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

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    N-Carbamylglutamate

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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 Nuray Chemicals Private Limited
    India
    		 NOVITIUM PHARMA LLC 33166 CARGLUMIC ACID 2018-12-07 Active II Complete 2019-01-11 2018-12-14
    26/09/2024 Dipharma SA
    Switzerland
    		 DIPHARMA SA 39329 CARGLUMIC ACID 2024-02-06 Active II Complete 2024-05-06 2024-02-01