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

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    HELSINN

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    Helsinn Advanced Synthesis
    Switzerland Flag
    Country
    Country
    Switzerland
    Address
    Address
    Via Industria 246710 Biasca – Switzerland
    Telephone
    Telephone
    +41 (0) 91 873.94.00
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://helsinn.com/
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    https://www.linkedin.com/company/helsinn-group/
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    Pyridostigmine

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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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    • FDA
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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

    Close WC

    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

    Close WC

    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

    Close JDMF

    Written Confirmation

    Close WC

    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

    Close WC

    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

    Close WC

    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

    Close WC

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

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    USDMF

    Found USDMF

    32486
    Active
    TRIFAROTENE
    2018-07-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32486
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRIFAROTENE
    Issue/Submission Date
    2018-07-16
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    Chlorzoxazone

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    USDMF

    Caution USDMF

    6518
    Inactive
    CHLORZOXAZONE DRUG SUBSTANCE
    1986-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6518
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORZOXAZONE DRUG SUBSTANCE
    Issue/Submission Date
    1986-04-11
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    • FDA
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    Guanabenz

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    USDMF

    Caution USDMF

    5897
    Inactive
    GUANABENZ ACETATE
    1985-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5897
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GUANABENZ ACETATE
    Issue/Submission Date
    1985-06-10
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    Melatonin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11575
    Inactive
    MELATONIN
    1995-07-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11575
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MELATONIN
    Issue/Submission Date
    1995-07-04
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    Meso-2,3-Dimercaptosuccinic Acid

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    USDMF

    Caution USDMF

    17801
    Inactive
    DMSAM
    2004-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17801
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DMSAM
    Issue/Submission Date
    2004-10-29
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    Modafinil

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    USDMF

    Caution USDMF

    17815
    Inactive
    MODAFINIL
    2004-11-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17815
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MODAFINIL
    Issue/Submission Date
    2004-11-10
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    Sodium Benzoate

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    USDMF

    Caution USDMF

    19426
    Inactive
    SODIUM BENZOATE
    2006-05-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19426
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM BENZOATE
    Issue/Submission Date
    2006-05-12
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    Tramadol Hydrochloride

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    USDMF

    Caution USDMF

    11605
    Inactive
    TRAMADOL HYDROCHLORIDE
    1995-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11605
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Issue/Submission Date
    1995-07-28
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    Trospium Chloride

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    USDMF

    Caution USDMF

    18544
    Inactive
    TROSPIUM CHLORIDE
    2005-07-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18544
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TROSPIUM CHLORIDE
    Issue/Submission Date
    2005-07-29
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