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

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$ API Ref.Price (USD/KG) : 312Xls 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 Newgen Biotech USA
U.S.A
NEWGEN BIOTECH (NINGBO) 30889 LACTASE USP 2016-08-22 Active II N/A
26/09/2024 Specialty Enzymes & Probiotics
U.S.A
SPECIALTY ENZYMES AND BIOCHEMICALS CO 22034 LACTASE USP 2008-09-18 Active II N/A