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    ACTIVE PHARMA INGREDIENTS

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    ANALYTICAL

    PharmaCompass

    Synopsis

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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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REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BORYUNG CORPORATION","customerCountry":"REPUBLIC OF KOREA","quantity":"8.05","actualQuantity":"8.05","unit":"KGS","unitRateFc":"15000","totalValueFC":"119085.7","currency":"USD","unitRateINR":1256967.3925465837,"date":"09-Dec-2024","totalValueINR":"10118587.51","totalValueInUsd":"119085.7","indian_port":"Hyderabad Air","hs_no":"29141990","bill_no":"6291790","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1632508200,"product":"DASATINIB ANHYDROUS (API) (DASATINIB ANHYDROUS FINE) (BATCHNO. 7SM109028740521) (FOR R&D PURPOSED ONLY)","address":"B\/2 MAHALAXMI CHAMBERS22 BHULABHAI DESAI ROAD","city":"MUMBAI. MAHARASHTRA","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"CROATIA","foreign_port":"","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"14000","totalValueFC":"14160.6","currency":"USD","unitRateINR":"1041600","date":"25-Sep-2021","totalValueINR":"1041600","totalValueInUsd":"14160.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"5581077","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS22 BHULABHAI DESAI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1639593000,"product":"DASATINIB ANHYDROUS","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"CROATIA","foreign_port":"N\/A","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7000","totalValueFC":"7044","currency":"USD","unitRateINR":"531300","date":"16-Dec-2021","totalValueINR":"531300","totalValueInUsd":"7044","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29341000","bill_no":"1005030","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"PIET HEIN BUILDING,PIET HEINKADE 10 7, 1019 GM AMSTERDAM, THE NETHERLAN DS Amsterdam - 1019, , Netherlands Netherlands","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668018600,"product":"DASATINIB MONOHYDRATE BATCH NO. HS5720211201","address":"B-106,TECHNO CITY, X 4\/1,,TTC AREA , MIDC, MAHAPE","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"HAO RUI ENTERPRISES LTD.","supplierCountry":"CHINA","foreign_port":"NA","customer":"CELOGEN PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3700","totalValueFC":"3799.2","currency":"USD","unitRateINR":"310060","date":"10-Nov-2022","totalValueINR":"310060","totalValueInUsd":"3799.2","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"3238174","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B-106,TECHNO CITY, X 4\/1,,TTC AREA , MIDC, MAHAPE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"DASATINIB ANHYDROUS IH, B\/N: DO23080005&DO23080006(EXP. VIDESB NO:3738471,DT:06-09-23-INV NO: SI3623223610\/30-08-2023)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"CBC GROUP","supplierCountry":"INDIA","foreign_port":"TOKYO","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"8000","totalValueFC":"242287.6","currency":"USD","unitRateINR":"676800","date":"27-Sep-2024","totalValueINR":"20304000","totalValueInUsd":"242287.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5830803","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO","supplierAddress":"2-15-13, TSUKISHIMA CHUO KU TOKYO 104-0052 JP","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"DASATINIB ANHYDROUS IH, B\/N: DO23080006(EXP. VIDE SB NO:3738548,DT:06-09-23-INV NO: SI3623223654\/30-08-2023)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"CBC GROUP","supplierCountry":"INDIA","foreign_port":"TOKYO","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"8000","totalValueFC":"80762.5","currency":"USD","unitRateINR":"676800","date":"27-Sep-2024","totalValueINR":"6768000","totalValueInUsd":"80762.5","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5830803","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO","supplierAddress":"2-15-13, TSUKISHIMA CHUO KU TOKYO 104-0052 JP","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"}]
    25-Feb-2021
    09-Dec-2024
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    ABOUT THIS PAGE

    Dasatinib Manufacturers

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

    Dasatinib Suppliers

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

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

    Dasatinib USDMF

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

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

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

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

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

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

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

    Dasatinib WC

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

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

    Dasatinib 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 as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dasatinib GMP

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

    Dasatinib CoA

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

    Dasatinib CoA mostly includes findings from lab analyses of a specific batch. For each Dasatinib 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Dasatinib EP), Dasatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dasatinib 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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