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

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    Insulin Lispro

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    EXCIPIENTS BY APPLICATIONS

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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 Sanofi
    France
    		 SANOFI AVENTIS DEUTSCHLAND GMBH 4846 HUMAN INSULIN-SEMISYNTHETIC, BULK MATRLS & FINISHED DOS. FORM 1983-03-11 Inactive II N/A
    26/09/2024 Biocon
    India
    		 BIOCON BIOLOGICS INDIA LTD 23892 HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE) 2010-06-07 Active II N/A