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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/07/2025 | Hefei TianRui Pharmaceutical Chemical |
China |
HEFEI TIANRUI PHARMACEUTICAL CHEMICAL CO LTD | 42168 | DIFAMILAST | 2025-06-30 | Active | II | N/A | ||
| 29/07/2025 | Otsuka Holdings |
Japan |
OTSUKA PHARMACEUTICAL CO LTD | 30529 | OPA-15406 DRUG SUBSTANCE | 2016-05-23 | Active | II | N/A |
