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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
30/12/2025 Shenyang Hongqi Pharmaceutical
China
SHENYANG HONGQI PHARMACEUTICAL CO LTD 38642 PRETOMANID 2023-09-28 Active II Complete 2024-01-08 2023-12-26
30/12/2025 Viatris
U.S.A
TIANISH LABORATORIES PRIVATE LTD 38796 PRETOMANID 2023-10-31 Active II N/A