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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 Changzhou Pharmaceutical Factory
China
CHANGZHOU PHARMACEUTICAL FACTORY 40968 BICTEGRAVIR SODIUM 2024-12-18 Active II N/A
28/03/2025 Cipla
India
CIPLA LTD 35866 BICTEGRAVIR SODIUM 2021-05-24 Active II Complete 2021-07-06 2021-05-28