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    List of Drug Master Files (DMF) for 30687 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alchem International Private Ltd

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    Alchem International Private Ltd

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    Virtual BoothAlchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-09-14

    Pay. Date : 2017-06-02

    DMF Number : 30687

    Submission : 2016-07-06

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 30687 of Alchem International Private Ltd

    Looking for Drug Master Files (DMF) for 30687 of Alchem International Private Ltd 1

    20

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

    They are recognized for Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

    One of their notable products is HYOSCINE EP (SCOPOLAMINE), with a corresponding US DMF Number 30687.

    Remarkably, this DMF maintains an Active status since its submission on July 06, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2017, and payment made on June 02, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II