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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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    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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    Gedeon Richter

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    Gedeon Richter Plc

    Hungary
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    BePharma
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9136

    Submission : 1991-05-20

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 9136 of Gedeon Richter Plc

    Looking for Drug Master Files (DMF) for 9136 of Gedeon Richter Plc 1

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    Gedeon Richter Plc, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is NORGESTREL USP, with a corresponding US DMF Number 9136.

    Remarkably, this DMF maintains an Active status since its submission on May 20, 1991, 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.