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    List of Drug Master Files (DMF) for 32030 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alkem Laboratories

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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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    TOLVAPTAN

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    32030
    Active
    2017-10-06
    Complete
    2017-11-15
    2017-10-12
    II
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    Looking for Drug Master Files (DMF) for 32030 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 32030 of Alkem Laboratories Ltd 1

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    Alkem 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 TOLVAPTAN, with a corresponding US DMF Number 32030.

    Remarkably, this DMF maintains an Active status since its submission on October 06, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 15, 2017, and payment made on October 12, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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