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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 MSN Laboratories
India
MSN LABORATORIES PRIVATE LTD 23599 TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1] 2010-03-02 Inactive II N/A
28/03/2025 Zhejiang Yongtai Technology
China
ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD 35320 TERT-BUTYL 2-[(4R,6S)-6-[(E)-2-[4-(4-FLUOROPHENYL)-2-[METHYL (METHYLSULFONYL)AMINO]-6-PROPAN-2-YLPYRIMIDIN-5-YL]ETHENYL]-2,2-DIMETHYL-1,3-DIOXAN-4-YL]ACETATE 2020-10-28 Active II N/A