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    European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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    Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.

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    Aurore Life Sciences Private Ltd

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35844

    Submission : 2021-04-26

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 35844 of Aurore Life Sciences Private Ltd

    Looking for Drug Master Files (DMF) for 35844 of Aurore Life Sciences Private Ltd 1

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    Aurore Life Sciences Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

    They are recognized for An integrated company with complete control of key starting materials, advanced intermediates & high-quality APIs.

    One of their notable products is TOFACITINIB CITRATE, with a corresponding US DMF Number 35844.

    Remarkably, this DMF maintains an Active status since its submission on April 26, 2021, highlighting commitment to regulatory compliance.

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.