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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.
We are a specialty pharmaceutical company developing transformative therapies to advance the treatment of gastrointestinal (GI) disorders. We focus on developing treatments for GI disorders for which meaningful therapeutic innovation is required to satisfy unmet patient need and disease burden. Our management team and board of directors are comprised of professionals with extensive backgrounds in drug research and development, commercialization, finance and business development for leading global pharmaceutical companies and growth-stage biopharmaceutical companies. Our scientific advisory board consists of well-known gastroenterologists and clinical thought leaders. Today, our pipeline consists of two unique clinical stage therapies with the potential to bring benefit to millions of patients with chronic and debilitating GI disorders that are not adequately controlled.
CPEX Pharmaceuticals is a Exeter, NH-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Moog Medical designs reliable and easy-to-use CURLIN infusion and Infinity enteral feeding pumps that allow our patients to live life more fully.
Biosynexus understands that bringing a new pharmaceutical product to market is a complicated process that involves not only having strong research and development capabilities, but also having deep clinical development, manufacturing and marketing