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    List of Drug Master Files (DMF) for 30806 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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    MIDODRINE HYDROCHLORIDE USP

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    30806
    Active
    2016-09-27
    Complete
    2017-03-17
    2016-09-26
    II
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    Looking for Drug Master Files (DMF) for 30806 of Enaltec Labs Private Ltd

    Looking for Drug Master Files (DMF) for 30806 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 MIDODRINE HYDROCHLORIDE USP, with a corresponding US DMF Number 30806.

    Remarkably, this DMF maintains an Active status since its submission on September 27, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2017, and payment made on September 26, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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