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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 Gangwal Healthcare
    India
    		 GANGWAL HEALTHCARE PRIVATE LTD 39536 BETADEX USP 2024-02-14 Active IV N/A
    30/12/2025 Zibo Qianhui Biological Technology Co Ltd
    China
    		 ZIBO QIANHUI BIOLOGICAL TECHNOLOGY CO LTD 37123 HYDROXYPROPYL GAMMA CYCLODEXTRIN 2022-05-19 Active IV N/A
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