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

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    Bioindustria L.I.M. Spa
    Italy Flag
    Country
    Country
    Italy
    Address
    Address
    Via De Ambrosiis, 2-4 15067 - Novi Ligure (AL)
    Telephone
    Telephone
    +39 0143 3131, +39 0143 480611
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.bioindustrialim.it
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    https://www.linkedin.com/company/bioindustria-farmaceutici-s-r-l-
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    Indapamide

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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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    • FDA
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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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    • FDA
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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

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    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

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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

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    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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    • FDA
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    Terazosin HCl

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    USDMF

    Found USDMF

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

    Close CEP/COS

    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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    • FDA
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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

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    Written Confirmation

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    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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    • FDA
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    Terazosin HCl

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    USDMF

    Caution USDMF

    12424
    Inactive
    TERAZOSIN HCI. 2H20 BULK SUBSTANCE
    1997-03-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    12424
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERAZOSIN HCI. 2H20 BULK SUBSTANCE
    Issue/Submission Date
    1997-03-17
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    Terazosin HCl

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    USDMF

    Caution USDMF

    12802
    Inactive
    TERAZOSIN HCL 2H20
    1997-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12802
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERAZOSIN HCL 2H20
    Issue/Submission Date
    1997-12-22
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    8567
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1990-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    8567
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1990-05-09
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    • FDA
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    Aprepitant

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
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    • FDA
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    Disodium Pamidronate Pentahydrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
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    Disodium Pamidronate Pentahydrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Fosaprepitant

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
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    • FDA
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    Gabexate Mesylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    Status
     
    Filing Details
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    • FDA
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    Methylene Blue

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Sildenafil Citrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Tamsulosin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
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    Tazarotene

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
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    Filing Details
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    • FDA
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    Triprolidine Hcl

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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