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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
    29/01/2026 Chunghwa Chemical Synthesis & Biotech
    Taiwan
    		 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD 18494 MYCOPHENOLATE MOFETIL USP 2005-07-11 Active II Complete 2017-02-01 2016-11-22
    29/01/2026 TAPI Technology & API Services
    Israel
    		 TAPI NL BV 20072 MYCOPHENOLATE MOFETIL DRUG SUBSTANCE 2006-12-20 Active II Complete 2012-11-23 2012-11-09
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