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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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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
    29/01/2026 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 37010 TEGASEROD MALEATE 2022-03-30 Active II N/A
    29/01/2026 Alembic Pharmaceuticals Limited
    India
    		 ALEMBIC PHARMACEUTICALS LTD 35367 TEGASEROD MALEATE 2020-11-30 Active II N/A
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