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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 19552 | NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE | 2006-06-26 | Active | II | N/A | ||
28/03/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 40235 | NICARDIPINE HYDROCHLORIDE USP | 2024-08-31 | Active | II | Complete | 2025-03-04 | 2025-02-14 |