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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
28/03/2025 Nuray Chemicals Private Limited
India
SS PHARMA LLC 32444 RAMELTEON 2018-06-06 Active II Complete 2018-07-27 2018-06-04
28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 34414 RAMELTEON 2019-12-31 Active II Complete 2020-11-12 2020-09-24