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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Arevipharma Gmbh

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    Meißner Str. 35 01445 Radebeul
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    • FDA
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    Bisoprolol Fumarate

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    USDMF

    Found USDMF

    23241
    Active
    BISOPROLOL FUMARATE
    2009-11-02
    CEP/COS

    Found CEP/COS

    CEP 2008-022 - Rev 03
    Valid
    Bisoprolol fumarate
    2023-12-05
    Japanese DMF

    Found JDMF

    301MF10029
    Bisoprolol Fumarate at Meissner Str...
    2019-07-05
    Written Confirmation

    Close WC

    Application Number
    23241
    CEP 2008-022 - Rev 03
    301MF10029
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BISOPROLOL FUMARATE
    Bisoprolol fumarate
    Bisoprolol Fumarate at Meissner Str...
    Issue/Submission Date
    2009-11-02
    2023-12-05
    2019-07-05
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    Torsemide

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    USDMF

    Caution USDMF

    25845
    Inactive
    TORASEMIDE
    2012-02-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-127 - Rev 04
    Valid
    Torasemide
    2021-07-23
    Japanese DMF

    Found JDMF

    223MF10112
    Torasemide at Meissner Strasse 35 D...
    2011-07-19
    Written Confirmation

    Close WC

    Application Number
    25845
    R1-CEP 2006-127 - Rev 04
    223MF10112
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TORASEMIDE
    Torasemide
    Torasemide at Meissner Strasse 35 D...
    Issue/Submission Date
    2012-02-27
    2021-07-23
    2011-07-19
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    Buprenorphine

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    USDMF

    Found USDMF

    27547
    Active
    BUPRENORPHINE
    2013-09-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-051 - Rev 01
    Valid
    Buprenorphine
    2017-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27547
    R1-CEP 2010-051 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUPRENORPHINE
    Buprenorphine
    Issue/Submission Date
    2013-09-23
    2017-01-20
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    Buprenorphine Hydrochloride

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    USDMF

    Found USDMF

    24594
    Active
    BUPRENORPHINE HYDROCHLORIDE
    2011-01-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-431 - Rev 00
    Valid
    Buprenorphine hydrochloride, Site A
    2022-01-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24594
    R0-CEP 2021-431 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUPRENORPHINE HYDROCHLORIDE
    Buprenorphine hydrochloride, Site A
    Issue/Submission Date
    2011-01-24
    2022-01-21
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    • FDA
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    Clozapine

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    USDMF

    Caution USDMF

    10862
    Inactive
    CLOZAPINE
    1994-04-05
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-205 - Rev 01
    Withdrawn by Holder
    Clozapine
    2015-11-05
    Japanese DMF

    Found JDMF

    220MF10053
    Clozapine crude at Meissner Strasse...
    2008-02-08
    Written Confirmation

    Close WC

    Application Number
    10862
    R1-CEP 2006-205 - Rev 01
    220MF10053
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CLOZAPINE
    Clozapine
    Clozapine crude at Meissner Strasse...
    Issue/Submission Date
    1994-04-05
    2015-11-05
    2008-02-08
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    • FDA
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    Esketamine Hydrochloride

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    USDMF

    Found USDMF

    36990
    Active
    ESKETAMINE HYDROCHLORIDE
    2022-11-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-404 - Rev 00
    Valid
    Esketamine hydrochloride
    2023-06-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36990
    R0-CEP 2022-404 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESKETAMINE HYDROCHLORIDE
    Esketamine hydrochloride
    Issue/Submission Date
    2022-11-04
    2023-06-21
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    Ketamine Hydrochloride

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    USDMF

    Found USDMF

    29094
    Active
    KETAMINE HYDROCHLORIDE
    2015-04-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-037 - Rev 01
    Valid
    Ketamine hydrochloride
    2023-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29094
    R1-CEP 2015-037 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    KETAMINE HYDROCHLORIDE
    Ketamine hydrochloride
    Issue/Submission Date
    2015-04-14
    2023-02-08
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    Sotalol Hydrochloride

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    USDMF

    Caution USDMF

    23752
    Inactive
    SOTALOL HYDROCHLORIDE
    2010-04-19
    CEP/COS

    Found CEP/COS

    CEP 2005-154 - Rev 04
    Valid
    Sotalol hydrochloride
    2024-02-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23752
    CEP 2005-154 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SOTALOL HYDROCHLORIDE
    Sotalol hydrochloride
    Issue/Submission Date
    2010-04-19
    2024-02-20
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    Amiodarone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2005-225 - Rev 03
    Valid
    Amiodarone hydrochloride
    2024-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2005-225 - Rev 03
    Status
    Valid
     
    Filing Details
    Amiodarone hydrochloride
    Issue/Submission Date
    2024-03-11
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    Buprenorphine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-346 - Rev 01
    Valid
    Buprenorphine hydrochloride
    2017-02-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-346 - Rev 01
    Status
    Valid
     
