Societal CDMO, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges, expanded its suite of CDMO services to address the biopharmaceutical industry’s expanding activity in the area of psychedelic drug development. This expansion of capabilities will support the growing number of ongoing and planned clinical trials in this area.
 
Societal has completed key regulatory requirements for this work and can support customers with the manufacture of high-quality cGMP clinical supplies. The company received U.S. Drug Enforcement Agency (DEA) approval to add certain Schedule 1 psychedelic compounds to their controlled substance manufacturing registration, expanding its Schedule 2 manufacturing registration with the DEA. Societal is able to expand its capabilities into the psychedelic drug development market without committing any additional capital investment.
 
“With a long track record of successfully manufacturing controlled substances for a number of biopharmaceutical companies, the Societal team has amassed deep expertise in seamlessly and effectively navigating this strictly regulated segment of the drug development space. In doing so, we have built strong credibility with the DEA, which we believe allowed for an efficient path to add Schedule 1 substances to our manufacturing registration,” said Richard Sidwell, Ph.D., senior vice president and chief scientific officer. “As more and more companies are focusing research and development efforts on the therapeutic potential of psychedelic compounds, we are aligned well to partner with those groups to support their clinical development programs.”