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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
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
Molecular Weight | 488.0 g/mol |
---|---|
Molecular Formula | C22H26ClN7O2S |
XLogP3 | 3.6 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 7 |
Exact Mass | 487.1557220 g/mol |
Monoisotopic Mass | 487.1557220 g/mol |
Topological Polar Surface Area | 135 Ų |
Heavy Atom Count | 33 |
Formal Charge | 0 |
Complexity | 642 |
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 2 | |
---|---|
Drug Name | Sprycel |
PubMed Health | Dasatinib (By mouth) |
Drug Classes | Antineoplastic Agent, Immunological Agent |
Drug Label | SPRYCEL (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 Ingredient | Dasatinib |
Dosage Form | Tablet |
Route | oral; Oral |
Strength | 140mg; 100mg; 50mg; 80mg; 70mg; 20mg |
Market Status | Prescription |
Company | Bristol Myers Squibb |
2 of 2 | |
---|---|
Drug Name | Sprycel |
PubMed Health | Dasatinib (By mouth) |
Drug Classes | Antineoplastic Agent, Immunological Agent |
Drug Label | SPRYCEL (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 Ingredient | Dasatinib |
Dosage Form | Tablet |
Route | oral; Oral |
Strength | 140mg; 100mg; 50mg; 80mg; 70mg; 20mg |
Market Status | Prescription |
Company | Bristol Myers Squibb |
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.
Dasatinib is an oral dual BCR/ABL and Src family tyrosine kinase inhibitor
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.)
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
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
Dasatinib is extensively metabolized in humans, primarily by the cytochrome P450 enzyme 3A4
The overall mean terminal half-life of dasatinib is 3-5 hours.
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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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
Lead Product(s) : Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Aurobindo Pharma Limited
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Pharma Arm gets USFDA Nod for Generic Blood Cancer Drug
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
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
Lead Product(s) : Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Handa Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Handa Acquires FDA-Approved PHYRAGO (dasatinib) Tablets for CML
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
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
FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024
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
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
Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission
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
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
Lead Product(s) : Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Apotex Launches Generic Dasatinib Tablets in The U.S.
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
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
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
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
Lead Product(s) : Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alembic Gets USFDA Nod for Cancer Treatment Drug
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
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
Lead Product(s) : Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Xspray Pharma Reports Positive Results From a Study with Dasatinib During Omeprazole Treatment
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
2-(N-BOC)-Aminothiazole-5-carboxylic acid
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 ...
(E)-N-(2-Chloro-6-Methyl Phenyl)-3-Ethoxy Acrylami...
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 ...
2-Amino-N-(2-chloro-6-methylphenyl)thiazole-5-carb...
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 ...
4,6-dichloro-2-methylpyrimidine
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 ...
(E)-N-(2-Chloro-6-methylphenyl)-3-ethoxyacrylamide
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...
N-(2-Chloro-6-methylphenyl)-2-[(6-chloro-2-methyl-...
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...
2-[(tert-butoxycarbonyl)amino] -1,3 -thiazole-5 -c...
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...
N-(2-Chloro-6-methylphenyl)-2-[(6-chloro-2-methyl-...
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...
2-Amino-N-(2-chloro-6-methylphenyl)thiazole-5-carb...
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...
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 ...
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Dasatinib Zentiva
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Dasatinib Zentiva
Dosage Form : Film-Coated Tablets
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Dasatinib Zentiva
Dosage Form : Film-Coated Tablets
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Dasatinib Zentiva
Dosage Form : Filmtabl
Dosage Strength : 70mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Tablet
Dosage Strength : 140MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Tablet
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Tablet
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
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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.
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.
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.
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.
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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.
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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).
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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.
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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).
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.
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.
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.
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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.
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).