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    List of Drug Master Files (DMF) for 23170 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    AMOLI ORGANICS PVT LTD

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    CARBAMAZEPINE USP

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    23170
    Active
    2009-10-14
    Complete
    2013-09-27
    2013-01-15
    II
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    Looking for Drug Master Files (DMF) for 23170 of Amoli Organics Pvt Ltd

    Looking for Drug Master Files (DMF) for 23170 of Amoli Organics Pvt Ltd 1

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

    One of their notable products is CARBAMAZEPINE USP, with a corresponding US DMF Number 23170.

    Remarkably, this DMF maintains an Active status since its submission on October 14, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 27, 2013, and payment made on January 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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