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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhejiang Huahai Pharmaceutical

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    01 Ambrisentan (1)

    02 Amisulpride (1)

    03 Amlodipine Besylate (1)

    04 Apixaban (1)

    05 Apremilast (1)

    06 Aripiprazole (1)

    07 Azelaic Acid (1)

    08 Benazepril Hydrochloride (1)

    09 Benserazide Hydrochloride (1)

    10 Brexpiprazole (1)

    11 Brivaracetam (1)

    12 Canagliflozin (1)

    13 Candesartan Cilexetil (1)

    14 Captopril (1)

    15 Cariprazine Hydrochloride (1)

    16 Carvedilol (1)

    17 Carvedilol Phosphate (1)

    18 Citalopram Hydrobromide (1)

    19 Clofazimine (1)

    20 Clopidogrel (1)

    21 Dabigatran Etexilate Mesylate (1)

    22 Dapagliflozin Propanediol Monohydrate (1)

    23 Dimethyl Fumarate (2)

    24 Donepezil (2)

    25 Duloxetine (1)

    26 Efavirenz (1)

    27 Elagolix Sodium (1)

    28 Empagliflozin (2)

    29 Enalapril Maleate (1)

    30 Entecavir (1)

    31 Eprosartan Mesylate (1)

    32 Escitalopram Oxalate (1)

    33 Ethanol (1)

    34 Etilevodopa (1)

    35 Febuxostat (1)

    36 Fingolimod Hydrochloride (1)

    37 Fosinopril (1)

    38 Gabapentin (1)

    39 Gefitinib (1)

    40 Hydrochlorothiazide (1)

    41 Irbesartan (2)

    42 Ketotifen Fumarate (1)

    43 Lacosamide (1)

    44 Lamotrigine (1)

    45 Levetiracetam (4)

    46 Linagliptin (1)

    47 Lisinopril (2)

    48 Losartan Potassium (5)

    49 Metoprolol Succinate (1)

    50 Milnacipran HCl (1)

    51 Mirabegron (1)

    52 Montelukast Sodium (1)

    53 Nebivolol (1)

    54 Nevirapine (2)

    55 Olmesartan Medoxomil (2)

    56 Paliperidone (1)

    57 Paroxetine Hydrochloride (3)

    58 Paroxetine Mesylate (1)

    59 Perindopril Erbumine (2)

    60 Pioglitazone Hydrochloride (1)

    61 Pregabalin (1)

    62 Quetiapine Hemifumarate (1)

    63 Quinapril (1)

    64 Ramipril (1)

    65 Ranolazine (1)

    66 Risperidone (1)

    67 Rivaroxaban (1)

    68 Rocuronium Bromide (1)

    69 Ropinirole Hydrochloride (1)

    70 Safinamide Mesylate (1)

    71 Silodosin (1)

    72 Sitagliptin Phosphate (1)

    73 Strontium Ranelate (1)

    74 Tadalafil (1)

    75 Telmisartan (2)

    76 Tenofovir Disoproxil Fumarate (1)

    77 Thiaproline-M-Amino Benzoic Acid Hydrochloride (1)

    78 Tofacitinib Citrate (1)

    79 Tolvaptan (1)

    80 Topiramate (1)

    81 Torsemide (1)

    82 UNII-B7XF2TD73C (1)

    83 Valsartan (2)

    84 Voriconazole (1)

    85 Vortioxetine Hydrobromide (1)

    86 Blank (4)

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    01 Active (84)

    02 Inactive (10)

    03 Blank (14)

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    01 Valid (56)

    02 Withdrawn by Holder (2)

    03 Blank (50)

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    01 217MF10883 (1)

    02 219MF10148 (1)

    03 224MF10164 (1)

    04 227MF10149 (1)

    05 227MF10237 (1)

    06 227MF10268 (1)

    07 228MF10003 (1)

    08 301MF10091 (1)

    09 303MF10094 (1)

    10 303MF10128 (1)

    11 304MF10122 (1)

    12 Blank (97)

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    01 Blank (108)

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    Candesartan Cilexetil

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    USDMF

    Found USDMF

    25455
    Active
    CANDESARTAN CILEXETIL USP
    2011-10-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-309 - Rev 04
    Valid
    Candesartan cilexetil
    2022-11-28
    Japanese DMF

    Found JDMF

    304MF10122
    Candesartan Cilexetil at Xunqiao, L...
    2022-08-17
    Written Confirmation

    Close WC

    Application Number
    25455
    R1-CEP 2011-309 - Rev 04
    304MF10122
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CANDESARTAN CILEXETIL USP
    Candesartan cilexetil
    Candesartan Cilexetil at Xunqiao, L...
    Issue/Submission Date
    2011-10-21
    2022-11-28
    2022-08-17
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    Captopril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14311
    Active
    CAPTOPRIL USP
    1999-07-22
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-023 - Rev 10
    Valid
    Captopril
    2020-10-19
    Japanese DMF

    Found JDMF

    227MF10237
    Captopril at Xunqiao, Linhai, Zheji...
    2015-09-24
    Written Confirmation

    Close WC

    Application Number
    14311
    R1-CEP 1997-023 - Rev 10
    227MF10237
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CAPTOPRIL USP
    Captopril
    Captopril at Xunqiao, Linhai, Zheji...
    Issue/Submission Date
    1999-07-22
    2020-10-19
    2015-09-24
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    Enalapril Maleate

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    USDMF

    Found USDMF

    14355
    Active
    ENALAPRIL MALEATE USP
    1999-06-22
    CEP/COS

    Found CEP/COS

    CEP 2000-053 - Rev 07
    Valid
    Enalapril maleate
    2023-11-23
    Japanese DMF

