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

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

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

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    Nitisinone

    ACTIVE PHARMA INGREDIENTS

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    $ API Ref.Price (USD/KG) : 84,223Xls download

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    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 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 33948 NITISINONE 2019-07-17 Active II Complete 2020-08-28 2020-08-06
    26/09/2024 Nuray Chemicals Private Limited
    India
    		 NOVITIUM PHARMA LLC 31250 NITISINONE 2017-01-02 Active II Complete 2017-02-01 2016-12-26