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Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.
Strategic Behavioral Health is a national mental health facility offering inpatient & outpatient treatment programs. We help families put their lives back together.
Avadim Health is a life sciences company that offers advanced, safe solutions in everything from immune health to neuromuscular care. They are committed to helping those in need benefit from their products and have a strong pipeline across a broad rang...
Schmidt and Sons Pharmacy Inc is a Tecumseh, MI-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Kyowa Kirin North America is a fully integrated specialty pharmaceutical company, where people work together to understand clinical needs and opportunities for innovation that can result in real advances for patients. Since 2018, the North American organization has received approval from the US Food and Drug Administration (FDA) to market 3 first-in-class medicines – achievements we share with the scientific, medical, and advocacy communities who contributed greatly to the success of these programs.