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 100-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.
Our well-equipped GLP analytical laboratory offers medicinal chemistry and custom synthesis capabilities, 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.
Our facilities at this site include:
- 2 GMP synthesis laboratories
- 3 R&D laboratories
- cGMP analytical laboratory
Services offered from our US facility include:
- 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 II-IV)
- Drug discovery services including new route development, lead optimisation
Sterling Pharma USA, LLC
1001 Sheldon Drive, Suite 101
US telephone: (919) 678 0702