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    List of Drug Master Files (DMF) for 33563 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Unichem Laboratories Limited

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    UNICHEM LABORATORIES LTD

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    TICAGRELOR

    PDF Supplier PDF
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    33563
    Active
    2019-03-26
    Complete
    2019-05-10
    2019-01-14
    II
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    Looking for Drug Master Files (DMF) for 33563 of Unichem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 33563 of Unichem Laboratories Ltd 1

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

    One of their notable products is TICAGRELOR, with a corresponding US DMF Number 33563.

    Remarkably, this DMF maintains an Active status since its submission on March 26, 2019, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 10, 2019, and payment made on January 14, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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