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List of Drug Master Files (DMF) of Spinosyn D 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 36707 SPINOSAD 2022-06-01 Active II N/A
26/09/2024 BrightGene Bio-Medical Technology Co.,Ltd
China
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD 36293 SPINOSAD 2021-09-27 Active II Complete 2021-11-15 2021-09-16