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    Also known as: 1256589-74-8, Af-802 hydrochloride, Alectinib hcl, Alecensa, P9yy73lo6j, Alectinib hydrochloride (jan)
    Molecular Formula
    C30H35ClN4O2
    Molecular Weight
    519.1  g/mol
    InChI Key
    GYABBVHSRIHYJR-UHFFFAOYSA-N
    FDA UNII
    P9YY73LO6J
    Alectinib Hydrochloride
    1 2D Structure

    Alectinib Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5H-benzo[b]carbazole-3-carbonitrile;hydrochloride
    2.1.2 InChI
    InChI=1S/C30H34N4O2.ClH/c1-4-20-16-23-24(17-26(20)34-9-7-21(8-10-34)33-11-13-36-14-12-33)30(2,3)29-27(28(23)35)22-6-5-19(18-31)15-25(22)32-29;/h5-6,15-17,21,32H,4,7-14H2,1-3H3;1H
    2.1.3 InChI Key
    GYABBVHSRIHYJR-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCC1=CC2=C(C=C1N3CCC(CC3)N4CCOCC4)C(C5=C(C2=O)C6=C(N5)C=C(C=C6)C#N)(C)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    P9YY73LO6J
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Alecensa

    2. Alectinib

    3. Ch5424802

    4. Ro5424802

    2.3.2 Depositor-Supplied Synonyms

    1. 1256589-74-8

    2. Af-802 Hydrochloride

    3. Alectinib Hcl

    4. Alecensa

    5. P9yy73lo6j

    6. Alectinib Hydrochloride (jan)

    7. Alectinib (hydrochloride)

    8. Ch5424802 (hydrochloride)

    9. Schembl14991271

    10. 5h-benzo[b]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-, Hydrochloride (1:1)

    11. Alectinib Hydrochloride [jan]

    12. 9-ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5h-benzo[b]carbazole-3-carbonitrile Hydrochloride

    13. Unii-p9yy73lo6j

    14. Alecensa (tn)

    15. 5h-benzo(b)carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-(4-(4-morpholinyl)-1-piperidinyl)-11-oxo-, Hydrochloride (1:1)

    16. Alectinib Monohydrochloride

    17. Af-802 (hydrochloride)

    18. Agn-pc-09o9bf

    19. Ro5424802 (hydrochloride)

    20. Chembl3707320

    21. Chebi:62268

    22. Ch5424802 Hcl

    23. Dtxsid10154841

    24. Ch 5424802, Alectinib Hcl

    25. Bcp09075

    26. Ex-a1553

    27. Alectinib Hydrochloride [mi]

    28. Ch-5424802 Hydrochloride

    29. Hy-13011a

    30. Mfcd27987893

    31. S5232

    32. Ccg-264759

    33. Cs-3480

    34. Sb16516

    35. Alectinib Hydrochloride [who-dd]

    36. 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5h-benzo[b]carbazole-3-carbonitrile,hydrochloride

    37. Ac-29721

    38. As-17062

    39. Alectinib Hydrochloride [orange Book]

    40. D10450

    41. Q27104897

    42. Ch5424802 Hcl Salt, Alectinib Hcl Salt, Af802 Hcl Salt

    43. Ch-5428402 Hcl; Af-802 Hydrochloride; Rg-7853 Hydrochloride; Ro-5424802 Hydrochloride

    44. 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5h-benzo[b]carbazole-3-carbonitrile Hydrochloride (1:1)

    45. 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5h-benzo[b]carbazole-3-carbonitrile Monohydrochloride Salt

    46. 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5h-benzo[b]carbazole-3-carbonitrile;hydrochloride

    47. Alectinib Hydrochloride;af-802 Hydrochloride;ch-5424802 Hydrochloride;rg-7853 Hydrochloride;ro-5424802 Hydrochloride

    2.3.3 Other Synonyms

    1. Alectinib

    2. 1256580-46-7

    3. Arq-761

    4. Cas 1416163-60-4

    5. Cas 1256580-46-7

    2.4 Create Date
    2011-07-05
    3 Chemical and Physical Properties
    Molecular Weight 519.1 g/mol
    Molecular Formula C30H35ClN4O2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count3
    Exact Mass518.2448541 g/mol
    Monoisotopic Mass518.2448541 g/mol
    Topological Polar Surface Area72.4 Ų
    Heavy Atom Count37
    Formal Charge0
    Complexity867
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Indication

    Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

    Alecensa as monotherapy is indicated for the treatment of adult patients with ALKpositive advanced NSCLC previously treated with crizotinib.

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
    5.2 ATC Code

    L01ED03

    API Reference Price

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    Drugs in Development

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    Study of Alectinib + Duvelisib In ALK+ALCL Patients

    Details:

    Alectinib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Lymphoma, Large-Cell, Anaplastic.


    Lead Product(s): Alectinib Hydrochloride,Duvelisib

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Genentech | Secura Bio

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 03, 2025

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    01

    Memorial Sloan Kettering Cancer Center

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    IPPE
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    Memorial Sloan Kettering Cancer Center

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    Lead Product(s) : Alectinib Hydrochloride,Duvelisib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Genentech | Secura Bio

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study of Alectinib + Duvelisib In ALK+ALCL Patients

    Details : Alectinib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Lymphoma, Large-Cell, Anaplastic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 03, 2025

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    Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

    Details:

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


    Lead Product(s): Osimertinib Mesylate,Alectinib Hydrochloride,Toripalimab

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Miscellaneous

    Sponsor: Nanjing Geneseeq Technology Inc.

