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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/02/2026 | Hetero Drugs |
India |
HETERO LABS LTD | 42455 | LENACAPAVIR SODIUM | 2025-10-27 | Active | II | Complete | 2025-12-23 | 2025-11-21 |
| 27/02/2026 | Lee Pharma |
India |
LEE PHARMA LTD | 42394 | LENACAPAVIR SODIUM | 2025-08-06 | Active | II | N/A |
