World-class facilities supporting your product from pre-clinical through to Phase II with full service API development and manufacturing
We deliver expert chemistry solutions for pre-clinical and early phase clinical supply from the facility and can cater for volumes from millilitres up to 200-litre batches, ideal for small volume products or products in the early stages of clinical trials.
Our facility features cGMP API manufacturing capabilities and allows us to produce high value, low volume APIs including high barrier to entry compounds that are generally difficult to manufacture. ... Read more
Our well-equipped GLP analytical laboratory offers a range of analytical services from method development to validation, which is used to support our GMP laboratory. The quality control staff on site are highly trained and oversee all release testing and certification to ensure our products meet the highest standards before being released to the US market for export.
Sterling's Cary facility
Opened in 1994
50 employees
27,000sq/ft from 14,000sq/ft
40+ molecules
Approved for schedule I to V controlled substances
- Three GMP synthesis laboratories
- Three R&D laboratories
- cGMP analytical laboratory
- cGMP API manufacturing
- Support documentation for IND/ANDA/NDA filings
- Process development including optimisation of existing processes and identification of new, non-infringing processes
- Handling of controlled substances (Schedule I-V)
- Drug discovery services including new route development, lead optimisation, impurity identification, structure elucidation and stability testing
- Method and assay development, and biomarker analysis and assay
