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    List of Drug Master Files (DMF) for 30732 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Dr. Reddy's Laboratories

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    DR REDDYS LABORATORIES LTD

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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    APREMILAST (FORM B)

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    Other DMF BR, CA, CN
    30732
    Active
    2016-09-30
    Complete
    2017-01-05
    2016-11-15
    II
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    Looking for Drug Master Files (DMF) for 30732 of Dr Reddys Laboratories Ltd

    Looking for Drug Master Files (DMF) for 30732 of Dr Reddys Laboratories Ltd 1

    20

    Dr Reddys Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    One of their notable products is APREMILAST (FORM B), with a corresponding US DMF Number 30732.

    Remarkably, this DMF maintains an Active status since its submission on September 30, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2017, and payment made on November 15, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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