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

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$ API Ref.Price (USD/KG) : 12,777Xls 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 Charioteer
China
ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD 39852 LETERMOVIR 2024-04-30 Active II N/A
26/09/2024 Lupin Ltd
India
LUPIN MANUFACTURING SOLUTIONS LTD 35981 LETERMOVIR 2021-06-10 Active II Complete 2021-07-06 2021-06-16