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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lek Pharmaceuticals

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    01 Amlodipine Besylate (2)

    02 Apremilast (1)

    03 Atorvastatin (1)

    04 Auranofin (1)

    05 Bromocriptine Mesylate (1)

    06 Calcium Gluceptate (1)

    07 Candesartan Cilexetil (1)

    08 Caspofungin (1)

    09 Cimetidine (1)

    10 Clavulanic Acid (7)

    11 Dihydroergotamine Mesylate (1)

    12 Dolutegravir Sodium (1)

    13 Enalapril Maleate (1)

    14 Entecavir (1)

    15 Ferric Carboxymaltose (1)

    16 Ferumoxytol (1)

    17 Fesoterodine (1)

    18 Gentamicin Sulfate (1)

    19 Lisinopril (1)

    20 Lithium Carbonate (2)

    21 Losartan Potassium (1)

    22 Lovastatin (2)

    23 Mycophenolate Mofetil (2)

    24 Nifedipine (1)

    25 Nitrofurantoin (1)

    26 Olanzapine (1)

    27 Omeprazole (2)

    28 Pravastatin (2)

    29 Propranolol Hydrochloride (1)

    30 Rosuvastatin Calcium (3)

    31 Silver Sulfadiazine (1)

    32 Simvastatin (1)

    33 Sirolimus (1)

    34 Sugammadex Sodium (1)

    35 Tacrolimus (2)

    36 Tamsulosin (1)

    37 Ticagrelor (1)

    38 Tolterodine Tartrate (1)

    39 Vancomycin Hydrochloride (2)

    40 Vortioxetine Hydrobromide (1)

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    01 Active (26)

    02 Inactive (26)

    03 Blank (4)

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    01 Expired (1)

    02 Valid (11)

    03 Withdrawn by Holder (8)

    04 Blank (36)

    filter

    01 217MF10493 (1)

    02 217MF10740 (1)

    03 220MF10041 (1)

    04 221MF10054 (1)

    05 222MF10151 (1)

    06 222MF10232 (1)

    07 225MF10145 (1)

    08 228MF10155 (1)

    09 Blank (48)

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    01 Blank (56)

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    Gentamicin Sulfate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13704
    Active
    GENTAMICIN SULFATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-121 - Rev 01
    Valid
    Gentamicin sulfate
    2016-02-03
    Japanese DMF

    Found JDMF

    220MF10041
    Gentamicin sulfate at Verovskova ul...
    2008-02-05
    Written Confirmation

    Close WC

    Application Number
    13704
    R1-CEP 2005-121 - Rev 01
    220MF10041
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    GENTAMICIN SULFATE
    Gentamicin sulfate
    Gentamicin sulfate at Verovskova ul...
    Issue/Submission Date
    1998-09-01
    2016-02-03
    2008-02-05
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    20765
    Active
    ROSUVASTATIN CALCIUM
    2007-08-09
    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-321 - Rev 01
    Withdrawn by Holder
    Rosuvastatin calcium, Process C
    2019-04-15
    Japanese DMF

    Found JDMF

    228MF10155
    Rosuvastatin calcium at Verovskova ...
    2016-08-08
    Written Confirmation

    Close WC

    Application Number
    20765
    R0-CEP 2016-321 - Rev 01
    228MF10155
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium, Process C
    Rosuvastatin calcium at Verovskova ...
    Issue/Submission Date
    2007-08-09
    2019-04-15
    2016-08-08
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    Vancomycin Hydrochloride

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    USDMF

    Caution USDMF

    13223
    Inactive
    VANCOMYCIN HYDROCHLORIDE
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-179 - Rev 03
    Valid
    Vancomycin hydrochloride
    2019-12-18
    Japanese DMF

    Found JDMF

    217MF10740
    Vancomycin Hydrochloride at Verovsk...
    2005-10-07
    Written Confirmation

    Close WC

    Application Number
    13223
    R1-CEP 2004-179 - Rev 03
    217MF10740
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin Hydrochloride at Verovsk...
    Issue/Submission Date
    1998-04-30
    2019-12-18
    2005-10-07
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    Amlodipine Besylate

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    USDMF

    Caution USDMF

    16887
    Inactive
    AMLODIPINE BESYLATE
    2003-10-02
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-210 - Rev 00
    Withdrawn by Holder
    Amlodipine besilate
    2011-07-01
    Japanese DMF

    Found JDMF

    222MF10151
    Amlodipine besylate "FIA" at Verovs...
    2010-05-17
    Written Confirmation

    Close WC

    Application Number
    16887
    R1-CEP 2004-210 - Rev 00
    222MF10151
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    AMLODIPINE BESYLATE
    Amlodipine besilate
    Amlodipine besylate "FIA" at Verovs...
    Issue/Submission Date
    2003-10-02
    2011-07-01
    2010-05-17
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    Atorvastatin

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    USDMF

    Found USDMF

    18082
    Active
    ATORVASTATIN CALCIUM
    2005-02-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10232
    Atorvastatin calcium hydrate at Ver...
    2010-09-24
    Written Confirmation

    Close WC

    Application Number
    18082
    222MF10232
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin calcium hydrate at Ver...
    Issue/Submission Date
    2005-02-01
    2010-09-24
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    Bromocriptine Mesylate

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    USDMF

    Found USDMF

    6827
    Active
    BROMOCRIPTINE MESYLATE USP
    1987-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10054
    Bromocriptine mesylate at Verovskov...
    2009-03-16
    Written Confirmation

    Close WC

    Application Number
    6827
    221MF10054
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    BROMOCRIPTINE MESYLATE USP
    Bromocriptine mesylate at Verovskov...
    Issue/Submission Date
    1987-02-13
    2009-03-16
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    Clavulanic Acid

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    USDMF

    Found USDMF

    15211
    Active
    CLAVULANATE POTASSIUM
    2000-12-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-262 - Rev 03
    Valid
    Potassium clavulanate
    2020-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15211
    R1-CEP 2003-262 - Rev 03
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM
    Potassium clavulanate
    Issue/Submission Date
    2000-12-26
    2020-06-17
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    Clavulanic Acid

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    USDMF

    Found USDMF

    32777
    Active
    CLAVULANATE POTASSIUM DILUTED WITH ...
    2018-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-241 - Rev 03
    Valid
    Potassium clavulanate, diluted, wit...
    2020-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32777
    R1-CEP 2004-241 - Rev 03
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM DILUTED WITH ...
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2018-05-17
    2020-02-07
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    Clavulanic Acid

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    USDMF

    Found USDMF

    36941
    Active
    POTASSIUM CLAVULANATE DILUTED WITH ...
    2023-01-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-242 - Rev 03
    Valid
    Potassium clavulanate, diluted, wit...
    2020-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36941
    R1-CEP 2004-242 - Rev 03
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE DILUTED WITH ...
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2023-01-17
    2020-02-07
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    Clavulanic Acid

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    USDMF

    Found USDMF

    37008
    Active
    POTASSIUM CLAVULANATE DILUTED WITH ...
    2023-09-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-001 - Rev 09
    Valid
    Potassium clavulanate, Code Number ...
    2020-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37008
    R1-CEP 1998-001 - Rev 09
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE DILUTED WITH ...
    Potassium clavulanate, Code Number ...
    Issue/Submission Date
    2023-09-27
    2020-02-25
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