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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Quimica Sintetica S.a.

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    Quimica Sintetica S.A.

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    01 6-Aminopenicillanic Acid (1)

    02 Acebutolol Hydrochloride (1)

    03 Aciclovir (1)

    04 Amoxicillin Trihydrate (1)

    05 Apremilast (2)

    06 Astemizole (1)

    07 Azithromycin (1)

    08 Beclomethasone Dipropionate (1)

    09 Benazepril Hydrochloride (1)

    10 Benznidazole (1)

    11 Betamethasone (1)

    12 Betamethasone Acetate (1)

    13 Betamethasone Dipropionate (1)

    14 Betamethasone Sodium Phosphate (1)

    15 Betamethasone Valerate (1)

    16 Bumetanide (1)

    17 Buspirone (1)

    18 Butoconazole Nitrate (1)

    19 Candesartan Cilexetil (1)

    20 Captopril (1)

    21 Celecoxib (1)

    22 Chloramphenicol (1)

    23 Chloramphenicol Palmitate (1)

    24 Cimetidine (1)

    25 Cinoxacin (1)

    26 Ciprofloxacin (2)

    27 Ciprofloxacin Hydrochloride (2)

    28 Dexamethasone (1)

    29 Droxidopa (1)

    30 Edaravone (1)

    31 Eltrombopag (1)

    32 Etodolac (1)

    33 Famotidine (2)

    34 Fluconazole (1)

    35 Fluoxetine Hydrochloride (1)

    36 Fosfomycin (1)

    37 Fosinopril (1)

    38 Guanfacine (1)

    39 Hydrocortisone Sodium Succinate (1)

    40 Indapamide (1)

    41 Irbesartan (1)

    42 Itraconazole (2)

    43 Ketoconazole (3)

    44 Ketorolac Trometamol (1)

    45 Ketotifen Fumarate (1)

    46 Lansoprazole (3)

    47 Levofloxacin (2)

    48 Levofloxacin Hemihydrate (2)

    49 Loperamide Hydrochloride (1)

    50 Loratadine (2)

    51 Losartan Potassium (1)

    52 Meclofenamic Acid (1)

    53 Mefenamic Acid (1)

    54 Meloxicam (1)

    55 Methylprednisolone (1)

    56 Miconazole Nitrate (1)

    57 Milnacipran HCl (1)

    58 Norfloxacin (1)

    59 Ofloxacin (1)

    60 Omeprazole (1)

    61 Pantoprazole Sodium (1)

    62 Posaconazole (1)

    63 Praziquantel (1)

    64 Prednisolone Sodium Phosphate (1)

    65 Progesterone (1)

    66 Rabeprazole (4)

    67 Ranitidine Hydrochloride (2)

    68 Rivaroxaban (1)

    69 Sumatriptan (2)

    70 Tamsulosin (1)

    71 Terbinafine Hydrochloride (1)

    72 Terconazole (1)

    73 Terfenadine (1)

    74 Tianeptine Sodium (1)

    75 Triamcinolone Acetonide (1)

    76 Venlafaxine Hydrochloride (2)

    77 Zolpidem Tartrate (1)

    78 Blank (1)

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    01 Active (31)

    02 Inactive (47)

    03 Blank (18)

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    01 Valid (26)

    02 Withdrawn by Holder (2)

    03 Blank (68)

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    01 217MF11306 (1)

    02 218MF10191 (1)

    03 218MF10922 (1)

    04 220MF10029 (1)

    05 221MF10016 (1)

    06 221MF10133 (1)

    07 226MF10016 (1)

    08 226MF10118 (1)

    09 226MF10127 (1)

    10 226MF10189 (1)

    11 226MF10194 (1)

    12 227MF10091 (1)

    13 227MF10293 (1)

    14 230MF10154 (1)

    15 Blank (82)

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    01 Blank (96)

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    Omeprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12605
    Active
    OMEPRAZOLE
    1997-07-23
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-093 - Rev 08
    Valid
    Omeprazole
    2019-02-04
    Japanese DMF

    Found JDMF

    218MF10191
    Omeprazole at Calle Dulcinea, s/n 2...
    2006-02-08
    Written Confirmation

