Since 2000, PharmaCore has performed a variety of chemistry services for leading pharmaceutical and biotechnology companies including: custom organic synthesis; cGMP scale-up; nonGMP and GMP API manufacture; ; chemical process research and development; analytical services and controlled substance R&D and manufacture. Now with the recent issuance of state and federal permits to manufacture controlled substances in schedules 2-5 PharmaCore’s capabilities are further enhanced.
Rob Maddox, President of PharmaCore explains “Previously PharmaCore was able to perform Schedules 2-3 research for our clients. This Schedule II quota allows for the manufacture of Schedule 2 and 2N, to complement our existing 3, 3N 4 and 5 compound licenses. The involved process to be granted this license included adding a walk-in secured vault, 24/7 camera monitoring and high security badge access.” Mr. Maddox adds “At PharmaCore, we have experience in the logistics management of these regulated materials under licenses that now include Analytical, Research and Manufacturing.”
PharmaCore is 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. Most GMP analytical testing and GMP regulatory support are provided on-site. PharmaCore's GMP manufacturing facility is designed with maximum versatility with process conditions of -70 to 160+°, glass and Hastelloy, computer monitoring and flexible equipment configurations. Reactors have process volumes from 2000 liters to laboratory scale. PharmaCore's GMP analytical laboratories are equipped with the most up-to-date instrumentation to serve your analytical needs, including ICH Q1A-compliant stability chambers. Our seasoned team of scientists brings a wealth of pharmaceutical industry experience to your project.