Cingulate, societal CDMO enters manufacturing pact for ADHD drug

Cingulate Inc.a biopharmaceutical company using its Precision Timed Release™ (PTR™) drug delivery platform technology to create and advance a pipeline of next-generation pharmaceuticals, has signed a Master Services Agreement (MSA) with Societal CDMOInc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges, primarily in the therapeutic development of small molecules.

With capabilities ranging from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging of a wide range of therapeutic dosage forms, Societal CDMO will manufacture all clinical, registration and commercial batches of lead candidate CTx-1301 of Cingulate, an experimental drug for the treatment of attention deficit/hyperactivity disorder (ADHD). Societal CDMO will dedicate a dedicated manufacturing suite within its Gainesville, GA facility and outfit it with proprietary equipment provided by Cingulate.

“Choosing the right manufacturing partner is critical to the success of any pharmaceutical business, and we are excited to have the opportunity to work with an organization that has the capability and operational expertise to deliver quality manufacturing at every scale. “said Cingulate Chairman & CEO Shane J. Schaffer. “As Cingulate continues to advance its mission to bring next-generation medicines to patients where standard treatments fail to deliver optimal results, we believe Societal CDMO is the right partner at the right time.”

“The work we will be conducting on this MSA with Cingulate provides an excellent opportunity for Societal CDMO to showcase our team’s extensive expertise in formulating and manufacturing complex therapies to help deliver innovative medicines to patients. in need. In fact, the innovative nature of Cingulate’s PTR technology platform requires us to install specialized manufacturing equipment provided by Cingulate in a dedicated suite within our facilities, demonstrating Societal CDMO’s ability to customize solutions to the unique needs of our individual clients,” said David Enloe, Managing Director of Societal CDMO. “We are delighted that Cingulate has trusted Societal CDMO to carry out these essential activities to support CTx-1301 at such a critical time in its clinical development and commercialization.


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