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    Chemistry

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    Also known as: 877399-52-5, Xalkori, Pf-02341066, (r)-crizotinib, Pf-2341066, Pf 2341066
    Molecular Formula
    C21H22Cl2FN5O
    Molecular Weight
    450.3  g/mol
    InChI Key
    KTEIFNKAUNYNJU-GFCCVEGCSA-N
    FDA UNII
    53AH36668S
    Crizotinib
    A piperidine and aminopyridine derivative that acts as an inhibitor of RECEPTOR PROTEIN-TYROSINE KINASES, including ANAPLASTIC LYMPHOMA KINASE (ALK) and HEPATOCYTE GROWTH FACTOR RECEPTOR (HGFR; c-Met). It is used in the treatment of NON-SMALL CELL LUNG CANCER.
    Crizotinib is a Kinase Inhibitor. The mechanism of action of crizotinib is as a Cytochrome P450 3A Inhibitor, and Receptor Tyrosine Kinase Inhibitor, and Cytochrome P450 2B6 Inhibitor, and P-Glycoprotein Inhibitor, and Organic Cation Transporter 1 Inhibitor, and Organic Cation Transporter 2 Inhibitor.
    1 2D Structure

    Crizotinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-(1-piperidin-4-ylpyrazol-4-yl)pyridin-2-amine
    2.1.2 InChI
    InChI=1S/C21H22Cl2FN5O/c1-12(19-16(22)2-3-17(24)20(19)23)30-18-8-13(9-27-21(18)25)14-10-28-29(11-14)15-4-6-26-7-5-15/h2-3,8-12,15,26H,4-7H2,1H3,(H2,25,27)/t12-/m1/s1
    2.1.3 InChI Key
    KTEIFNKAUNYNJU-GFCCVEGCSA-N
    2.1.4 Canonical SMILES
    CC(C1=C(C=CC(=C1Cl)F)Cl)OC2=C(N=CC(=C2)C3=CN(N=C3)C4CCNCC4)N
    2.1.5 Isomeric SMILES
    C[C@H](C1=C(C=CC(=C1Cl)F)Cl)OC2=C(N=CC(=C2)C3=CN(N=C3)C4CCNCC4)N
    2.2 Other Identifiers
    2.2.1 UNII
    53AH36668S
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Pf 02341066

    2. Pf 2341066

    3. Pf-02341066

    4. Pf-2341066

    5. Pf02341066

    6. Pf2341066

    7. Xalkori

    2.3.2 Depositor-Supplied Synonyms

    1. 877399-52-5

    2. Xalkori

    3. Pf-02341066

    4. (r)-crizotinib

    5. Pf-2341066

    6. Pf 2341066

    7. Crizotinib (pf-02341066)

    8. (r)-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1h-pyrazol-4-yl)pyridin-2-amine

    9. 3-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(4-piperidinyl)-1h-pyrazol-4-yl]-2-pyridinamine

    10. Pf 02341066

    11. Pf2341066

    12. Chembl601719

    13. Crizotinib (pf-2341066)

    14. Chebi:64310

    15. 877399-52-5 (free Base)

    16. 53ah36668s

    17. Nsc-756645

    18. 3-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1h-pyrazol-4-yl]pyridin-2-amine

    19. 2-pyridinamine, 3-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(4-piperidinyl)-1h-pyrazol-4-yl)-

    20. 3-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-(1-piperidin-4-yl-1h-pyrazol-4-yl)pyridin-2-amine

    21. 3-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-(1-piperidin-4-ylpyrazol-4-yl)pyridin-2-amine

    22. 3-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(4-piperidinyl)-1h-pyrazol-4-yl]pyridin-2-amine

    23. (r)-3-[1-(2,6-dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1h-pyrazol-4-yl)-pyridin-2-ylamine

    24. Xalkori (tn)

    25. Crizotinib [usan]

    26. Crizotinib [usan:inn]

    27. Crizotinibum

    28. Unii-53ah36668s

    29. 3-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1h-pyrazol-4-yl)pyridin-2-amine

