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

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    Saneca Pharmaceuticals
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    Slovakia
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    Nitrianska 100, Hlohovec, 920 27
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    + 421 33 736 1111
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    enquiries@pharmacompass.com
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    Pethidine Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2010-243 - Rev 00
    Valid
    Pethidine hydrochloride, For use in...
    2016-11-23
    Japanese DMF

    Found JDMF

    223MF10069
    Pethidine hydrochloride at Nitrians...
    2011-05-25
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-243 - Rev 00
    223MF10069
    Status
    Valid
     
    Filing Details
    Pethidine hydrochloride, For use in...
    Pethidine hydrochloride at Nitrians...
    Issue/Submission Date
    2016-11-23
    2011-05-25
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    Tramadol Hydrochloride

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    CEP/COS

    Found CEP/COS

    R1-CEP 2009-214 - Rev 02
    Valid
    Tramadol hydrochloride
    2017-09-15
    Japanese DMF

    Found JDMF

    229MF10138
    Tramadol hydrochloride at Nitriansk...
    2017-07-24
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-214 - Rev 02
    229MF10138
    Status
    Valid
     
    Filing Details
    Tramadol hydrochloride
    Tramadol hydrochloride at Nitriansk...
    Issue/Submission Date
    2017-09-15
    2017-07-24
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    Codeine Phosphate

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    CEP/COS

    Found CEP/COS

    R1-CEP 2007-023 - Rev 05
    Valid
    Codeine phosphate hemihydrate
    2020-08-19
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2007-023 - Rev 05
    Status
    Valid
     
    Filing Details
    Codeine phosphate hemihydrate
    Issue/Submission Date
    2020-08-19
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    Dihydrocodeine Tartrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2008-018 - Rev 01
    Valid
    Dihydrocodeine hydrogen tartrate
    2021-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2008-018 - Rev 01
    Status
    Valid
     
    Filing Details
    Dihydrocodeine hydrogen tartrate
    Issue/Submission Date
    2021-07-07
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    Doxazosin Mesylate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2011-097 - Rev 02
    Valid
    Doxazosin mesilate
    2020-12-17
    Japanese DMF

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    Application Number
    R1-CEP 2011-097 - Rev 02
    Status
    Valid
     
    Filing Details
    Doxazosin mesilate
    Issue/Submission Date
    2020-12-17
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    Duloxetine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2014-297 - Rev 00
    Valid
    Duloxetine hydrochloride
    2021-08-05
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2014-297 - Rev 00
    Status
    Valid
     
    Filing Details
    Duloxetine hydrochloride
    Issue/Submission Date
    2021-08-05
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    Fentanyl Citrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2009-230 - Rev 00
    Valid
    Fentanyl citrate
    2016-07-13
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2009-230 - Rev 00
    Status
    Valid
     
    Filing Details
    Fentanyl citrate
    Issue/Submission Date
    2016-07-13
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    Methadone Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2007-068 - Rev 01
    Valid
    Methadone hydrochloride
    2018-09-07
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2007-068 - Rev 01
    Status
    Valid
     
    Filing Details
    Methadone hydrochloride
    Issue/Submission Date
    2018-09-07
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    Morphine Sulfate

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2010-061 - Rev 03
    Valid
    Morphine hemisulfate 2.5-hydrate
    2023-12-19
    Japanese DMF

    Close JDMF

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    Application Number
    CEP 2010-061 - Rev 03
    Status
    Valid
     
    Filing Details
    Morphine hemisulfate 2.5-hydrate
    Issue/Submission Date
    2023-12-19
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    Naloxone Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2022-344 - Rev 00
    Valid
    Naloxone hydrochloride dihydrate
    2023-04-20
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2022-344 - Rev 00
    Status
    Valid
     
    Filing Details
    Naloxone hydrochloride dihydrate
    Issue/Submission Date
    2023-04-20
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    Naltrexone

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    USDMF

    Found USDMF

    31691
    Active
    NALTREXONE
    2017-07-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    31691
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    NALTREXONE
    Issue/Submission Date
    2017-07-25
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    Naltrexone Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2017-313 - Rev 01
    Valid
    Naltrexone hydrochloride
    2020-01-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2017-313 - Rev 01
    Status
    Valid
     
    Filing Details
    Naltrexone hydrochloride
    Issue/Submission Date
    2020-01-10
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    Oxycodone Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2006-244 - Rev 04
    Valid
    Oxycodone hydrochloride
    2022-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-244 - Rev 04
    Status
    Valid
     
    Filing Details
    Oxycodone hydrochloride
    Issue/Submission Date
    2022-08-16
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    Pentoxifylline

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2014-356 - Rev 00
    Valid
    Pentoxifylline
    2021-10-07
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2014-356 - Rev 00
    Status
    Valid
     
    Filing Details
    Pentoxifylline
    Issue/Submission Date
    2021-10-07
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    Pholcodine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-154 - Rev 00
    Valid
    Pholcodine monohydrate
    2021-08-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-154 - Rev 00
    Status
    Valid
     
    Filing Details
    Pholcodine monohydrate
    Issue/Submission Date
    2021-08-30
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    Rivastigmine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2015-276 - Rev 00
    Valid
    Rivastigmine
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-276 - Rev 00
    Status
    Valid
     
    Filing Details
    Rivastigmine
    Issue/Submission Date
    2023-01-25
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    Rivastigmine Tartrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2018-215 - Rev 00
    Valid
    Rivastigmine hydrogen tartrate
    2020-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2018-215 - Rev 00
    Status
    Valid
     
    Filing Details
    Rivastigmine hydrogen tartrate
    Issue/Submission Date
    2020-06-16
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    Rivastigmine Tartrate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2023-074 - Rev 00
    Valid
    Rivastigmine hydrogen tartrate, Pro...
    2023-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2023-074 - Rev 00
    Status
    Valid
     
    Filing Details
    Rivastigmine hydrogen tartrate, Pro...
    Issue/Submission Date
    2023-05-19
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    Hydromorphone hydrochloride, Milled

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2012-099 - Rev 02
    Valid
    Hydromorphone hydrochloride, Milled
    2024-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    CEP 2012-099 - Rev 02
    Status
    Valid
     
    Filing Details
    Hydromorphone hydrochloride, Milled
    Issue/Submission Date
    2024-03-20
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    Atorvastatin

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-271 - Rev 00
    Expired
    Atorvastatin calcium
    2017-06-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2015-271 - Rev 00
    Status
    Expired
     
    Filing Details
    Atorvastatin calcium
    Issue/Submission Date
    2017-06-28
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    Losartan Potassium

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-020 - Rev 00
    Withdrawn by Holder
    Losartan potassium
    2016-06-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2010-020 - Rev 00
    Status
    Withdrawn by Holder
     
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    Losartan potassium
    Issue/Submission Date
    2016-06-28
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    Metoprolol Succinate

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-022 - Rev 00
    Withdrawn by Holder
    Metoprolol succinate
    2015-06-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-022 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Metoprolol succinate
    Issue/Submission Date
    2015-06-08
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    Terbinafine Hydrochloride

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-343 - Rev 02
    Withdrawn by Holder
    Terbinafine hydrochloride
    2013-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2010-343 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Terbinafine hydrochloride
    Issue/Submission Date
    2013-10-22
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    Hydrocodone Bitartrate

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Hydromorphone Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Mirabegron

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Nalbuphine

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    Pimobendan

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