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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | 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 |
| 31/10/2025 | 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 |
