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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.
Tiber Laboratories is a Suwanee, GA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Abbott is a global healthcare company that conducts innovative research and manufactures products for human health through every life stage. They bring new products and technologies to the world in nutrition, diagnostics, medical devices and branded ge...
Exeter Group is a New York, NY-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D. Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.