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

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$ API Ref.Price (USD/KG) : 638Xls 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 Chongqing DaXin Pharmaceutical
China
CHONGQING DAXIN PHARMACEUTICAL CO LTD 24185 VANCOMYCIN HYDROCHLORIDE 2010-09-17 Active II Complete 2014-02-12 2013-06-13
26/09/2024 Concord Biotech
India
CONCORD BIOTECH LTD 22528 VANCOMYCIN HYDROCHLORIDE USP 2009-02-10 Active II Complete 2017-01-19 2016-12-19