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    List of Drug Master Files (DMF) for 21322 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Calyx Chemicals & Pharmaceuticals Limited

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    ISONIAZID

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    21322
    Active
    2008-02-07
    Complete
    2015-10-14
    2015-09-30
    II
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    Looking for Drug Master Files (DMF) for 21322 of Calyx Chemicals And Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 21322 of Calyx Chemicals And Pharmaceuticals Ltd 1

    20

    Calyx Chemicals And Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

    One of their notable products is ISONIAZID, with a corresponding US DMF Number 21322.

    Remarkably, this DMF maintains an Active status since its submission on February 07, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2015, and payment made on September 30, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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