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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
28/03/2025 Porton Pharma Solutions
China
PORTON PHARMA SOLUTIONS LTD 40455 BALOXAVIR MARBOXIL 2024-09-05 Active II N/A
28/03/2025 Changzhou Pharmaceutical Factory
China
CHANGZHOU PHARMACEUTICAL FACTORY 36657 BALOXAVIR MARBOXIL 2021-12-31 Active II Complete 2022-04-06 2022-02-25