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    List of Drug Master Files (DMF) for 33173 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    APOTEX PHARMACHEM INC

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    ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

    PDF Supplier PDF
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    33173
    Active
    2018-11-02
    Complete
    2019-02-12
    2018-11-06
    II
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    Looking for Drug Master Files (DMF) for 33173 of Apotex Pharmachem Inc

    Looking for Drug Master Files (DMF) for 33173 of Apotex Pharmachem Inc 1

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    Apotex Pharmachem Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP, with a corresponding US DMF Number 33173.

    Remarkably, this DMF maintains an Active status since its submission on November 02, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2019, and payment made on November 06, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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