma

Sweden
arrow
STLE Annual Meeting
Not Confirmed

Xspray Pharma

Sweden
arrow
STLE Annual Meeting
Not Confirmed

Details : Xspray Pharma's lead product XS004 (dasatinib) is being evaluated in the late-stage clinical trial studies for treating patients suffering from chronic myeloid leukemia.

Product Name : Dasynoc

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 19, 2024

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Details:

Sprycel (dasatinib) is an oral film-coated tablet, a protein kinase inhibiting small molecule drug. It is indicated for the treatment of chronic myeloid leukemia.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Sprycel-Generic

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 09, 2024

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05

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Sprycel (dasatinib) is an oral film-coated tablet, a protein kinase inhibiting small molecule drug. It is indicated for the treatment of chronic myeloid leukemia.

Product Name : Sprycel-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 09, 2024

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Details:

Under the agreement, EVERSANA will support the U.S. launch and commercialization of the company's first innovative cancer therapy Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL).


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Dasynoc

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Xspray Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement February 24, 2023

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06

Eversana

U.S.A
arrow
STLE Annual Meeting
Not Confirmed

Eversana

U.S.A
arrow
STLE Annual Meeting
Not Confirmed

Details : Under the agreement, EVERSANA will support the U.S. launch and commercialization of the company's first innovative cancer therapy Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL).

Product Name : Dasynoc

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

February 24, 2023

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Details:

Dasatinib Tablet is indicated for treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) CML in chronic phase, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Dasatinib-Generic

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 06, 2022

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07

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Dasatinib Tablet is indicated for treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) CML in chronic phase, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.

Product Name : Dasatinib-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 06, 2022

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Details:

Xspray Pharma has received positive preliminary results from a bioavailability study in healthy volunteers with an improved HyNap-Dasa version of the reference drug Sprycel™, demonstrating that absorption of HyNap-Dasa is not dependent on the gastric pH level.


Lead Product(s): Dasatinib

Therapeutic Area: Oncology Brand Name: Dasynoc

Study Phase: UndisclosedProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 30, 2020

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08

Xspray Pharma

Sweden
arrow
STLE Annual Meeting
Not Confirmed

Xspray Pharma

Sweden
arrow
STLE Annual Meeting
Not Confirmed

Details : Xspray Pharma has received positive preliminary results from a bioavailability study in healthy volunteers with an improved HyNap-Dasa version of the reference drug Sprycel™, demonstrating that absorption of HyNap-Dasa is not dependent on the gastric p...

Product Name : Dasynoc

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 30, 2020

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INTERMEDIATE SUPPLIERS

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01

American Thoracic Society
Not Confirmed
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American Thoracic Society
Not Confirmed
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CAS Number : 302964-02-9

End Use API : Dasatinib

About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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02

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
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CAS Number : 863127-76-8

End Use API : Dasatinib

About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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03

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
arrow

CAS Number : 302964-24-5

End Use API : Dasatinib

About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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04

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
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CAS Number : 1780-26-3

End Use API : Dasatinib

About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

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05

American Thoracic Society
Not Confirmed
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American Thoracic Society
Not Confirmed
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CAS Number : 863127-76-8

End Use API : Dasatinib

About The Company : Chengdu Yazhong Bio-pharmaceutical Co., Ltd., founded in 2002, is a leading company with plant extracts, APIs and medical intermediates. Our company is equipped...

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06

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
arrow

CAS Number : 302964-08-5

End Use API : Dasatinib

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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07

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
arrow

CAS Number : 302964-02-9

End Use API : Dasatinib

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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08

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
arrow

CAS Number : 302964-08-5

End Use API : Dasatinib

About The Company : Hunan Ouya Biological Company locates at Changsha National Biomedical Base; we are pharmaceutical manufacturer with integrated R&D, production and individual sa...

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09

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
arrow

CAS Number : 302964-24-5

End Use API : Dasatinib

About The Company : Hunan Ouya Biological Company locates at Changsha National Biomedical Base; we are pharmaceutical manufacturer with integrated R&D, production and individual sa...

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10

American Thoracic Society
Not Confirmed
arrow
American Thoracic Society
Not Confirmed
arrow

CAS Number : 353-83-3

End Use API : Dasatinib

About The Company : At Infinium Pharmachem Pvt. Ltd., we are well focused to Iodine chemistry & this is the only core area of ours. We are working as CRAMS, but our domain is very ...

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Europe

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01

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
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Regulatory Info :

Registration Country : Switzerland

Dasatinibum

Brand Name : Dasatinib Zentiva

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Dasatinibum

Brand Name : Dasatinib Zentiva

Dosage Form : Film-Coated Tablets

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Dasatinibum

Brand Name : Dasatinib Zentiva

Dosage Form : Film-Coated Tablets

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

04

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Dasatinibum

Brand Name : Dasatinib Zentiva

Dosage Form : Filmtabl

Dosage Strength : 70mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Status- Under Registration

Registration Country : Germany

Dasatinib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Status- Under Registration

Registration Country : Germany

Tiefenbacher Compnay Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Status- Under Registration

Registration Country : Germany

Dasatinib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 140MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Status- Under Registration

Registration Country : Germany

Tiefenbacher Compnay Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Status- Under Registration

Registration Country : Germany

Dasatinib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Status- Under Registration

Registration Country : Germany

Tiefenbacher Compnay Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Status- Under Registration

Registration Country : Germany

Dasatinib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Status- Under Registration

Registration Country : Germany

Tiefenbacher Compnay Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Status- Under Registration

Registration Country : Germany

Dasatinib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Status- Under Registration

Registration Country : Germany

Tiefenbacher Compnay Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Status- Under Registration

Registration Country : Germany

Dasatinib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 80MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Status- Under Registration

Registration Country : Germany

Tiefenbacher Compnay Banner
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ABOUT THIS PAGE

Looking for 302962-49-8 / Dasatinib API manufacturers, exporters & distributors?

Dasatinib manufacturers, exporters & distributors 1

96

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

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

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

API | Excipient name

Dasatinib

Synonyms

302962-49-8, Sprycel, Bms-354825, Dasatinib anhydrous, Bms 354825, Bms354825

Cas Number

302962-49-8

Unique Ingredient Identifier (UNII)

X78UG0A0RN

About Dasatinib

A pyrimidine and thiazole derived ANTINEOPLASTIC AGENT and PROTEIN KINASE INHIBITOR of BCR-ABL KINASE. It is used in the treatment of patients with CHRONIC MYELOID LEUKEMIA who are resistant or intolerant to IMATINIB.

Dasatinib anhydrous Manufacturers

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

Dasatinib anhydrous Suppliers

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

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

Dasatinib anhydrous USDMF

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

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

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

Dasatinib anhydrous 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 Dasatinib anhydrous Drug Master File in Japan (Dasatinib anhydrous JDMF) empowers Dasatinib anhydrous 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 Dasatinib anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Dasatinib anhydrous 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 Dasatinib anhydrous suppliers with JDMF on PharmaCompass.

Dasatinib anhydrous KDMF

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

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

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

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

Dasatinib anhydrous WC

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

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

Dasatinib anhydrous 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 Dasatinib anhydrous as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Dasatinib anhydrous GMP

Dasatinib anhydrous 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 Dasatinib anhydrous 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 Dasatinib anhydrous GMP manufacturer or Dasatinib anhydrous GMP API supplier for your needs.

Dasatinib anhydrous CoA

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

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

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