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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.
Hi-Tech Pharmacal Co Inc is a Amityville, NY-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Gate Pharmaceuticals is a North Wales, PA-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Bioray Pharma is a Omaha, NE-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Pliant Therapeutics is focused on discovering, developing and commercializing breakthrough treatments for fibrotic diseases. By harnessing the therapeutic potential of integrin biology and TGF-β modulation, Pliant aims to prevent or even reverse fibrosis to address the needs of many patients. The company also aims to build a patient registry for certain areas of fibrotic disease to both increase understanding of natural disease progression, and fuel biomarker discovery. Pliant`s co-founders include world-renowned researchers from University of California, San Francisco (UCSF), who bring broad experience in fibrosis biology and small molecule chemistry. Together, the Pliant team is dedicated to translating scientific advances in fibrosis biology into novel therapies for patients in need.