Societal CDMO, Inc. (NASDAQ: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that the United States Food and Drug Administration (FDA) has approved the company as a manufacturer of a commercial tablet product. Societal CDMO expects to begin commercial manufacturing of the product at its Gainesville, Georgia facilities later this year.
“This FDA approval, which represents the first commercial tablet that Societal CDMO has been approved to manufacture, is a tremendous achievement for our company and speaks to the great strides we have made in our evolution into a leading CDMO trusted by customers around the world,” said David Smithwick, Societal CDMO’s vice president of operations and site head in Gainesville, Georgia.
“I’d like to personally express my gratitude and admiration to all of the members of the Societal CDMO team who have worked tirelessly on this project over the past two years, helping to successfully complete technology transfer and secure FDA manufacturing approval.”
Societal CDMO 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.
CDMO shares gained two cents, or 1.9%, to $1.07.
