PCI Synthesis, a drug substance contract manufacturing organization (CMO) of new chemical entities (NCEs) and generic active pharmaceutical ingredients (APIs), announced that it has obtained registration and certification from the U.S. Drug Enforcement Administration (DEA) to handle Schedule II, III, IV, and V controlled substances.
With DEA registration, the company will be able to work on behalf of clients on projects that are considered controlled substances or the raw materials that are used to produce them. The ability to handle controlled substances is becoming a much needed requirement as the company expands its offerings to the Life Science sector.
“Expanding the type of substances we can work with positions PCI Synthesis to meet the growing demand for new molecules that make use of the medical value of controlled substances,” said Edward S. Price, president of PCI Synthesis. “As a cGMP facility that has DEA certification, we can assure our sponsors that the work we do can take them from discovery all the way through commercialization.”
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.
“DEA certification for these kinds of controlled substances opens a new dimension for PCI Synthesis in terms of the types of projects the company can pursue,” said Jim Bruno at Chemical and Pharmaceutical Solutions, a New Jersey-based consultancy. “Once PCI Synthesis receives the DEA certification, it will be able to do R&D and move those projects into commercial production.”
PCI Synthesis, which provides small and mid-sized companies with the expertise to manufacture complex small molecules to be used as APIs, earlier this year announced that its commercially approved products portfolio now includes nine commercial products that either have or are imminently receiving FDA approval for sale in the U.S. The company has more than 17 API and other advanced materials products in its commercial pipeline.