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    List of Drug Master Files (DMF) for 18468 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 (AMORPHOUS) (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 (AMORPHOUS)

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    Other DMF BR, EU, CA, CN, RU
    18468
    Active
    2005-06-29
    Complete
    2013-02-27
    2013-02-05
    II
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    Looking for Drug Master Files (DMF) for 18468 of Dr Reddys Laboratories Ltd

    Looking for Drug Master Files (DMF) for 18468 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 (AMORPHOUS), with a corresponding US DMF Number 18468.

    Remarkably, this DMF maintains an Active status since its submission on June 29, 2005, 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 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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