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

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    Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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    Gadoterate Meglumine

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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 36148 GADOTERATE MEGLUMINE 2021-07-29 Active II N/A
    29/01/2026 Beijing Beilu Pharma
    China
    		 BEIJING BEILU PHARMACEUTICAL CO LTD 40935 GADOTERATE MEGLUMINE 2024-12-25 Active II N/A
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