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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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 38693 | VARENICLINE TARTRATE | 2023-08-30 | Active | II | N/A | ||
| 31/10/2025 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 23708 | VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE | 2010-04-12 | Active | II | Complete | 2012-11-23 | 2012-11-13 |
