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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
29/11/2025 Alivus Life Sciences
India
ALIVUS LIFE SCIENCES LTD 34741 SOLRIAETOL HYDROCHLORIDE 2020-03-31 Active II Complete 2022-12-16 2022-11-14
29/11/2025 Alkem Laboratories
India
ALKEM LABORATORIES LTD 36951 Solriaetol Hydrochloride 2022-03-28 Active II Complete 2023-02-15 2023-02-03