    Close WC

    Application Number
    12605
    R1-CEP 1999-093 - Rev 08
    218MF10191
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Omeprazole at Calle Dulcinea, s/n 2...
    Issue/Submission Date
    1997-07-23
    2019-02-04
    2006-02-08
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    Ciprofloxacin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    8517
    Inactive
    CIPROFLOXACIN HYDROCHLORIDE
    1990-04-05
    CEP/COS

    Found CEP/COS

    CEP 1999-096 - Rev 08
    Valid
    Ciprofloxacin Hydrochloride
    2024-02-16
    Japanese DMF

    Found JDMF

    217MF11306
    Ciprofloxacin hydrochloride at Call...
    2005-12-22
    Written Confirmation

    Close WC

    Application Number
    8517
    CEP 1999-096 - Rev 08
    217MF11306
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CIPROFLOXACIN HYDROCHLORIDE
    Ciprofloxacin Hydrochloride
    Ciprofloxacin hydrochloride at Call...
    Issue/Submission Date
    1990-04-05
    2024-02-16
    2005-12-22
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    Lansoprazole

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    USDMF

    Caution USDMF

    17329
    Inactive
    LANZOPRAZOLE
    2004-04-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-123 - Rev 01
    Valid
    Lansoprazole, Micronised
    2021-07-23
    Japanese DMF

    Found JDMF

    220MF10029
    Lansoprazole at Calle Dulcinea, s/n...
    2008-01-23
    Written Confirmation

    Close WC

    Application Number
    17329
    R1-CEP 2015-123 - Rev 01
    220MF10029
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LANZOPRAZOLE
    Lansoprazole, Micronised
    Lansoprazole at Calle Dulcinea, s/n...
    Issue/Submission Date
    2004-04-27
    2021-07-23
    2008-01-23
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    Aciclovir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8584
    Active
    ACYCLOVIR
    1990-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-126 - Rev 03
    Valid
    Aciclovir
    2017-04-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8584
    R1-CEP 1998-126 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACYCLOVIR
    Aciclovir
    Issue/Submission Date
    1990-05-25
    2017-04-27
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    Ciprofloxacin

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    USDMF

    Found USDMF

    15913
    Active
    CIPROFLOXACIN
    2002-03-20
    CEP/COS

    Found CEP/COS

    CEP 2004-199 - Rev 07
    Valid
    Ciprofloxacin
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15913
    CEP 2004-199 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CIPROFLOXACIN
    Ciprofloxacin
    Issue/Submission Date
    2002-03-20
    2023-12-06
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    Famotidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13036
    Active
    FAMOTIDINE
    1998-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10922
    Famotidine at Calle Dulcinea, s/n 2...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    13036
    218MF10922
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FAMOTIDINE
    Famotidine at Calle Dulcinea, s/n 2...
    Issue/Submission Date
    1998-06-17
    2006-11-21
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    Guanfacine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8661
    Active
    GUANFACINE HYDROCHLORIDE
    1990-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10293
    Guanfacine hydrochloride at Calle D...
    2015-12-24
    Written Confirmation

    Close WC

    Application Number
    8661
    227MF10293
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GUANFACINE HYDROCHLORIDE
    Guanfacine hydrochloride at Calle D...
    Issue/Submission Date
    1990-07-12
    2015-12-24
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    Indapamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    9064
    Active
    INDAPAMIDE
    1991-03-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-159 - Rev 00
    Valid
    Indapamide
    2023-06-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9064
    R0-CEP 2021-159 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    INDAPAMIDE
    Indapamide
    Issue/Submission Date
    1991-03-25
    2023-06-19
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    Itraconazole

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    USDMF

    Found USDMF

    13012
    Active
    ITRACONAZOLE
    1998-05-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-006 - Rev 00
    Valid
    Itraconazole, Process II
    2021-04-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13012
    R1-CEP 2016-006 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ITRACONAZOLE
    Itraconazole, Process II
    Issue/Submission Date
    1998-05-28
    2021-04-16
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    Lansoprazole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-361 - Rev 02
    Valid
    Lansoprazole, GP2
    2020-06-24
    Japanese DMF

    Found JDMF

    230MF10154
    Lansoprazole at Calle Dulcinea, s/n...
    2018-11-14
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-361 - Rev 02
    230MF10154
    Status
    Valid
     
    Filing Details
    Lansoprazole, GP2
    Lansoprazole at Calle Dulcinea, s/n...
    Issue/Submission Date
    2020-06-24
    2018-11-14
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