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About Mayne Pharma
Mayne Pharma International (Mayne Pharma) is an oral drug delivery pharmaceutical company that specialises in the development and manufacture of pharmaceuticals.
A technology driven company, Mayne Pharma competes in the following markets;
- Branded generic product
- Specialty generic product (generics with high barriers to competition)
- Improved chemical entity (ICE) and
- Value added active pharmaceutical ingredients (APIs).
With expertise spanning 40 years in the drug delivery systems field and developing global products, Mayne Pharma’s capabilities encompass the use of novel and patent protected technologies and proprietary knowledge to solve a range of oral drug delivery challenges.
Based in Salisbury, South Australia and well equipped to develop and manufacture oral, controlled-release and dermaceutical formulations for both its own product pipeline and external customers, 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.