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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 ALP Pharm
China
ALP PHARM BEIJING CO LTD 23997 POLYMYXIN B SULFATE USP 2010-07-02 Active II N/A
28/03/2025 BIOTIKA a.s.
Slovakia
BIOTIKA AS 23876 POLYMYXIN B SULFATE 2010-05-31 Active II Complete 2014-09-29 2013-12-11