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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 32728 PREDNISOLONE ACETATE USP 2018-06-04 Active II Complete 2020-05-19 2020-04-13
28/03/2025 Axplora
Germany
FARMABIOS SPA 32896 STERILE PREDNISOLONE-21-ACETATE MICRONIZED 2018-07-16 Active II Complete 2020-12-29 2020-09-22