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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 | SPI Pharma |
U.S.A |
SPI PHARMA INC | 21367 | CALCIUM CARBONATE DC TYPE CS90 PRODUCTS | 2008-02-27 | Active | II | N/A | ||
28/03/2025 | Gangotri Inorganic |
India |
GANGOTRI INORGANIC (P) LTD | 35753 | CALCIUM CARBONATE IP/BP/USP/EP/JP | 2021-08-17 | Active | IV | N/A |