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

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    01 31139-87-4 (1)

    02 4-Biphenylacetic Acid (1)

    03 Acarbose (1)

    04 Adenosine (1)

    05 Anastrozole (1)

    06 Apixaban (1)

    07 Aripiprazole (1)

    08 Atorvastatin (1)

    09 Bicalutamide (1)

    10 Biotin (1)

    11 Bisbentiamine (1)

    12 Bleomycin (3)

    13 Bortezomib (1)

    14 Candesartan Cilexetil (1)

    15 Capecitabine (1)

    16 Capreomycin (2)

    17 Celecoxib (2)

    18 Chloramphenicol (1)

    19 Cladribine (1)

    20 Clonazepam (1)

    21 Cyclophosphamide (1)

    22 Cytarabine (1)

    23 Dabigatran Etexilate Mesylate (1)

    24 Dactinomycin (1)

    25 Daptomycin (2)

    26 Dasatinib (1)

    27 Daunorubicin HCl (1)

    28 Decitabine (1)

    29 Demeclocycline Hydrochloride (1)

    30 Docetaxel (1)

    31 Donepezil (1)

    32 Doxorubicin Hydrochloride (2)

    33 Epirubicin Hydrochloride (2)

    34 Escitalopram Oxalate (1)

    35 Famciclovir (1)

    36 Favipiravir (1)

    37 Fipronil (1)

    38 Floxuridine (1)

    39 Fludarabine Phosphate (1)

    40 Fluvastatin Sodium (1)

    41 Gefitinib (1)

    42 Gemcitabine (1)

    43 Granisetron (1)

    44 Granisetron Hydrochloride (1)

    45 Hydroxy Echinocandin (1)

    46 Idarubicin Hydrochloride (1)

    47 Imatinib Mesylate (1)

    48 Irinotecan Hydrochloride (1)

    49 Isepamicin Sulfate (1)

    50 Ivermectin (1)

    51 Letrozole (1)

    52 Linezolid (1)

    53 Losartan Potassium (1)

    54 Lovastatin (1)

    55 Lurasidone Hydrochloride (1)

    56 Meropenem (1)

    57 Mesna (1)

    58 Methotrexate (1)

    59 Mevastatin (2)

    60 Micafungin (1)

    61 Milbemycin Oxime (1)

    62 Minocycline Hydrochloride (1)

    63 Mitomycin (2)

    64 Moxidectin (3)

    65 Moxifloxacin Hydrochloride (2)

    66 Mycophenolate Mofetil (2)

    67 Mycophenolic Acid (2)

    68 Olanzapine (1)

    69 Orlistat (2)

    70 Oxaliplatin (1)

    71 Palbociclib (1)

    72 Pioglitazone Hydrochloride (1)

    73 Pitavastatin (1)

    74 Pneumocandin M1 (1)

    75 Polaprezinc (1)

    76 Pravastatin (3)

    77 Praziquantel (2)

    78 Procainamide Hydrochloride (1)

    79 Quetiapine Hemifumarate (1)

    80 Romidepsin (1)

    81 Rosuvastatin Calcium (1)

    82 Simvastatin (2)

    83 Sirolimus (2)

    84 Sulbactam Sodium (1)

    85 Tacrolimus (2)

    86 Tazobactam Sodium (2)

    87 Ticagrelor (1)

    88 Tigecycline (1)

    89 Tobramycin (1)

    90 Tolterodine Tartrate (1)

    91 Valsartan (1)

    92 Vancomycin Hydrochloride (1)

    93 Vinblastine Sulfate (1)

    94 Vinorelbine Tartrate (1)

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    01 Active (42)

    02 Inactive (56)

    03 Blank (18)

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    01 Valid (18)

    02 Withdrawn by Holder (25)

    03 Blank (73)

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    01 217MF10344 (1)

    02 217MF10345 (1)

    03 217MF10346 (1)

    04 217MF10347 (1)

    05 218MF10411 (1)

    06 218MF10970 (1)

    07 223MF10167 (1)

    08 224MF10216 (1)

    09 225MF10116 (1)

    10 226MF10124 (1)

    11 226MF10139 (1)

    12 227MF10144 (1)

    13 303MF10122 (1)

    14 304MF10048 (1)

    15 Blank (102)

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    01 Blank (116)

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    Acarbose

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    USDMF

    Found USDMF

    19069
    Active
    ACARBOSE USP
    2005-12-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-144 - Rev 01
    Valid
    Acarbose
    2021-03-17
    Japanese DMF

    Found JDMF

    218MF10411
    Acarbose at 46 Waisha Road, Jiaojia...
    2006-04-14
    Written Confirmation

