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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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    5-oxo-6H-benzo[b][1]benzazepine-11-carboxamide

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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
    28/10/2024 Hubei Gedian Humanwell Pharmaceutical
    China
    		 HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD 32999 OXCARBAZEPINE 2018-07-22 Active II Complete 2019-04-12 2019-02-12
    28/10/2024 Polpharma
    Poland
    		 ZAKLADY FARMACEUTYCZNE POLPHARMA SA 34418 OXCARBAZEPINE 2019-12-20 Active II Complete 2020-08-04 2020-02-03