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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.
Mccrone Group Inc is a Westmont, IL-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
CSL is a global biotech leader that develops and delivers life-saving medicines to treat disorders such as haemophilia and primary immune deficiencies, and vaccines to prevent influenza. They have over 30,000 employees worldwide and are committed to co...
Headquartered in Carney's Point, New Jersey, CannaPharmaRx is a pharmaceutical company whose mission is to advance cannabinoid discovery, science, research & development, and to bring novel prescription, veterinary and personal care cannabinoid-based products to market in the U.S. and worldwide.
Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to treat important diseases such as the liver disease NASH and specific cancers, with focus on targeting dysfunctional metabolic pathways. The company has unique expertise in FASN biology and has created a platform of proprietary FASN inhibitors.