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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 Apicore
    India
    		 APICORE PHARMACEUTICALS PRIVATE LTD 24646 PERPHENAZINE USP 2012-11-28 Active II Complete 2013-09-27 2012-11-28
    29/01/2026 Emcure Pharmaceuticals
    India
    		 EMCURE PHARMACEUTICALS LTD 27224 PERPHENAZINE USP 2013-06-29 Active II Complete 2014-10-06 2014-01-22
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