| Name | Title | Contact Details |
|---|
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.
Diva Pharmaceuticals is a Upper Saddle River, NJ-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Global Napi Pharmaceuticals is a Th October Egypt, NJ-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Global Research Services is a Rockville, MD-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
RotaChrom Technologies is the inventor and first worldwide manufacturer of the Industrial Scale Centrifugal Partition Chromatography (iCPC) platforms. The company revolutionizes the pharmaceutical and cannabis industries by manufacturing and selling unique inventions of a special purifying technology. A cost-efficient and easily adaptable separation solution is offered for active pharmaceutical ingredients (API) and cannabinoids. The cost and the risk profile of R&D, as well as production can be significantly lower by using CPC tools, thereby pharmaceutical and cannabis-based products can become more widely available. Since its establishment, the company has achieved massive international success in pharmaceutical and pharma-graded cannabis purification. It has become an industry-leading company by setting global purification standards in the cannabis industry. RotaChrom’s CPC platforms are quintessential applications when looking for a high-purity and high-capacity, yield-focused solution.