Scope of Work Spans Full Range of Services including Analytical Method Transfer, Formulation Development, Process Development, and Clinical Trial Material Batch Manufacturing
SAN DIEGO and GAINESVILLE, Ga., June 29, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced the signing of a master service agreement (MSA) with CivicaScript. This agreement covers an initial project supporting a generic drug candidate that is moving through development and registration efforts, with the potential to expand to include support of additional CivicaScript programs.
Under terms of the agreement, Societal CDMO will execute a range of services including analytic method and tech transfer, formulation development, process development, and non-GMP batch manufacturing. The work will then culminate in registration scale batch manufacturing to produce clinical trial materials intended for registration with the U.S. Food and Drug Administration. This will include registration batch bottle packaging, labeling, and clinical supply distribution.
“The work that we will conduct under this MSA with CivicaScript provides an excellent opportunity for Societal CDMO to showcase our team’s ability to support the full range of activities required for the development and registration of a generic medicine. We are excited to team up with CivicaScript on this project as we share the company’s commitment to making an impact on the lives of patients. Their dedication to making quality generic medicines affordable and available to everyone fits well with our mission of bringing science to society,” said David Enloe, chief executive officer of Societal CDMO.
About Societal CDMO
Societal CDMO ( SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit societalcdmo.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, the Company’s expectations regarding the completion of the proposed public offering, the Company’s use of proceeds from the proposed offering, and other statements. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.
Contacts: Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 [email protected] [email protected] Tim Brons (Media) Vida Strategic Partners 415-675-7402 [email protected] Ryan D. Lake (CFO) Societal CDMO 770-531-8365 [email protected]
