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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
28/11/2024 HRV Global Life Sciences
India
NEW HORIZON PHARMA US INC 39721 PITOLISANT HYDROCHLORIDE IN-HOUSE 2024-04-01 Active II N/A
28/11/2024 Nuray Chemicals Private Limited
India
SS PHARMA LLC 36859 PITOLISANT HYDROCHLORIDE 2022-03-01 Active II Complete 2023-03-31 2023-03-15