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    List of Drug Master Files (DMF) for 31304 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 AMOXICILLIN USP (ENZYME ROUTE) (1)

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    APITORIA PHARMA PRIVATE LTD

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    AMOXICILLIN USP (ENZYME ROUTE)

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    31304
    Active
    2017-01-10
    Complete
    2017-02-13
    2017-01-06
    II
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    Looking for Drug Master Files (DMF) for 31304 of Apitoria Pharma Private Ltd

    Looking for Drug Master Files (DMF) for 31304 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 AMOXICILLIN USP (ENZYME ROUTE), with a corresponding US DMF Number 31304.

    Remarkably, this DMF maintains an Active status since its submission on January 10, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 13, 2017, and payment made on January 06, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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