Mayne Pharma’s Australian GMP accredited manufacturing facility is located in Salisbury, South Australia, approximately 19 kms from the capital city of Adelaide on a 12-hectare site with 12,000 m2 (130,000 sqft) of manufacturing space. The facility has comprehensive manufacturing capabilities that allow for commercial scale solid oral and topical manufacturing and filling of a range of products including pellet products, powders, tablets, capsules, liquids & creams.
The site is approved by major regulatory authorities including FDA, TGA and MHRA.
Mayne Pharma’s GMP-accredited facility has the proven ability to successfully assist clients with formulation development and analysis through to technology transfer and commercial manufacture. Please visit Mayne Contract Services for further information.
Mayne Pharma has comprehensive experience in developing Drug Delivery Systems for oral and topical product filings for the global market; NDAs, 505(b)(2) and ANDAs.
- Over 40 years’ experience successfully developing products for global markets.
- Dedicated product development facility, which meets cGMP standards, and includes pilot scale plant equipment facilitating a scale-up pathway from small pre-clinical and clinical trial batches through to full commercial manufacture.
- Proven ability to develop and transfer manufactured product and technology to other sites around the world.
- Proven ability to develop and transfer oral drug delivery technologies internally and externally.
- Established capabilities in development and commercialisation of granulation, fluid bed coating, spray drying, tableting, encapsulation, liquid & creams processes.
- Full analytical chemistry support for formulation development including UPLC, HPLC, dissolution testing and physical characterization.
Additional information available for Mayne Pharma’s specialty technologies.
Using best practise techniques and procedures, Mayne Pharma’s agile and responsive team offer chemistry support for formulation development including:
- Raw material testing, product characterisation and stability assessment
- Analytical method development, validation and optimisation of complex test procedures
- Bidirectional analytical method transfer
- Testing of commercial scale-up, exhibit, clinical trial manufacture and pivotal stability programs
- Compendial verification and qualification
- Cleaning validation and development
- Transfer of analytical procedures (receiving and sending)
- Preparation of GMP documentation and reports and providing pivotal data sets to support regulatory submissions
Commercial Manufacturing and Technical Services
Mayne Pharma offers extensive contract services for upscaling new formulations into commercial scale production, as well as managing the technology transfer of existing products and line extensions. Our capabilities include:
- Manufacturing – solid, semi-solid, liquid and topical product
- Packaging – solids, semi-solids and liquid products
- Special handling – high potent compounds and controlled substances
- Elemental impurities
- Stability storage and testing
- Raw material testing and release
- Microbiology services
- Distribution and logistics services
- Procurement – packaging and materials
- Product enhancement – reformulation, process development
- Validation – process, cleaning and equipment systems