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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 | Alcedo Pharmachem |
India |
ALCEDO PHARMACHEM PRIVATE LTD | 42036 | CALCIUM STEARATE USP-NF | 2025-06-02 | Active | IV | N/A | ||
| 31/10/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
MALLINCKRODT INC | 2355 | STEAR-O-WET C (CALCIUM STEARATE) | 1974-11-19 | Inactive | II | N/A |
