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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
27/02/2026 ALPS Pharmaceutical Ind. Co. Ltd.
Japan
ALPS PHARMACEUTICAL IND CO LTD 20538 PROTAMINE SULFATE 2007-05-11 Active II Complete 2018-10-18 2018-09-27
27/02/2026 Amphastar Pharmaceuticals
U.S.A
AMPHASTAR NANJING PHARMACEUTICALS INC (ANP) AN AMPHASTAR CO 30429 PROTAMINE SULFATE USP 2016-09-16 Active II Complete 2022-10-19 2022-10-11