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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.
ABO Pharmaceuticals is a San Diego, CA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Greenwich Biosciences is the leader in researching cannabinoid medicines for rare epilepsies like Dravet Syndrome, LGS, TSC, and others.
TransparentRx is a fiduciary and transparent PBM company that specializes in providing effective solutions for self-funded employer groups, health plans, TPAs, business coalitions and government entities.
SCA Pharma is a leading FDA 503B outsourcing facility delivering the highest quality sterile admixtures and pre-filled syringes to hospitals and health systems nationwide. SCA Pharma prides itself on being the most customer- and patient-focused 503B in the industry. Known for its unwavering quality and high-touch customer service, SCA Pharma is headquartered in Little Rock, AR with a sister facility in Windsor, CT. The Windsor facility boasts more than 90,000 square feet of sterile compounding laboratory and manufacturing space while Little Rock is home to SCA Pharma`s 17,000 square foot sterile compounding facility. Both facilities meet or exceed FDA cGMP manufacturing guidelines. SCA Pharma employs more than 500 people across both facilities, as well as a team of sales representatives across the country.