Our manufacturing suite boasts the following features:
- DEA registration for the handling of Class II-IV controlled substances
- Dedicated ISO Class 8 Formulation Room for product compounding
- ISO Class 8 Filling Room with high-speed, an 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