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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/01/2025 | Bachem AG |
Switzerland |
BACHEM AMERICAS INC | 33336 | LANREOTIDE ACETATE | 2019-02-08 | Active | II | Complete | 2020-04-03 | 2019-02-01 |
28/01/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 39768 | LANREOTIDE ACETATE | 2024-06-28 | Active | II | N/A |