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 sq ft) 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 and liquids & creams.
The site has annual production capacity:
- Approximately 3.0 billion capsules and tablets
- 100 metric tons of bulk product
- 16 million units of liquids and creams
The site is approved by major regulatory authorities including FDA: United States and TGA: Australia and through TGA mutual recognition agreements approved by the MHRA: UK, TPD: Canada and 23 other European and Asian authorities.
Mayne Pharma has comprehensive experience in the solid oral Drug Delivery System (DDS) market, encompassing development and manufacture of these products.
- Over 30 years experience in successfully developing DDS products for the global market.
- Has a dedicated Product Development facility, which meets cGMP standards, and includes pilot scale plant equipment. This allows a scale-up pathway from small pre-clinical, clinical trial batches through to full commercial manufacture.
- Proven ability to develop and successfully transfer manufactured product and technology to other sites around the world.
- Formulation assistance to help with product lifecycle management.
- Proven ability to develop and successfully transfer oral drug delivery technologies to our own manufacturing sites and the sites of development partners.
- Established capabilities in development and commercialization 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
The pharmaceutical development and manufacturing GMP facility comprises two main service departments:
- Contract services: providing product development and contract manufacturing capabilities
- Clinical trial services: providing clinical trial supply
Key Services Include
- Analytical support
- Formulation and process optimization
- Logistics (Distribution)
- Packaging Service
- Project management
- Quality Assurance
- Regulatory support for contract manufacturing
- Stability Services
- Validation Services
Commercial Scale Manufacturing Capacity
|Machine||Mode of operation||Batch size|
|Pellet Products||WSG-200 Fluid bed||Top spray coating||400kg|
|WSG-200 Fluid bed||Rotor coating (GRG - 100)||175kg|
|18" Wurster coating||50kg|
|WST-60 Fluid bed||Core drying||120kg|
|Microcapsule (CleanstateTM)||Spray drying - N4.5m3||Semi-Continuous|
|Liquids & Cream||Koruma Cream plant||Cream manufacturing||350kg|
|2 Metric Ton Cream plant||1,800kg|
|Liquid mixing vessels||Stirred||2x6000L|
|Stirred, temp & vacuum||4,500L|
Commercial Scale Filling Capacity
|IMA C62||Blister packaging||29|
|Liquids & Cream||IWKA