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

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$ API Ref.Price (USD/KG) : 225Xls 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 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INDIA PVT LTD 21487 VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP 2008-04-01 Active II N/A
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 21688 VALACYCLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) 2008-06-07 Active II Complete 2014-04-18 2014-04-10