· Over 90% of our chemists hold PhDs
· Experience with a wide variety of difficult chemistry
· Full development capability from grams to hundreds of kilos
· Preclinical to Commercial
· DEA licenses for controlled substance R&D and manufacturing
· Full GMP analytical capability
· ICH stability program
PharmaCore has strong experience performing a variety of chemistry services for leading pharmaceutical and biotechnology companies including: custom organic synthesis; cGMP scale-up; nonGMP and GMP API manufacture; controlled substance R&D and manufacture; chemical process research and development; and analytical services. Headquartered in High Point, NC, the 35,000 square foot facility is fully equipped with 43 bench-top hoods, 18 walk-in hoods, and eight GMP process suites. Full GMP analytical testing and GMP regulatory support are provided for all projects.
PharmaCore's GMP manufacturing facility is designed with maximum versatility with process conditions of -70 to +160°C, glass and Hastelloy, control system monitoring and flexible equipment configurations. Reactors with process volumes from 2000 liters to laboratory scale are ready to supply your clinical API needs.
PharmaCore's GMP analytical laboratories are equipped with the most up-to-date instrumentation to meet your analytical needs, including a fully ICH Q1A-compliant stability program. Our seasoned team of scientists brings a wealth of pharmaceutical industry experience to your project.
Our DEA approved controlled substance licenses allow PharmaCore to perform research and manufacture Schedule 2, 2N, 3, 3N, 4 and 5 compounds. In addition, we have experience in the logistics management of these regulated materials and the regulated facility to support these syntheses.
With increasing dependence of the industry on outsourcing synthetic chemistry, large and small companies alike come to PharmaCore to access our highly trained and experienced chemists for both custom synthesis and R&D projects.
At PharmaCore we strive to add value as we provide preclinical to clinical API R&D and manufacture.