Sancilio & Company, Inc., has complete development capabilities for soft gelatin capsules, hard gelatin capsules, tablets and oral non-sterile liquids. As one of a few developers and manufacturers of soft gelatin products there are a myriad of development opportunities available to us. Although we have our own core research projects, we also partner with other biopharma companies to help them develop line extensions, generic products or novel formulations of existing products. We welcome the opportunity to co-develop products on a shared-risk basis with qualified teams.
Currently, we have partnered with several major companies to provide product development and manufacturing support for Abbreviated New Drug Applications (ANDA’s). Several ANDA products are awaiting approval from the Food and Drug Administration (FDA) and several more are in development. We also partner with branded pharmaceutical companies to develop 505(b)2 NDA products and have five such products at various stages of development including late Phase III programs. SCI is one of the only soft gelatin manufacturers that can formulate, provide regulatory support, scale-up and package clinical trial materials as well as commercial products. We also have full distribution capabilities that are provided through our in-house 3PL network.