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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Xellia Pharmaceuticals ApS

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    Xellia Pharmaceuticals ApS
    Denmark Flag
    Country
    Country
    Denmark
    Address
    Address
    Dalslandsgade 11, 2300 Copenhagen S
    Telephone
    Telephone
    45 32 64 55 00
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    https://www.xellia.com/
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    • FDA
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    Amphotericin B

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    USDMF

    Found USDMF

    13682
    Active
    AMPHOTERICIN B
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-079 - Rev 09
    Valid
    Amphotericin B
    2023-05-12
    Japanese DMF

    Found JDMF

    303MF10154
    Amphotericin B at Dalslandsgade 11,...
    2021-09-28
    Written Confirmation

    Close WC

    Application Number
    13682
    R1-CEP 2002-079 - Rev 09
    303MF10154
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMPHOTERICIN B
    Amphotericin B
    Amphotericin B at Dalslandsgade 11,...
    Issue/Submission Date
    1998-09-01
    2023-05-12
    2021-09-28
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    Bacitracin Zinc

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    USDMF

    Found USDMF

    13341
    Active
    BACITRACIN STERILE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-224 - Rev 08
    Valid
    Bacitracin, Sterile
    2018-02-07
    Japanese DMF

    Found JDMF

    225MF10193
    Japanese Pharmacopoeia bacitracin a...
    2013-10-09
    Written Confirmation

    Close WC

    Application Number
    13341
    R1-CEP 2002-224 - Rev 08
    225MF10193
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BACITRACIN STERILE USP
    Bacitracin, Sterile
    Japanese Pharmacopoeia bacitracin a...
    Issue/Submission Date
    1998-09-01
    2018-02-07
    2013-10-09
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    Colistimethate Sodium

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    USDMF

    Found USDMF

    13363
    Active
    COLISTIMETHATE SODIUM USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-209 - Rev 05
    Valid
    Colistimethate sodium
    2017-07-19
    Japanese DMF

    Found JDMF

    221MF10198
    Colistin sodium methanesulfonate at...
    2009-09-14
    Written Confirmation

    Close WC

    Application Number
    13363
    R1-CEP 2000-209 - Rev 05
    221MF10198
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    COLISTIMETHATE SODIUM USP
    Colistimethate sodium
    Colistin sodium methanesulfonate at...
    Issue/Submission Date
    1998-09-01
    2017-07-19
    2009-09-14
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    Polymyxin B Sulfate

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    USDMF

    Found USDMF

    13536
    Active
    POLYMYXIN B SULFATE, STERILE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-061 - Rev 05
    Valid
    Polymyxin B sulfate
    2018-11-21
    Japanese DMF

    Found JDMF

    219MF10071
    Polymyxin B sulfate sterile at Dals...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    13536
    R1-CEP 1998-061 - Rev 05
    219MF10071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    POLYMYXIN B SULFATE, STERILE
    Polymyxin B sulfate
    Polymyxin B sulfate sterile at Dals...
    Issue/Submission Date
    1998-09-01
    2018-11-21
    2007-03-14
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    Polymyxin B Sulfate

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    USDMF

    Found USDMF

    14187
    Active
    POLYMYXIN B SULFATE
    1999-06-10
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-062 - Rev 06
    Valid
    Polymyxin B sulfate, Sterile
    2019-04-05
    Japanese DMF

    Found JDMF

    218MF10934
    Polymyxin B sulfate salt at Dalslan...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    14187
    R1-CEP 1998-062 - Rev 06
    218MF10934
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    POLYMYXIN B SULFATE
    Polymyxin B sulfate, Sterile
    Polymyxin B sulfate salt at Dalslan...
    Issue/Submission Date
    1999-06-10
    2019-04-05
    2006-11-21
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    • FDA
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    13691
    Active
    VANCOMYCIN HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-110 - Rev 10
    Valid
    Vancomycin hydrochloride
    2023-02-21
    Japanese DMF

    Found JDMF

    219MF10091
    Vancomycin-based, dry at Dalslandsg...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    13691
    R1-CEP 1999-110 - Rev 10
    219MF10091
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin-based, dry at Dalslandsg...
    Issue/Submission Date
    1998-09-01
    2023-02-21
    2007-03-14
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    13794
    Active
    VANCOMYCIN HYDROCHLORIDE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-195 - Rev 02
    Valid
    Vancomycin hydrochloride
    2019-08-30
    Japanese DMF

    Found JDMF

    221MF10171
    Vancomycin hydrochloride at H-1107 ...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    13794
    R1-CEP 2007-195 - Rev 02
    221MF10171
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin hydrochloride at H-1107 ...
    Issue/Submission Date
    1998-09-01
    2019-08-30
    2009-07-30
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    20614
    Active
    VANCOMYCIN HYDROCHLORIDE
    2007-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-006 - Rev 10
    Valid
    Vancomycin hydrochloride
    2019-12-03
    Japanese DMF

    Found JDMF

    219MF10216
    Vancomycin hydrochloride sterile go...
    2007-06-25
    Written Confirmation

    Close WC

    Application Number
    20614
    R1-CEP 1996-006 - Rev 10
    219MF10216
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin hydrochloride sterile go...
    Issue/Submission Date
    2007-06-11
    2019-12-03
    2007-06-25
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    Bacitracin Zinc

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    USDMF

    Caution USDMF

    13388
    Inactive
    BACITRACIN ZINC STERILE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-226 - Rev 07
    Valid
    Bacitracin
    2022-04-06
    Japanese DMF

