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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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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    30/12/2025 Lupin Manufacturing Solutions
    India
    		 LUPIN MANUFACTURING SOLUTIONS LTD 36413 SODIUM ZIRCONIUM CYCLOSILICATE 2022-03-16 Active II Complete 2022-04-18 2022-03-23
    30/12/2025 Hetero Drugs
    India
    		 HETERO DRUGS LTD 36915 SODIUM ZIRCONIUM CYCLOSILICATE 2022-03-17 Active II Complete 2022-04-19 2022-03-17
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