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    About

    Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company that develops and manufactures branded and generic products, which it distributes directly or through distribution partners and also provides contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems for both generic and proprietary ...
    Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company that develops and manufactures branded and generic products, which it distributes directly or through distribution partners and also provides contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems for both generic and proprietary applications including: Lozanoc® – super-bioavailable itraconazole used to treat fungal infections. Doryx® – delayed-release oral formulation of doxycycline used to treat acne, certain bacterial infections or as an anti-malarial Astrix® – delayed-release low-dose aspirin used to treat cardiovascular disease Eryc® – delayed-release erythromycin used in the treatment of bacterial infections Kadian®/Kapanol® – sustained-release oral morphine used in the management of chronic pain A technology driven company, Mayne Pharma has a significant product portfolio and pipeline, global reach through distribution partners in Australia, USA, Europe and Asia and two manufacturing facilities based in Salisbury, South Australia and Greenville, North Carolina, USA. The12,000m2 facility in Salisbury, South Australia is capable of developing products from formulation and clinical trial stages to validation and registration, right through to commercial scale manufacture of packaged goods. The drug development and manufacturing operations are supported by approximately 160 staff with 20 formulation and analytical scientists dedicated to the development of new products. The Mayne Pharma site: Is GMP compliant as certified by chief regulatory authorities (FDA, TGA and with mutual recognition from the MHRA, TPD and various Asian regulatory authorities). Is licensed to handle CII/S8 compounds (controlled drug substances) and utilise chlorinated solvents and alcohols in the manufacturing process. Includes an established manufacturing facility with capacity to produce 2.5 billion capsules and tablets, 100 ton of bulk product and 16 million units of liquid and cream product annually. Includes extensive product development laboratory space to accommodate all analytical processes and bench scale formulation through to pilot scale manufacturing and scale-up for multiple concurrent development projects. Is a centre for product development activities, from formulation and clinical trial stage, to validation and registration, to commercial scale manufacture of packaged goods ready to be dispensed. Metrics, Inc. (Metrics) a fully owned subsidiary occupies a state of the art 9,200m2 facility in Greenville, North Carolina. Metrics is a full-service contract development and manufacturing organization (CDMO) specializing in oral dosage forms. The Greenville site has approximately 300 employees with more than 150 analytical and formulation scientists and technicians dedicated to proprietary product pipeline and third party services. The Greenville site: Offers quality pharmaceutical formulation development, analytical testing services and commercial and CTM manufacturing for Phase I – III Offers particular expertise in First-Time-In-Man (FTIM) and Phase I, II, and III Clinical Trial Manufacturing (CTM) – conducting more than 130 FTIM projects for different chemical entities while concurrently developing more than 700 CTM batches. Is GMP compliant with 5 analytical laboratories and 7 large scale manufacturing and packaging suites. Is capable of handling potent and cytotoxic products and are DEA-approved for Schedule II-V controlled substances. Globally, the business provides a broad spectrum of contract services to support investigational new drug (IND), new drug (NDA) and abbreviated new drug (ANDA) submissions to regulatory agencies.

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    CONTACT DETAILS

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    Mayne PharmaAustralia Flag
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    Country
    Australia
    Address
    Address
    1538 Main North Road, Salisbury South, SA 5106
    Telephone
    Telephone
    +61 8 8209 2666 
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.maynepharma.com/
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    NEWS #PharmaBuzz

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    Termination of Proposed Acquisition of Mayne Pharma
    Termination of Proposed Acquisition of Mayne Pharma

    11 Dec 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20251211144905/en/Termination-of-Proposed-Acquisition-of-Mayne-Pharma

    BUSINESSWIRE
    11 Dec 2025
    Share Share
    Australian government blocks Cosette's Mayne Pharma buy
    Australian government blocks Cosette's Mayne Pharma buy

    21 Nov 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/australian-government-rejects-cosettes-proposed-mayne-pharma-buyout-citing-national-interest

    FIERCE PHARMA
    21 Nov 2025
    Share Share
    Mayne Pharma Shares Fall as Cosette Bid Faces Australian Review
    Mayne Pharma Shares Fall as Cosette Bid Faces Australian Review

    31 Oct 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/australias-mayne-pharma-falls-treasurer-considers-blocking-cosettes-437-million-2025-10-31/

    REUTERS
    31 Oct 2025
    Share Share
    Court Blocks Cosette's $438M Mayne Deal Drop; Shares Surge
    Court Blocks Cosette's $438M Mayne Deal Drop; Shares Surge

    15 Oct 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/cosettes-attempt-drop-438-million-mayne-pharma-deal-denied-by-court-2025-10-15/

    REUTERS
    15 Oct 2025
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    Mayne Pharma drops 30% as Cosette considers canceling $432M deal
    Mayne Pharma drops 30% as Cosette considers canceling $432M deal

    21 May 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/mayne-pharma-slumps-30-cosette-threatens-scrap-432-million-deal-2025-05-21/

    REUTERS
    21 May 2025
    Share Share
    Mayne hit by 'misleading' drug safety claims from FDA
    Mayne hit by 'misleading' drug safety claims from FDA

    14 May 2025

    // FDA

    https://www.fda.gov/media/186470/download?attachment

    FDA
    14 May 2025
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