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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 | Gedeon Richter |
Hungary |
GEDEON RICHTER LTD | 5590 | TOLPERISONE HCl | 1984-10-24 | Inactive | II | N/A | ||
| 31/10/2025 | Syn-Tech Chem. & Pharm |
Taiwan |
SYN-TECH CHEM AND PHARM CO LTD | 25466 | TOLPERISONE HYDROCHLORIDE | 2011-10-31 | Active | II | N/A |
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