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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | PMC Isochem |
France |
PMC ISOCHEM | 19765 | TRIMEBUTINE MALEATE | 2006-09-12 | Active | II | N/A | ||
| 27/09/2025 | Hainan Poly Pharm |
China |
HAINAN POLY PHARM CO LTD | 34948 | TRIMEBUTINE MALEATE DRUG SUBSTANCE | 2020-06-24 | Active | II | N/A |
