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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 : 2019-12-27

    Pay. Date : 2019-12-03

    DMF Number : 31349

    Submission : 2017-01-12

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 31349 of Symbiotec Pharmalab Private Ltd

    Looking for Drug Master Files (DMF) for 31349 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 HYDROCORTISONE USP, with a corresponding US DMF Number 31349.

    Remarkably, this DMF maintains an Active status since its submission on January 12, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2019, and payment made on December 03, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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