    Close WC

    Application Number
    19069
    R1-CEP 2006-144 - Rev 01
    218MF10411
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACARBOSE USP
    Acarbose
    Acarbose at 46 Waisha Road, Jiaojia...
    Issue/Submission Date
    2005-12-14
    2021-03-17
    2006-04-14
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    13773
    Active
    DOXORUBICIN HYDROCHLORIDE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-262 - Rev 00
    Valid
    Doxorubicin Hydrochloride, Fermenta...
    2022-05-10
    Japanese DMF

    Found JDMF

    226MF10124
    Doxorubicin hydrochloride at 46 Wai...
    2014-07-01
    Written Confirmation

    Close WC

    Application Number
    13773
    R1-CEP 2013-262 - Rev 00
    226MF10124
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE USP
    Doxorubicin Hydrochloride, Fermenta...
    Doxorubicin hydrochloride at 46 Wai...
    Issue/Submission Date
    1998-09-01
    2022-05-10
    2014-07-01
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    Ivermectin

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    USDMF

    Found USDMF

    21624
    Active
    IVERMECTIN USP
    2008-05-08
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-176 - Rev 05
    Valid
    Ivermectin
    2021-03-31
    Japanese DMF

    Found JDMF

    304MF10048
    Ivermectin at 46 Waisha Road, Jiaoj...
    2022-03-02
    Written Confirmation

    Close WC

    Application Number
    21624
    R1-CEP 1999-176 - Rev 05
    304MF10048
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IVERMECTIN USP
    Ivermectin
    Ivermectin at 46 Waisha Road, Jiaoj...
    Issue/Submission Date
    2008-05-08
    2021-03-31
    2022-03-02
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    Pravastatin

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    USDMF

    Caution USDMF

    16309
    Inactive
    PRAVASTATIN SODIUM USP
    2002-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-009 - Rev 02
    Valid
    Pravastatin sodium
    2021-03-17
    Japanese DMF

    Found JDMF

    227MF10144
    Pravastatin sodium at 46 Waisha Roa...
    2015-05-20
    Written Confirmation

    Close WC

    Application Number
    16309
    R1-CEP 2002-009 - Rev 02
    227MF10144
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PRAVASTATIN SODIUM USP
    Pravastatin sodium
    Pravastatin sodium at 46 Waisha Roa...
    Issue/Submission Date
    2002-12-13
    2021-03-17
    2015-05-20
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    Adenosine

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    USDMF

    Found USDMF

    17306
    Active
    ADENOSINE USP
    2004-04-12
    CEP/COS

    Found CEP/COS

    CEP 2013-044 - Rev 02
    Valid
    Adenosine
    2024-03-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17306
    CEP 2013-044 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ADENOSINE USP
    Adenosine
    Issue/Submission Date
    2004-04-12
    2024-03-06
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    Daunorubicin HCl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13775
    Active
    DAUNORUBICIN HYDROCHLORIDE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 2012-380 - Rev 02
    Valid
    Daunorubicin Hydrochloride
    2024-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13775
    CEP 2012-380 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DAUNORUBICIN HYDROCHLORIDE USP
    Daunorubicin Hydrochloride
    Issue/Submission Date
    1998-09-01
    2024-03-08
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    27311
    Active
    DOXORUBICIN HYDROCHLORIDE USP (FERM...
    2013-09-09
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-151 - Rev 07
    Valid
    Doxorubicin Hydrochloride
    2022-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27311
    R1-CEP 1999-151 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE USP (FERM...
    Doxorubicin Hydrochloride
    Issue/Submission Date
    2013-09-09
    2022-05-19
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    Lovastatin

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    USDMF

    Found USDMF

    12133
    Active
    LOVASTATIN USP
    1996-09-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-406 - Rev 05
    Valid
    Lovastatin
    2021-07-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12133
    R1-CEP 2001-406 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LOVASTATIN USP
    Lovastatin
    Issue/Submission Date
    1996-09-17
    2021-07-02
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    Simvastatin

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    USDMF

    Found USDMF

    16305
    Active
    SIMVASTATIN USP
    2002-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-172 - Rev 04
    Valid
    Simvastatin
    2021-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16305
    R1-CEP 2002-172 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SIMVASTATIN USP
    Simvastatin
    Issue/Submission Date
    2002-12-11
    2021-03-17
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    Bicalutamide

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    USDMF

    Found USDMF

    17878
    Active
    BICALUTAMIDE USP
    2004-12-03
    CEP/COS

    Caution CEP/COS

    R0-CEP 2013-195 - Rev 00
    Withdrawn by Holder
    Bicalutamide
    2014-09-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17878
    R0-CEP 2013-195 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide
    Issue/Submission Date
    2004-12-03
    2014-09-19
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