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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Aurobindo Pharma Limited

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    AUROBINDO PHARMA LIMITED

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    Aurobindo Pharma Limited
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    Country
    Country
    India
    Address
    Address
    Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh
    Telephone
    Telephone
    +91 (40) 6672 5000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.aurobindo.com/
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    Sertraline Hydrochloride

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    USDMF

    Found USDMF

    17435
    Active
    SERTRALINE HYDROCHLORIDE USP (CRYST...
    2004-05-31
    CEP/COS

    Found CEP/COS

    CEP 2008-019 - Rev 05
    Valid
    Sertraline hydrochloride, Form I
    2024-02-07
    Japanese DMF

    Found JDMF

    226MF10098
    Sertraline hydrochloride at Plot No...
    2014-05-14
    Written Confirmation

    Found WC

    Indian CDSCO WC-0017
    Valid
    Sertraline Hydrochloride (Ph.Eur.)
    2022-06-06
    Application Number
    17435
    CEP 2008-019 - Rev 05
    226MF10098
    Indian CDSCO WC-0017
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-06-10
    Filing Details
    SERTRALINE HYDROCHLORIDE USP (CRYST...
    Sertraline hydrochloride, Form I
    Sertraline hydrochloride at Plot No...
    Sertraline Hydrochloride (Ph.Eur.)
    Issue/Submission Date
    2004-05-31
    2024-02-07
    2014-05-14
    2022-06-06
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    • FDA
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    Sertraline Hydrochloride

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    USDMF

    Found USDMF

    22652
    Active
    SERTRALINE HYDROCHLORIDE USP CRYSTA...
    2009-03-21
    CEP/COS

    Caution CEP/COS

    R0-CEP 2022-446 - Rev 00
    Withdrawn by Holder
    Sertraline hydrochloride, Process I...
    2023-06-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0023
    Expired
    Sertraline Hydrochloride Ph. Eur
    2019-06-26
    Application Number
    22652
    R0-CEP 2022-446 - Rev 00
    Indian CDSCO WC-0023
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Expired
    2022-06-25
    Filing Details
    SERTRALINE HYDROCHLORIDE USP CRYSTA...
    Sertraline hydrochloride, Process I...
    Sertraline Hydrochloride Ph. Eur
    Issue/Submission Date
    2009-03-21
    2023-06-05
    2019-06-26
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