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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.
Fruth Pharmacy has been serving Southwestern West Virginia and Southern Ohio Since 1952. We cater to the needs of our customers by providing the best customer service in town. Fruth's pharmacists are on duty 7 days a week and are dedicated to serving
Qserve is your MedTech Partner for Regulatory & Quality Affairs and Clinical Trials. Need regulatory advice, support or training? Contact us.
VIATRIS™ is a new kind of global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce of approximately ~45,000, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.
Capstone Development Services is a shared services development company focused on complex generic pharmaceuticals and medical devices. Capstone leads development, manages regulatory services, and achieves timely approval of healthcare products through ...