mayne pharma

About Mayne Pharma

Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company that develops and manufactures branded and generic products, which it distributes globally; either 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 and these technologies have been successfully commercialised in numerous products that have been marketed around the world including:

  • Lozanoc/Itragerm - 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/Erymax - 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, North America, Europe and Asia and two drug development and manufacturing facilities based in Salisbury, Australia and Greenville, North Carolina, USA with expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds.

The 12,000m2 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 180 staff with more than 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.

The 9,200m2 facility in Greenville, North Carolina specialises in oral dosage forms including highly potent compounds, Schedule II-V controlled substances, inherently unstable compounds and products with poor bioequivalence. 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 and inspected by the FDA and MHRA with manufacturing capacity to produce over 1.0 billion tablets and capsules annually.
  • Is capable of handling potent and cytotoxic products and is 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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