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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hetero Drugs Limited (Unit IX)

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    HETERO DRUGS LIMITED (UNIT IX)

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    Hetero Drugs
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    Country
    Country
    India
    Address
    Address
    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
    Telephone
    Telephone
    +91 40 23704923/24
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.hetero.com/
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    Linkedin
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    Twitter

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    Imatinib Mesylate

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    USDMF

    Caution USDMF

    25116
    Inactive
    IMATINIB MESYLATE AMORPHOUS
    2011-07-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-289 - Rev 01
    Valid
    Imatinib mesilate, Form-β
    2020-01-23
    Japanese DMF

    Found JDMF

    225MF10046
    Imatinib mesylate at 7-2-A2,Hetero ...
    2013-03-05
    Written Confirmation

    Found WC

    Indian CDSCO WC-0041
    Valid
    Imatinib Mesylate(1H)
    2022-09-16
    Application Number
    25116
    R0-CEP 2018-289 - Rev 01
    225MF10046
    Indian CDSCO WC-0041
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    IMATINIB MESYLATE AMORPHOUS
    Imatinib mesilate, Form-β
    Imatinib mesylate at 7-2-A2,Hetero ...
    Imatinib Mesylate(1H)
    Issue/Submission Date
    2011-07-12
    2020-01-23
    2013-03-05
    2022-09-16
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    26687
    Active
    IMATINIB MESYLATE (FORM-A)
    2012-12-07
    CEP/COS

    Found CEP/COS

    CEP 2018-222 - Rev 04
    Valid
    Imatinib mesilate, Form α, Process...
    2024-02-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26687
    CEP 2018-222 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IMATINIB MESYLATE (FORM-A)
    Imatinib mesilate, Form α, Process...
    Issue/Submission Date
    2012-12-07
    2024-02-20
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    • FDA
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    30960
    Active
    IMATINIB MESYLATE (FORM-B)
    2016-09-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-275 - Rev 00
    Valid
    Imatinib mesilate, Form-α
    2023-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30960
    R1-CEP 2016-275 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IMATINIB MESYLATE (FORM-B)
    Imatinib mesilate, Form-α
    Issue/Submission Date
    2016-09-21
    2023-06-09
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