    30. Vgh

    31. Crizotinib- Bio-x

    32. Crizotinib [mi]

    33. Crizotinib [inn]

    34. Crizotinib [jan]

    35. Pf02341066

    36. Crizotinib [vandf]

    37. Crizotinib [mart.]

    38. Crizotinib [who-dd]

    39. Schembl93829

    40. Pf-2341066,crizotinib

    41. Crizotinib (jan/usan/inn)

    42. Gtpl4903

    43. Crizotinib [orange Book]

    44. Crizotinib, >=98% (hplc)

    45. Pf-2341066 - Crizotinib

    46. Ex-a096

    47. Bcpp000116

    48. Dtxsid701009329

    49. Amy10313

    50. Bdbm50306682

    51. Mfcd12407409

    52. Nsc749005

    53. Nsc749769

    54. Nsc800080

    55. Zinc35902489

    56. Akos015901233

    57. Akos015995207

    58. Ccg-264803

    59. Db08865

    60. Gs-6178

    61. Nsc 756645

    62. Nsc-749005

    63. Nsc-749769

    64. Nsc-800080

    65. Ncgc00250400-01

    66. Ncgc00250400-02

    67. Ncgc00250400-09

    68. Ncgc00250400-12

    69. Bc164334

    70. Hy-50878

    71. Bb 0261738

    72. Sw202555-3

    73. D09731

    74. 399p525

    75. J-510370

    76. Q5186964

    77. Brd-k78431006-001-01-1

    78. Brd-k78431006-001-03-7

    79. 877399-52-5, 877399-53-6 (acetate)

    80. 3-(2,6-dichloro-3-fluorobenzyloxy)-5-(1-(piperidin-4-yl)-1h-pyrazol-4-yl)pyridin-2-amine

    81. (r)-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1h-pyrazol-4-yl)pyridin-2-am Ine

    82. 3-(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy-5-1-(4-piperidinyl)-1h-pyrazol-4-yl-2-pyridinamine

    83. 3-[(r)-1-(2,6-dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1h-pyrazol-4-yl)-pyridin-2-ylamine

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 450.3 g/mol
    Molecular Formula C21H22Cl2FN5O
    XLogP33.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass449.1185439 g/mol
    Monoisotopic Mass449.1185439 g/mol
    Topological Polar Surface Area78 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity558
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 NameXalkori
    PubMed HealthCrizotinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelXALKORI (crizotinib) is an oral receptor tyrosine kinase inhibitor. The molecular formula for crizotinib is C21H22Cl2FN5O. The molecular weight is 450.34 Daltons. Crizotinib is described chemically as (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[...
    Active IngredientCrizotinib
    Dosage FormCapsule
    RouteOral
    Strength200mg; 250mg
    Market StatusPrescription
    CompanyPf Prism Cv

    2 of 2  
    Drug NameXalkori
    PubMed HealthCrizotinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelXALKORI (crizotinib) is an oral receptor tyrosine kinase inhibitor. The molecular formula for crizotinib is C21H22Cl2FN5O. The molecular weight is 450.34 Daltons. Crizotinib is described chemically as (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[...
    Active IngredientCrizotinib
    Dosage FormCapsule
    RouteOral
    Strength200mg; 250mg
    Market StatusPrescription
    CompanyPf Prism Cv

    4.2 Drug Indication

    Crizotinib is used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic-lymphoma kinase (ALK)-positive as detected by a FDA-approved test.

    FDA Label

    Xalkori is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

    Xalkori is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

    Treatment of lung malignant neoplasms

    Treatment of anaplastic large cell lymphoma, Treatment of inflammatory myofibroblastic tumours

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents

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

    Protein Kinase Inhibitors

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

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    CRIZOTINIB
    5.2.2 FDA UNII
    53AH36668S
    5.2.3 Pharmacological Classes
    Cytochrome P450 3A Inhibitors [MoA]; Kinase Inhibitor [EPC]; Organic Cation Transporter 1 Inhibitors [MoA]; Organic Cation Transporter 2 Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]; Receptor Tyrosine Kinase Inhibitors [MoA]; Cytochrome P450 2B6 Inhibitors [MoA]
    5.3 ATC Code

    L01ED01

    L01XE16

    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

    L01ED - Anaplastic lymphoma kinase (alk) inhibitors

    L01ED01 - Crizotinib

    5.4 Absorption, Distribution and Excretion

    Absorption

    The peak serum concentration was reached in 4 to 6 hours following an oral single-dose administration. Steady state was reached within 15 days when a dose of 250 mg twice daily was administered. The mean absolute bioavailability was 43% (range of 32% to 66%) following a single 250 mg oral dose. When taken with high-fat meal, AUC and Cmax were reduced.

