loader
Please Wait
Applying Filters...
menu
    • menu

    List of Drug Master Files (DMF) of Pitolisant Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

    Client Email Product
    2024 US Elections: Harris, Trump differ on abortion rights, ACA, public health spends; agree on need to cut drug prices

    Data Compilation
    #PharmaFlow

    Pipeline Prospector Aug 2024: Otsuka buys Jnana, Lilly’s market cap gains by over US$ 108 bn post new guidance

    Stock Recap
    #PipelineProspector

    Menu

    Pitolisant

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    PharmaCompass
    Xls download

    Filters

    clear-filterReset all filters
    Left Arrow
    Right Arrow
    ListList of Suppliers
    refreshReset Filter
    refresh Reset Filter
    Price Info Price Info
    product-page Product Main Page

    Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 Nuray Chemicals Private Limited
    India
    		 SS PHARMA LLC 36859 PITOLISANT HYDROCHLORIDE 2022-03-01 Active II Complete 2023-03-31 2023-03-15
    26/09/2024 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 37753 PITOLISANT HYDROCHLORIDE SOLID DISPERSION 2022-12-31 Active II Complete 2023-07-28 2023-07-06