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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.
DeGolers Pharmacies is a Kansas City, KS-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Chemrx is a South Plainfield, NJ-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Diabetes poses one of today`s biggest global health challenges. We work for a future where fewer people get diabetes, everyone with diabetes is diagnosed, and everyone who is diagnosed receives adequate treatment and can live a life with as few limitations as possible. Since the company was founded in Denmark more than 90 years ago, we have been changing diabetes. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done. This page isn`t intended for discussions about products. As such, postings or comments that contain product discussions may be removed. This page is for discussions about Novo Nordisk and its subsidiaries and the initiatives and projects we are involved in. While we welcome everyone to make comments, we reserve the right to remove those that are off-topic, abusive or intended to spam.