    Route of Elimination

    Following the administration of a single 250 mg radiolabeled crizotinib dose to healthy subjects, 63% and 22% of the administered dose was recovered in feces and urine, respectively. Unchanged crizotinib represented approximately 53% and 2.3% of the administered dose in feces and urine, respectively.

    Volume of Distribution

    Mean volume of distribution (Vss) is 1772 L following intravenous administration of a 50 mg dose. This high volume of distribution suggest extensive distribution into tissue from plasma.

    Clearance

    The mean apparent clearance (CL/F) of crizotinib was lower at steady state (60 L/hr) after 250 mg twice daily than that after a single 250 mg oral dose (100 L/hr), which was likely due to autoinhibition of CYP3A by crizotinib after multiple dosing.

    5.5 Metabolism/Metabolites

    Crizotinib is metabolized by CYP3A4 and CYP3A5 in which these enzymes mediates the O-dealkylation of the drug.

    5.6 Biological Half-Life

    Plasma terminal half-life, patients = 42 hours

    5.7 Mechanism of Action

    Crizotinib is a tyrosine kinase receptor inhibitor. More specifically, it inhibits anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR, c-MET), and Recepteur d'Origine Nantais (RON). Abnormalities in the ALK gene caused by mutations or translocations may lead to expression of oncogenic fusion proteins. In patients with NSCLC, they have the EML4-ALK gene. Crizotinib inhibits ALK tyrosine kinase which ultimately results in decreased proliferation of cells that carry the genetic mutation and tumour survivability.

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    04

    Navinta Llc

    U.S.A
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39325

    Submission : 2024-01-08

    Status : Active

    Type : II

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    01

    Hetero Drugs

    India
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    Hetero Drugs

    India
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    Crizotinib IH

    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...

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    MSN Laboratories

    India
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    Crizotinib IH

    Date of Issue : 2024-07-01

    Valid Till : 2027-06-30

    Written Confirmation Number : WC-0586

    Address of the Firm : Unit-III, Sy. No. 111/E & 111/EE, Cheriyal (Village),Kandi (Mandal), Sanga Reddy...

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    17-Jan-2022
    29-Oct-2025
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    Drugs in Development

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    IDEAYA Announces Successful FDA Type D Meeting on Phase 3 Design for Darovasertib

    Details:

    IDE196 (darovasertib) is a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of primary uveal melanoma.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 14, 2025

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    01

    Ideaya Biosciences

    U.S.A
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    COMPAMED
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    Ideaya Biosciences

    U.S.A
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    COMPAMED
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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    IDEAYA Announces Successful FDA Type D Meeting on Phase 3 Design for Darovasertib

    Details : IDE196 (darovasertib) is a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of primary uveal melanoma.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 14, 2025

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    IDEAYA Announces Pricing of Public Offering

    Details:

    The net proceeds will fund ongoing clinical development of IDE196 (darovasertib), a protein kinase C (PKC) inhibitor, and crizotinib, as combination therapy in metastatic uveal melanoma, including our Phase 2/3 potential registrational clinical trial.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: J.P. Morgan

    Deal Size: $125.0 million Upfront Cash: Undisclosed

    Deal Type: Public Offering October 24, 2023

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    02

    Ideaya Biosciences

    U.S.A
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    COMPAMED
    Not Confirmed

    Ideaya Biosciences

    U.S.A
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    COMPAMED
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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : J.P. Morgan

