Societal CDMO Announces U.S. FDA Approval for Manufacturing of Commercial Tablet at Gainesville, Georgia Site
Societal CDMO has received FDA approval to manufacture its first commercial tablet product, expanding its capabilities beyond capsules. This milestone is set to enhance the company’s position in the pharmaceutical manufacturing sector. Expected to commence production at its Gainesville, Georgia facilities later this year, the approval signifies a critical advancement in Societal CDMO's operational capabilities. With extensive experience in small molecule therapeutics, the company aims to address complex manufacturing challenges in a competitive market. This achievement reflects two years of dedicated efforts in technology transfer and regulatory compliance.
- FDA approval for first commercially manufactured tablet product.
- Expansion of manufacturing capabilities beyond capsules.
- Expected production commencement later this year.
- None.
Represents Societal CDMO’s First Commercially Manufactured Tablet Product, Expanding Beyond Expertise in Commercial Capsules
SAN DIEGO, Calif. and GAINESVILLE, Ga., March 20, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO” or “Societal”; 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 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.”
About Societal CDMO
Societal CDMO (NASDAQ: 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.
FAQ
What is the significance of Societal CDMO's FDA approval?
When will Societal CDMO begin commercial manufacturing of the tablet?
What type of products does Societal CDMO focus on?
How does this approval impact Societal CDMO's market position?
