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    List of Drug Master Files (DMF) for 20502 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Aarti Pharmalabs

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    AARTI PHARMALABS LTD

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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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    BICALUTAMIDE

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    20502
    Active
    2007-05-01
    Complete
    2023-11-22
    2023-11-09
    II
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    Looking for Drug Master Files (DMF) for 20502 of Aarti Pharmalabs Ltd

    Looking for Drug Master Files (DMF) for 20502 of Aarti Pharmalabs Ltd 1

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

    They are recognized for Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    One of their notable products is BICALUTAMIDE, with a corresponding US DMF Number 20502.

    Remarkably, this DMF maintains an Active status since its submission on May 01, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 22, 2023, and payment made on November 09, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II

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