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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 Alivus Life Sciences
India
GLENMARK LIFE SCIENCES LTD 27665 TELAPREVIR 2014-07-30 Active II Complete 2014-10-28 2013-12-05
28/03/2025 Johnson & Johnson Innovative Medicine
U.S.A
JANSSEN PHARMACEUTICA NV 23787 TELAPREVIR DRUG SUBSTANCE (R600109) 2010-06-24 Inactive II N/A