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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 TAPI Technology & API Services
    Israel
    		 TAPI NL BV 17565 ZALEPLON 2004-07-22 Active II N/A
    29/01/2026 Amino Chemicals
    Malta
    		 AMINO CHEMICALS LTD 16785 ZALEPLON 2003-08-20 Inactive II N/A
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