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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Helsinn Advanced Synthesis

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    01 Adapalene (1)

    02 Anamorelin HCl (2)

    03 Chlorzoxazone (1)

    04 Dantrolene (1)

    05 Fosnetupitant Chloride (1)

    06 Guanabenz (1)

    07 Isotretinoin (1)

    08 Melatonin (1)

    09 Meso-2,3-Dimercaptosuccinic Acid (1)

    10 Modafinil (1)

    11 Netupitant (1)

    12 Nimesulide (1)

    13 Palonosetron (1)

    14 Pyridostigmine (1)

    15 Sodium Benzoate (1)

    16 Tramadol Hydrochloride (1)

    17 Trifarotene (1)

    18 Trospium Chloride (1)

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    01 Active (9)

    02 Inactive (9)

    03 Blank (1)

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    01 Valid (4)

    02 Blank (15)

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    01 220MF10072 (1)

    02 221MF10103 (1)

    03 302MF10154 (1)

    04 Blank (16)

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    01 Blank (19)

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    Pyridostigmine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    10877
    Inactive
    PYRIDOSTIGMINE BROMIDE
    1994-04-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-348 - Rev 04
    Valid
    Pyridostigmine bromide
    2022-03-01
    Japanese DMF

    Found JDMF

    221MF10103
    Pyridostigmine bromide at Via Indus...
    2009-05-27
    Written Confirmation

    Close WC

    Application Number
    10877
    R1-CEP 2001-348 - Rev 04
    221MF10103
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PYRIDOSTIGMINE BROMIDE
    Pyridostigmine bromide
    Pyridostigmine bromide at Via Indus...
    Issue/Submission Date
    1994-04-11
    2022-03-01
    2009-05-27
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    Adapalene

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    USDMF

    Found USDMF

    18826
    Active
    ADAPALENE
    2005-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-328 - Rev 00
    Valid
    Adapalene, Micronised
    2022-09-05
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    18826
    R0-CEP 2021-328 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ADAPALENE
    Adapalene, Micronised
    Issue/Submission Date
    2005-09-30
    2022-09-05
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    Fosnetupitant Chloride

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    USDMF

    Found USDMF

    31323
    Active
    FOSNETUPITANT CHLORIDE
    2017-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10154
    Phosnetupitant chloride hydrochlori...
    2020-12-15
    Written Confirmation

    Close WC

    Application Number
    31323
    302MF10154
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOSNETUPITANT CHLORIDE
    Phosnetupitant chloride hydrochlori...
    Issue/Submission Date
    2017-03-31
    2020-12-15
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    Isotretinoin

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    USDMF

    Found USDMF

    19918
    Active
    ISOTRETINOIN
    2006-10-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-281 - Rev 01
    Valid
    Isotretinoin
    2022-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    19918
    R1-CEP 2004-281 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ISOTRETINOIN
    Isotretinoin
    Issue/Submission Date
    2006-10-30
    2022-03-01
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    Palonosetron

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    USDMF

    Found USDMF

    16063
    Active
    PALONOSETRON HYDROCHLORIDE USP
    2002-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10072
    Palonosetron hydrochloride at Via I...
    2008-03-14
    Written Confirmation

    Close WC

    Application Number
    16063
    220MF10072
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PALONOSETRON HYDROCHLORIDE USP
    Palonosetron hydrochloride at Via I...
    Issue/Submission Date
    2002-07-19
    2008-03-14
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    Anamorelin HCl

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    USDMF

    Found USDMF

    30961
    Active
    ANAMORELIN HYDROCHLORIDE, 100 MG TA...
    2016-11-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    30961
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANAMORELIN HYDROCHLORIDE, 100 MG TA...
    Issue/Submission Date
    2016-11-16
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    Anamorelin HCl

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    USDMF

    Found USDMF

    31120
    Active
    ANAMORELIN HYDROCHLORIDE (API)
    2016-11-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    31120
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANAMORELIN HYDROCHLORIDE (API)
    Issue/Submission Date
    2016-11-16
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    Dantrolene

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    USDMF

    Found USDMF

    19498
    Active
    DANTROLENE SODIUM DRUG SUBSTANCE
    2006-06-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19498
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DANTROLENE SODIUM DRUG SUBSTANCE
    Issue/Submission Date
    2006-06-01
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    Netupitant

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    USDMF

    Found USDMF

    26715
    Active
    NETUPITANT
    2013-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    26715
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NETUPITANT
    Issue/Submission Date
    2013-07-19
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    Nimesulide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-377 - Rev 02
    Valid
    Nimesulide, Micronised
    2022-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2010-377 - Rev 02
    Status
    Valid
     
    Filing Details
    Nimesulide, Micronised
    Issue/Submission Date
    2022-03-01
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