    Deal Size : $125.0 million

    Deal Type : Public Offering

    DEALS_DEV arrow-down

    IDEAYA Announces Pricing of Public Offering

    Details : The net proceeds will fund ongoing clinical development of IDE196 (darovasertib), a protein kinase C (PKC) inhibitor, and crizotinib, as combination therapy in metastatic uveal melanoma, including our Phase 2/3 potential registrational clinical trial.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    October 24, 2023

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    IDEAYA Biosciences Announces Phase 2 Expansion of Darovasertib and Crizotinib Combination in GNAQ/11 Metastatic Cutaneous Melanoma

    Details:

    IDE196 (darovasertib) is a clinical stage, potent and selective small molecule inhibitor of PKC, a protein kinase that functions downstream of the GTPases GNAQ and GNA11. Currently being developed in combination with Crizotinib for metastatic cutaneous melanoma.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 16, 2023

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    03

    Ideaya Biosciences

    U.S.A
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    COMPAMED
    Not Confirmed

    Ideaya Biosciences

    U.S.A
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    COMPAMED
    Not Confirmed
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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    IDEAYA Biosciences Announces Phase 2 Expansion of Darovasertib and Crizotinib Combination in GNAQ/...

    Details : IDE196 (darovasertib) is a clinical stage, potent and selective small molecule inhibitor of PKC, a protein kinase that functions downstream of the GTPases GNAQ and GNA11. Currently being developed in combination with Crizotinib for metastatic cutaneous m...

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 16, 2023

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    Pharmacogenomics ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

    Details:

    Crizotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


    Lead Product(s): Crizotinib,Inapplicable

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 02, 2023

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    04

    Han Xu

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    COMPAMED
    Not Confirmed

    Han Xu

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    Not Confirmed
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    Lead Product(s) : Crizotinib,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacogenomics ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

    Details : Crizotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 02, 2023

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    IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

    Details:

    IDE196 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Uveal Melanoma.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 14, 2023

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    05

    Ideaya Biosciences

    U.S.A
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    Not Confirmed

    Ideaya Biosciences

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    COMPAMED
    Not Confirmed
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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Mel...

    Details : IDE196 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Uveal Melanoma.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 14, 2023

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    IDEAYA Expands Clinical Trial Collaboration and Supply Agreements with Pfizer to Support Registrational Trial Evaluating Darovasertib and Crizotinib Com...

    Details:

    Under the collaboration, Pfizer will support evaluation of IDE196 (darovasertib) and crizotinib combination therapy in the IDEAYA's planned Phase 2/3 clinical trial in Metastatic Uveal Melanoma and to continue support of the company's ongoing Phase 2 clinical trial in MUM.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Pfizer Inc

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Expanded Collaboration May 16, 2023

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    Ideaya Biosciences

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    Ideaya Biosciences

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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Pfizer Inc

    Deal Size : Undisclosed

    Deal Type : Expanded Collaboration

    DEALS_DEV arrow-down

    IDEAYA Expands Clinical Trial Collaboration and Supply Agreements with Pfizer to Support Registrat...

    Details : Under the collaboration, Pfizer will support evaluation of IDE196 (darovasertib) and crizotinib combination therapy in the IDEAYA's planned Phase 2/3 clinical trial in Metastatic Uveal Melanoma and to continue support of the company's ongoing Phase 2 cli...

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    May 16, 2023

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    Ideaya Announces Darovasertib Phase 2 Initiation in Neoadjuvant and Adjuvant Uveal Melanoma and Guidance for Clinical Data Update in Metastatic Uveal Me...

    Details:

    IDE196 (darovasertib) is a clinical stage, potent and selective small molecule inhibitor of PKC, a protein kinase that functions downstream of the GTPases GNAQ and GNA11. Currently being developed for metastatic uveal melanoma.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 23, 2023

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    07

    Ideaya Biosciences

    U.S.A
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    Ideaya Biosciences

    U.S.A
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    COMPAMED
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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Ideaya Announces Darovasertib Phase 2 Initiation in Neoadjuvant and Adjuvant Uveal Melanoma and Gu...

