Cingulate Inc., a biopharmaceutical company utilizing its Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, has executed a Master Services Agreement (MSA) with Societal CDMO, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development.
 
With capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms, Societal CDMO will manufacture all clinical, registration, and commercial batches of Cingulate’s lead candidate CTx-1301, an investigational medication for the treatment of Attention Deficit / Hyperactivity Disorder (ADHD). Societal CDMO will dedicate a specific manufacturing suite within its Gainesville, GA facility and outfit it with proprietary equipment supplied by Cingulate. 
 
“Choosing the right manufacturing partner is critical to the success of any pharmaceutical company, and we are excited for the opportunity to work with an organization which has the capacity and operational expertise to provide quality manufacturing at each and every scale,” said Cingulate Chairman & CEO Shane J. Schaffer. “As Cingulate continues to advance its mission to bring next-generation medications to patients where standard of care treatments fail to achieve optimal outcomes, we believe that Societal CDMO is the right partner at the right time.”
 
“The work that we will conduct under this MSA with Cingulate provides an excellent opportunity for Societal CDMO to showcase our team’s extensive expertise in formulating and manufacturing complex therapeutics to assist in the delivery of innovative drugs to the patients that need them. In fact, the innovative nature of Cingulate’s PTR technology platform dictates that we install specialty manufacturing equipment provided by Cingulate into a dedicated suite within our facility, demonstrating Societal CDMO’s ability to customize solutions for the unique needs of our individual customers,” said David Enloe, chief executive officer of Societal CDMO. “We are pleased that Cingulate has trusted Societal CDMO to carry out these essential activities to support CTx-1301 at such a critical juncture on its path through clinical development and toward commercialization.”