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    List of Drug Master Files (DMF) for 28038 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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    ABIRATERONE ACETATE

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    Other DMF BR, EU, RU
    28038
    Active
    2014-03-27
    Complete
    2014-08-13
    2014-05-05
    II
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    Looking for Drug Master Files (DMF) for 28038 of Dr Reddys Laboratories Ltd

    Looking for Drug Master Files (DMF) for 28038 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 ABIRATERONE ACETATE, with a corresponding US DMF Number 28038.

    Remarkably, this DMF maintains an Active status since its submission on March 27, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 13, 2014, and payment made on May 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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