Societal CDMO and Civicascript Establish Master Service Agreement for CDMO Services
Friday, June 30, 2023
Societal CDMO, Inc. (NASDAQ: SCTL) has recently entered into a master service agreement (MSA) with CivicaScript, a significant development in the contract development and manufacturing organization (CDMO) sector. Societal CDMO is dedicated to addressing complex formulation and manufacturing challenges, particularly in the realm of small molecule therapeutic development.
The MSA between Societal CDMO and CivicaScript covers an initial project focused on supporting a generic drug candidate as it progresses through the stages of development and registration. The agreement also holds the potential for future collaboration on additional programs by CivicaScript.
As part of the agreement, Societal CDMO will provide various services, including analytic method and technology transfer, formulation development, process development, and non-GMP batch manufacturing. The ultimate goal is to manufacture registration scale batch materials for clinical trials that will be submitted to the U.S. Food and Drug Administration. This encompasses activities such as registration batch bottle packaging, labeling, and distribution of clinical supplies.
David Enloe, CEO of Societal CDMO, expressed excitement about the partnership with CivicaScript. He emphasized the opportunity for Societal CDMO to demonstrate its capabilities in supporting the complete development and registration process of generic medicines. Enloe highlighted the shared commitment between the two companies to positively impact patients' lives and make quality generic medicines more affordable and accessible to a wider population, aligning with Societal CDMO's overarching mission of bridging the gap between science and society.
