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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hainan Poly Pharm

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    01 Acyclovir Sodium (1)

    02 Amiodarone Hydrochloride (1)

    03 Apremilast (1)

    04 Aspirin (1)

    05 Azithromycin (1)

    06 Captopril (1)

    07 Crisaborole (1)

    08 Desloratadine (1)

    09 Diclofenac Sodium (1)

    10 Dobutamine Hydrochloride (1)

    11 Esomeprazole Sodium (1)

    12 Felodipine (1)

    13 Gadoterate Meglumine (1)

    14 Gadoteridol (1)

    15 Ganciclovir (1)

    16 Ganciclovir Sodium (1)

    17 Glucosamine Hydrochloride (1)

    18 Glycopyrronium Bromide (1)

    19 Ketotifen Fumarate (1)

    20 L-Cysteine (1)

    21 Magnesium Hydroxide (1)

    22 Memantine Hydrochloride (2)

    23 Metformin (1)

    24 Naproxen (1)

    25 Nicergoline (1)

    26 Oxybutynin (1)

    27 Pantoprazole Sodium (1)

    28 Sodium Nitroprusside (1)

    29 Tecovirimat (1)

    30 Theophylline (1)

    31 Trimebutine Maleate (3)

    32 Blank (2)

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    01 Active (17)

    02 Inactive (11)

    03 Blank (8)

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    01 Valid (7)

    02 Blank (29)

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    01 Blank (36)

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    Amiodarone Hydrochloride

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    USDMF

    Found USDMF

    36163
    Active
    AMIODARONE HYDROCHLORIDE USP
    2021-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-481 - Rev 00
    Valid
    Amiodarone hydrochloride
    2023-03-09
    Japanese DMF

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    Application Number
    36163
    R0-CEP 2021-481 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMIODARONE HYDROCHLORIDE USP
    Amiodarone hydrochloride
    Issue/Submission Date
    2021-09-07
    2023-03-09
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    Dobutamine Hydrochloride

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    USDMF

    Found USDMF

    35217
    Active
    DOBUTAMINE HYDROCHLORIDE USP
    2020-09-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-415 - Rev 00
    Valid
    Dobutamine hydrochloride
    2021-09-22
    Japanese DMF

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    Application Number
    35217
    R0-CEP 2020-415 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOBUTAMINE HYDROCHLORIDE USP
    Dobutamine hydrochloride
    Issue/Submission Date
    2020-09-27
    2021-09-22
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    Esomeprazole Sodium

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    USDMF

    Found USDMF

    35059
    Active
    ESOMEPRAZOLE SODIUM
    2020-08-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-351 - Rev 00
    Valid
    Esomeprazole sodium
    2021-10-15
    Japanese DMF

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    Application Number
    35059
    R0-CEP 2020-351 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE SODIUM
    Esomeprazole sodium
    Issue/Submission Date
    2020-08-13
    2021-10-15
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    35446
    Active
    GLYCOPYRROLATE
    2021-05-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-154 - Rev 00
    Valid
    Glycopyrronium bromide
    2022-11-16
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    Application Number
    35446
    R0-CEP 2021-154 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GLYCOPYRROLATE
    Glycopyrronium bromide
    Issue/Submission Date
    2021-05-13
    2022-11-16
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    Magnesium Hydroxide

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    USDMF

    Found USDMF

    36567
    Active
    MAGNESIUM HYDROXIDE USP
    2021-12-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-010 - Rev 00
    Valid
    Magnesium Hydroxide
    2022-07-26
    Japanese DMF

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    Application Number
    36567
    R0-CEP 2022-010 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MAGNESIUM HYDROXIDE USP
    Magnesium Hydroxide
    Issue/Submission Date
    2021-12-16
    2022-07-26
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    Sodium Nitroprusside

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    USDMF

    Found USDMF

    33023
    Active
    SODIUM NITROPRUSSIDE USP
    2018-09-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-114 - Rev 01
    Valid
    Sodium nitroprusside
    2022-03-14
    Japanese DMF

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    Application Number
    33023
    R0-CEP 2020-114 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SODIUM NITROPRUSSIDE USP
    Sodium nitroprusside
    Issue/Submission Date
    2018-09-06
    2022-03-14
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    Desloratadine

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    USDMF

    Caution USDMF

    23926
    Inactive
    DESLORATADINE
    2010-06-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-174 - Rev 01
    Valid
    Desloratadine
    2022-03-16
    Japanese DMF

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    Application Number
    23926
    R0-CEP 2018-174 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DESLORATADINE
    Desloratadine
    Issue/Submission Date
    2010-06-25
    2022-03-16
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    Acyclovir Sodium

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    USDMF

    Found USDMF

    35112
    Active
    ACYCLOVIR SODIUM DRUG SUBSTANCE
    2020-08-31
    CEP/COS

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    Japanese DMF

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    Application Number
    35112
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ACYCLOVIR SODIUM DRUG SUBSTANCE
    Issue/Submission Date
    2020-08-31
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    Apremilast

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    USDMF

    Found USDMF

    38437
    Active
    APREMILAST
    2023-08-15
    CEP/COS

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    Application Number
    38437
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2023-08-15
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    Crisaborole

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    USDMF

    Found USDMF

    39148
    Active
    CRISABOROLE
    2023-11-30
    CEP/COS

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    Application Number
    39148
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CRISABOROLE
    Issue/Submission Date
    2023-11-30
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