Our FDA and EMA Certified cGMP Facility

Summit's current facilities will double in size at the conclusion of a major expansion effort in Lexington, KY. They are designed for cGMP production of nasal spray drug products. Summit formulates, fills, assembles, labels and packages unit dose, nasal spray products for preclinical, clinical, or commercial needs. The company has experience with bi-dose and multi-dose applications in preclinical and clinical product candidates. Summit has capacity for commercial production using these platforms.

Contract Manufacturing

Our manufacturing suite boasts the following features:

  • DEA registration for handling of Class II - IV controlled substances
  • Dedicated ISO Class 8 Formulation Room for product compounding
  • ISO Class 8 Filling Room with high-speed, automated filling machine specifically designed for the manufacture of nasal spray products
  • Custom fabricated inspection/assembly machine capable of producing 60 units/minute
  • Blistering and cartoning capability
  • Saturated steam autoclave for the preparation of equipment and terminal sterilization of products
  • USP purified water system

Materials and Supply Chain Management

Our experienced Materials and Supply Chain Management group supports incoming and outgoing supply chain activities including:

  • Establish relationships with high volume device suppliers
  • Negotiate and manage supply chain agreements
  • Source new suppliers to continually improve quality, operational efficiency and reduce cost
  • Manage onsite GMP warehousing
  • DEA and KY Board of Pharmacy and KY Cabinet of Health certified storage and handling of Schedule I-IV Materials
  • 24/7 security with interior and exterior video monitoring
  • Dual temperature storage environments, ambient and controlled (20 °C and 50% humidity) with 24/7 continuous monitoring

Packaging

  • Full capability from vial filling through actuator assembly, labeling, blister packaging and cartoning

Additional Services

  • Compliant with U.S. FDA serialization requirements (full compliance by Q2 2018)