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

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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 Ajinomoto Company
Japan
AJINOMOTO CO INC 1076 AMINO ACID PRODUCTS 1967-08-15 Active II Complete 2018-08-14 2018-07-02
26/09/2024 Ajinomoto Company
Japan
AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INC 4555 AMINO ACIDS 1982-03-17 Active II Complete 2018-08-14 2018-07-02