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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 Symbiotec Pharmalab
India
SYMBIOTEC PHARMALAB PRIVATE LTD 32885 DROSPIRENONE USP 2018-08-30 Active II N/A
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 22878 DROSPIRENONE 2009-06-18 Active II Complete 2012-11-23 2012-11-08