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    List of Drug Master Files (DMF) for 16371 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Neuland Laboratories

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    01 Neuland Laboratories (1)

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    01 ALBUTEROL SULFATE USP (1)

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    NEULAND LABORATORIES LTD

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    ALBUTEROL SULFATE USP

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    16371
    Active
    2003-01-20
    Complete
    2013-09-26
    2013-08-29
    II
    Neuland

    CPhI North America

    Booth #1218

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    Looking for Drug Master Files (DMF) for 16371 of Neuland Laboratories Ltd

    Looking for Drug Master Files (DMF) for 16371 of Neuland Laboratories Ltd 1

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    Neuland Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Neuland Laboratories- A dedicated 100% API provider.

    One of their notable products is ALBUTEROL SULFATE USP, with a corresponding US DMF Number 16371.

    Remarkably, this DMF maintains an Active status since its submission on January 20, 2003, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 26, 2013, and payment made on August 29, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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