    Details : IDE196 (darovasertib) is a clinical stage, potent and selective small molecule inhibitor of PKC, a protein kinase that functions downstream of the GTPases GNAQ and GNA11. Currently being developed for metastatic uveal melanoma.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 23, 2023

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    IDEAYA Biosciences Receives Fast Track Designation for Darovasertib Combination Therapy with Crizotinib for the Treatment of Metastatic Uveal Melanoma

    Details:

    IDE196 (darovasertib), a PKC inhibitor, is a clinical stage development compound for patients with tumors harboring GNAQ or GNA11 mutations, including in metastatic uveal melanoma (MUM) and skin melanoma.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 05, 2022

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    08

    Ideaya Biosciences

    U.S.A
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    Ideaya Biosciences

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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    IDEAYA Biosciences Receives Fast Track Designation for Darovasertib Combination Therapy with Crizo...

    Details : IDE196 (darovasertib), a PKC inhibitor, is a clinical stage development compound for patients with tumors harboring GNAQ or GNA11 mutations, including in metastatic uveal melanoma (MUM) and skin melanoma.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 05, 2022

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    IDEAYA Announces First-Patient-In for Phase I Clinical Trial to Evaluate Darovasertib Monotherapy in (Neo)Adjuvant Uveal Melanoma

    Details:

    Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). Mutations in GNAQ or GNA11 (GNAQ/11) have been identified in approximately 90% of patients with metastatic UM.


    Lead Product(s): Darovasertib,Crizotinib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 06, 2022

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    09

    Ideaya Biosciences

    U.S.A
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    Ideaya Biosciences

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    COMPAMED
    Not Confirmed
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    Lead Product(s) : Darovasertib,Crizotinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    IDEAYA Announces First-Patient-In for Phase I Clinical Trial to Evaluate Darovasertib Monotherapy ...

    Details : Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). Mutations in GNAQ or GNA11 (GNAQ/11) have been identified in approximately 90% of patients with metastatic UM.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 06, 2022

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    FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

    Details:

    Crizotinib (Xalkori), a tyrosine kinase inhibitor for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).


    Lead Product(s): Crizotinib,Inapplicable

    Therapeutic Area: Oncology Brand Name: Xalkori

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: National Cancer Institute

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 14, 2022

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    10

    Pfizer Inc

    U.S.A
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    Pfizer Inc

    U.S.A
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    Lead Product(s) : Crizotinib,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : National Cancer Institute

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

    Details : Crizotinib (Xalkori), a tyrosine kinase inhibitor for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).

    Product Name : Xalkori

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 14, 2022

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    INTERMEDIATE SUPPLIERS

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    01

    Jinan Tantu Chemicals

    China
    COMPAMED
    Not Confirmed
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

    N-BOC-4-Hydroxypiperidine

    CAS Number : 109384-19-2

    End Use API : Crizotinib

    About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

    Jinan Tantu Chemicals

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    02

    Ami Organics Private Limited

    India
    COMPAMED
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    Ami Organics Private Limited

    India
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    4-IODO PYRAZOLE

    CAS Number : 3469-69-0

    End Use API : Crizotinib

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    Ami Organics Private Limited

    India
    COMPAMED
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    India
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    4-IODO PYRAZOLE

    CAS Number : 3469-69-0

    End Use API : Crizotinib

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    Ami Organics Private Limited

    India
    COMPAMED
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    India
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    2-CHLORO-1,1,1-TRIETHOXYETHANE

    CAS Number : 51076-95-0

    End Use API : Crizotinib

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    05

    HUNAN OUYA BIOLOGICAL CO.,LTD

    China
    COMPAMED
    Not Confirmed
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    HUNAN OUYA BIOLOGICAL CO.,LTD

    China
    COMPAMED
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    5-bromo-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)p...

    CAS Number : 877399-00-3

    End Use API : Crizotinib

    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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    HUNAN OUYA BIOLOGICAL CO.,LTD

    China
    COMPAMED
    Not Confirmed
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    HUNAN OUYA BIOLOGICAL CO.,LTD

    China
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    4-[4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)...

