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    List of Drug Master Files (DMF) of Tiotropium Bromide Hydrate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Tiotropium Bromide Hydrate

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    $ API Ref.Price (USD/KG) : 188,414Xls download

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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
    26/09/2024 Inke S.A
    Spain
    		 INKE SA 34410 TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED) 2020-03-17 Active II Complete 2021-04-30 2020-01-13
    26/09/2024 Vamsi Labs
    India
    		 VAMSI LABS LTD 34808 TIOTROPIUM BROMIDE MONOHYDRATE 2020-04-15 Active II Complete 2021-01-11 2020-11-04