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    List of Drug Master Files (DMF) for 14334 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ALENDRONATE SODIUM USP

    PDF Supplier PDF
    URL Supplier Web Content
    14334
    Active
    1999-08-06
    Complete
    2019-12-15
    2019-12-11
    II
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    Looking for Drug Master Files (DMF) for 14334 of Cipla Ltd

    Looking for Drug Master Files (DMF) for 14334 of Cipla Ltd 1

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    Cipla Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is ALENDRONATE SODIUM USP, with a corresponding US DMF Number 14334.

    Remarkably, this DMF maintains an Active status since its submission on August 06, 1999, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2019, and payment made on December 11, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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