    CAS Number : 877399-74-1

    End Use API : Crizotinib

    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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    07

    LinkChem

    China
    COMPAMED
    Not Confirmed
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    LinkChem

    China
    COMPAMED
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    2-AMINO-5-BROMOPYRIDIN-3-OL

    CAS Number : 39903-01-0

    End Use API : Crizotinib

    About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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    08

    Synartis Pharma

    India
    COMPAMED
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    India
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    1-Boc-4-hydroxypiperidine

    CAS Number : 109384-19-2

    End Use API : Crizotinib

    About The Company : SYNARTIS Pharma is a dynamic company dedicated to growth through a commitment to quality and communication. Our goal is to become a preferred partner in complex...

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    09

    Vasudha Pharma Chem Limited

    India
    COMPAMED
    Not Confirmed
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    Vasudha Pharma Chem Limited

    India
    COMPAMED
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    N-Boc-4-hydroxypiperidine

    CAS Number : 109384-19-2

    End Use API : Crizotinib

    About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...

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    10

    Wuxi Further Pharmaceutical Co Ltd

    China
    COMPAMED
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    Wuxi Further Pharmaceutical Co Ltd

    China
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    1-(1-boc-4-piperidyl)pyrazole-4-boronic acid pinac...

    CAS Number : 877399-74-1

    End Use API : Crizotinib

    About The Company : Further Pharmaceutical (www.further-pharm.com) is an innovation-driven and service-oriented biopharmaceutical company with global operations that develops and m...

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    FDF Dossiers

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    01

    Pfizer Inc

    U.S.A
    COMPAMED
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    Pfizer Inc

    U.S.A
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    COMPAMED
    Not Confirmed
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    Flag U.S.A
    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 2011-08-26

    Application Number : 202570

    Regulatory Info : RX

    Registration Country : USA

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    02

    Pfizer Inc

    U.S.A
    COMPAMED
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    Pfizer Inc

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2011-08-26

    Application Number : 202570

    Regulatory Info : RX

    Registration Country : USA

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    03

    Pfizer Inc

    U.S.A
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    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE, PELLETS;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2023-09-07

    Application Number : 217581

    Regulatory Info : RX

    Registration Country : USA

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    Pfizer Inc

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE, PELLETS;ORAL

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2023-09-07

    Application Number : 217581

    Regulatory Info : RX

    Registration Country : USA

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    05

    Pfizer Inc

    U.S.A
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    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE, PELLETS;ORAL

    Dosage Strength : 150MG

    Packaging :

    Approval Date : 2023-09-07

    Application Number : 217581

    Regulatory Info : RX

    Registration Country : USA

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    06

    Pfizer Inc

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Crizotinib

    Brand Name : Xalkori

    Dosage Form : Crizotinib 200Mg 60 Units Oral Use

    Dosage Strength : 60 cps 200 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Pfizer Inc

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Crizotinib

    Brand Name : Xalkori

    Dosage Form : Crizotinib 250Mg 60 Units Oral Use

    Dosage Strength : 60 cps 250 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Pfizer Inc

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Crizotinib

    Brand Name : Xalkori

    Dosage Form : Capsule, hard

    Dosage Strength : 200 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Pfizer Inc

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Crizotinib

    Brand Name : Xalkori

    Dosage Form : Capsule, hard

    Dosage Strength : 250 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    10

    Pluviaendo

    Turkey
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    Turkey
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    Regulatory Info :

    Registration Country : Turkey

    Crizotinib

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 200MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Turkey

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    FDA Orange Book

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    01

    PF PRISM CV

    U.S.A
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    PF PRISM CV

    U.S.A
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    RLD : Yes

    TE Code :

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 200MG

    Approval Date : 2011-08-26

    Application Number : 202570

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    PF PRISM CV

    U.S.A
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    PF PRISM CV

    U.S.A
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    RLD : Yes

    TE Code :

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

    Approval Date : 2011-08-26

    Application Number : 202570

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    PF PRISM CV

    U.S.A
    COMPAMED
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    PF PRISM CV

    U.S.A
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    RLD : Yes

    TE Code :

