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

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    Tirzepatide

    ACTIVE PHARMA INGREDIENTS

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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 Sinopep Pharmaceutical Inc
    China
    		 SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD 39465 TIRZEPATIDE 2024-02-06 Active II N/A
    26/09/2024 Zhejiang Peptites Biotech Co.,Ltd
    China
    		 ZHEJIANG PEPTITES BIOTECH CO LTD 39655 TIRZEPATIDE 2024-03-17 Active II N/A