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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 | 25893 | ARGATROBAN HYDRATE | 2012-02-20 | Active | II | N/A | ||
28/03/2025 | BrightGene Bio-Medical Technology Co.,Ltd |
China |
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD | 35491 | ARGATROBAN | 2020-12-26 | Active | II | Complete | 2021-10-01 | 2021-04-14 |