Societal CDMO Inc (SCTL)

Overview

Societal CDMO, Inc., previously known as Recro Pharma, Inc., is a recognized contract development and manufacturing organization (CDMO) that focuses on the creation, production, and packaging of various therapeutic dosage forms, predominantly for small molecules. The corporation offers its extensive services both within the United States and on an international scale. Having undergone a name change in March 2022, Societal CDMO, Inc. traces its origins back to 2007 and has its headquarters situated in Exton, Pennsylvania. The company's expertise in navigating regulatory requirements, alongside their comprehensive end-to-end service offerings, positions them as a key partner in the pharmaceutical industry, from the early stages of drug development to final product release.

Products and Services

• Formulation Development: Focuses on complex formulations, reformulation, physical characterization, and excipient compatibility. This service aims to address the challenges of drug formulation, ensuring that medications are developed for optimal delivery and efficacy.
• Analytical Methods Development: Offers a broad spectrum of analytical testing capabilities which include product testing, ICH stability, method development and validation, equipped with advanced chromatography and spectroscopy equipment, stability chambers, and resources for microbial testing. These analytical services are crucial for ensuring drug safety and efficacy throughout the development process.
• Pharmaceutical Manufacturing: Provides an extensive range of manufacturing processes such as milling, blending, compression, spray and rotary granulation, particle and bead coating, encapsulation, liquids, lyophilization, and sterile fill and finish services. This comprehensive manufacturing capability allows for the production of pharmaceuticals across a variety of dosage forms, meeting stringent quality standards.
• Regulatory Support: Includes handling communications with the Food and Drug Administration (FDA) and seeking consultation and guidance for client FDA meetings and responses. This support is vital for navigating the complex regulatory landscape, ensuring compliance and facilitating market entry.
• Pharmaceutical Packaging and Logistics: Offers smaller-scale primary and secondary packaging, labeling, and kitting options suited for clinical trial materials and development packaging needs across dosage forms. Efficient packaging and logistics are essential for the safe and effective distribution of pharmaceuticals.