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    List of Drug Master Files (DMF) for 19153 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Aurobindo Pharma Limited

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    01 BUPROPION HYDROCHLORIDE USP (1)

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    APITORIA PHARMA PRIVATE LTD

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    BUPROPION HYDROCHLORIDE USP

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    19153
    Active
    2006-01-30
    Complete
    2021-02-22
    2021-01-13
    II
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    Looking for Drug Master Files (DMF) for 19153 of Apitoria Pharma Private Ltd

    Looking for Drug Master Files (DMF) for 19153 of Apitoria Pharma Private Ltd 1

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    Apitoria Pharma Private 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 BUPROPION HYDROCHLORIDE USP, with a corresponding US DMF Number 19153.

    Remarkably, this DMF maintains an Active status since its submission on January 30, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 22, 2021, and payment made on January 13, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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