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    List of Drug Master Files (DMF) for 16473 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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    AMLODIPINE BESILATE USP

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    Other DMF CA, RU
    16473
    Active
    2003-03-19
    Complete
    2013-05-21
    2013-05-10
    II
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    Looking for Drug Master Files (DMF) for 16473 of Dr Reddys Laboratories Ltd

    Looking for Drug Master Files (DMF) for 16473 of Dr Reddys Laboratories Ltd 1

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    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 AMLODIPINE BESILATE USP, with a corresponding US DMF Number 16473.

    Remarkably, this DMF maintains an Active status since its submission on March 19, 2003, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 21, 2013, and payment made on May 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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