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    List of Drug Master Files (DMF) for 31939 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Enaltec Labs Private Limited

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    01 Enaltec Labs Private Limited (1)

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    01 DOFETILIDE USP (1)

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    DOFETILIDE USP

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    31939
    Active
    2018-05-30
    Complete
    2018-10-16
    2018-05-29
    II
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    Looking for Drug Master Files (DMF) for 31939 of Enaltec Labs Private Ltd

    Looking for Drug Master Files (DMF) for 31939 of Enaltec Labs Private Ltd 1

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    Enaltec Labs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

    One of their notable products is DOFETILIDE USP, with a corresponding US DMF Number 31939.

    Remarkably, this DMF maintains an Active status since its submission on May 30, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 16, 2018, and payment made on May 29, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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