About Mayne Pharma
Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals. Mayne Pharma also provides contract development and manufacturing services to more than 125 clients worldwide.
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:
- Astrix™ - delayed-release low-dose aspirin used to treat cardiovascular disease.
- Doryx™ - delayed-release oral formulation of doxycycline used to treat acne, certain bacterial infections or as an anti-malarial.
- 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.
- Lozanoc™/Itragerm™ - super-bioavailable itraconazole used to treat fungal infections.
Mayne Pharma’s roots can be traced to FH Faulding and Co, for many years one of the largest and most prominent public companies headquartered in South Australia.
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 product 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 business is supported by over 600 staff globally with more than 180 scientists employed.
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 Salisbury 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 and topical dosage forms including highly potent compounds, Schedule II-V controlled substances, inherently unstable compounds and products with poor bioequivalence. 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 140 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.