PCI Synthesis, a Newburyport, Massachusetts-based contract manufacturing organization of active pharmaceutical ingredients (APIs), has obtained registration and certification from the US Drug Enforcement Administration to handle Schedule II, III, IV, and V controlled substances.

With DEA registration, the company will be able to work on projects that are considered controlled substances or the raw materials that are used to produce them. In preparation for these new substances, the company has invested in new systems, processes, and training so that it can manufacture controlled substances in its Newburyport facility. It has also conducted an audit by a third party to ensure PCI Synthesis is in compliance required to earn and maintain its DEA registration.

Earlier this year, PCI Synthesis announced that its products portfolio now includes nine commercial products that either have or are imminently receiving US Food and Drug Administration approval. The company has over 17 APIs and other advanced materials products in its commercial pipeline.

Source: PCI Synthesis