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Australian Facilities

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.

Australian Facilities

Pharmaceutical Development

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

Specialty Services

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)
  • Manufacturing
  • 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
  32"Wurster coating 200kg
  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
  Stirred 850L

Commercial Scale Filling Capacity

  Machine Process operation Capacity/annum
(millions units)
Pellet Products MG-37
MG-60
MG-Futura
Pellet encapsulation 1,000
MG-37
MG Compact
Powder encapsulation 680
Kilian TX32
Kilian S250
Tableting 1,330
IMA C62 Blister packaging 29
Liquids & Cream IWKA
Comadis line
Creams filling 8
Assett line
B&S line
Liquids/capsules/tablet filling 8