    Found JDMF

    227MF10268
    Enalapril maleate at Xunqiao, Linha...
    2015-11-19
    Written Confirmation

    Close WC

    Application Number
    14355
    CEP 2000-053 - Rev 07
    227MF10268
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ENALAPRIL MALEATE USP
    Enalapril maleate
    Enalapril maleate at Xunqiao, Linha...
    Issue/Submission Date
    1999-06-22
    2023-11-23
    2015-11-19
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    Escitalopram Oxalate

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    USDMF

    Found USDMF

    20081
    Active
    ESCITALOPRAM OXALATE USP
    2006-10-17
    CEP/COS

    Found CEP/COS

    CEP 2016-178 - Rev 01
    Valid
    Escitalopram oxalate
    2024-02-23
    Japanese DMF

    Found JDMF

    303MF10128
    Escitalopram Oxalate at Xunqiao, Li...
    2021-08-16
    Written Confirmation

    Close WC

    Application Number
    20081
    CEP 2016-178 - Rev 01
    303MF10128
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESCITALOPRAM OXALATE USP
    Escitalopram oxalate
    Escitalopram Oxalate at Xunqiao, Li...
    Issue/Submission Date
    2006-10-17
    2024-02-23
    2021-08-16
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    Lisinopril

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    USDMF

    Found USDMF

    14801
    Active
    LISINOPRIL DIHYDRATE, USP
    2000-03-24
    CEP/COS

    Found CEP/COS

    CEP 2003-064 - Rev 05
    Valid
    Lisinopril dihydrate
    2024-01-17
    Japanese DMF

    Found JDMF

    219MF10148
    Lisinopril hydrate at Xunqiao, Linh...
    2007-04-27
    Written Confirmation

    Close WC

    Application Number
    14801
    CEP 2003-064 - Rev 05
    219MF10148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LISINOPRIL DIHYDRATE, USP
    Lisinopril dihydrate
    Lisinopril hydrate at Xunqiao, Linh...
    Issue/Submission Date
    2000-03-24
    2024-01-17
    2007-04-27
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    Nevirapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19712
    Active
    NEVIRAPINE USP
    2006-08-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-153 - Rev 00
    Valid
    Nevirapine hemihydrate
    2023-01-19
    Japanese DMF

    Found JDMF

    227MF10149
    Nevirapine at Xunqiao, Linhai, Zhej...
    2015-05-26
    Written Confirmation

    Close WC

    Application Number
    19712
    R1-CEP 2016-153 - Rev 00
    227MF10149
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NEVIRAPINE USP
    Nevirapine hemihydrate
    Nevirapine at Xunqiao, Linhai, Zhej...
    Issue/Submission Date
    2006-08-11
    2023-01-19
    2015-05-26
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    Irbesartan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21754
    Inactive
    IRBESARTAN
    2008-06-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-033 - Rev 03
    Valid
    Irbesartan
    2021-05-05
    Japanese DMF

    Found JDMF

    228MF10003
    Irbesartan at Xunqiao, Linhai, Zhej...
    2016-01-08
    Written Confirmation

    Close WC

    Application Number
    21754
    R1-CEP 2010-033 - Rev 03
    228MF10003
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IRBESARTAN
    Irbesartan
    Irbesartan at Xunqiao, Linhai, Zhej...
    Issue/Submission Date
    2008-06-27
    2021-05-05
    2016-01-08
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    Levetiracetam

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    USDMF

    Caution USDMF

    22235
    Inactive
    LEVETIRACETAM USP
    2008-11-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-399 - Rev 00
    Valid
    Levetiracetam, Process VII
    2023-01-18
    Japanese DMF

    Found JDMF

    301MF10091
    Levetiracetam at Xunqiao, Linhai, Z...
    2019-11-15
    Written Confirmation

    Close WC

    Application Number
    22235
    R0-CEP 2022-399 - Rev 00
    301MF10091
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LEVETIRACETAM USP
    Levetiracetam, Process VII
    Levetiracetam at Xunqiao, Linhai, Z...
    Issue/Submission Date
    2008-11-21
    2023-01-18
    2019-11-15
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    Losartan Potassium

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    USDMF

    Found USDMF

    22073
    Active
    LOSARTAN POTASSIUM USP
    2008-08-05
    CEP/COS

    Caution CEP/COS

    R1-CEP 2009-296 - Rev 01
    Withdrawn by Holder
    Losartan potassium
    2019-04-26
    Japanese DMF

    Found JDMF

    224MF10164
    Losartan potassium at Xunqiao, Linh...
    2012-08-16
    Written Confirmation

    Close WC

    Application Number
    22073
    R1-CEP 2009-296 - Rev 01
    224MF10164
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan potassium at Xunqiao, Linh...
    Issue/Submission Date
    2008-08-05
    2019-04-26
    2012-08-16
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    Losartan Potassium

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    USDMF

    Caution USDMF

    20716
    Inactive
    LOSARTAN POTASSIUM, USP
    2007-04-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-139 - Rev 05
    Valid
    Losartan potassium, Process II
    2022-09-08
    Japanese DMF

    Found JDMF

    303MF10094
    Losartan Potassium at Xunqiao, Linh...
    2021-06-15
    Written Confirmation

    Close WC

    Application Number
    20716
    R1-CEP 2010-139 - Rev 05
    303MF10094
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LOSARTAN POTASSIUM, USP
    Losartan potassium, Process II
    Losartan Potassium at Xunqiao, Linh...
    Issue/Submission Date
    2007-04-25
    2022-09-08
    2021-06-15
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