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

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    01 Azithromycin (2)

    02 Azithromycin Dihydrate (1)

    03 Clarithromycin (2)

    04 Erythromycin (2)

    05 Erythromycin Estolate (1)

    06 Erythromycin Ethyl Succinate (1)

    07 Erythromycin Stearate (1)

    08 Famotidine (1)

    09 Formaldehyde (1)

    10 Fosfomycin (2)

    11 Fosfomycin Calcium (1)

    12 Fosfomycin Sodium (1)

    13 Fusidic Acid (2)

    14 Lovastatin (2)

    15 Mevastatin (1)

    16 Sodium Fusidate (1)

    17 Terbinafine Hydrochloride (1)

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    01 Active (9)

    02 Inactive (5)

    03 Blank (9)

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    01 Valid (7)

    02 Blank (16)

    filter

    01 218MF10462 (1)

    02 218MF10649 (1)

    03 218MF10685 (1)

    04 218MF10830 (1)

    05 218MF10942 (1)

    06 220MF10030 (1)

    07 221MF10079 (1)

    08 224MF10053 (1)

    09 225MF10103 (1)

    10 225MF10104 (1)

    11 226MF10186 (1)

    12 301MF10083 (1)

    13 Blank (11)

    filter

    01 Blank (23)

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    Erythromycin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13466
    Active
    ERYTHROMYCIN BASE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-129 - Rev 02
    Valid
    Erythromycin, Micronised, powder
    2021-03-26
    Japanese DMF

    Found JDMF

    218MF10942
    erythromycin at Paseo del Deleite, ...
    2006-11-24
    Written Confirmation

    Close WC

    Application Number
    13466
    R1-CEP 2003-129 - Rev 02
    218MF10942
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ERYTHROMYCIN BASE
    Erythromycin, Micronised, powder
    erythromycin at Paseo del Deleite, ...
    Issue/Submission Date
    1998-09-01
    2021-03-26
    2006-11-24
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    Erythromycin Ethyl Succinate

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    USDMF

    Found USDMF

    13654
    Active
    ERYTHROMYCIN ETHYLSUCCINATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-136 - Rev 07
    Valid
    Erythromycin ethylsuccinate, Powder...
    2019-11-21
    Japanese DMF

    Found JDMF

    225MF10104
    Erythromycin ethyl succinate at Pas...
    2013-05-15
    Written Confirmation

    Close WC

    Application Number
    13654
    R1-CEP 2002-136 - Rev 07
    225MF10104
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ERYTHROMYCIN ETHYLSUCCINATE
    Erythromycin ethylsuccinate, Powder...
    Erythromycin ethyl succinate at Pas...
    Issue/Submission Date
    1998-09-01
    2019-11-21
    2013-05-15
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    Clarithromycin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-014 - Rev 04
    Valid
    Clarithromycin
    2021-03-01
    Japanese DMF

    Found JDMF

    220MF10030
    Clarithromycin at Paseo del Deleite...
    2008-01-23
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-014 - Rev 04
    220MF10030
    Status
    Valid
     
    Filing Details
    Clarithromycin
    Clarithromycin at Paseo del Deleite...
    Issue/Submission Date
    2021-03-01
    2008-01-23
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    Famotidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13086
    Active
    FAMOTIDINE
    1998-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10186
    Famotidine at Paseo del Deleite, s/...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    13086
    226MF10186
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FAMOTIDINE
    Famotidine at Paseo del Deleite, s/...
    Issue/Submission Date
    1998-07-21
    2014-09-30
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    Fosfomycin

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    USDMF

    Found USDMF

    11582
    Active
    FOSFOMYCIN PHENYLAMMONIUM SALT
    1995-07-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10649
    [Japanese Pharmacopoeia] fosfomycin...
    2006-07-20
    Written Confirmation

    Close WC

    Application Number
    11582
    218MF10649
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOSFOMYCIN PHENYLAMMONIUM SALT
    [Japanese Pharmacopoeia] fosfomycin...
    Issue/Submission Date
    1995-07-10
    2006-07-20
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    Fosfomycin Sodium

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    USDMF

    Found USDMF

    14341
    Active
    FOSFOMYCIN SODIUM
    1999-08-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10083
    Fosfomycin Sodium at Paseo del Dele...
    2019-10-25
    Written Confirmation

    Close WC

    Application Number
    14341
    301MF10083
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOSFOMYCIN SODIUM
    Fosfomycin Sodium at Paseo del Dele...
    Issue/Submission Date
    1999-08-04
    2019-10-25
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    Fusidic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20479
    Active
    FUSIDIC ACID
    2007-04-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-121 - Rev 02
    Valid
    Fusidic acid, Powder, Micronised
    2021-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20479
    R1-CEP 2006-121 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FUSIDIC ACID
    Fusidic acid, Powder, Micronised
    Issue/Submission Date
    2007-04-27
    2021-11-17
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    Sodium Fusidate

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    USDMF

    Found USDMF

    20405
    Active
    SODIUM FUSIDATE
    2007-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-120 - Rev 02
    Valid
    Sodium fusidate, Powder, Micronised
    2022-02-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20405
    R1-CEP 2006-120 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SODIUM FUSIDATE
    Sodium fusidate, Powder, Micronised
    Issue/Submission Date
    2007-03-29
    2022-02-18
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    Erythromycin Stearate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    13467
    Inactive
    ERYTHROMYCIN STEARATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10103
    Erythromycin stearate at Paseo del ...
    2013-05-15
    Written Confirmation

    Close WC

    Application Number
    13467
    225MF10103
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ERYTHROMYCIN STEARATE
    Erythromycin stearate at Paseo del ...
    Issue/Submission Date
    1998-09-01
    2013-05-15
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    Azithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10053
    Azithromycin hydrate at Paseo del D...
    2012-03-12
    Written Confirmation

    Close WC

    Application Number
    224MF10053
    Status
     
    Filing Details
    Azithromycin hydrate at Paseo del D...
    Issue/Submission Date
    2012-03-12
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