About Us

Our Vision

Our vision is to be recognized as the leader in the field of intranasal pharmaceutical drug products development and manufacturing. We intend to accomplish this by applying our unique formulation and manufacturing expertise and by leveraging our state-of-the-art cGMP manufacturing facility and our high-speed nasal products manufacturing and packaging equipment to address a high-growth, niche market.

Our Facilities

Our headquarters and FDA approved manufacturing plant are located in Lexington, Kentucky on the University of Kentucky’s Coldstream Research Campus. Our facility contains a cGMP laboratory, cGMP manufacturing and warehousing areas, offices and utility areas to support commercial manufacturing operations. Our manufacturing facility is dedicated to the formulation, filling, assembly, packaging and testing operations of nasal spray drug products. Our cleanrooms and equipment are designed to enable us to fill aseptically or terminally sterilize our products. The manufacturing facility, associated systems and equipment have been designed to be in full compliance with FDA cGMPs. Security systems and controls in compliance with DEA regulations have been installed, inspected by the DEA and are currently operational.

Our Core Values

Our culture is based on quality, integrity and passion in everything that we do.

  • We strive to provide exceptional customer service to all of our internal and external customers and stakeholders.
     
  • We provide and promote an environment of continuous learning and improvement which will lead to and harness innovation.
     
  • We aspire to lead our industry in the quality of work that we perform and in our compliance with regulations while at the same time finding and applying innovative ways to manage risk in all areas.
     
  • We conduct ourselves with professionalism and integrity and set the standard for others to follow.
     
  • We place high emphasis on creating and nurturing relationships with partners, customers, suppliers, regulators, administrators and the community to successfully grow our business.
     
  • We plan well and establish efficient and flexible methodologies for our work to enable reliable delivery of high quality product.
     


Summit Biosciences Inc.    I   UK Coldstream Research Campus
1513 Bull Lea Rd, Lexington, KY 40511   I   P: 859-254-0180