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE, PELLETS;ORAL

    Dosage Strength : 20MG

    Approval Date : 2023-09-07

    Application Number : 217581

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    PF PRISM CV

    U.S.A
    COMPAMED
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    U.S.A
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    RLD : Yes

    TE Code :

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE, PELLETS;ORAL

    Dosage Strength : 50MG

    Approval Date : 2023-09-07

    Application Number : 217581

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    PF PRISM CV

    U.S.A
    COMPAMED
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    PF PRISM CV

    U.S.A
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    RLD : Yes

    TE Code :

    CRIZOTINIB

    Brand Name : XALKORI

    Dosage Form : CAPSULE, PELLETS;ORAL

    Dosage Strength : 150MG

    Approval Date : 2023-09-07

    Application Number : 217581

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Europe

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    01

    PFIZER LTD (SANDWICH UK)

    U.S.A
    COMPAMED
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    Approval Date : 29/08/2024

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    Approval Date : 29/08/2024

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    Regulatory Info : Approved

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    Approval Date : 22/08/2024

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    Regulatory Info : Approved

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    Approval Date : 23/10/2012

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    Approval Date : 22/08/2024

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    Regulatory Info : Authorized

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    Crizotinib

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    Approval Date : 2012-11-12

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    Brand Name : GELATIN BOVINE 140B 6M

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    Excipient Details : Gelatin bovine 140B 6M is used as a stabilizer in parenteral drug products and as a binder and filler in capsules, tablets, granules, and pellets.

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    Brand Name : PIG SKIN GELATIN 100B 20M

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    india-flag.png
    Crizotinib (18 kg - 55 kg) API needed in India [ENA19185]
    A MNC that focuses on manufacturing & development of generics, branded generics, specialty drugs, OTC products, ARV drugs, APIs, intermediates and nutraceuticals is looking for suppliers of Crizotinib (18 kg - 55 kg) API for both commercial & development purposes. The suppliers must support this enquiry with ODMF, LOA & CoA.
    13 Mar 2024

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    13 Mar 2024

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    13 Mar 2024

    india-flag.png
    Various APIs needed in India [ENA06378]
    A well-known pharmaceutical company manufacturing high quality sterile powder formulations, liquid & lyophilized injection, non-sterile oral formulations and active pharmaceutical ingredients is looking for suppliers of various APIs: 1. Dabrafenib Mesylate 2. Trametinib DMSO 3. Ruxolitinib Phosphate 4. Ceritinib 5. Crizotinib
    24 Jan 2020

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    24 Jan 2020

    india-flag.png
    Crizotinib API (20kg) needed in India [ENA02672]
    Rushabh Forex Services is a developing company in exporting, trading and importing of superior quality Pharmaceutical Pellet and Veterinary API and are looking for Crizotinib API (20kg). Interested suppliers must contact Biren Shah via Tel: +91-9426707759| Watsapp: +91-9925046797 or via E-mail: biren031174@gmail.com
    17 Nov 2018

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    17 Nov 2018

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    17 Nov 2018

    india-flag.png
    Crizotinib API (2 kg) needed in India [ENA02455]
    A youthful organization occupied with the advancement, enlistment, assembling and showcasing of Pharmaceutical items to nations in Asia, Eastern Europe and Africa is looking for suppliers of Crizotinib API (2 kg).
    27 Oct 2018

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    27 Oct 2018

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    27 Oct 2018

    Iran.png
    Crizotinib API (10kg) needed in Iran [ENA02049]
    Zistdaru Danesh is a private company active in the development, manufacturing and marketing of biopharmaceuticals is looking for suppliers of Crizotinib API (10kg). Interested suppliers must contact Dr Ali Asghar Hemmati via E-mail: hemmati_aa@yahoo.com or Tel: +989161114668.
    22 Sep 2018

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    22 Sep 2018

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    22 Sep 2018

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    CRIZOTINIB

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    ODE-407
    2029-07-14
    202570
    2
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    CRIZOTINIB

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    CRIZOTINIB

    Exclusivity Code : ODE-407

    Exclusivity Expiration Date : 2029-07-14

    Application Number : 202570

    Product Number : 2

    Exclusivity Details :

