Pharmaceutical drug product development, analytical testing and CTM manufacturing all under one roof.
The US location currently occupies a state-of-the-art, fully qualified cGMP facility totaling nearly 8,650 m2 (93,000 sq ft). Located in Greenville, North Carolina, near the Research Triangle Park, a growing hub for pharmaceutical research activities in the US.
Today, our development and manufacturing space offers the following benefits:
- A dedicated and segregated potent and cytotoxic facility
- DEA-approved for Schedule II-V controlled substances
- Stability studies, methods development and validation, raw materials, trace metals and microbiology laboratories
- Drug product development and clinical trial manufacturing area
- Manufacturing and packaging area for Phase III clinical trial materials and commercial manufacturing
US Facility expansion and renovation will deliver a 'Concept to Commercialization' solution for clients.
Mayne Pharma is investing $65 million to expand facilities and equipment at their site in Greenville, N.C.
The $65 million strategic investment will fund:
- A new 11,700 m2 (126,000-sq-ft), large-scale oral-dose commercial manufacturing facility
- Expansion of contract analytical laboratory, formulation development and services capacity
- A new visitor and staff administrative center
This means we can offer clients a comprehensive concept-to-commercialization solution in a single, contiguous site.
Other benefits of the expanded and improved facilities include:
- Increased capacity in formulation development and analytical services
- Engineered solutions to mitigate cross-contamination risks and support the handling of highly potent compounds
- Expanded modified release platform
- Planned solvent-capable fluid bed processing and film coating
- Designed to serve international markets