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    List of Drug Master Files (DMF) for 3505 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Cambrex Corporation

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    CAMBREX PROFARMACO MILANO SRL

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    AMIODARONE HCL

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    3505
    Active
    1979-04-11
    Complete
    2016-07-15
    2016-06-17
    II
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    Looking for Drug Master Files (DMF) for 3505 of Cambrex Profarmaco Milano Srl

    Looking for Drug Master Files (DMF) for 3505 of Cambrex Profarmaco Milano Srl 1

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    Cambrex Profarmaco Milano Srl, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Cambrex is an innovative life sciences company with a refreshingly human approach.

    One of their notable products is AMIODARONE HCL, with a corresponding US DMF Number 3505.

    Remarkably, this DMF maintains an Active status since its submission on April 11, 1979, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2016, and payment made on June 17, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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