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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Rolabo Outsourcing, S.l.

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    01 Atovaquone (1)

    02 Atropine (1)

    03 Atropine Sulfate (1)

    04 Benazepril Hydrochloride (1)

    05 Desloratadine (1)

    06 Dolasetron Mesylate (1)

    07 Loratadine (1)

    08 Palonosetron (1)

    09 Perindopril Erbumine (1)

    10 Pirfenidone (1)

    11 Tetrabenazine (1)

    12 Trandolapril (1)

    13 Blank (1)

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    01 Active (6)

    02 Inactive (3)

    03 Blank (4)

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    01 Valid (7)

    02 Blank (6)

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    01 227MF10089 (1)

    02 231MF10003 (1)

    03 304MF10093 (1)

    04 Blank (10)

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    01 Blank (13)

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    Loratadine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14155
    Active
    LORATADINE USP
    1999-05-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-283 - Rev 01
    Valid
    Loratadine
    2017-03-01
    Japanese DMF

    Found JDMF

    304MF10093
    Loratadine at Poligono Industrial M...
    2022-06-28
    Written Confirmation

    Close WC

    Application Number
    14155
    R1-CEP 2007-283 - Rev 01
    304MF10093
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LORATADINE USP
    Loratadine
    Loratadine at Poligono Industrial M...
    Issue/Submission Date
    1999-05-26
    2017-03-01
    2022-06-28
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    Atropine

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    USDMF

    Found USDMF

    29521
    Active
    ATROPINE USP
    2015-09-25
    CEP/COS

    Found CEP/COS

    CEP 2015-255 - Rev 01
    Valid
    Atropine
    2023-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29521
    CEP 2015-255 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATROPINE USP
    Atropine
    Issue/Submission Date
    2015-09-25
    2023-09-04
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    Atropine Sulfate

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    USDMF

    Found USDMF

    29396
    Active
    ATROPINE SULFATE USP
    2015-05-25
    CEP/COS

    Found CEP/COS

    CEP 2015-002 - Rev 01
    Valid
    Atropine sulfate
    2023-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    29396
    CEP 2015-002 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATROPINE SULFATE USP
    Atropine sulfate
    Issue/Submission Date
    2015-05-25
    2023-09-04
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    Pirfenidone

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-260 - Rev 00
    Valid
    Pirfenidone
    2020-06-26
    Japanese DMF

    Found JDMF

    231MF10003
    Pirfenidone at Poligono Industrial ...
    2019-01-10
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-260 - Rev 00
    231MF10003
    Status
    Valid
     
    Filing Details
    Pirfenidone
    Pirfenidone at Poligono Industrial ...
    Issue/Submission Date
    2020-06-26
    2019-01-10
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    Trandolapril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18947
    Active
    TRANDOLAPRIL
    2005-11-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-251 - Rev 01
    Valid
    Trandolapril
    2019-12-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18947
    R1-CEP 2009-251 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TRANDOLAPRIL
    Trandolapril
    Issue/Submission Date
    2005-11-08
    2019-12-16
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    Benazepril Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10089
    Benazepril hydrochloride at Poligon...
    2015-03-12
    Written Confirmation

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    Application Number
    227MF10089
    Status
     
    Filing Details
    Benazepril hydrochloride at Poligon...
    Issue/Submission Date
    2015-03-12
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    Desloratadine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2017-303 - Rev 00
    Valid
    Desloratadine
    2023-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2017-303 - Rev 00
    Status
    Valid
     
    Filing Details
    Desloratadine
    Issue/Submission Date
    2023-08-11
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    Palonosetron

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24497
    Active
    PALONOSETRON HYDROCHLORIDE
    2010-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    24497
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PALONOSETRON HYDROCHLORIDE
    Issue/Submission Date
    2010-12-23
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    Perindopril Erbumine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2004-284 - Rev 02
    Valid
    Perindopril tert-butylamine
    2024-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2004-284 - Rev 02
    Status
    Valid
     
    Filing Details
    Perindopril tert-butylamine
    Issue/Submission Date
    2024-01-11
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    Tetrabenazine

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    USDMF

    Found USDMF

    29828
    Active
    TETRABENAZINE
    2015-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29828
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TETRABENAZINE
    Issue/Submission Date
    2015-10-09
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