    Found JDMF

    218MF10935
    Japanese Pharmacopoeia bacitracin a...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    13388
    R1-CEP 2002-226 - Rev 07
    218MF10935
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BACITRACIN ZINC STERILE USP
    Bacitracin
    Japanese Pharmacopoeia bacitracin a...
    Issue/Submission Date
    1998-09-01
    2022-04-06
    2006-11-21
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    • FDA
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    Gramicidin

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    USDMF

    Caution USDMF

    13494
    Inactive
    GRAMICIDIN
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-132 - Rev 06
    Valid
    Gramicidin
    2018-12-18
    Japanese DMF

    Found JDMF

    218MF10936
    Gramicidin at H-1107 Budapest, Sza(...
    2006-11-21
    Written Confirmation

    Close WC

    Application Number
    13494
    R1-CEP 2006-132 - Rev 06
    218MF10936
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GRAMICIDIN
    Gramicidin
    Gramicidin at H-1107 Budapest, Sza(...
    Issue/Submission Date
    1998-09-01
    2018-12-18
    2006-11-21
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    Bacitracin Zinc

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    USDMF

    Found USDMF

    13607
    Active
    BACITRACIN USP NON-STERILE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-103 - Rev 10
    Valid
    Bacitracin zinc
    2022-08-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13607
    R1-CEP 2002-103 - Rev 10
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BACITRACIN USP NON-STERILE
    Bacitracin zinc
    Issue/Submission Date
    1998-09-01
    2022-08-18
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    • FDA
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    Colistimethate Sodium

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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-207 - Rev 06
    Valid
    Colistimethate sodium, Sterile
    2023-04-04
    Japanese DMF

    Found JDMF

    223MF10046
    Colistin methanesulfonate sodium st...
    2011-03-25
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2000-207 - Rev 06
    223MF10046
    Status
    Valid
     
    Filing Details
    Colistimethate sodium, Sterile
    Colistin methanesulfonate sodium st...
    Issue/Submission Date
    2023-04-04
    2011-03-25
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    Colistin Sulfate

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    USDMF

    Found USDMF

    13362
    Active
    COLISTIN SULFATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-241 - Rev 03
    Valid
    Colistin sulfate
    2018-12-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13362
    R1-CEP 2002-241 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    COLISTIN SULFATE
    Colistin sulfate
    Issue/Submission Date
    1998-09-01
    2018-12-07
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    Daptomycin

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    USDMF

    Found USDMF

    27179
    Active
    DAPTOMYCIN NON-STERILE
    2013-07-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10078
    Daptomycin at H-1107 Budapest, Sza(...
    2016-03-29
    Written Confirmation

    Close WC

    Application Number
    27179
    228MF10078
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DAPTOMYCIN NON-STERILE
    Daptomycin at H-1107 Budapest, Sza(...
    Issue/Submission Date
    2013-07-16
    2016-03-29
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    31868
    Active
    VANCOMYCIN WET BASE, NON-STERILE
    2017-07-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-245 - Rev 02
    Valid
    Vancomycin hydrochloride, Sterile
    2019-12-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31868
    R1-CEP 2006-245 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    VANCOMYCIN WET BASE, NON-STERILE
    Vancomycin hydrochloride, Sterile
    Issue/Submission Date
    2017-07-20
    2019-12-03
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    Tobramycin Sulfate

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    USDMF

    Caution USDMF

    16810
    Inactive
    TOBRAMYCIN SULFATE, USP STERILE
    2003-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10200
    Tobramycin sulfate salt at Dalsland...
    2016-10-21
    Written Confirmation

    Close WC

    Application Number
    16810
    228MF10200
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TOBRAMYCIN SULFATE, USP STERILE
    Tobramycin sulfate salt at Dalsland...
    Issue/Submission Date
    2003-08-20
    2016-10-21
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    Amphotericin B

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10325
    Japanese Pharmacopoeia amphotericin...
    2007-10-24
    Written Confirmation

    Close WC

    Application Number
    219MF10325
    Status
     
    Filing Details
    Japanese Pharmacopoeia amphotericin...
    Issue/Submission Date
    2007-10-24
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    Bacitracin Zinc

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13608
    Active
    BACITRACIN ZINC USP NON-STERILE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13608
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BACITRACIN ZINC USP NON-STERILE
    Issue/Submission Date
    1998-09-01
    ASK
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    Bacitracin Zinc

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    USDMF

    Found USDMF

    28355
    Active
    BACITRACIN ZINC, STERILE
    2014-06-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28355
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BACITRACIN ZINC, STERILE
    Issue/Submission Date
    2014-06-20
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    Gramicidin

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    USDMF

    Found USDMF

    17538
    Active
    GRAMICIDIN, USP
    2004-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17538
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GRAMICIDIN, USP
    Issue/Submission Date
    2004-07-12
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    Tobramycin

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    USDMF

    Found USDMF

    15021
    Active
    TOBRAMYCIN SULPHATE, NON-STERILE BU...
    2000-09-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15021
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOBRAMYCIN SULPHATE, NON-STERILE BU...
    Issue/Submission Date
    2000-09-12
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    Tobramycin

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    USDMF

    Found USDMF

    15629
    Active
    TOBRAMYCIN SULPHATE, USP STERILE BU...
    2001-09-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15629
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOBRAMYCIN SULPHATE, USP STERILE BU...
    Issue/Submission Date
    2001-09-17
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    Tyrothricin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-205 - Rev 02
    Valid
    Tyrothricin
    2021-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-205 - Rev 02
    Status
    Valid
     
    Filing Details
    Tyrothricin
    Issue/Submission Date
    2021-12-20
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    Caspofungin

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    USDMF

    Caution USDMF

    27156
    Inactive
    CASPOFUNGIN (ACETATE)
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