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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 | Kyowa Hakko Bio |
Japan |
KYOWA HAKKO KOGYO CO LTD | 12270 | BUCILLAMINE BULK SUBSTANCE | 1996-11-22 | Inactive | II | N/A | ||
28/03/2025 | Optimus Pharma |
India |
OPTIMUS DRUGS PRIVATE LTD | 36652 | BUCILLAMINE | 2021-12-23 | Active | II | N/A |