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

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    ROLABO OUTSOURCING, S.L.

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    Rolabo Outsourcing, S.L.
    Spain_new Flag
    Country
    Country
    Spain
    Address
    Address
    Polígono Industrial Malpica,calle J, Parcelas 3-4,Zaragoza SPAIN
    Telephone
    Telephone
    34 976 57 17 44
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.rolabo.com/
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    Loratadine

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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

    Close WC

    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

    Close WC

    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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    • FDA
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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

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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

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    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

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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

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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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    • FDA
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    Atovaquone

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    USDMF

    Caution USDMF

    21360
    Inactive
    ATOVAQUONE USP
    2008-02-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21360
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ATOVAQUONE USP
    Issue/Submission Date
    2008-02-15
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    Dolasetron Mesylate

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    USDMF

    Caution USDMF

    21852
    Inactive
    DOLASETRON MESYLATE
    2008-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    21852
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DOLASETRON MESYLATE
    Issue/Submission Date
    2008-07-31
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    MANUFACTURING SITES, FACILITIES, PERSONNEL AND GENERAL ...

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    USDMF

    Caution USDMF

    12351
    Inactive
    MANUFACTURING SITES, FACILITIES, PE...
    1997-02-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12351
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITES, FACILITIES, PE...
    Issue/Submission Date
    1997-02-02
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