Societal CDMO Inc., a contract development and manufacturing organization (CDMO), has signed multiple CDMO service agreements with both new and existing customers. The new contracts are focused on a range of analytic method, tech transfer, formulation, manufacturing and packaging services designed to support ongoing clinical development programs, as well as planned commercial activities.
 
The first contract is focused on supporting a new Societal CDMO customer’s preparations for development and commercial manufacturing of its novel attention-deficit/hyperactivity disorder (ADHD) treatment upon regulatory approval. The product uses a unique delivery system combining immediate release and sustained release formulations of the active ingredient in a single, oral tablet. Under terms of the contract, Societal CDMO will conduct tech transfer, manufacturing of engineering and registration batches, and packaging of the final product. Due to the complex formulation and manufacturing requirements for this product, Societal CDMO will dedicate a specific manufacturing suite within its Gainesville, Georgia, facility and outfit it with customer-supplied proprietary equipment.
 
As part of the second new agreement, Societal CDMO will conduct a range of activities supporting a new customer’s ongoing development of multiple novel topical therapies for inflammatory dermatological and neuropathic pain conditions. The services provided by Societal CDMO will include analytic development, manufacturing, filling, packaging/repackaging and labeling of clinical trial material, both active and placebo, for use in planned clinical studies. This work will span three different development programs for three unique topical therapies.
 
“These latest contract wins further drive the impressive increase in new business backlog we are generating for the company. The efforts of the business development group, working side by side with the entire Societal CDMO team, are helping the company to continue to significantly diversify its customer base, which allows us to play an ever-expanding role in bringing important medicines to patients,” said David Enloe, chief executive officer of Societal CDMO. “While new customer wins are key to our business development strategy, we are also focused on growing revenue by expanding the scope of work with our current customers. This is exemplified by our newly signed agreements, which include a contract to provide additional tech transfer work for one of our existing clients for whom we are already conducting a tech transfer of a different product within their portfolio.”