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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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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 Biocon
    India
    		 BIOCON LTD 32877 ANIDULAFUNGIN (DRUG SUBSTANCE INTERMEDIATE) 2018-06-12 Active II N/A
    29/01/2026 BrightGene Bio-Medical Technology Co.,Ltd
    China
    		 BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD 32010 ANIDULAFUNGIN (NON-STERILE API) 2017-08-28 Active II N/A
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