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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Zhejiang Huahai Pharmaceutical to the U.S. FDA. Original Data : FDA Website

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    Zhejiang Huahai Pharmaceutical

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    01 (3S, 4R) ALCOHOL COMPOUND (1)

    02 AMBRISENTAN (1)

    03 AMLODIPINE BESYLATE USP (1)

    04 APIXABAN (1)

    05 APREMILAST (1)

    06 ARIPIPRAZOLE USP (1)

    07 AZELAIC ACID (1)

    08 BENAZEPRIL HYDROCHLORIDE USP (1)

    09 BREXPIPRAZOLE (1)

    10 BRIVARACETAM (1)

    11 CANAGLIFLOZIN (1)

    12 CANDESARTAN CILEXETIL USP (1)

    13 CAPTOPRIL USP (1)

    14 CARIPRAZINE HYDROCHLORIDE (1)

    15 CARVEDILOL DIHYDROGEN PHOSPHATE HEMIHYDRATE USP (1)

    16 CARVEDILOL USP (1)

    17 CITALOPRAM HYDROBROMIDE USP (1)

    18 CLOFAZIMINE USP (1)

    19 CLOPIDOGREL BISULFATE USP (1)

    20 DABIGATRAN ETEXILATE MESYLATE (1)

    21 DAPAGLIFLOZIN PROPANEDIOL (1)

    22 DAPAGLIFLOZIN PROPANEDIOL (PROCESS II) USP (1)

    23 DIMETHYL FUMARATE (1)

    24 DIMETHYL FUMARATE USP (PROCESS II) (1)

    25 DONEPEZIL HYDROCHLORIDE (PROCESS II) USP (1)

    26 DONEPEZIL HYDROCHLORIDE USP (1)

    27 DULOXETINE HYDROCHLORIDE, USP (1)

    28 ECCPA DRUG SUBSTANCE INTERMEDIATE (1)

    29 EDOXABAN TOSYLATE MONOHYDRATE (1)

    30 EFAVIRENZ USP (1)

    31 ELAGOLIX SODIUM (1)

    32 EMPAGLIFLOZIN (1)

    33 EMPAGLIFLOZIN (PROCESS II) (1)

    34 ENALAPRIL MALEATE USP (1)

    35 ENTECAVIR USP (1)

    36 EPROSARTAN MESYLATE (1)

    37 ESCITALOPRAM OXALATE USP (1)

    38 FEBUXOSTAT (1)

    39 FINGOLIMOD HYDROCHLORIDE USP (1)

    40 FOSINOPRIL SODIUM USP (1)

    41 GABAPENTIN USP (1)

    42 HYDROCHLOROTHIAZIDE USP (1)

    43 IRBESARTAN (1)

    44 IRBESARTAN USP (1)

    45 LAMOTRIGINE USP (1)

    46 LEVETIRACETAM USP (1)

    47 LEVETIRACETAM USP (PROCESS II) (1)

    48 LEVETIRACETAM USP (PROCESS V) (1)

    49 LEVETIRACETAM, USP (PROCESS VII) (1)

    50 LEVODOPA USP (1)

    51 LEVOMILNACIPRAN HYDROCHLORIDE (1)

    52 LINAGLIPTIN (1)

    53 LISINOPRIL DIHYDRATE, USP (1)

    54 LOSARTAN POTASSIUM (1)

    55 LOSARTAN POTASSIUM USP (2)

    56 LOSARTAN POTASSIUM, USP (1)

    57 METOPROLOL SUCCINATE USP (1)

    58 MIRABEGRON (1)

    59 MONTELUKAST BACKONE DIOL (1)

    60 NEBIVOLOL HYDROCHLORIDE (1)

    61 NEVIRAPINE HEMIHYDRATE USP (1)

    62 NEVIRAPINE USP (1)

    63 OLMESARTAN MEDOXOMIL USP (1)

    64 OSELTAMIVIR PHOSPHATE USP (1)

    65 PALIPERIDONE USP (1)

    66 PAROXETINE BASE (BULK) (1)

    67 PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP (1)

    68 PAROXETINE MESYLATE (1)

    69 PIOGLITAZONE HYDROCHLORIDE USP (1)

    70 PREGABALIN USP (1)

    71 QUETIAPINE FUMARATE USP (1)

    72 QUINAPRIL HYDROCHLORIDE USP (1)

    73 RAMIPRIL USP (1)

    74 RANOLAZINE (1)

    75 RISPERIDONE USP (1)

    76 RIVAROXABAN USP (1)

    77 ROCURONIUM BROMIDE USP (1)

    78 ROPINIROLE HYDROCHLORIDE, USP (1)

    79 SAFINAMIDE MESYLATE (1)

    80 SILODOSIN (1)

    81 SITAGLIPTIN PHOSPHATE USP (1)

    82 TADALAFIL USP (1)

    83 TELMISARTAN USP (1)

    84 TENOFOVIR DISOPROXIL FUMARATE (1)

    85 THIAPROLINE-M-AMINO BENZOIC ACID HYDROCHLORIDE (TPAB HYDROCHLORIDE) DRUG SUBSTANCE (1)

    86 TOFACITINIB CITRATE (1)

    87 TOLVAPTAN (1)

    88 TOPIRAMATE (1)

    89 TORSEMIDE, USP (1)

    90 VALSARTAN DRUG SUBSTANCE (1)

    91 VALSARTAN USP (PROCESS II) (1)

    92 VORICONAZOLE USP (1)

    93 VORTIOXETINE HYDROBROMIDE (1)

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    01 LINHAI TIANYU PHARMACEUTICAL CO LTD (1)

    02 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD (93)

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    01 China (94)

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    01 Active (84)

    02 Inactive (10)

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    01 Complete (76)

    02 Blank (18)

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    (3S, 4R) ALCOHOL COMPOUND

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    ZHEJIANG HUAHAI PHARM...
    Active
    26756
    N/A
    2013-01-30
    II
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    AMBRISENTAN

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    ZHEJIANG HUAHAI PHARM...
    Active
    27505
    Complete
    2014-05-23
    2013-09-27
    2013-09-30
    II
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    AMLODIPINE BESYLATE USP

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    ZHEJIANG HUAHAI PHARM...
    Active
    28886
    Complete
    2015-07-14
    2014-12-31
    2015-02-16
    II
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    APIXABAN

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    ZHEJIANG HUAHAI PHARM...
    Active
    29667
    Complete
    2015-12-18
    2015-09-25
    2015-09-02
    II
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    APREMILAST

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    ZHEJIANG HUAHAI PHARM...
    Active
    31882
    Complete
    2017-09-14
    2017-08-08
    2017-07-12
    II
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    ARIPIPRAZOLE USP

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    ZHEJIANG HUAHAI PHARM...
    Active
    25685
    Complete
    2013-04-09
    2012-11-23
    2011-12-20
    II
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    AZELAIC ACID

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    ZHEJIANG HUAHAI PHARM...
    Active
    33485
    Complete
    2020-01-17
    2019-09-30
    2019-09-17
    II
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    BENAZEPRIL HYDROCHLORIDE USP

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    ZHEJIANG HUAHAI PHARM...
    Active
    17792
    Complete
    2013-03-07
    2013-02-25
    2004-10-27
    II
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    BREXPIPRAZOLE

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    ZHEJIANG HUAHAI PHARM...
    Active
    33810
    Complete
    2019-06-04
    2019-04-26
    2019-04-25
    II
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    BRIVARACETAM

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    ZHEJIANG HUAHAI PHARM...
    Active
    37524
    Complete
    2022-10-27
    2022-10-14
    2022-09-26
    II
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