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    List of Drug Master Files (DMF) for 21879 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Coral Drugs Private Limited

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    01 Coral Drugs Private Limited (1)

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    01 FLUTICASONE PROPIONATE (1)

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    01 India (1)

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    01 Active (1)

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    CORAL DRUGS PVT LTD

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    • FDA
    • EDQM
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    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
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    FLUTICASONE PROPIONATE

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    21879
    Active
    2008-08-12
    Complete
    2018-05-11
    2018-04-10
    II
    Corel Drugs cGMP partner for APIs

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    Looking for Drug Master Files (DMF) for 21879 of Coral Drugs Pvt Ltd

    Looking for Drug Master Files (DMF) for 21879 of Coral Drugs Pvt Ltd 1

    20

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

    They are recognized for Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.

    One of their notable products is FLUTICASONE PROPIONATE, with a corresponding US DMF Number 21879.

    Remarkably, this DMF maintains an Active status since its submission on August 12, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 11, 2018, and payment made on April 10, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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