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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Bioindustria L.i.m. Spa

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    01 Amiloride (1)

    02 Aprepitant (1)

    03 Baclofen (1)

    04 Disodium Pamidronate Pentahydrate (2)

    05 Dobutamine Hydrochloride (1)

    06 Fosaprepitant (1)

    07 Gabexate Mesylate (1)

    08 Hyaluronidase (1)

    09 Indapamide (1)

    10 Levodropropizine (1)

    11 Methylene Blue (1)

    12 Prazosin Hydrochloride (1)

    13 Sildenafil Citrate (1)

    14 Tamsulosin (2)

    15 Tazarotene (1)

    16 Terazosin HCl (3)

    17 Torsemide (1)

    18 Triprolidine Hcl (1)

    19 Blank (1)

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    01 Active (4)

    02 Inactive (3)

    03 Blank (16)

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    01 Suspended by EDQM GMP non-compliance (1)

    02 Valid (7)

    03 Withdrawn by Holder (1)

    04 Blank (14)

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    01 Blank (23)

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    01 Blank (23)

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    Indapamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    9026
    Active
    INDAPAMIDE
    1991-03-28
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-075 - Rev 05
    Valid
    Indapamide
    2022-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9026
    R1-CEP 1998-075 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    INDAPAMIDE
    Indapamide
    Issue/Submission Date
    1991-03-28
    2022-03-17
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    Prazosin Hydrochloride

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    USDMF

    Found USDMF

    15321
    Active
    PRAZOSIN HYDROCHLORIDE BULK SUBSTAN...
    2001-02-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-221 - Rev 03
    Valid
    Prazosin hydrochloride
    2021-06-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15321
    R1-CEP 2004-221 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PRAZOSIN HYDROCHLORIDE BULK SUBSTAN...
    Prazosin hydrochloride
    Issue/Submission Date
    2001-02-28
    2021-06-07
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    Torsemide

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    USDMF

    Found USDMF

    19237
    Active
    TORSEMIDE (MOD 1) BULK SUBSTANCE
    2006-03-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-251 - Rev 01
    Valid
    Torasemide
    2018-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19237
    R1-CEP 2008-251 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TORSEMIDE (MOD 1) BULK SUBSTANCE
    Torasemide
    Issue/Submission Date
    2006-03-08
    2018-03-07
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    Amiloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-015 - Rev 05
    Valid
    Amiloride hydrochloride dihydrate
    2018-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-015 - Rev 05
    Status
    Valid
     
    Filing Details
    Amiloride hydrochloride dihydrate
    Issue/Submission Date
    2018-03-07
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    Baclofen

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-360 - Rev 01
    Valid
    Baclofen
    2020-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-360 - Rev 01
    Status
    Valid
     
    Filing Details
    Baclofen
    Issue/Submission Date
    2020-09-09
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    Dobutamine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-261 - Rev 01
    Valid
    Dobutamine hydrochloride
    2018-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-261 - Rev 01
    Status
    Valid
     
    Filing Details
    Dobutamine hydrochloride
    Issue/Submission Date
    2018-03-07
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    Tamsulosin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-297 - Rev 01
    Valid
    Tamsulosin hydrochloride
    2018-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-297 - Rev 01
    Status
    Valid
     
    Filing Details
    Tamsulosin hydrochloride
    Issue/Submission Date
    2018-03-07
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    Terazosin HCl

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    USDMF

    Found USDMF

    14916
    Active
    TERAZOSIN HCL. 2H2O
    2000-06-12
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    14916
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TERAZOSIN HCL. 2H2O
    Issue/Submission Date
    2000-06-12
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    Hyaluronidase

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-068 - Rev 00
    Suspended by EDQM GMP non-compliance
    Hyaluronidase
    2007-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-068 - Rev 00
    Status
    Suspended by EDQM GMP non-compliance
     
    Filing Details
    Hyaluronidase
    Issue/Submission Date
    2007-04-04
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    Levodropropizine

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2013-156 - Rev 01
    Withdrawn by Holder
    Levodropropizine
    2018-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2013-156 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Levodropropizine
    Issue/Submission Date
    2018-03-07
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