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 29, 2024

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    02

    Guangdong Association of Clinical Trials

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    Guangdong Association of Clinical Trials

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    Lead Product(s) : Osimertinib Mesylate,Alectinib Hydrochloride,Toripalimab

    Therapeutic Area : Oncology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Nanjing Geneseeq Technology Inc.

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

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

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    November 29, 2024

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    Roche’s Alecensa Receives NICE Recommendation to Treat ALK-Positive Lung Cancer

    Details:

    Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, approved by NICE authority for treating patients with ALK-positive early-stage NSCLC.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 21, 2024

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    03

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Roche’s Alecensa Receives NICE Recommendation to Treat ALK-Positive Lung Cancer

    Details : Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, approved by NICE authority for treating patients with ALK-positive early-stage NSCLC.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 21, 2024

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    A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

    Details:

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


    Lead Product(s): Alectinib Hydrochloride,Cisplatin,Carboplatin,Pemetrexed

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 02, 2024

    blank

    04

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Cisplatin,Carboplatin,Pemetrexed

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With N...

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

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 02, 2024

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    Chugai's Alecensa Approved in Japan for Adjuvant Treatment in Early-Stage ALK+ NSCLC

    Details:

    Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, approved y MHLW authority for treating patients with ALK-positive early-stage NSCLC.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 29, 2024

    blank

    05

    Chugai Pharmaceutical

    Japan
    arrow
    IPPE
    Not Confirmed

    Chugai Pharmaceutical

    Japan
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Chugai's Alecensa Approved in Japan for Adjuvant Treatment in Early-Stage ALK+ NSCLC

    Details : Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, approved y MHLW authority for treating patients with ALK-positive early-stage NSCLC.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 29, 2024

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    Taiwan FDA approves Chugai’s Alecensa for the treatment of early stage ALK-positive NSCLC

    Details:

    Alecensa (alectinib) is a tyrosine kinase inhibitor that targets ALK and RET. It is used as adjuvant treatment after surgery in patients with early-stage ALK-positive non–small cell lung cancer.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: F. Hoffmann-La Roche

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 03, 2024

    blank

    06

    Chugai Pharmaceutical

    Japan
    arrow
    IPPE
    Not Confirmed

    Chugai Pharmaceutical

    Japan
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : F. Hoffmann-La Roche

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Taiwan FDA approves Chugai’s Alecensa for the treatment of early stage ALK-positive NSCLC

    Details : Alecensa (alectinib) is a tyrosine kinase inhibitor that targets ALK and RET. It is used as adjuvant treatment after surgery in patients with early-stage ALK-positive non–small cell lung cancer.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 03, 2024

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    EC Approves Roche’s Alecensa as First Adjuvant Treatment for ALK-Positive Lung Cancer

    Details:

    Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is now approved in EU for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 10, 2024

    blank

    07

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    EC Approves Roche’s Alecensa as First Adjuvant Treatment for ALK-Positive Lung Cancer

    Details : Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is now approved in EU for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 10, 2024

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    CHMP Recommends EU Approval Of Alecensa As Adjuvant Treatment For ALK-Positive Lung Cancer

    Details:

    Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is under phase 3 clinical trials for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 30, 2024

    blank

    08

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    CHMP Recommends EU Approval Of Alecensa As Adjuvant Treatment For ALK-Positive Lung Cancer

    Details : Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is under phase 3 clinical trials for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 30, 2024

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    FDA Approves Genentech's Alecensa as First Adjuvant Treatment for ALK-Positive Lung Cancer

    Details:

    Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is now approved & indicated for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 18, 2024

    blank

    09

    Genentech

    U.S.A
    arrow
    IPPE
    Not Confirmed

    Genentech

    U.S.A
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FDA Approves Genentech's Alecensa as First Adjuvant Treatment for ALK-Positive Lung Cancer

    Details : Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is now approved & indicated for postoperative adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 18, 2024

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    Alectinib Deemed “Highly Promising” for Pediatric ALK Fusion-Positive Cancers

    Details:

    Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is currentlt being evaluated in pediatric patients with ALK fusion-positive cancers.


    Lead Product(s): Alectinib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Alecensa

    Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 11, 2024

    blank

    10

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed

    F. Hoffmann-La Roche

    Switzerland
    arrow
    IPPE
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Alectinib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alectinib Deemed “Highly Promising” for Pediatric ALK Fusion-Positive Cancers

    Details : Alecensa (alectinib) is an ALK tyrosine kinase receptor inhibitor, which is currentlt being evaluated in pediatric patients with ALK fusion-positive cancers.

    Product Name : Alecensa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 11, 2024

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    ABOUT THIS PAGE

    Looking for 1256589-74-8 / Alectinib Hydrochloride API manufacturers, exporters & distributors?

    Alectinib Hydrochloride manufacturers, exporters & distributors 1

    23

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

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

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

    API | Excipient name

    Alectinib Hydrochloride

    Synonyms

    1256589-74-8, Af-802 hydrochloride, Alectinib hcl, Alecensa, P9yy73lo6j, Alectinib hydrochloride (jan)

    Cas Number

    1256589-74-8

    Unique Ingredient Identifier (UNII)

    P9YY73LO6J

    Alectinib Hydrochloride Manufacturers

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

    Alectinib Hydrochloride Suppliers

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

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

    Alectinib Hydrochloride USDMF

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

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

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

    Alectinib Hydrochloride KDMF

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

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

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

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

    Alectinib Hydrochloride WC

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

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

    Alectinib Hydrochloride 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 Alectinib Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Alectinib Hydrochloride GMP

    Alectinib Hydrochloride 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 Alectinib Hydrochloride 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 Alectinib Hydrochloride GMP manufacturer or Alectinib Hydrochloride GMP API supplier for your needs.

    Alectinib Hydrochloride CoA

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

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

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