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     129  0 Kommentare Recce Pharmaceuticals Completes 5,000 RECCE 327 Doses a Week under Good Manufacturing Practice (GMP) - Seite 2

    GMP covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. It prevents errors that cannot be eliminated through quality control of the finished product. Without GMP, it is impossible to be sure that every unit of medicine is of the same quality as the units tested in the laboratory.1

    About Recce Pharmaceuticals Ltd
    Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

    Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE 435 as an orally administered therapy for bacterial infections; and RECCE 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

    The FDA has awarded RECCE 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

    Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

    Corporate Contact
    James Graham
    Recce Pharmaceuticals Ltd
    +61 (02) 9256 2571
    James.graham@recce.com.au

    Media & Investor Relations (AU)
    Andrew Geddes
    CityPR
    +61 (02) 9267 4511
    ageddes@citypublicrelations.com.au

    Media (USA)
    Michael Fitzhugh
    LifeSci Communications
    mfitzhugh@lifescicomms.com

    Investor Relations (USA & EU)
    Guillame van Renterghem
    LifeSci Advisors
    gvanrenterghem@lifesciadvisors.com

                                                                

    1 https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes#:~:text=GMP%20prevents%20errors%20that%20cannot,medicine%20tested%20in%20the%20laboratory. 


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    Recce Pharmaceuticals Completes 5,000 RECCE 327 Doses a Week under Good Manufacturing Practice (GMP) - Seite 2 Successful production of 5,000 x RECCE 327 (R327) doses per week under Good Manufacturing Practises (GMP) campaignR327 manufactured under GMP standards in support of current and anticipated clinical trials, demonstrating compliance with guidelines …

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