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    List of Drug Master Files (DMF) for 26631 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Apotex Pharmachem

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    01 Apotex Pharmachem (1)

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    01 ERLOTINIB HYDROCHLORIDE (1)

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    APOTEX PHARMACHEM INC

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    ERLOTINIB HYDROCHLORIDE

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    26631
    Active
    2013-01-22
    Complete
    2014-10-28
    2012-12-12
    II
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    Looking for Drug Master Files (DMF) for 26631 of Apotex Pharmachem Inc

    Looking for Drug Master Files (DMF) for 26631 of Apotex Pharmachem Inc 1

    20

    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 ERLOTINIB HYDROCHLORIDE, with a corresponding US DMF Number 26631.

    Remarkably, this DMF maintains an Active status since its submission on January 22, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2014, and payment made on December 12, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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