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    List of Drug Master Files (DMF) for 27204 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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    BUPROPION HYDROCHLORIDE

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    Other DMF EUDMF
    27204
    Active
    2013-06-17
    Complete
    2013-10-19
    2013-06-25
    II
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    Looking for Drug Master Files (DMF) for 27204 of Aarti Pharmalabs Ltd

    Looking for Drug Master Files (DMF) for 27204 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 BUPROPION HYDROCHLORIDE, with a corresponding US DMF Number 27204.

    Remarkably, this DMF maintains an Active status since its submission on June 17, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2013, and payment made on June 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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