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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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    Lopinavir

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    USDMF

    Found USDMF

    19852
    Active
    LOPINAVIR USP
    2006-10-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-396 - Rev 00
    Valid
    Lopinavir
    2022-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0041
    Valid
    Lopinavir (USP/IH/Ph. Eur)
    2022-09-16
    Application Number
    19852
    R0-CEP 2020-396 - Rev 00
    Indian CDSCO WC-0041
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    LOPINAVIR USP
    Lopinavir
    Lopinavir (USP/IH/Ph. Eur)
    Issue/Submission Date
    2006-10-10
    2022-10-28
    2022-09-16
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    Lopinavir

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    USDMF

    Found USDMF

    26303
    Active
    LOPINAVIR AMORPHOUS
    2012-08-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0066
    Expired
    Lopinavir (USP/Ph.Eur/IH)
    2019-08-09
    Application Number
    26303
    Indian CDSCO WC-0066
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-08
    Filing Details
    LOPINAVIR AMORPHOUS
    Lopinavir (USP/Ph.Eur/IH)
    Issue/Submission Date
    2012-08-13
    2019-08-09
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    Lopinavir

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    USDMF

    Found USDMF

    30636
    Active
    LOPINAVIR (PROCESS-II)
    2016-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    30636
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LOPINAVIR (PROCESS-II)
    Issue/Submission Date
    2016-07-30
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