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    List of Drug Master Files (DMF) for 20097 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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    • FDA
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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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    BENAZEPRIL HYDROCHLORIDE

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    20097
    Active
    2006-12-27
    Complete
    2024-01-26
    2023-10-05
    II
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    Looking for Drug Master Files (DMF) for 20097 of Aarti Pharmalabs Ltd

    Looking for Drug Master Files (DMF) for 20097 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 BENAZEPRIL HYDROCHLORIDE, with a corresponding US DMF Number 20097.

    Remarkably, this DMF maintains an Active status since its submission on December 27, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 26, 2024, and payment made on October 05, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II

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