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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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    Astellas Pharma Inc

    Japan
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    RNA Leaders Europe
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16667

    Submission : 2003-06-27

    Status : Inactive

    Type : II

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    Looking for Drug Master Files (DMF) for 16667 of Astellas Pharma Inc

    Looking for Drug Master Files (DMF) for 16667 of Astellas Pharma Inc 1

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    Astellas Pharma Inc, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is FK 881 DRUG SUBSTANCE, with a corresponding US DMF Number 16667.

    Remarkably, this DMF maintains an Inactive status since its submission on June 27, 2003, 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.