    Filing Details
    Buprenorphine hydrochloride
    Issue/Submission Date
    2017-02-20
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    Carbamazepine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-011 - Rev 05
    Valid
    Carbamazepine
    2017-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-011 - Rev 05
    Status
    Valid
     
    Filing Details
    Carbamazepine
    Issue/Submission Date
    2017-01-18
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    Cetirizine Dihydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-220 - Rev 04
    Valid
    Cetirizine dihydrochloride
    2022-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-220 - Rev 04
    Status
    Valid
     
    Filing Details
    Cetirizine dihydrochloride
    Issue/Submission Date
    2022-09-09
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    Dimethyl Fumarate

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    USDMF

    Found USDMF

    28561
    Active
    DIMETHYL FUMARATE
    2014-10-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28561
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIMETHYL FUMARATE
    Issue/Submission Date
    2014-10-16
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    Ebastine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-160 - Rev 02
    Valid
    Ebastine
    2019-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-160 - Rev 02
    Status
    Valid
     
    Filing Details
    Ebastine
    Issue/Submission Date
    2019-03-08
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    Fentanyl

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-153 - Rev 03
    Valid
    Fentanyl
    2021-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-153 - Rev 03
    Status
    Valid
     
    Filing Details
    Fentanyl
    Issue/Submission Date
    2021-01-05
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    Fentanyl Citrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-340 - Rev 01
    Valid
    Fentanyl citrate
    2017-04-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-340 - Rev 01
    Status
    Valid
     
    Filing Details
    Fentanyl citrate
    Issue/Submission Date
    2017-04-26
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    Flutamide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23507
    Inactive
    FLUTAMIDE
    2010-01-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-297 - Rev 01
    Withdrawn by Holder
    Flutamide, Micronised
    2014-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23507
    R1-CEP 2006-297 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    FLUTAMIDE
    Flutamide, Micronised
    Issue/Submission Date
    2010-01-27
    2014-02-06
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    • FDA
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    Hydromorphone Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-322 - Rev 00
    Valid
    Hydromorphone hydrochloride
    2015-06-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-322 - Rev 00
    Status
    Valid
     
    Filing Details
    Hydromorphone hydrochloride
    Issue/Submission Date
    2015-06-04
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    Metoprolol Succinate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21155
    Inactive
    Metoprolol Succinate
    2007-12-06
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-223 - Rev 00
    Withdrawn by Holder
    Metoprolol succinate
    2013-02-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21155
    R1-CEP 2005-223 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    Metoprolol Succinate
    Metoprolol succinate
    Issue/Submission Date
    2007-12-06
    2013-02-05
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    • FDA
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    Moxonidine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-122 - Rev 00
    Valid
    Moxonidine
    2020-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-122 - Rev 00
    Status
    Valid
     
    Filing Details
    Moxonidine
    Issue/Submission Date
    2020-01-09
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    Propiverine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10123
    Propiverin hydrochloride at Meissne...
    2011-07-28
    Written Confirmation

    Close WC

    Application Number
    223MF10123
    Status
     
    Filing Details
    Propiverin hydrochloride at Meissne...
    Issue/Submission Date
    2011-07-28
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    Pyridostigmine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2008-111 - Rev 02
    Valid
    Pyridostigmine bromide
    2017-04-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2008-111 - Rev 02
    Status
    Valid
     
    Filing Details
    Pyridostigmine bromide
    Issue/Submission Date
    2017-04-26
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    Remifentanil

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2018-070 - Rev 01
    Valid
    Remifentanil hydrochloride
    2024-02-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2018-070 - Rev 01
    Status
    Valid
     
    Filing Details
    Remifentanil hydrochloride
    Issue/Submission Date
    2024-02-19
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    Tilidine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-013 - Rev 02
    Valid
    Tilidine hydrochloride hemihydrate
    2020-10-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-013 - Rev 02
    Status
    Valid
     
    Filing Details
    Tilidine hydrochloride hemihydrate
    Issue/Submission Date
    2020-10-15
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    Tramadol Hydrochloride

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    USDMF

    Caution USDMF

    19117
    Inactive
    TRAMADOL HYDROCHLORIDE
    2006-01-19
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-020 - Rev 01
    Withdrawn by Holder
    Tramadol hydrochloride
    2015-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19117
    R1-CEP 2005-020 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Tramadol hydrochloride
    Issue/Submission Date
    2006-01-19
    2015-10-21
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    Buprenorphine, Process N

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-298 - Rev 01
    Valid
    Buprenorphine, Process N
    2024-02-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-298 - Rev 01
    Status
    Valid
     
    Filing Details
    Buprenorphine, Process N
    Issue/Submission Date
    2024-02-01
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    Acetylcysteine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-018 - Rev 00
    Withdrawn by Holder
    Acetylcysteine
    2011-04-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2005-018 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
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