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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shouguang Fukang Pharmaceutical Co., Ltd

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    Shouguang Fukang Pharmaceutical Co., Ltd

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    01 Clozapine (1)

    02 Esomeprazole Magnesium (3)

    03 Esomeprazole Sodium (1)

    04 Lansoprazole (1)

    05 Metformin (3)

    06 Omeprazole (2)

    07 Omeprazole Magnesium (1)

    08 Pantoprazole Sodium (1)

    09 Phloroglucinol (2)

    10 Rabeprazole (1)

    11 Sulfamethoxazole (1)

    12 Trimethoprim (1)

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    01 Active (11)

    02 Blank (7)

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    01 Valid (18)

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    01 226MF10185 (1)

    02 228MF10214 (1)

    03 301MF10106 (1)

    04 303MF10042 (1)

    05 Blank (14)

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    01 Blank (18)

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    Esomeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28548
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    2014-07-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-169 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate, P...
    2021-07-29
    Japanese DMF

    Found JDMF

    303MF10042
    Esomeprazole magnesium hydrate at N...
    2021-03-15
    Written Confirmation

    Close WC

    Application Number
    28548
    R0-CEP 2021-169 - Rev 00
    303MF10042
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    Esomeprazole magnesium dihydrate, P...
    Esomeprazole magnesium hydrate at N...
    Issue/Submission Date
    2014-07-03
    2021-07-29
    2021-03-15
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    Lansoprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25877
    Active
    LANSOPRAZOLE
    2012-03-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-372 - Rev 00
    Valid
    Lansoprazole
    2019-09-03
    Japanese DMF

    Found JDMF

    301MF10106
    Lansoprazole at NORTH-EAST OF DONGW...
    2019-12-10
    Written Confirmation

    Close WC

    Application Number
    25877
    R1-CEP 2012-372 - Rev 00
    301MF10106
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LANSOPRAZOLE
    Lansoprazole
    Lansoprazole at NORTH-EAST OF DONGW...
    Issue/Submission Date
    2012-03-02
    2019-09-03
    2019-12-10
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    Metformin

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    USDMF

    Found USDMF

    23273
    Active
    METFORMIN HYDROCHLORIDE
    2009-10-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-141 - Rev 00
    Valid
    Metformin Hydrochloride
    2021-03-22
    Japanese DMF

    Found JDMF

    228MF10214
    Metformin hydrochloride at NORTH-EA...
    2016-11-09
    Written Confirmation

    Close WC

    Application Number
    23273
    R0-CEP 2019-141 - Rev 00
    228MF10214
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METFORMIN HYDROCHLORIDE
    Metformin Hydrochloride
    Metformin hydrochloride at NORTH-EA...
    Issue/Submission Date
    2009-10-27
    2021-03-22
    2016-11-09
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    Omeprazole

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    USDMF

    Found USDMF

    22897
    Active
    OMEPRAZOLE
    2009-06-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-051 - Rev 00
    Valid
    Omeprazole
    2014-09-23
    Japanese DMF

    Found JDMF

    226MF10185
    Omeprazole at NORTH-EAST OF DONGWAI...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    22897
    R1-CEP 2008-051 - Rev 00
    226MF10185
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Omeprazole at NORTH-EAST OF DONGWAI...
    Issue/Submission Date
    2009-06-19
    2014-09-23
    2014-09-30
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    Clozapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25182
    Active
    CLOZAPINE
    2011-08-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-006 - Rev 00
    Valid
    Clozapine
    2018-04-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25182
    R1-CEP 2012-006 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLOZAPINE
    Clozapine
    Issue/Submission Date
    2011-08-03
    2018-04-12
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    Esomeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31924
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    2017-07-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-027 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2022-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31924
    R1-CEP 2016-027 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Esomeprazole magnesium dihydrate
    Issue/Submission Date
    2017-07-15
    2022-09-09
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    Omeprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24923
    Active
    OMEPRAZOLE
    2011-05-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-237 - Rev 00
    Valid
    Omeprazole, Process B
    2017-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24923
    R1-CEP 2011-237 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole, Process B
    Issue/Submission Date
    2011-05-02
    2017-01-20
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    Omeprazole Magnesium

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    USDMF

    Found USDMF

    27734
    Active
    OMEPRAZOLE MAGNESIUM
    2013-11-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-341 - Rev 00
    Valid
    Omeprazole magnesium
    2021-05-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27734
    R1-CEP 2015-341 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEPRAZOLE MAGNESIUM
    Omeprazole magnesium
    Issue/Submission Date
    2013-11-13
    2021-05-12
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    Pantoprazole Sodium

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    USDMF

    Found USDMF

    27375
    Active
    PANTOPRAZOLE SODIUM
    2013-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-350 - Rev 00
    Valid
    Pantoprazole sodium sesquihydrate
    2020-09-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27375
    R1-CEP 2013-350 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PANTOPRAZOLE SODIUM
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2013-07-31
    2020-09-15
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    Sulfamethoxazole

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    USDMF

    Found USDMF

    25214
    Active
    SULFAMETHOXAZOLE
    2011-08-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-332 - Rev 01
    Valid
    Sulfamethoxazole
    2017-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25214
    R1-CEP 2007-332 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SULFAMETHOXAZOLE
    Sulfamethoxazole
    Issue/Submission Date
    2011-08-01
    2017-07-11
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