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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhuhai United Laboratories Co ., Ltd.

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    ZHUHAI UNITED LABORATORIES CO ., LTD.

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    Zhuhai United Laboratories Co ., Ltd.
    China Flag
    Country
    Country
    China
    Address
    Address
    Sanzao Science&Technology Park Natitional Hi-Tech Zone Zhuhai,Guangdong
    Telephone
    Telephone
    +86-756-77876977787434
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://zhuhai-united.en.ywsp.com/
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    • FDA
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    22857
    Active
    AMPICILLIN TRIHYDRATE
    2009-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-090 - Rev 03
    Valid
    Ampicillin trihydrate, Compacted, p...
    2021-07-13
    Japanese DMF

    Found JDMF

    230MF10038
    Ampicillin Trihydrate at No. 2428, ...
    2018-02-28
    Written Confirmation

    Close WC

    Application Number
    22857
    R1-CEP 2010-090 - Rev 03
    230MF10038
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMPICILLIN TRIHYDRATE
    Ampicillin trihydrate, Compacted, p...
    Ampicillin Trihydrate at No. 2428, ...
    Issue/Submission Date
    2009-06-10
    2021-07-13
    2018-02-28
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    Amoxicillin Trihydrate

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    USDMF

    Caution USDMF

    15377
    Inactive
    AMOXICILLIN USP BULK SUBSTANCE
    2001-04-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-191 - Rev 03
    Valid
    Amoxicillin trihydrate, Compacted
    2019-02-06
    Japanese DMF

    Found JDMF

    229MF10091
    Amoxicillin Trihydrate at No. 2428,...
    2017-05-01
    Written Confirmation

    Close WC

    Application Number
    15377
    R1-CEP 2007-191 - Rev 03
    229MF10091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN USP BULK SUBSTANCE
    Amoxicillin trihydrate, Compacted
    Amoxicillin Trihydrate at No. 2428,...
    Issue/Submission Date
    2001-04-06
    2019-02-06
    2017-05-01
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    Amoxicillin Trihydrate

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    USDMF

    Caution USDMF

    20517
    Inactive
    AMOXICILLIN TRIHYDRATE USP
    2007-05-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-039 - Rev 02
    Valid
    Amoxicillin trihydrate, Micronised,...
    2020-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20517
    R1-CEP 2006-039 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE USP
    Amoxicillin trihydrate, Micronised,...
    Issue/Submission Date
    2007-05-09
    2020-10-16
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    Clavulanic Acid

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    USDMF

    Caution USDMF

    26111
    Inactive
    POTASSIUM CLAVULANATE - MICROCRYSTA...
    2012-05-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-083 - Rev 00
    Valid
    Potassium clavulanate
    2021-11-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26111
    R1-CEP 2015-083 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE - MICROCRYSTA...
    Potassium clavulanate
    Issue/Submission Date
    2012-05-29
    2021-11-26
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    Clavulanic Acid

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    USDMF

    Caution USDMF

    28638
    Inactive
    POTASSIUM CLAVULANATE DILUTED WITH ...
    2014-09-15
    CEP/COS

    Found CEP/COS

    CEP 2013-133 - Rev 02
    Valid
    Potassium clavulanate, Sterile
    2024-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28638
    CEP 2013-133 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE DILUTED WITH ...
    Potassium clavulanate, Sterile
    Issue/Submission Date
    2014-09-15
    2024-03-04
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    Amoxicillin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-125 - Rev 03
    Valid
    Amoxicillin sodium, Sterile
    2023-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-125 - Rev 03
    Status
    Valid
     
    Filing Details
    Amoxicillin sodium, Sterile
    Issue/Submission Date
    2023-03-15
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    Ampicillin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10053
    Ampicillin Sodium at No. 2428, Anji...
    2019-08-28
    Written Confirmation

    Close WC

    Application Number
    301MF10053
    Status
     
    Filing Details
    Ampicillin Sodium at No. 2428, Anji...
    Issue/Submission Date
    2019-08-28
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    Clavulanic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-163 - Rev 00
    Valid
    Potassium clavulanate, diluted, Wit...
    2019-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-163 - Rev 00
    Status
    Valid
     
    Filing Details
    Potassium clavulanate, diluted, Wit...
    Issue/Submission Date
    2019-11-12
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    Clavulanic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-187 - Rev 00
    Valid
    Potassium clavulanate, diluted, Wit...
    2019-11-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-187 - Rev 00
    Status
    Valid
     
    Filing Details
    Potassium clavulanate, diluted, Wit...
    Issue/Submission Date
    2019-11-13
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    Amoxicillin Trihydrate

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    USDMF

    Caution USDMF

    21197
    Inactive
    AMOXICILLIN (COMPACTED)
    2008-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21197
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AMOXICILLIN (COMPACTED)
    Issue/Submission Date
    2008-01-04
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    Cefoperazone Sodium

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    USDMF

    Caution USDMF

    26115
    Inactive
    CEFOPERAZONE SODIUM USP
    2012-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26115
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CEFOPERAZONE SODIUM USP
    Issue/Submission Date
    2012-05-28
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    Cefotaxime

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    USDMF

    Caution USDMF

    25844
    Inactive
    CEFOTAXIME SODIUM USP
    2012-02-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25844
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CEFOTAXIME SODIUM USP
    Issue/Submission Date
    2012-02-29
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    Ceftriaxone

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    USDMF

    Caution USDMF

    25946
    Inactive
    CEFTRIAXONE SODIUM USP
    2012-02-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25946
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CEFTRIAXONE SODIUM USP
    Issue/Submission Date
    2012-02-29
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    Cefuroxime Sodium

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    USDMF

    Caution USDMF

    26114
    Inactive
    CEFUROXIME SODIUM USP
    2012-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26114
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CEFUROXIME SODIUM USP
    Issue/Submission Date
    2012-05-28
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    Cilastatin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-184 - Rev 01
    Withdrawn by Holder
    Cilastatin sodium, Sterile
    2018-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-184 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Cilastatin sodium, Sterile
    Issue/Submission Date
    2018-10-26
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    Imipenem

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-163 - Rev 01
    Withdrawn by Holder
    Imipenem monohydrate, Sterile
    2018-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-163 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Imipenem monohydrate, Sterile
    Issue/Submission Date
    2018-10-26
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    Meropenem

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23858
    Inactive
    MEROPENEM CRUDE NON-STERILE
    2010-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23858
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MEROPENEM CRUDE NON-STERILE
    Issue/Submission Date
    2010-05-28
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    Meropenem

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    USDMF

    Caution USDMF

    25891
    Inactive
    MEROPENEM FOR INJECTION BULK STERIL...
    2012-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25891
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MEROPENEM FOR INJECTION BULK STERIL...
    Issue/Submission Date
    2012-04-16
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    Sulbactam Sodium

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    USDMF

    Caution USDMF

    23769
    Inactive
    SULBACTAM SODIUM USP, NON-STERILE
    2010-05-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23769
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SULBACTAM SODIUM USP, NON-STERILE
    Issue/Submission Date
    2010-05-03
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