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

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$ API Ref.Price (USD/KG) : 471Xls 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 Fareva
Luxembourg
EXCELLA GMBH AND CO KG 16992 GANCICLOVIR SODIUM 2003-11-17 Active II Complete 2013-10-05 2013-09-26
26/09/2024 Hainan Poly Pharm
China
HAINAN POLY PHARMACEUTICAL CO LTD 25122 GANCICLOVIR SODIUM 2011-07-13 Inactive II N/A