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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 33260 | PENCICLOVIR | 2018-11-07 | Active | II | Complete | 2019-01-07 | 2018-11-06 |
29/07/2025 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 35243 | PENCICLOVIR | 2020-09-26 | Active | II | Complete | 2022-07-19 | 2022-05-31 |