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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Hainan Poly Pharm. Co Ltd to the U.S. FDA. Original Data : FDA Website

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    HAINAN POLY PHARM. CO LTD

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    Hainan Poly Pharm
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    China
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    Guilingyang Economic Development Area, Haikou, Hainan 571127
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    +86 571-89385087
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    enquiries@pharmacompass.com
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    https://www.hnpoly.com/en/
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    ACYCLOVIR SODIUM DRUG SUBSTANCE

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    HAINAN POLY PHARM CO ...
    Active
    35112
    Complete
    2020-10-06
    2020-08-26
    2020-08-31
    II
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    AMIODARONE HYDROCHLORIDE USP

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    HAINAN POLY PHARM CO ...
    Active
    36163
    Complete
    2021-10-20
    2021-09-07
    2021-09-07
    II
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    APREMILAST

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    ANHUI POLY PHARM CO L...
    Active
    38437
    Complete
    2023-10-30
    2023-09-25
    2023-08-15
    II
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    ASPIRIN AND DIPYRIDAMOLE EXTENDED R...

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    HAINAN POLY PHARMACEU...
    Inactive
    23734
    N/A
    2010-04-14
    II
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    AZITHROMYCIN GRANULES FOR ORAL SUSP...

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    HAINAN POLY PHARMACEU...
    Inactive
    23486
    N/A
    2010-01-27
    II
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    CRISABOROLE

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    ANHUI POLY PHARM CO L...
    Active
    39148
    Complete
    2024-01-09
    2023-12-15
    2023-11-30
    II
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    DESLORATADINE

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    HAINAN POLY PHARMACEU...
    Inactive
    23926
    N/A
    2010-06-25
    II
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    DICLOFENAC SODIUM EXTENDED RELEASE ...

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    HAINAN POLY PHARMACEU...
    Inactive
    23243
    N/A
    2009-11-02
    II
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    DOBUTAMINE HYDROCHLORIDE USP

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    HAINAN POLY PHARM CO ...
    Active
    35217
    Complete
    2020-11-06
    2020-09-24
    2020-09-27
    II
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    ESOMEPRAZOLE SODIUM

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    HAINAN POLY PHARM CO ...
    Active
    35059
    Complete
    2020-09-17
    2020-08-13
    2020-08-13
    II
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    FELODIPINE EXTENDED RELEASE TABLETS

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    HAINAN POLY PHARMACEU...
    Inactive
    23724
    N/A
    2010-04-14
    II
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    GADOTERATE MEGLUMINE

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    ANHUI POLY PHARM CO L...
    Active
    37072
    Complete
    2022-06-22
    2022-06-02
    2022-05-31
    II
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    GADOTERIDOL USP

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    ANHUI POLY PHARM CO L...
    Active
    37960
    Complete
    2023-03-21
    2023-02-03
    2023-02-09
    II
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    GANCICLOVIR SODIUM

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    HAINAN POLY PHARMACEU...
    Inactive
    25122
    N/A
    2011-07-13
    II
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    GLUCOSAMINE HYDROCHLORIDE PELLETS C...

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    HAINAN POLY PHARMACEU...
    Inactive
    23487
    N/A
    2010-01-27
    II
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    GLYCOPYRROLATE

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    HAINAN POLY PHARM CO ...
    Active
    35446
    Complete
    2021-08-30
    2021-07-13
    2021-05-13
    II
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    MAGNESIUM HYDROXIDE USP

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    ANHUI POLY PHARM CO L...
    Active
    36567
    N/A
    2021-12-16
    II
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    MEMANTINE HYDROCHLORIDE USP

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    ANHUI POLY PHARM CO L...
    Active
    37704
    N/A
    2022-11-29
    II
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    MEMANTINE HYDROCHLORIDE, USP

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    HAINAN POLY PHARMACEU...
    Active
    34870
    N/A
    2020-05-29
    II
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    METFORMIN HYDROCHLORIDE EXTENDED RE...

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    HAINAN POLY PHARMACEU...
    Inactive
    23726
    N/A
    2010-04-14
    II
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    SODIUM NITROPRUSSIDE USP

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    HAINAN POLY PHARMACEU...
    Active
    33023
    Complete
    2018-11-06
    2018-09-11
    2018-09-06
    II
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    TECOVIRIMAT MONOHYDRATE

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    ANHUI POLY PHARM CO L...
    Active
    38852
    N/A
    2023-09-20
    II
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    THEOPHYLLINE EXTENDED RELEASE CAPSU...

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    HAINAN POLY PHARMACEU...
    Inactive
    23244
    N/A
    2009-11-02
    II
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    TRIMEBUTINE MALEATE DRUG SUBSTANCE

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    HAINAN POLY PHARM CO ...
    Active
    34948
    N/A
    2020-06-24
    II
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    TRIMEBUTINE MALEATE DRUG SUBSTANCE

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    HAINAN POLY PHARMACEU...
    Inactive
    24203
    N/A
    2010-08-26
    II
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    TRIMEBUTINE MALEATE TABLETS

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    HAINAN POLY PHARMACEU...
    Inactive
    23725
    N/A
    2010-04-14
    II
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    GADOBUTROL USP

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    ANHUI POLY PHARM CO L...
    Active
    39149
    Complete
    2024-01-08
    2023-12-13
    2023-11-30
    II
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    VORICONAZOLE USP

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    ANHUI POLY PHARM CO L...
    Active
    38466
    Complete
    2023-10-12
    2023-09-26
    2023-09-01
    II
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