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    List of Drug Master Files (DMF) for 19997 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 (FORM P) USP, SEMICRYSTALLINE (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 (FORM P) USP, SEMICRYSTALLINE

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    Other DMF BR, EU, CA, CN, RU
    19997
    Active
    2006-11-27
    Complete
    2014-01-27
    2013-01-04
    II
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    Looking for Drug Master Files (DMF) for 19997 of Dr Reddys Laboratories Ltd

    Looking for Drug Master Files (DMF) for 19997 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 (FORM P) USP, SEMICRYSTALLINE, with a corresponding US DMF Number 19997.

    Remarkably, this DMF maintains an Active status since its submission on November 27, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 27, 2014, and payment made on January 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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