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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by China Sinopharm International Corp.

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    01 6-Aminopenicillanic Acid (1)

    02 7-Amino Cephalosporanic Acid (1)

    03 Abacavir Sulfate (1)

    04 Adenine (1)

    05 Alpha Lipoic Acid (1)

    06 Amoxicillin Trihydrate (3)

    07 Ampicillin Trihydrate (1)

    08 Azithromycin Dihydrate (2)

    09 Caspofungin (1)

    10 Cefpirome Sulphate (1)

    11 Ceftriaxone (3)

    12 Cefuroxime Axetil (1)

    13 Clavulanic Acid (3)

    14 Deacetyl-7-Aminocephalosporanic Acid (1)

    15 Human Chorionic Gonadotropin (1)

    16 Hydroxy Echinocandin (2)

    17 Menotropins (1)

    18 Metronidazole (1)

    19 Micafungin (1)

    20 Potassium (1)

    21 Ritalinic Acid (2)

    22 Urokinase (1)

    23 Zidovudine (1)

    24 Blank (1)

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    01 Active (16)

    02 Inactive (10)

    03 Blank (7)

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    01 Valid (8)

    02 Blank (25)

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    01 220MF10013 (1)

    02 Blank (32)

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    01 Blank (33)

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    • FDA
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    32811
    Active
    AMOXICILLIN TRIHYDRATE, USP
    2018-05-15
    CEP/COS

    Found CEP/COS

    CEP 2021-461 - Rev 01
    Valid
    Amoxicillin trihydrate, Compacted
    2023-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    32811
    CEP 2021-461 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE, USP
    Amoxicillin trihydrate, Compacted
    Issue/Submission Date
    2018-05-15
    2023-12-20
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    36579
    Active
    AMOXICILLIN TRIHYDRATE (POWDER)
    2021-12-23
    CEP/COS

    Found CEP/COS

    CEP 2019-244 - Rev 02
    Valid
    Amoxicillin trihydrate
    2023-12-18
    Japanese DMF

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    Written Confirmation

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    Application Number
    36579
    CEP 2019-244 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE (POWDER)
    Amoxicillin trihydrate
    Issue/Submission Date
    2021-12-23
    2023-12-18
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    Clavulanic Acid

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    USDMF

    Found USDMF

    27903
    Active
    CLAVULANATE POTASSIUM, USP
    2014-02-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-329 - Rev 00
    Valid
    Potassium clavulanate, diluted, wit...
    2021-03-03
    Japanese DMF

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    Written Confirmation

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    Application Number
    27903
    R1-CEP 2014-329 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM, USP
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2014-02-05
    2021-03-03
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    Clavulanic Acid

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    USDMF

    Found USDMF

    27966
    Active
    CLAVULANATE POTASSIUM DILUTED 1:1 W...
    2014-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-320 - Rev 00
    Valid
    Potassium clavulanate
    2021-03-05
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    27966
    R1-CEP 2014-320 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM DILUTED 1:1 W...
    Potassium clavulanate
    Issue/Submission Date
    2014-03-12
    2021-03-05
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    • FDA
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    6-Aminopenicillanic Acid

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    USDMF

    Found USDMF

    30779
    Active
    6-AMINOPENICILLANIC ACID
    2016-08-02
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    30779
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    6-AMINOPENICILLANIC ACID
    Issue/Submission Date
    2016-08-02
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    7-Amino Cephalosporanic Acid

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    USDMF

    Found USDMF

    30473
    Active
    7-AMINOCEPHALOSPORANIC ACID
    2016-05-09
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    30473
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    7-AMINOCEPHALOSPORANIC ACID
    Issue/Submission Date
    2016-05-09
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    Abacavir Sulfate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-198 - Rev 00
    Valid
    Abacavir sulfate
    2022-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2020-198 - Rev 00
    Status
    Valid
     
    Filing Details
    Abacavir sulfate
    Issue/Submission Date
    2022-07-12
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    Alpha Lipoic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-119 - Rev 01
    Valid
    Thioctic acid
    2019-10-03
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2008-119 - Rev 01
    Status
    Valid
     
    Filing Details
    Thioctic acid
    Issue/Submission Date
    2019-10-03
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    36698
    Active
    AMOXICILLIN TRIHYDRATE (COMPACTED P...
    2022-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    36698
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMOXICILLIN TRIHYDRATE (COMPACTED P...
    Issue/Submission Date
    2022-02-13
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    38056
    Active
    AMPICILLIN TRIHYDRATE (POWDER)
    2023-03-30
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    38056
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMPICILLIN TRIHYDRATE (POWDER)
    Issue/Submission Date
    2023-03-30
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