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    I-897
    2025-07-14
    217581
    1
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    CRIZOTINIB

    Exclusivity Code : I-897

    Exclusivity Expiration Date : 2025-07-14

    Application Number : 217581

    Product Number : 1

    Exclusivity Details :

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    217581
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    Exclusivity Code : I-897

    Exclusivity Expiration Date : 2025-07-14

    Application Number : 217581

    Product Number : 2

    Exclusivity Details :

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    Product Number : 3

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    Health Canada Patents

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    01

    Pfizer Canada ULC

    Crizotinib
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    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2024-02-26

    Date Granted : 2013-04-30

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2517256

    Filing Date : 2004-02-26

    Strength per Unit : 200 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2024-02-26

    Date Granted : 2013-04-30

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    Pfizer Canada ULC

    Crizotinib
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    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2025-08-15

    Date Granted : 2010-12-21

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2577937

    Filing Date : 2005-08-15

    Strength per Unit : 200 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-08-15

    Date Granted : 2010-12-21

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    Pfizer Canada ULC

    Crizotinib
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    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2026-11-23

    Date Granted : 2011-11-15

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2632286

    Filing Date : 2006-11-23

    Strength per Unit : 200 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2026-11-23

    Date Granted : 2011-11-15

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    04

    Pfizer Canada ULC

    Crizotinib
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    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2025-08-15

    Date Granted : 2017-04-11

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2578066

    Filing Date : 2005-08-15

    Strength per Unit : 200 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-08-15

    Date Granted : 2017-04-11

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    05

    Pfizer Canada ULC

    Crizotinib
    arrow
    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2024-02-26

    Date Granted : 2013-04-30

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2517256

    Filing Date : 2004-02-26

    Strength per Unit : 250 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2024-02-26

    Date Granted : 2013-04-30

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    06

    Pfizer Canada ULC

    Crizotinib
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    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2026-11-23

    Date Granted : 2011-11-15

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2632286

    Filing Date : 2006-11-23

    Strength per Unit : 250 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2026-11-23

    Date Granted : 2011-11-15

    blank

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    07

    Pfizer Canada ULC

    Crizotinib
    arrow
    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2025-08-15

    Date Granted : 2017-04-11

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2578066

    Filing Date : 2005-08-15

    Strength per Unit : 250 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-08-15

    Date Granted : 2017-04-11

    blank

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    08

    Pfizer Canada ULC

    Crizotinib
    arrow
    COMPAMED
    Not Confirmed

    Pfizer Canada ULC

    U.S.A
    arrow
    COMPAMED
    Not Confirmed

    Patent Expiration Date : 2025-08-15

    Date Granted : 2010-12-21

    Crizotinib

    Brand Name : XALKORI

    Patent Number : 2577937

    Filing Date : 2005-08-15

    Strength per Unit : 250 mg

    Dosage Form : Capsule

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-08-15

    Date Granted : 2010-12-21

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    ABOUT THIS PAGE

    Looking for 877399-52-5 / Crizotinib API manufacturers, exporters & distributors?

    Crizotinib manufacturers, exporters & distributors 1

    69

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

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

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

    API | Excipient name

    Crizotinib

    Synonyms

    877399-52-5, Xalkori, Pf-02341066, (r)-crizotinib, Pf-2341066, Pf 2341066

    Cas Number

    877399-52-5

    Unique Ingredient Identifier (UNII)

    53AH36668S

    About Crizotinib

    A piperidine and aminopyridine derivative that acts as an inhibitor of RECEPTOR PROTEIN-TYROSINE KINASES, including ANAPLASTIC LYMPHOMA KINASE (ALK) and HEPATOCYTE GROWTH FACTOR RECEPTOR (HGFR; c-Met). It is used in the treatment of NON-SMALL CELL LUNG CANCER.

    Crizotinib Manufacturers

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

    Crizotinib Suppliers

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

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

    Crizotinib USDMF

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

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

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

    Crizotinib KDMF

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

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

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

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

    Crizotinib WC

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

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

    Crizotinib 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 Crizotinib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Crizotinib GMP

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

    Crizotinib CoA

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

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

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