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    Symbiotec Pharmalab Private Ltd

    India
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    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-05-06

    Pay. Date : 2021-04-09

    DMF Number : 34505

    Submission : 2020-02-21

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 34505 of Symbiotec Pharmalab Private Ltd

    Looking for Drug Master Files (DMF) for 34505 of Symbiotec Pharmalab Private Ltd 1

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    Symbiotec Pharmalab Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    They are recognized for Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    One of their notable products is PREDNISOLONE USP, with a corresponding US DMF Number 34505.

    Remarkably, this DMF maintains an Active status since its submission on February 21, 2020, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 06, 2021, and payment made on April 09, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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