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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 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 28148 FINGOLIMOD HYDROCHLORIDE 2014-04-27 Active II Complete 2014-08-20 2014-04-25
28/03/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 28057 FINGOLIMOD HYDROCHLORIDE USP 2014-03-28 Active II Complete 2014-06-10 2014-03-24