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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 42456 LENACAPAVIR SPRAY-DRIED DISPERSION 2025-10-27 Active II N/A
27/02/2026 ANHUI HAOYUAN PHARMACEUTICAL CO LTD 41775 INTERMEDIATE OF LENACAPAVIR-1 (CAS NO.: 1620056-83-8) 2025-04-30 Active II N/A