Mayne Pharma has more than 30 years of specialist manufacturing experience and has produced many prescription and pharmacy medications that have been successfully sold in markets around the world.
With established GMP accredited manufacturing facilities as certified by chief regulatory authorities (including the FDA, TGA, MHRA, TPD and various other European and Asian regulatory bodies), the company's sites are licensed to handle CII/S8 compounds (controlled drug substances) as well as use of chlorinated solvents and alcohols in the manufacturing process.
Mayne Pharma has the capacity to provide a seamless manufacture scale up pathway from formulation and clinical trial stage, (including pilot scale studies), right through to commercial scale manufacture of packaged goods ready to be dispensed.
Clients enjoy flexibility and choice due to Mayne Pharma's ability to manufacture, fill and package finished products, in a variety of formats, on site ready for shipment, as well as ship bulk manufactured product to external filling and packaging locations in line with regulatory requirements and client preference.
Contract Manufacturing Equipment
- Fluid bed granulators
- Fluid beds
- Hammer mills
- High shear mixers
- Rotor coaters
- Spray dryers
- Tablet coaters
- Tablet presses
- Wurster coaters
Mayne Pharma’s on-site commercial manufacturing capabilities include the following processes:
- Blending of powder
- Fluid Bed Coating and Drying
- High Shear and Fluid Bed Granulation
- High shear granulation mixing
- Liquid and Cream Manufacturing and Packaging
- Manufacture of product for clinical assessment
- Packaging into Bottles (HDPE & Glass), Blisters and Cartons
- Pellet and Powder Coating
- Rotor Coating and Granulation
- Spray Drying
- Tablet Coating
- Wurster Coating (type of fluid bed coating)
These processes allow Mayne Pharma to produce pharmaceuticals in a variety of finished product formats, including:
- Capsules (pellets & powders)
- Creams (non-sterile)
- Liquids (non- sterile)
- Microencapsulated powders
- Microencapsulated pellets
- Modified release pellets in tablets
For further information, please visit Metrics Contract Services equipment lists.