Innovator Embraces Psychedelic Horizons With New Schedule 1 Manufacturing License

A new player is entering the psychedelics production space.

Small molecule therapeutic contract developer Societal CDMO Inc. SCTL has secured a DEA Schedule 1 Controlled Substances manufacturer’s license and is entering the biopharma industry’s psychedelic drugs subsection.

This is actually an expansion of Societal’s drug development capabilities, building on its stated 25 years-experience manufacturing Schedule 2 compounds without committing “any additional capital investment.”

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The company will now offer research and commercial customers high-quality cGMP clinical psychedelic supplies.

“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,” stated senior VP and CSO Dr. Richard Sidwell. “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.”

Societal is “well aligned” to partner and support the clinical programs of the numerous companies advancing R&D on psychedelic compounds, and assured the team is already in “encouraging” talks with drug developers working in the field, Sidwell says.

Societal works as a bi-coastal contract development and manufacturing organization (CDMO). Its capabilities spanning from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. 

The company’s primary focus is in the area of small molecules, but it holds an overall expertise in solving complex manufacturing problems. 

Its services reportedly include therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharma market.

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Photo: Benzinga edit with photo by Olia Danilevich on Pexels.