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    List of Drug Master Files (DMF) for 27192 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Auronext Pharma Private Limited

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    01 Auronext Pharma Private Limited (1)

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    01 MEROPENEM FOR INJECTION (STERILE BULK) (1)

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    EUGIA PHARMA SPECIALITIES LTD

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    MEROPENEM FOR INJECTION (STERILE BULK)

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    27192
    Active
    2013-06-18
    Complete
    2013-08-25
    2013-06-17
    II
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    Looking for Drug Master Files (DMF) for 27192 of Eugia Pharma Specialities Ltd

    Looking for Drug Master Files (DMF) for 27192 of Eugia Pharma Specialities Ltd 1

    20

    Eugia Pharma Specialities Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM and WHO-GMP.

    One of their notable products is MEROPENEM FOR INJECTION (STERILE BULK), with a corresponding US DMF Number 27192.

    Remarkably, this DMF maintains an Active status since its submission on June 18, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 25, 2013, and payment made on June 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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