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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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    Shouguang Fukang Pharmaceutical Co., Ltd
    China Flag
    Country
    Country
    China
    Address
    Address
    5# Xueyuan East Street,Shouguang City,Shandong,China 
    Telephone
    Telephone
    +86-536-5102364
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.shouguangpharm.com/
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    • FDA
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    Esomeprazole Magnesium

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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

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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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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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    • FDA
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    Omeprazole

    PDF Supplier PDF
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    See Less

    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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    See Less

    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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    • FDA
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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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    • FDA
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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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    • FDA
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    Trimethoprim

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25195
    Active
    TRIMETHOPRIM
    2011-08-01
    CEP/COS

    Found CEP/COS

    CEP 2005-115 - Rev 02
    Valid
    Trimethoprim
    2024-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25195
    CEP 2005-115 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIMETHOPRIM
    Trimethoprim
    Issue/Submission Date
    2011-08-01
    2024-02-06
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    • FDA
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    Esomeprazole Magnesium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-334 - Rev 00
    Valid
    Esomeprazole magnesium trihydrate
    2021-02-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-334 - Rev 00
    Status
    Valid
     
    Filing Details
    Esomeprazole magnesium trihydrate
    Issue/Submission Date
    2021-02-10
    ASK
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    PHARMACOMPASS
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    your Marketing & Sales content
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    • FDA
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    Esomeprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-009 - Rev 01
    Valid
    Esomeprazole sodium
    2023-04-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-009 - Rev 01
    Status
    Valid
     
    Filing Details
    Esomeprazole sodium
    Issue/Submission Date
    2023-04-26
    ASK
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    • FDA
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    Metformin

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-495 - Rev 00
    Valid
    Metformin Hydrochloride, Process 2
    2023-03-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-495 - Rev 00
    Status
    Valid
     
    Filing Details
    Metformin Hydrochloride, Process 2
    Issue/Submission Date
    2023-03-09
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    Metformin

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-043 - Rev 07
    Valid
    Metformin Hydrochloride, Micronised...
    2022-02-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-043 - Rev 07
    Status
    Valid
     
    Filing Details
    Metformin Hydrochloride, Micronised...
    Issue/Submission Date
    2022-02-21
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    • FDA
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    Phloroglucinol

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-099 - Rev 01
    Valid
    Phloroglucinol dihydrate
    2022-10-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-099 - Rev 01
    Status
    Valid
     
    Filing Details
    Phloroglucinol dihydrate
    Issue/Submission Date
    2022-10-06
    ASK
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    Phloroglucinol

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-007 - Rev 00
    Valid
    Phloroglucinol
    2021-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-007 - Rev 00
    Status
    Valid
     
    Filing Details
    Phloroglucinol
    Issue/Submission Date
    2021-10-22
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    • FDA
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    Rabeprazole

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-463 - Rev 00
    Valid
    Rabeprazole sodium hydrate
    2023-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-463 - Rev 00
    Status
    Valid
     
    Filing Details
    Rabeprazole sodium hydrate
    Issue/Submission Date
    2023-05-31
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