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    List of Drug Master Files (DMF) for 21125 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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    01 ATORVASTATIN CALCIUM (NO BHA PREMIX) (1)

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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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    ATORVASTATIN CALCIUM (NO BHA PREMIX)

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    Other DMF BR, EU, CA, CN, RU
    21125
    Active
    2007-12-14
    Complete
    2013-02-27
    2013-02-06
    II
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    Looking for Drug Master Files (DMF) for 21125 of Dr Reddys Laboratories Ltd

    Looking for Drug Master Files (DMF) for 21125 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 ATORVASTATIN CALCIUM (NO BHA PREMIX), with a corresponding US DMF Number 21125.

    Remarkably, this DMF maintains an Active status since its submission on December 14, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 27, 2013, and payment made on February 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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