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    List of Drug Master Files (DMF) for 28128 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    RITONAVIR, USP (FORM-I)

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    28128
    Active
    2014-03-31
    Complete
    2014-09-03
    2014-03-28
    II
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    Looking for Drug Master Files (DMF) for 28128 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 28128 of Raks Pharma Pvt Ltd 1

    20

    Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from WHO-GMP.

    One of their notable products is RITONAVIR, USP (FORM-I), with a corresponding US DMF Number 28128.

    Remarkably, this DMF maintains an Active status since its submission on March 31, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 03, 2014, and payment made on March 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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