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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Acebright India Pharma Private Limited |
India |
CDYMAX (INDIA) PHARMA PRIVATE LTD | 24847 | EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)] | 2011-04-08 | Active | II | Complete | 2013-12-17 | 2013-05-08 |
24/02/2025 | Arene Lifesciences |
India |
ARENE LIFE SCIENCES PRIVATE LTD | 33854 | EFAVIRENZ USP | 2019-06-12 | Active | II | N/A |