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List of Drug Master Files (DMF) of (L)-PROLINE 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 Evonik
Germany
EVONIK REXIM SAS 26400 L-PROLINE 2012-09-03 Active II N/A
26/09/2024 Ajinomoto Company
Japan
AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INC 31557 L-PROLINE 2017-03-21 Active II Complete 2021-08-27 2020-11-30