Popis
Societal CDMO, Inc., a contract development and manufacturing organization, engages in the research and development, manufacturing, and packaging for various therapeutic dosage forms primarily in the small molecules in the United States and internationally. The company provides end-to-end services, such as formulation development focusing on complex formulations, reformulation, physical characterization, and excipient compatibility; analytical methods development which offers a range of analytical testing capabilities, including product testing, ICH stability, method development and validation, chromatography and spectroscopy equipment, stability chambers, and microbial testing; and pharmaceutical manufacturing that provides milling, blending, compression, spray and rotary granulation, particle and bead coating, encapsulation, liquids, lyophilization, and sterile fill and finish services. It also offers regulatory support, including handling communications with the food and drug administration (FDA) and seek consultation and guidance for client FDA meetings and responses; and pharmaceutical packaging and logistics, as well as smaller-scale primary and secondary packaging, labeling and kitting options suited for clinical trial materials and development packaging needs across dosage forms. The company was formerly known as Recro Pharma, Inc. and changed its name to Societal CDMO, Inc. in March 2022. Societal CDMO, Inc. was incorporated in 2007 and is based in Exton, Pennsylvania.