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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Cspc Zhongrun Pharmaceutical Inner Mongolia Co., Ltd.

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    CSPC Zhongrun Pharmaceutical Inner Mongolia Co., Ltd.

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    01 6-Aminopenicillanic Acid (1)

    02 7-Amino Cephalosporanic Acid (2)

    03 Amoxicillin Trihydrate (2)

    04 Ampicillin (1)

    05 Ampicillin Trihydrate (1)

    06 Benzyl Penicillin (1)

    07 Benzylpenicillin Sodium (1)

    08 Ephedrine Hydrochloride (1)

    09 Milk Thistle Extract (3)

    10 Oxytetracycline Dihydrate (1)

    11 Oxytetracycline Hydrochloride (1)

    12 Penicillin G Potassium (2)

    13 Piperacillin Sodium (1)

    14 Sulbactam (1)

    filter

    01 Active (11)

    02 Inactive (2)

    03 Blank (6)

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    01 Valid (6)

    02 Blank (13)

    filter

    01 226MF10047 (1)

    02 302MF10096 (1)

    03 304MF10055 (1)

    04 305MF10104 (1)

    05 Blank (15)

    filter

    01 Blank (19)

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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    37924
    Active
    AMOXICILLIN TRIHYDRATE
    2023-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-315 - Rev 02
    Valid
    Amoxicillin trihydrate
    2020-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    37924
    R1-CEP 2007-315 - Rev 02
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE
    Amoxicillin trihydrate
    Issue/Submission Date
    2023-01-19
    2020-01-31
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    35735
    Active
    AMPICILLIN TRIHYDRATE
    2021-03-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-133 - Rev 00
    Valid
    Ampicillin trihydrate
    2022-04-05
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    35735
    R0-CEP 2020-133 - Rev 00
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AMPICILLIN TRIHYDRATE
    Ampicillin trihydrate
    Issue/Submission Date
    2021-03-26
    2022-04-05
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    Piperacillin Sodium

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    USDMF

    Found USDMF

    35825
    Active
    PIPERACILLIN
    2021-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10055
    Piperacillin at Industry Zone, Tuok...
    2022-03-16
    Written Confirmation

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    Application Number
    35825
    304MF10055
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PIPERACILLIN
    Piperacillin at Industry Zone, Tuok...
    Issue/Submission Date
    2021-04-29
    2022-03-16
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    Sulbactam

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    USDMF

    Found USDMF

    38539
    Active
    SULBACTAM ACID
    2023-06-28
    CEP/COS

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    Japanese DMF

    Found JDMF

    305MF10104
    Sulbactam at Industry Zone, Tuoketu...
    2023-08-30
    Written Confirmation

    Close WC

    Application Number
    38539
    305MF10104
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SULBACTAM ACID
    Sulbactam at Industry Zone, Tuoketu...
    Issue/Submission Date
    2023-06-28
    2023-08-30
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    6-Aminopenicillanic Acid

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    USDMF

    Found USDMF

    19525
    Active
    6-AMINOPENICILLANIC ACID
    2006-06-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19525
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    6-AMINOPENICILLANIC ACID
    Issue/Submission Date
    2006-06-19
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    7-Amino Cephalosporanic Acid

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    USDMF

    Found USDMF

    33773
    Active
    7-AMINOCEPHALOSPORANIC ACID
    2019-07-28
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    33773
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    7-AMINOCEPHALOSPORANIC ACID
    Issue/Submission Date
    2019-07-28
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    7-Amino Cephalosporanic Acid

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    USDMF

    Found USDMF

    35604
    Active
    DEACETYL-7-AMINOCEPHALOSPORANIC ACI...
    2021-02-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    35604
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DEACETYL-7-AMINOCEPHALOSPORANIC ACI...
    Issue/Submission Date
    2021-02-25
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    • FDA
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    Amoxicillin Trihydrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2016-310 - Rev 00
    Valid
    Amoxicillin trihydrate, Compacted
    2022-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2016-310 - Rev 00
    Status
    Valid
     
    Filing Details
    Amoxicillin trihydrate, Compacted
    Issue/Submission Date
    2022-03-08
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    Ampicillin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10096
    Ampicillin hydrate at Industry Zone...
    2020-08-05
    Written Confirmation

    Close WC

    Application Number
    302MF10096
    Status
     
    Filing Details
    Ampicillin hydrate at Industry Zone...
    Issue/Submission Date
    2020-08-05
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    Benzyl Penicillin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10047
    Benzylpenicillin Potassium at Indus...
    2014-02-20
    Written Confirmation

    Close WC

    Application Number
    226MF10047
    Status
     
    Filing Details
    Benzylpenicillin Potassium at Indus...
    Issue/Submission Date
    2014-02-20
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