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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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    Alivus Life Sciences

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    Alivus Life Sciences Ltd

    India
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-11-16

    Pay. Date : 2022-11-14

    DMF Number : 20593

    Submission : 2007-06-12

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 20593 of Alivus Life Sciences Ltd

    Looking for Drug Master Files (DMF) for 20593 of Alivus Life Sciences Ltd 1

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

    One of their notable products is ROPINIROLE HYDROCHLORIDE USP, with a corresponding US DMF Number 20593.

    Remarkably, this DMF maintains an Active status since its submission on June 12, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 16, 2022, and payment made on November 14, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II

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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.