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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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 31574 | SACUBITRIL/VALSARTAN | 2017-08-29 | Active | II | Complete | 2017-12-22 | 2017-11-08 |
28/03/2025 | Mankind Pharma |
India |
MANKIND PHARMA LTD | 36637 | SACUBITRIL VALSARTAN TRISODIUM (AMORPHOUS) | 2022-01-17 | Active | II | N/A |