The full package
Outstanding facilities, watertight quality systems and a peerless regulatory track record (90% of scheduled Pre-Approval Inspections waived) combine to make our Finished Dosage business a true value-based solution. Whether it’s sterile or solid dosage forms or specialist filling, we accelerate the speed-to-market for our customers while mitigating risk.
Our holistic approach also takes in pharmaceutical development services (in particular Tech Transfer) and regulatory support and includes everything from blending, granulation, encapsulation and compression to printing embossing, banding and packaging – as well as aseptic liquid filling lines with unique proprietary technology.
Solid dosage forms
We’re a leader in dosage form manufacturing of tablets and capsules with almost four decades of experience covering the production of instant and sustained-release, and scheduled and non-scheduled drugs.
Our facility in Greenville, North Carolina has a capacity of 200,000 square feet dedicated to solid dosage form manufacturing at both clinical and commercial stages, supported by an outstanding regulatory record and intimate knowledge of what the FDA and other regulators expect.
We cover everything from blending, granulation, compression, encapsulation, coating, drying and formulation to packaging (blister and bottle), printing, embossing and banding – with the guaranteed security of supply you would expect from a multi-billion dollar global company.
Sterile Dosage Forms
Our expertise in sterile dosage forms covers aseptic liquid filling, cytotoxic formulation and filling, and lyophilization.
In aseptic liquid filling we offer a highly efficient distributed control solution called LiquidAdvantage™. Used on all filling lines operating under aseptic production methods, it controls SCADA, D3 and electronic cycle run report functions in a single, unified solution that is extremely sterile with minimal human contact.
We also offer precision lyophilization services for both chemical and biopharmaceutical products in the form of our LYOADVANTAGE™ solution, which can efficiently scale up from an eight-square foot, non-cGMP unit to any commercial unit (up to 640 square feet).
Meanwhile in cycocoxic formulation and filling we offer a flexible solution in aseptic liquid filling and lyophilization which includes variable batch sizes, options for expanded development and analytical services, and adaptable scheduling.
Services
We support you with a broad range of Pharmaceutical Development Services for dosage form drugs through a dedicated scientific team that works to reduce costs and time to market.
These services including analytical development studies and validation, drug substance characterization, reformulation studies and formulation development – as well as ICH/custom stability studies and the continual evaluation of new delivery technologies.
In packaging, we help you with everything from CAD engineering and graphic design to materials selection and testing – for both primary and secondary packaging and always of course conducted to pharmacopoeia regulations.