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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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    Atorvastatin

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    USDMF

    Found USDMF

    26122
    Active
    ATORVASTATIN CALCIUM TRIHYDRATE (FO...
    2012-06-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-049 - Rev 01
    Valid
    Atorvastatin calcium, Form-I
    2023-03-24
    Japanese DMF

    Found JDMF

    229MF10202
    Atorvastatin calcium hydrate [Form-...
    2017-11-20
    Written Confirmation

    Found WC

    Indian CDSCO WC-0041
    Valid
    Atorvastatin Calcium Trihydrate (Ph...
    2022-09-16
    Application Number
    26122
    R0-CEP 2018-049 - Rev 01
    229MF10202
    Indian CDSCO WC-0041
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    ATORVASTATIN CALCIUM TRIHYDRATE (FO...
    Atorvastatin calcium, Form-I
    Atorvastatin calcium hydrate [Form-...
    Atorvastatin Calcium Trihydrate (Ph...
    Issue/Submission Date
    2012-06-04
    2023-03-24
    2017-11-20
    2022-09-16
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    Atorvastatin

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    USDMF

    Caution USDMF

    26751
    Inactive
    ATORVASTATIN CALCIUM AMORPHOUS
    2012-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0065
    Expired
    Atorvastatin Calcium Trihydrate EP
    2019-08-16
    Application Number
    26751
    Indian CDSCO WC-0065
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-15
    Filing Details
    ATORVASTATIN CALCIUM AMORPHOUS
    Atorvastatin Calcium Trihydrate EP
    Issue/Submission Date
    2012-12-20
    2019-08-16
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    • FDA
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0065a
    Expired
    Atorvastatin Calcium Trihydrate EP
    2019-08-16
    Application Number
    Indian CDSCO WC-0065a
    Status
     
    Expired
    2022-08-15
    Filing Details
    Atorvastatin Calcium Trihydrate EP
    Issue/Submission Date
    2019-08-16
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