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

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    Theophylline

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

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    $ API Ref.Price (USD/KG) : 19Xls 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 Alembic Pharmaceuticals Limited
    India
    		 ALEMBIC PHARMACEUTICALS LTD 35365 THEOPHYLLINE (ANHYDROUS) USP 2020-12-29 Active II N/A
    26/09/2024 Concordia Labs Inc
    Canada
    		 CONCORD LABORATORIES INC 3040 THEOPHYLLINE CAP 1977-10-24 Inactive II N/A