PCI Synthesis

CGMP Manufacturing of Controlled Substances

In 2016, PCI’s Newburyport facility, which produces bulk active pharmaceutical ingredients, New Chemical Entities (NCE’s) for clinical supply, and other custom manufactured products for the life science industry received its license from the U.S. Drug Enforcement Administration (DEA) to develop and produce controlled substances under Schedules II, III, IV and V. PCI’s is developing a robust pipeline of commercial and early stage products in this area which include analgesics, amphetamines and other classes of compounds which are regulated by the DEA.

As a fully integrated CMO, PCI is uniquely positioned to supply our customers with an entire suite of development, analytical and cGMP manufacturing services for DEA controlled substances. Our development and analytical capabilities insure that when we manufacture under cGMP it is only with robust processes that have the appropriate analytics to release those materials for clinically supply.