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List of Drug Master Files (DMF) of Benzenemethanol, alpha-(1-(methylamino)ethyl)-, hydrochloride, (S-(R*,R*))- (9CI) Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 53Xls 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 Malladi Drugs & Pharmaceuticals Limited
India
MALLADI DRUGS AND PHARMACEUTICALS LTD 10320 D-PSEUDOEPHEDRINE HYDROCHLORIDE 1993-06-24 Active II Complete 2014-03-25 2014-03-14
26/09/2024 Cheng Fong Chemical Co., Ltd
China
CHENG FONG CHEMICAL CO LTD 16977 PSEUDOEPHEDRINE HYDROCHLORIDE 2003-11-21 Active II N/A